ERMA New Zealand Evaluation and Review Report

Application for approval to field test in containment any genetically modified organism

Application code: GMF06002

To field test over 10 consecutive years, the vegetable species , and with genetically modified agronomic and quality traits in order to assess their performance in the field and investigate the environmental impacts of these

Table of contents

1 Introduction ...... 7 2 Information Review ...... 11 3 Risk management context ...... 13 4 Organism identification, description and characterisation...... 17 5 Containment of the organism ...... 46 6 Assessment of the ability of the organism to establish a self-sustaining population ...... 80 7 Identification of potentially significant adverse effects and beneficial effects (risks, costs and benefits) ...... 83 8 Assessment of potentially significant adverse and beneficial effects ...... 117 9 Evaluation of additional matters ...... 127 10 Monitoring of effects ...... 131 11 Previous similar applications ...... 133 12 Associated approvals ...... 135 13 International obligations ...... 136 14 Overall evaluation ...... 137 References ...... 139 Glossary ...... 152 Appendix 1: Proposed containment controls for GMF06002 ...... 158 Appendix 2: Decision pathway ...... 166 Appendix 3: Qualitative descriptors for risk/benefit assessment ...... 178 Appendix 4: Government Departments and other agencies notified of application ...... 183 Appendix 5a: Submitters who indicated that they wished to be heard (alphabetically by surname) ...... 185 Appendix 5b: Submitters who indicated that they did not wish to be heard (alphabetically by surname) ...... 187 Appendix 6: Summary of Public Submissions ...... 191 Appendix 7: Comments from Ministry of Agriculture and Forestry Biosecurity New Zealand (received 23 May 2008) ...... 211 Appendix 8: Comments from Department of Conservation (received 1 May 2008) ...... 214 Appendix 9: Brainstorming...... 217 Appendix 10: Summary of consultation ...... 219 Appendix 11: Details of onion experts used in this report...... 221

Evaluation and Review Report for GMF06002 page 2 of 221 Executive summary

The New Zealand Institute for Crop and Food Research Limited (Crop and Food Research) has applied to the Environmental Risk Management Authority (the Authority) to field test in containment genetically modified onion, spring onion, leek and garlic. The Agency (who carries out activities in support of the Authority) has written this Evaluation and Review (E&R) report which is an analysis of information from the field test application, from submissions and additional information sourced by the Agency. This E&R report is not a decision from the Authority but is a source of advice to the Authority.

The Authority will also evaluate information from public submissions and from the presentations of Crop and Food Research and submitters during the public hearing for this application. The Authority will make its decision following this public hearing.

Background to the application

Crop and Food Research is seeking approval to field test in containment onion, spring onion, leek and garlic that would be genetically modified to show: herbicide tolerance; resistance to pathogenic fungi, bacteria or viruses of ; resistance to insect pests of alliums; chemically-induced flowering; altered pungency, health and flavour; altered sweetness; and altered colour.

Crop and Food Research wish to field test genetically modified (GM) alliums to assess their performance in the field and investigate some environmental impacts of these plants.

It is proposed that this field test would take place within a Ministry of Agriculture and Forestry (MAF)-approved field containment facility in the Lincoln region over a period of ten years. At any one time a maximum 2.5 hectare area would be planted in GM alliums.

As part of this field test, Crop and Food Research wish to GM onion seed directly in the field and be allowed to let some plants flower within pollination cages using insects as pollinators. Crop and Food Research has requested that the resulting GM seeds be allowed to mature in the pollination cages and the seeds harvested before seed dispersal can occur.

Evaluation and Review Report for GMF06002 page 3 of 221 The risks, costs and benefits to New Zealand

The Authority will make its decision on whether to approve or decline the application based on weighing up of the beneficial and adverse effects of having the organisms in containment. This E&R report contains the Agency‟s identification and assessment of the beneficial (benefits) and adverse effects (risk and costs) of the organisms. For this assessment, the project team has taken into account the proposed containment system.

The Agency notes that this application is novel due to the request to allow flowering of GM onion plants within the field containment facility. The project investigated what risks would be associated with GM onion and considered that insect- dispersed pollen (rather than wind-dispersed pollen) is a potential pathway of escape, and so proposed controls that would prevent insects carrying pollen from escaping from the pollination cages (Appendix 1) including: That pollination cages would be inspected and endorsed by the MAF Inspector at the beginning of each planting season. That no insects capable of carrying pollen would be able to move through the mesh covering the pollination cages. That the pollination cages would be placed over flowering plants at least two weeks before the flowers open. That the pollination cages would be fixed to the ground so that they could not be dislodged. That the pollinating insects would be introduced in a manner so that insects could not escape. That the pollination cages would not be opened when live insects would be present.

The Agency considers that, should this application be approved, the proposed field test would pose a negligible risk on the environment, human health and safety, the relationship of Māori to the environment, society and the community and the market economy (sections 7 and 8 of this report).

The Agency considers that, based on the information currently available, there would be significant benefits to be derived from the proposed field test. These include enhancing New Zealand‟s ability to preserve options and maintain choices, increased scientific knowledge and the demonstration of the capacity to conduct field tests in New Zealand (section 8 of this report).

Other proposed controls (should this application be approved by the Authority)

Should the Authority approve this application, the Agency has evaluated the biological characteristics of onion, spring onion, leek and garlic, looked at the ways that the plants might escape from the containment system proposed by Crop and Food Research (pathways of escape) and then proposed a number of controls (sections 4, 5, 6 and Appendix 1 of this report).

Evaluation and Review Report for GMF06002 page 4 of 221 Controls are the requirements that Crop and Food Research must comply with should this application be approved. MAF Inspectors act as authorised agents of the Authority to ensure that all the controls would be complied with.

Should the application be approved, the controls proposed by the Agency (Appendix 1) include: Controls that would ensure that the field containment facility is secure. Controls that would ensure that GM onion seed could not escape the field containment facility during planting. Controls that would ensure that all GM allium material would be disposed of appropriately. Controls that would ensure that the field containment facility would be monitored so that no flowering of GM alliums would occur outside of pollination cages. Controls that state when the MAF Inspector would inspect the field containment facility.

The Agency considers that, should this application be approved ,with the proposed controls in place, the escape of GM alliums, or GM allium heritable material or genetic elements from the field containment facility would almost certainly not occur but cannot totally be ruled out (ie, be highly improbable).

Evaluation and Review Report for GMF06002 page 5 of 221 Key considerations 1. This is an application to field test in containment onion, spring onion, leek and garlic that have been genetically modified (GM). The plants would be genetically modified for specific agronomic and quality traits.

2. The purpose of the field test is to assess the agronomic performance of the plants within a contained field test facility near Lincoln. If approved, the field testing will be for a ten year period and at any one time will not be greater than 2.5 hectares.

3. The applicant wishes to plant seed, seedlings and within the field containment facility.

4. The project team proposes that, should this application be approved, in all but specific cases, flowering will not be allowed. The project team proposes that plants that begin to show signs of flower production, ie bolting, will either: have the developing flower head or the entire plant killed on-site; or the developing flower head or the entire plant will be securely transported back to the glasshouse or laboratory (PC2 containment facilities) for further research analysis or disposal. 5. The project team proposes that, should this application be approved, limited flowering will be allowed to occur in insect-proof pollination cages within the field containment facility. When seeds are mature, but before they are shed from the seed heads, the entire seed heads would be removed from the plant and securely transported to the laboratory or glasshouse (PC2 containment facilities) for further research. 6. A range of controls have been proposed by the project team to contain the GM alliums or heritable material from the GM alliums within the field test containment facility should this application be approved. These include controls on the pollination procedure, monitoring for flowering of GM alliums outside of pollination cages and the planting of onion seed.

Evaluation and Review Report for GMF06002 page 6 of 221 1 Introduction

1.1 The Environmental Risk Management Authority 1.1.1 The Environmental Risk Management Authority New Zealand (ERMA New Zealand) comprises of the Authority (a quasi-judicial decision-making body), the Agency (the support organisation for the Authority) and Ngā Kaihautū Tikanga Taiao (NKTT) (a committee to advise the Authority on Māori issues). The Agency provides administrative support to the Authority which includes advising applicants and evaluating and reviewing applications to assist the Authority.

1.2 The Evaluation and Review Report (E&R report)

1.2.1 This E&R report is written by the Agency and is a source of information that the Authority may use during the decision-making process. The aim of the E&R report is to assist and support decision-making by the Authority. This document represents one source of advice to the Authority; information from submissions and other sources is also evaluated by the Authority during their consideration of this application.

1.2.2 This E&R report consolidates the information provided by the applicant and obtained from other sources, including public submissions, into a format and sequence that is consistent with the decision-making requirements of the Hazardous Substances and New Organisms Act 1996 (the Act) and of the HSNO (Methodology) Order 1998 (the Methodology). This information has been evaluated to provide an opinion on its quality and credibility and to identify key issues associated with this application. The structure of this report follows the order the Authority will consider this application as dictated in the decision pathway in Appendix 2. Unless otherwise stated, “sections” or “Appendix” refer to sections or the Appendices of this report.

1.3 Field test applications

1.3.1 This is an application to field test new organisms. Section 2 of the Act defines a field test as “trials on the effects of the organism under conditions similar to those of the environment into which the organism is likely to be released, but from which the organisms, or any heritable material arising from it, could be retrieved or destroyed at the end of the trials”.

1.3.2 A field test must be a contained activity, and measures must be put in place to prevent the spread or escape of the organism or heritable material from the organism into the wider environment beyond the site of the field test.

1.3.3 The Agency‟s evaluation and assessment of this application is limited to the field test itself. Any adverse or beneficial effects that are related to a potential future release of a genetically modified organism (GMO) into the environment are beyond the scope of this application, and thus beyond the scope of the analysis in this report. Such effects would be assessed under any future application for release of a GMO.

Evaluation and Review Report for GMF06002 page 7 of 221

1.4 Project team

1.4.1 The project team consisted of the following Agency staff: Louise Edwards Project Leader, Environmental Risk Advisor Rhonda Gardner Environmental Risk Advisor Kirsty Allen Senior Environmental Risk Advisor Tereska Kozera Senior Applications Administrator Max Donelan Applications Administrator Linda Robinson General Manager, Māori Janet Gough Principal Analyst Frances Ikin Policy Analyst 1.4.2 This report was reviewed by Asela Atapattu (Applications Manager New Organisms), and signed out by Dr Geoff Ridley (Acting General Manager New Organisms) on 23 July 2008.

1.5 Decision pathway

1.5.1 This application is to be considered via the decision path for applications to develop or field test any GMO in containment. The relevant decision path is provided in Appendix 2. The source of this decision path is the ERMA New Zealand Policy Series: Protocol 2.

1.6 Application receipt

1.6.1 The application was formally received on 9 April 2008 and the Minister for the Environment1 was advised on the same day of the receipt of the application. The information in the application was checked and was considered by ERMA New Zealand to meet the information requirements for consideration via the standard notified process (that is, further information under section 52(1) of the Act was not requested).

1.7 Public notification and submissions

1.7.1 The application was publicly notified on 11 April 2008 as required under section 53(d) of the Act. In accordance with section 53(4) of the Act, the Minister for the Environment1 and a range of government departments and other agencies including district and regional councils (Appendix 4) were notified of the receipt of the application (and provided with an opportunity to comment or make a public submission). A notice was also printed in The Dominion Post, The New Zealand Herald, The Press and The Otago Daily Times on 16 April 2008.

1 Letters were sent to the Minister for the Environment on 9 April (advising of receipt of the application) and 11 April 2008 (advising of public notification of the application).

Evaluation and Review Report for GMF06002 page 8 of 221 1.7.2 Submissions closed on 26 May 2008, 30 working days after public notification. A total of 124 submissions were received. The list of submitters that did or did not wish to be heard at a hearing can be found in Appendices 5a and 5b. The submissions are summarised in Appendix 6 with the responses of the project team. Specific points from submissions are addressed throughout the report.

1.8 Authority appointment of a special committee to consider the application

1.8.1 The Authority established a Special Committee under section 19(2)(b) of the Act and in accordance with clause 43 of the Schedule 1 of the Act.

1.8.2 As per standard ERMA New Zealand protocol, all potential Committee members were asked to declare any potential conflicts of interest prior to potential appointment to the decision-making Committee.

1.8.3 Two external experts were appointed to the Special Committee. Due to the lack of specific expertise in plant molecular biology on the Decision-making Committee, Associate Professor Mike Pearson was appointed as an expert. Due to the lack of specific Māori expertise on the Decision-making Committee, Dr Shaun Ogilvie was appointed as an expert after recommendation from Ngā Kaihautū Tikanga Taiao (Ngā Kaihautū).

1.8.4 This application will be considered by Helen Atkins (Chair), Dr Val Orchard, Richard Woods, Associate Professor Mike Pearson and Dr Shaun Ogilvie.

1.9 Purpose of application

1.9.1 The New Zealand Institute for Crop and Food Research Limited (Crop and Food Research) is seeking approval to field test in containment genetically modified alliums (GM alliums) under section 40(1)(c) of the HSNO Act.

1.9.2 The purpose of this application is to field test allium (onion, spring onion, leek and garlic) lines, genetically modified to confer agronomic or quality traits, in order to assess their performance in the field and to investigate the environmental impacts of these plants. If approved, the field test would take place over a 10 year period within the Lincoln region on a 2.5 hectare maximum area at any one time. This purpose falls under section 39(1)(b) of the Act: “field testing any new organism”.

1.9.3 An agronomic trait is defined by the applicant as a characteristic that confers a benefit to the growing and production of alliums. The agronomic traits that the applicant wishes to field test are herbicide tolerance, resistance to pathogenic fungi, bacteria or viruses of alliums, resistance to insect pests of alliums, and the development of an inducible flowering system in alliums.

1.9.4 A quality trait is defined by the applicant as a characteristic that confers a consumer or processing benefit to the allium. The quality traits that the applicant wishes to field test are altered pungency, health and flavour (altered

Evaluation and Review Report for GMF06002 page 9 of 221 sulphur pathways), altered sweetness (altered carbohydrate levels) and altered colour (altered pigment pathways).

1.9.5 The applicant states that the plants to be field tested would have the agronomic or quality trait confirmed in the laboratory or glasshouse prior to the plants being planted in the field containment facility.

1.9.6 Field test methods would involve growing plots of GM onion, spring onion, leek and garlic within the field containment facility, and the monitoring and evaluating the growth and performance of these plants compared to unmodified plants, as well as monitoring of chemical applications and interactions with particular flora and fauna. Samples would be taken back into PC2 containment facilities for biochemical and genetic analysis.

1.9.7 While under most circumstances the flowering of the GM alliums would not be allowed, the applicant proposes that some GM be allowed to flower within insect-proof pollination cages. The applicant proposes that the GM seeds would mature in the field and the seed heads would be moved back into PC2 containment facilities prior to seed dispersal.

Evaluation and Review Report for GMF06002 page 10 of 221 2 Information Review

2.1 Information available 2.1.1 The following documents were available for the evaluation and review of the application by the project team: Application for approval to field test in containment any genetically modified organisms (Form NO-04) for GMF06002 GMF06002 Appendix 1: Previous applications relating to this proposal GMF06002 Appendix 2: Example of field trial operation manual GMF06002 Appendix 3: Summary of document sent to Māori groups GMF06002 Confidential Appendix 1: Location and Security of the containment facility Public submissions Summary of public submissions (Appendix 6) Comments from DOC and MAF BNZ (Appendices 7 and 8)

2.2 Confidential information

2.2.1 In addition to the information listed above, the following confidential information was provided to ERMA New Zealand as part of the application (appendices to the application): map of the field containment facility and security for the GM alliums field test (Confidential Appendix 1 of the application).

2.3 Additional information

2.3.1 The project team sought information as required on various aspects of allium biology from experienced New Zealand onion growers (see Appendix 11 for details). Comments made by the experts have been incorporated into the E&R report.

2.3.2 The project team has also sought an external expert review of the E&R report by Professor Clive Ronson. Comments on the scope of the field test and the organisms, the completeness of the identification and assessment of the risks, the adequacy of the containment controls proposed and any additional risk and/or scientific issues identified by the reviewer were sought. Comments made by Professor Clive Ronson have been incorporated into the final E&R report.

2.3.3 The project team has also reviewed scientific papers and other information in addition to those provided by the applicant. These references, and those provided by submitters are listed throughout this report where appropriate.

Evaluation and Review Report for GMF06002 page 11 of 221 2.4 Reports from other government agencies

2.4.1 The Ministry of Agriculture and Forestry Biosecurity New Zealand (MAF BNZ) provided comments on this application which can be found in Appendix 7.

2.4.2 The Department of Conservation (DOC) provided comments on this application which can be found in Appendix 8.

2.5 Ngā Kaihautū Tikanga Taiao report

2.5.1 Ngā Kaihautū Tikanga Taiao (Ngā Kaihautū) is a statutory committee established under Part 4A of the Act to provide the Authority with Māori perspectives advice and assistance, as sought by the Authority, on matters relating to policy, process and applications. In accordance with this mandate, Ngā Kaihautū has prepared a report to the Authority on this application. A copy of their report on the GMF06002 application can be obtained through the ERMA New Zealand website.

Evaluation and Review Report for GMF06002 page 12 of 221 3 Risk management context

3.1 The Act and the Methodology 3.1.1 The Authority decides whether to approve or decline applications to import, develop, field test or release new organisms based on the requirements of the Act. The Purpose of the Act is to “protect the environment and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms”. The Act and its associated Methodology regulation provide the foundation for the risk management context for the evaluation and review of this application, and set the scene for ensuring that the purpose of the Act is achieved.

3.1.2 This application is to field test GMOs. The nature of a field test is described in 1.3.1 - 1.3.3.

3.1.3 Section 45(1)(a) of the Act requires the Authority to consider adverse and beneficial effects of the organism(s), and to make a decision based on whether or not the beneficial effects of having the organism(s) in containment outweigh the adverse effects of the organism and any inseparable organism(s) in containment. The relevant adverse and beneficial effects are those that are associated with the GMO (ie, not with the unmodified organism).

3.1.4 The Methodology provides further guidance and requires a weighing up of risks and costs (adverse effects) and benefits (beneficial effects). The Methodology defines risk as “the combination of the magnitude of an adverse effect and the probability of its occurrence” (refer to Appendix 3: qualitative scales for describing effects). Costs and benefits are defined in the Methodology as the value of particular effects (clause 2 of the Methodology). However, in most cases, these „values‟ are not certain and have a likelihood attached to them. Thus costs and risks are generally linked and, in most cases, may be addressed together.

3.2 Identification and assessment

3.2.1 The first step in the decision-making process is to identify the effects associated with the organism(s), and to undertake a scoping exercise to determine which effects are potentially significant. Potentially significant effects are identified in section 7 of this report. Identifying adverse effects requires identification of the sources of effect (eg, the hazards), the pathways for exposure, and the areas of impact (outlined below), as well as the likelihood and magnitude of effect. In accordance with clauses 9 and 10 of the Methodology and sections 5 and 6 of the Act, the project team has categorised adverse and beneficial effects in relation to the following areas of impact: the environment, human health and safety, relationship of Māori to the environment, the market economy, and society and the community.

3.2.2 The second step is to assess the effects that have been identified as being potentially significant (see section 8). Those effects that are deemed to be not potentially significant are described, but are not assessed. Assessing

Evaluation and Review Report for GMF06002 page 13 of 221 effects involves combining the magnitude and likelihood resulting in a level of effect. In this instance the process used is a qualitative assessment described in Decision Making: A Technical Guide to Identifying, Assessing and Evaluating Risks, Costs and Benefits (ERMA New Zealand, 2007). A summary of this qualitative approach is included in Appendix 3.

3.2.3 In assessing the effects of the organism(s) the Act requires that consideration be given to: the ability of the organisms to establish an undesirable self-sustaining population (section 37(a) of the Act); the ease with which the organisms could be eradicated if it established an undesirable self-sustaining population (section 37(b) of the Act); and the ability of the organism to escape from containment (section 44(b) of the Act). 3.2.4 The information on the identification and assessment of the adverse and beneficial effects on the biological and physical environment and on human health and safety, the relationship of Māori to the environment, society and communities and the market economy can be found in sections 7 and 8.

3.3 Ethical considerations

3.3.1 In reviewing the information provided and identifying and assessing the adverse and beneficial effects of the organisms and the field test, the project team has taken into account the ethical matters that pertain to the conduct of the field test. For guidance the project team has relied on the ERMA New Zealand Ethics Framework Protocol (ERMA New Zealand, 2005).

3.3.2 The Ethics Framework Protocol acknowledges that individuals and communities hold a range of ethical views. It was developed as a tool to assist all participants in the ERMA New Zealand decision-making process to: ask the „right‟ questions in order to identify areas where there are ethical matters to be considered; and use the answers to these questions to explore whether and how ethical considerations need to be addressed both in preparation of applications and in decision making. 3.3.3 The foundation of the framework is a set of ethical principles supported by procedural standards. The two general principles which are embodied in the Act and the Methodology are: respect for the environment; and respect for people (including past, present and future generations).

3.3.4 Under these general principles is a set of specific principles: concern for animal welfare; concern for autonomy; concern for co-operation;

Evaluation and Review Report for GMF06002 page 14 of 221 concern for cultural identity/pluralism; concern for human rights; concern for human dignity; concern for justice and equality; concern for sustainability; and concern for wellbeing/non-harm. 3.3.5 The primary mechanisms for supporting the principles outlined in the framework, and for evaluating whether or not they are upheld are the procedural standards of: honesty and integrity; transparency and openness; a sound methodology; community and expert consultation; and a fair decision-making process. 3.3.6 The project team has applied the principles and procedural standards to its evaluation and review of all the information available to the project team, including that provided by the applicant and submitters, and additional information obtained directly by the project team. In assessing the adverse and beneficial effects of the organisms, the project team has made reference to these principles, concerns and standards.

3.3.7 In preparing this report, the project team has been conscious of the concerns expressed and the beliefs that are the legitimate basis for these concerns. When ethical dilemmas arise, the project team has described them in terms of the framework.

3.4 Analysis of scenarios

3.4.1 Applications for new organisms are evaluated against the existing situation in New Zealand. Therefore, the assessments of adverse and beneficial effects addresses the additional or incremental effects of the organism.

3.4.2 This requires: establishing a baseline scenario of what will happen if the organism is not approved; identifying and assessing the risks, costs and benefits if the organism is approved; and determining the difference between the two scenarios. 3.4.3 The baseline scenario is not static and will change over time. Therefore, a timeframe for the assessment needs to be considered. In this case, the time- frame analysed by the applicants is the proposed 10 year timeframe for the field test.

3.4.4 Once the baseline scenario has been established, the risks and benefits associated with the baseline scenario and approval of the application can be

Evaluation and Review Report for GMF06002 page 15 of 221 determined. Finally, the difference between the two scenarios provides the changes in adverse and beneficial effects that can be expected to occur if the substance is approved. Where possible, these changes are estimated as a „net‟ level of effect.

3.4.5 In this instance the baseline for assessing effects is the unmodified allium.

3.5 Risk management criteria

3.5.1 While the decision making process is based on the weighing up of adverse and beneficial effects, the Act also contains criteria for assessing applications for field testing of new organisms. These criteria are: is the application for a proper purpose – (section 39(1) of the Act)?; confirm that the application meets the criteria prescribed in section 40(2)(b) of the Act (information supplied); can the organism be adequately contained (section 45(1)(iii) of the Act)?; what is the ability of the organism to establish an undesirable self- sustaining population (section 37(a) of the Act) and the ease to which the organism could be eradicated if it established an undesirable self- sustaining population (section 37(b) of the Act)?; are there any alternative methods of achieving the research objectives that has fewer adverse effects on human health and safety and the environment (section 44A(2)(b) of the Act)?; and are there any effects resulting from the transfer of any genetic elements to other organisms in or around the site of the field test (section 44A(2)(c) of the Act)?

Evaluation and Review Report for GMF06002 page 16 of 221 4 Organism identification, description and characterisation

4.1 Identification of the host organism

4.1.1 The applicant wishes to field test four species of allium; onion (single bulb) and (several lateral bulbs), spring onion, leek and garlic genetically modified with specific traits.

4.1.2 Onion and shallot (Allium cepa Linnaeus 1753): Onions and are two distinct horticultural groups within the same species; the common onion group (onions) and the aggregatum group (shallots). The common onion group makes up the majority of the economically important varieties of A. cepa and are mostly grown from seed. The bulbs of the aggregatum group are smaller than the common onions and are typified by the formation of clusters of smaller bulbs. Bulbs of the aggregatum group are typically propagated vegetatively. Despite their different morphology, onions and shallots are interfertile (Brewster, 1994).

4.1.3 Onions have been cultivated for 5000 years and do not exist as a wild species. Their centre of origin is thought to be the Middle East where wild relatives are found (Brewster, 1994).

4.1.4 Onions are cool season, biennial plants (requiring two growing seasons to produce seed) that are grown as an annual crop (Voss et al, 1999).

4.1.5 Spring Onion ( Linnaeus 1753): Spring onions are a hardy clump-forming type and only develop a slightly enlarged bulb (Pollock and Griffith, 2005; Stephens, 1994).

4.1.6 Spring onion is not known as a wild species, but a wild relative A. altaicum, is widespread in the mountains of Mongolia and southern Siberia. Spring onions have been cultivated for more than 2000 years in and Japan (Brewster, 1994; Jones and Mann, 1963).

4.1.7 Leek ( Linnaeus 1753): The leaves of form a tight cylinder and normally no distinct bulb is formed (Jones and Mann, 1963; Pollock and Griffith, 2005). Leeks are raised from seed (Brewster, 1994).

4.1.8 Leek are not found in the wild, although they are derived from the wild A. ampeloprasum, which is found from to (Brewster, 1994).

4.1.9 Garlic (Allium sativum Linnaeus 1753): Garlic is a hardy perennial „bulb‟ made up of lateral buds that have developed into numerous bulbs (cloves) (Kamenetsky and Rabinowitch, 2006).

4.1.10 Many clones of garlic do not produce a flower stem, but in cloves where flowers are formed, often the flowers abort and bulbils (small bulbs) develop

Evaluation and Review Report for GMF06002 page 17 of 221 on the flower head (Brewster, 1994). Garlic is infertile, and propagated vegetatively from a clove (Simon and Jenderek, 2003).

4.1.11 Garlic is only known as a cultivated plant, and is thought to have originated from the same central Asian mountains as onions (Brewster, 1994).

Bulbs 4.1.12 An onion is a typical bulb. It is a compact shoot, consisting of numerous layers of colourless, fleshy, scale-like leaf bases mounted on a small, fore- shortened disc-shaped stem. The outermost scale leaves are thin and papery and serving to protect the bulb. A central apical bud contains immature foliage leaves that eventually emerge from the bulb (Capon, 1990).

4.1.13 In shallots, auxiliary buds can develop between the fleshy, scale-like leaves. These buds may develop into new bulbs, and it is the proliferation of new buds that make the aggregatum group so distinctive. It is also the proliferation of buds that gives garlic its distinctive morphology, with each clove representing an auxiliary bud developing into a new bulb (Capon, 1990).

4.1.14 As already noted, leeks and spring onions do not form distinctive bulbs but rather cylinders of tightly rolled leaves which form the edible vegetable. Rudimentary bulbs can form in leeks but “bulbiness” is an undesirable trait. Low soil temperatures can favour bulbiness (Brewster, 1994).

Plants and Flowers 4.1.15 When bulbs or seeds sprout, they typically grow leaves from the reduced stem described above to form a clump of leaves without any obvious stem. The stem as seen in leeks and spring onions is formed from tightly rolled leaves and is sometimes referred to as a pseudostem (Brewster, 1994).

4.1.16 An obvious stem only forms during flowering when the plant is said to bolt. At this stage the stem elongates rapidly to carry the flower head () into a prominent position for pollination to occur. Bolting is undesirable in onions grown for bulbs but is essential for onion seed production. Variety, plant size, temperature, and duration of temperature all interact to determine when bolting occurs. The formation of a bulb is not always required before bolting, but the plants must have leaf bases with diameters greater than 10 mm before flowering can be induced (Voss et al, 1999).

4.1.17 In general, flowering is promoted by low temperatures (onions and spring onions) and long photoperiods (onion and garlic). In most onion cultivars, only seedlings with 10-12 leaves respond to vernilisation (cold treatment), with optimal temperature ranges between 7-12°C. Shallots show a similar response, except a minimum of 6-7 leaves is required by seedlings for flowering (Kamenetsky and Rabinowitch, 2006). It is therefore possible to easily identify and remove flower heads or contain the bulbs before flower opening.

Evaluation and Review Report for GMF06002 page 18 of 221 4.1.18 Bolting is similar in all edible alliums (Brewster, 1994). If mature leeks or onion bulbs are left in the soil or are replanted following storage, during autumn or spring of the second year they will grow and produce an obvious flower stem and head (Currah, 1990). This matures over a period of at least four weeks before opening to show hundreds of receptive flowers for pollination. In onions, the flower stem is 1-2 m tall (Free, 1993), in leek the flower stems are up to 1 m tall (Brewster, 1994). Some shallot clones flower freely and set abundant seed, while others flower rarely, if at all (Brewster, 1994).

4.1.19 When mature, the spathe which encloses all of the flowers in the flower head opens. In onion there are commonly 200-600 flowers per flower head, and leek and spring onion flower heads also contain large numbers of flowers (Brewster, 1994). In onions, the stages of flower opening are: opening of the individual flower and the start of nectar secretion; pollen release; then the stigma (female part of flower) become receptive once the flower has ceased shedding pollen. This feature usually provides a barrier to self-pollination, but onions can still be self-pollinated because of the large number of flowers per head, and because flowers do not mature simultaneously. Pollen in an individual flower is released over a one to two day period, usually starting the day after the flower fully opens (Currah, 1990). Flowering in a single flower head usually lasts from three to four weeks and at peak flowering, over 50 flowers a day may open on a flower head (Currah, 1990).

4.1.20 The applicant states that in garlic, the flowers abort and are not known to be fertile in New Zealand (page 15 of the application). Small bulbils develop on the flower head, a form of asexual or clonal reproduction (Brewster, 1994).

Pollination and seed set 4.1.21 Onions are predominately cross pollinated, but they are also capable of self pollination. However, as onions suffer severely from inbreeding depression, self-pollination contributes to both poor seedling vigour and survival rates, and poor seed set (Brewster, 1994; Free, 1993). Pollination of onions is usually by insects. A study of insect visitors to six onion crops in Marlborough, Canterbury and Central Otago found that Diptera (flies) and Hymenoptera (bees) were the most abundant insect orders visiting onions (Howlett et al, 2005). Studies have shown that wind pollination of onions is unlikely, for example it has been shown that caged onion plots without bee pollinators will produce less than 1% of seed, compared with caged onion plots containing bees (Woyke, 1981).

4.1.22 Onion pollen is approximately 40 µm in diameter and is short lived (up to six days). The length of an individual onion flower‟s life depends on the prevailing weather, with high temperatures reducing pollen viability. Flowers generally take three or more days to become receptive after anthesis (fully opened), and remain receptive to pollen germination from two to seven days (Currah, 1990).

4.1.23 Seed develops over an approximate seven week period at the end of the second summer, and seed capsules crack open to release seed in the late

Evaluation and Review Report for GMF06002 page 19 of 221 summer to early autumn (Brewster, 1994). Commercial seed is usually harvested between five and seven weeks after flowering, just before the seed capsule starts to shatter and lose seeds (Brewster, 1994).

Seed and germination 4.1.24 Onion seeds are slow to germinate and temperature and the timing of rainfall or irrigation can strongly affect the timing of emergence. For onion, the optimal temperature range for seed emergence was found to be 13-28°C, while for leeks, this is 7-25°C (Bierhuizen and Wagenvoort, 1974). Eamon Balle (in litt.) states that in New Zealand, onion seed will germinate in a minimum temperature of 0-1°C with adequate soil moisture. Germination at this temperature, however, takes considerably longer than at optimal temperature.

4.1.25 At high temperature and humidity, onion seed loses viability faster than most vegetable seeds (Brewster, 1994). The expected viability of onion seed under Canterbury conditions is discussed in sections 5.6.58 - 5.6.59.

4.1.26 Allium seed size and number vary with species. Onion and spring onion have 300 seeds/gram, while leek has 350 seeds/gram (Brewster, 1994). Onion seed is 2-3 mm long, wrinkled and irregular in shape when dry, with no wind dispersal mechanisms (Jones and Mann, 1963).

Roots 4.1.27 Onion, spring onion, leek and garlic have similar root systems, and all have comparatively thick and sparsely branched roots compared to other vegetable crop species. The length of the root per unit volume of soil under allium crops is also low compared with other crop species, with 90% of the root length found in the top 18 cm of soil throughout the season, unlike other crop species that root more deeply as the season progresses (Brewster, 1994).

4.1.28 Allium roots are readily colonised by mycorrhizal fungi, thought to enhance nutrient absorption under conditions of nutrient scarcity (Brewster, 1994).

Plant growth, ecology and cultivation 4.1.29 Alliums are typically plants of open, sunny, dry sites in fairly arid climates. As alliums are only weakly competitive, they are not found in dense vegetation (Brewster, 1994).

4.1.30 Long term cultivation and selection by growers has seen the improvement of economical traits and adaption of alliums to various environmental conditions, affecting both their development processes and quality traits. These included single heart bulb in onions, maximum doubling in shallots, fast leaf growth in spring onions and long shafts in leeks (Kamenetsky and Rabinowitch, 2006).

4.1.31 Onions, spring onions and leek are cultivated as biennial crops, and are propagated by seed (Kamenetsky and Rabinowitch, 2006). Garlic and shallots are grown vegetatively (from bulbs), which are planted with their

Evaluation and Review Report for GMF06002 page 20 of 221 bases 2 - 3 cm deep (Brewster, 1994). Leek is either transplanted or planted as seed. In most countries, leeks seedlings are transplanted after 12 weeks in a glasshouse or nursery (Free, 1993).

4.1.32 Onions are generally sown in spring and harvested early autumn (especially if sown as seedlings). Bulbing begins when day length is around 16 hours (Walker, 1992). Shallots are sown in winter and harvested in late summer (Pollock and Griffiths, 2005; Walker, 1992). Spring onions are sown in spring (Pollock and Griffiths, 2005), while garlic is sown in winter and harvested in summer after the leaves have died off (Walker, 1992).

4.1.33 Alliums are considered weak competitors compared to most crops, and suffer from competition with weeds during their early stages of development. This is due to their slow growth rate and their upright and narrow foliage. Weed competition during the early stages of growth results in severe yield losses and a reduction in bulb size (Rubin, 1990). Weed control is said to be the greatest single cost in onion production (Rubin, 1990).

4.1.34 When onion leaves have died down, onion bulbs are said to enter a dormant state where leaf initiation is terminated. This dormancy is broken when temperatures are increased. In stored onion bulbs, temperatures of 15-20oC are shown to be optimal for dormancy to cease and sprouting to begin (Komochi, 1990). The applicant considers that this demonstrates that onion bulbs will not persist in a dormant state within the soil under normal Canterbury climatic conditions for more than six months (page 32 of the application).

4.1.35 The applicant claims that garlic cloves will not persist within the soil under normal Canterbury climatic conditions for more than eight months without breaking dormancy (page 15 of the application).

4.1.36 In contrast to onions and garlic, leek is harvested as a vegetatively growing shoot, with the object in crop production being the production of marketable shoots before the plants begin to bolt (Brewster, 1994).

4.1.37 The applicant states that leek vegetative structures will not persist within the soil under normal Canterbury climatic conditions for more than eight months without breaking dormancy (pages 15 and 16 of the application).

4.1.38 In New Zealand, garlic cloves are usually planted from May to August, and harvested in late summer (Walker, 1992). The applicant states that, at the end of a growing season when garlic is stressed by poor weather conditions such as rain, cold, drought or infection, they can produce a flower stem similar to that of onion and leek. However, in New Zealand, the flowers are sterile and are usually aborted in favour of the production of topset bulbules (a cluster of vegetative singular bulbs around the stalk). These are viable, but often when they are grown in subsequent years they form a terminal onion style bulb which cannot be propagated further. The applicant considers that the flower stem structure is similar to that for leek and onion, and is produced over a similar time period, enabling easy identification and removal (page 15 of the application).

Evaluation and Review Report for GMF06002 page 21 of 221 Relatives present in New Zealand 4.1.39 Sexual hybridisation between the allium species intended to be field tested and other allium species is very rare (Kik, 2002), and is not an issue in New Zealand due to the lack of close wild relatives (Healy and Edgar, 1980). The A. cepa species no longer exists in the wild (Brewster, 1994), and neither leek nor garlic has wild relatives in New Zealand with which they can cross (Kik, 2002). Onion, leek and garlic are rarely seen as casual garden outcasts in New Zealand, and are not common New Zealand weeds (Roy et al, 2004).

4.1.40 The nearest wild relative of A. cepa is A. vavilovii which the applicant considers is not present in New Zealand (page 43 of the application). These two species are completely interfertile and are also morphologically similar (Kik, 2002).

4.1.41 Only four naturalised wild relatives of the Allium genus are found in New Zealand; A. neapolitanum; A. roseum; A. triquetrum; and A. vineale (Healy and Edgar, 1980). All four species are found in pastures, gardens and waste areas throughout New Zealand, but none of these are considered to be interfertile with onion, leek, or garlic (Kik, 2002).

4.1.42 (wild garlic) is considered a serious weed in arable fields in Europe, while A. triquetrum (onion weed) is becoming a troublesome and persistent weed of gardens and shaded waste lands in New Zealand (Healy and Edgar, 1980; Roy et al, 2004). has evolutionary origins in south west Europe (Kamenetsky and Fritsch, 2002) which put it in a different subgenus to the Rhizirideum subgenus (to which A. cepa belongs) and therefore will not hybridise with A. cepa.

4.1.43 Studies have shown that, even within a subgenus, interspecific hybridisation is difficult and does not occur often (van Raamsdonk et al, 2003).

4.1.44 In the application for GMF03001, the applicant stated that the Māori onion Bulbinella angustifolia is not closely related to A. cepa. Bulbinella angustifolia is endemic to New Zealand and is found growing wild in Canterbury, Otago and Southland.

4.1.45 Based on this information the project team considers that A. cepa has no closely related native species with which it could hybridise.

4.1.46 In the E&R report for application GMF03001, it was noted cultivated crops of the same species and/or genus (such as shallot) can hybridise and are interfertile. It was also noted that onions had previously been crossed with other species within the same genus (such as garlic and leek), using embryo rescue (ERMA New Zealand, 2003). However, these interspecific hybrids were sterile (Kik, 2002). Based on this information, it is considered unlikely that GM alliums will hybridise with different cultivated allium species but that crossing within unmodified alliums may occur.

Evaluation and Review Report for GMF06002 page 22 of 221 4.2 Details of the genetic modifications of the organisms to be field tested

Brief summary of range of modifications 4.2.1 The project team notes that the GM alliums applied to be field tested would be imported or developed under appropriate HSNO Act approvals. The applicant has listed the existing import and development approvals for this research in Appendix 1 of the application (applications GMD01086, GMC04019 and GMD07033), but it is noted that, if this application is approved, the plants field tested would not be limited to only those developed or imported under those approvals. In addition, the applicant currently holds an approval to field test onions modified to carry the CP4 EPSPS gene (application GMF03001).

4.2.2 As summarised in Table 1, the applicant wishes to field test alliums with specific agronomic or quality traits. The applicant defines a quality trait as a characteristic that confers a consumer or processing benefit to the crop. The quality traits are altered pungency, health and flavour (altering the sulphur pathways), altered carbohydrates and altered colour (altering the anthocyanin pathway). A further description of these traits can be found in sections 4.5.1 - 4.5.21.

4.2.3 The applicant defines an agronomic trait as a characteristic that confers a benefit to the growing and production of the crop. The agronomic traits are herbicide tolerance, resistance to microbial or viral pathogens of alliums, resistance to insect pests of alliums, and the development of an inducible flowering system in alliums. A further description of these traits is in sections 4.4.1 - 4.4.49.

4.2.4 For clarification, the GM alliums described in Table 1 may be developed using two distinct approaches. The first approach is to produce alliums where “foreign” sequences or proteins (ie, not normally found in the organism) will be expressed in the plants to obtain the required trait. Examples of this are insect-resistant plants which produce a Cry protein (a protein found in the bacterium Bacillus thuringiensis), fungal-resistant plants which express the oxalate oxidase found in specific plants or herbicide-tolerant plants that express the EPSPS (5-enolpyruvyl-shikimate-3- phosphate synthase) gene from the Agrobacterium sp. strain CP4.

4.2.5 The second approach is by modifying the levels or activity of endogenous genes of the allium. An example of this is silencing the expression of genes that code for in the sulphur biosynthetic pathway.

Evaluation and Review Report for GMF06002 page 23 of 221 Table 1: Summary of the traits applied to be field tested (adapted from application GMF06002)

Trait What is the modification? The GM plants: investigated Microbial Examples of the types of genes that will be expressed Will have decreased resistance will include genes that code for proteins that inhibit susceptibility to one or fungal infection and growth, or proteins with more allium fungal or antibacterial activity. bacterial pathogen.

Viral Examples of the types of sequences that will be Will have decreased resistance transcribed will include RNAi hairpin sequences that susceptibility to one or contain viral coat protein (CP) or HC-pro, or Nia-pro, or more allium viral Nib sequences. pathogen.

Insect Examples of the types of genes that will be expressed Will have decreased resistance include genes that code for Cry proteins. susceptibility to one or more allium insect pest.

Herbicide Examples of the types of genes that will be expressed Will have decreased tolerance include genes that code for enzymes that degrade or fail susceptibility to one or to bind to glyphosate or phosphinothricin. more herbicide.

Inducible Examples of the types of genes that will be targeted Will not flower unless a flowering include genes that code for flowering determinancy. chemical inducer is applied.

Altered Examples of the types of genes that will be targeted Will have altered sulphur sulphur include genes that code for proteins involved in sulphur metabolic pathways eg, metabolic transport or enzymes involved in biosynthetic pathways alliums with reduced for sulphur-containing compounds. pungency. profiles

Altered Examples of the types of genes that will be targeted Will have altered carbohydrate include genes that code for enzymes involved in fructan carbohydrate profiles eg, metabolic production and polymerisation. alliums with altered sweetness. profiles

Altered Examples of the types of genes that will be targeted Will have altered colour colour include genes that code for transcription factors that eg, a totally red allium. profiles modify the expression of anthocyanin pathway transcriptional regulator genes such as bHLH and Myb transcription factors.

4.2.6 The applicant has stated that the silencing of specific traits (eg, sulphur or carbohydrate pathway genes) may occur either through the inhibition of enzyme activity (eg, through the expression of an inhibitory molecule) or by altering the levels of the protein (at either the transcriptional, post-transcriptional, translational or post-translational stage, such as through the use of RNA interference (RNAi) or antisense-based gene silencing). Alternatively the expression of sequences modified to inactivate the active

Evaluation and Review Report for GMF06002 page 24 of 221 site of enzymes may be used to reduce native protein function by competitive inhibition (page 20 of the application).

4.2.7 The applicant has stated that only GM alliums developed or imported under approvals given under the Hazardous Substances and New Organisms (Low Risk Genetic Modification) Regulations (the Low-Risk Regulations) would be field tested. However, the Low-Risk Regulations fall under section 41 of the Act and are used in the rapid assessment of projects for low-risk genetic modification (section 42A of the Act) and for the importation of GM organisms into containment (section 42B of the Act), and so any assessment of the plants described as “low risk” under the Low-Risk Regulations cannot be applied to a field test application.

4.3 Methods of genetic modification

Transformation of alliums 4.3.1 The applicant states that GM alliums would be developed using Agrobacterium tumefaciens-mediated transformation experiments involving the immersion of leaf or immature embryo explants in an Agrobacterium tumefaciens culture, followed by culture on hormone and antibiotic-containing selective media (to eliminate the bacteria and grow transformed plant material) and shoot regeneration (page 24 of the application).

4.3.2 Plant tissue culture is the growth of plant cells in an artificial medium (which contains essential macroelements and microelements, organic supplements and a carbon source and growth regulators), and is used to regenerate whole plants from plant cells or tissues that have been genetically modified (Slater et al, 2008).

Plant tissue culture 4.3.3 The applicant has published multiple peer-reviewed scientific papers detailing the development of GM onion, leek and garlic. The paper by Eady et al (2000) describes the technical procedure where immature onion embryos from seeds were isolated and then incubated with Agrobacterium tumefaciens carrying the genetic construct to be inserted into the plant genome. Pieces of embryo were then cultured to select for those carrying the integrated transgene. The tissue pieces confirmed to carry the transgene were then grown into plants.

4.3.4 By using this method, herbicide-resistant onions carrying the bar or CP4 EPSPS genes were developed (Eady et al, 2003a). Eady et al (2003b) showed that the majority of the GM onions did not show obvious detrimental phenotypic effects caused by the transgene, integration event, or somaclonal variation due to the tissue culture steps.

4.3.5 The applicant has also published a peer-reviewed scientific paper showing that by using an immature embryo transformation protocol similar to that

Evaluation and Review Report for GMF06002 page 25 of 221 described for onions above, GM leek and garlic could be developed (Eady et al, 2005).

RNA silencing (RNA interference) 4.3.6 RNA interference (RNAi) (also known as posttranscriptional gene silencing or RNA silencing) is an evolutionarily conserved mechanism to silence specific gene expression which is seen in a range of organisms including plants, fungi, invertebrates and humans (Baulcombe, 2004; Wang and Metzlaff, 2005; Chen, 2005; Agrawal et al, 2003).

4.3.7 The applicant stated that to silence traits, small (~500 bp) inverted repeat sequences or antisense sequences of specific genes would be transcribed within the plant (Waterhouse et al, 1998). In addition, the applicant states that RNAi hairpins would be used in virus-resistant plants (page 20 of the application).

4.3.8 Waterhouse et al (1998) demonstrated that plants producing the sense and antisense sequence in an inverted repeat configuration of the protease of Potato virus Y showed enhanced virus resistance compared to plants producing the sense or antisense sequences alone.

4.3.9 The RNA-silencing ability of plants has been exploited to produce GM plants that have specific endogenous genes silenced. For example, the expression of artificial short or long hairpin RNAs, microRNAs (miRNAs) or sense or antisense sequences have been shown to inhibit the expression of specific host genes in plants (Alvarez et al, 2006; Parizotto et al, 2004; Schwab et al, 2006; Lu et al, 2004; Smith et al, 2000; Agrawal et al, 2003; Waterhouse et al, 1998). The applicant has recently publicised the development of a “tearless onion” in the laboratory developed using RNAi technology directed against a gene involved in sulphur metabolism (Crop and Food Research, 2008).

4.3.10 RNA silencing has been investigated as a strategy to develop virus-resistant plants. For example, the expression of sense, antisense or hairpin RNAs targeting the Nia-protease viral gene of Potato Y virus inhibited Potato Y virus infection (Smith et al, 2000; Waterhouse et al, 1998), while the expression of artificial miRNAs directed towards a viral protein resulted in resistance to the Cucumber mosaic virus (Qu et al, 2007).

4.3.11 In addition, RNAi-based technologies are being investigated to create insect- resistant plants. For example, it has been observed that the ingestion of plant-expressed hairpin RNA targeting genes, such as the midgut enzyme vacuolar ATPase or cytochrome P450 monooxygenase has insecticidal effects (Baum et al, 2007; Mao et al, 2007).

4.4 Description of agronomic traits applied to be field tested 4.4.1 The applicant wishes to field test alliums with the following agronomic traits: microbial resistance; viral resistance; insect resistance; herbicide tolerance; and inducible flowering. The following sections provide a brief

Evaluation and Review Report for GMF06002 page 26 of 221 background to the traits, whether any crops with similar traits have been commercialised, and the kinds of genetic modifications that may be performed to achieve those traits.

Microbial resistance 4.4.2 The applicant wishes to field test alliums resistant to microbial diseases such as bacterial soft rot (for example caused by Erwinia carotovora, Erwinia chrysanthemi, Pseudomonas gladioli, Enterobacter cloacae) or fungal diseases such as downy mildew (Peronospora destructor), botrytis neck and bulb rot (Botrytis allii), and white rot (Sclerotium cepivorum) (page 20 of the application).

Allium microbial diseases

4.4.3 Bacterial soft rot (caused by bacteria such as Pseudomonas gladioli) is one of the most serious onion diseases in New Zealand and elsewhere, and can cause the rotting of plants in the field and more significantly the rotting of bulbs during storage (McCartney, 1991; Wright et al, 1993; Eady, 2002).

4.4.4 The fungal pathogen Botrytis allii affects onions and shallots and before seed treatment was the principal cause of decay in storage of onion and shallot bulbs. Peronospora destructor affects onion and shallot (and rarely leek) and reduces bulb growth and affects storage quality, while Sclerotium cepivorum causes one of the most important allium diseases. This fungus can kill Allium plantlets and can cause basal rot on maturing bulbs of onion, shallot, leek and garlic (FAO/IPGRI, 1997; OEPP/EPPO, 2000; McCartney, 1991). Onion white rot can result in over 85% of crop losses (page 8 of the application).

4.4.5 Conventional breeding of disease-resistant cultivars and the extensive use of pesticides are currently used as strategies to combat plant pathogens. However, the development of pesticide-resistant microbes is becoming a major problem in agriculture and so new strategies to fight these diseases are being explored (Vilcinskas and Gross, 2005). While fungal pathogens are currently controlled by rotation, fungicides and curing and storage regimes, control by fungicides is becoming increasingly difficult. In addition, bacterial rot can occur in the field in wet seasons, and due to the opportunistic nature of the diseases, the development of spray-based control strategies against bacterial diseases has been difficult (reviewed by Eady, 2002).

Microbial-resistant crops

4.4.6 The applicant has provided examples of the types of genes that would be expressed such as genes that encode for proteins that inhibit fungal growth (such as oxalate oxidase) or proteins with antibacterial activity such as small channel-forming peptides, T4 lysozyme and avidin (eg, magainin) (page 20 of the application).

Evaluation and Review Report for GMF06002 page 27 of 221 4.4.7 A number of different strategies are being currently investigated to develop microbial-resistant plants including the expression of proteins or peptides that directly affect the pathogen (eg, PR proteins, antimicrobial peptides) and the expression of proteins that neutralise a component of the pathogen infectivity, virulence or pathogenicity (eg, oxalate oxidase) (Punja, 2001).

4.4.8 The applicant gives T4 lysozyme as an example of an antimicrobial protein (page 20 of the application). T4 lysozyme is bactericidal due to lytic activity against the cell walls of Gram positive and Gram negative bacteria, and also has broader microbicial activity against a wide spectrum of fungal and bacterial pathogens possibly through cell membrane disruption (Düring et al, 1999).

4.4.9 The applicant gives oxalate oxidase as an example of an antifungal protein that may be expressed in the GM alliums (page 20 of the application). The secretion of oxalic acid by fungi such as Sclerotinia sclerotiorum determines its pathogenicity. Therefore plants expressing oxalate oxidase (OXO) which breaks down oxalic acid to CO2 and H2O2, have been developed (Lu, 2003; Eady, 2002). It was seen that soybean and sunflowers that expressed the wheat OXO gene have enhanced resistance to stem rot, mid-stalk rot, root rot and head rot (Lu, 2003).

4.4.10 The applicant has listed avidin as a protein with antibacterial activity. This protein is discussed in section 4.4.32.

4.4.11 A number of microbial-resistant GM plants have been developed eg, apples and pears expressing attacins (resistant to the fire blight pathogen Erwinia amylovora) (Vilcinskas and Gross, 2005) and potatoes expressing magainin (O‟Callaghan et al, 2008) or T4 lysozyme (Düring et al, 1993) (for a thorough review see Punja, 2001). At this stage, there are no commercial approvals for microbial-resistant GM plants.

Viral resistance 4.4.12 The applicant wishes to field test GM alliums resistant to allium viruses such as onion yellow dwarf virus, iris yellow spot virus and leek yellow streak virus (pages 20-21 of the application).

Allium viral diseases

4.4.13 Onion yellow dwarf virus, leek yellow streak virus and iris yellow spot virus can have severe impacts on allium production.

4.4.14 Onion yellow dwarf virus (OYDV) has a host range which consists of onion, shallots and garlic. In onion and shallot, OYDV causes leaf yellow striping and curling and stunting of the plant while in garlic, a variety of yellow striping and a reduction in growth and bulb size is seen (Brunt et al, 1996 onwards; FAO/IPGRI, 1997; Davis and Aegerter, 2007). OYDV is transmitted by specific aphids in a non-persistent manner and by mechanical inoculation. OYDV is not spread by contact between plants, or by seed or pollen (Brunt et al, 1996 onwards; FAO/IPGRI, 1997).

Evaluation and Review Report for GMF06002 page 28 of 221 4.4.15 Leek yellow streak virus (LYSV) has a host range which mainly consists of leek and garlic. LYSV has been shown to cause significant losses in yield for leek and garlic overseas. In leeks, LYSV causes yellow striping on the leaves and the infected plants are susceptible to early frost, while in garlic, green striping is seen and infected plants have reduced diameter of the pseudostems and bulbs. LYSV is transmitted by aphids in a non-persistent manner or by mechanical inoculation. LYSV is not spread by seed (FAO/IPGRI, 1997).

4.4.16 Iris yellow spot virus (IYSV) is an emerging threat to the onion industry. IYSV has a broad host range which includes iris, onion, leek and garlic. IYSV causes yellowish-tan lesions on the flower stalk and the bulb leaves. Infected stalks and leaves will fall over during the latter part of the growing season. The infected plant has reduced vigour and bulb size, and is susceptible to adverse environmental conditions (such as drought), pests and diseases. While IYSV is transmitted by onion thrips (Thrips tabaci), the virus does not appear to be seed-borne or seed-transmitted (Gent et al, 2006; Ocamb and Gent, 2007; Ockey and Thomson, no date; Goldberg, 2005).

Virus-resistant crops

4.4.17 A number of virus-resistant crops have been approved for commercial use elsewhere including papaya resistant to papaya ringspot virus (commercialised in the in 1998) and squash resistant to the cucumber mosaic, zucchini yellow mosaic and watermelon mosaic 2 viruses (deregulated in the United States in 1996) (Fuchs and Gonsalves, 2007). A number of field tests have been performed elsewhere for virus-resistant cereals, flowers, fruits, forage, grasses, legumes and vegetables (Fuchs and Gonsalves, 2007; Tepfer, 2002).

4.4.18 The applicant has stated that alliums carrying RNAi hairpin sequences from viral coat protein (CP) or HC-pro, or Nia-pro or Nib sequences of allium viral pathogens would be field tested (pages 20-21 of the application). For clarification, CP is the virus coat protein, HC-Pro is the aphid transmission helper component protease with silencing suppressor activity, NIa is the nuclear inclusion a; combined virus encoded genome linked protein (VPg)- protease protein), and Nib is the nuclear inclusion b; RNA replicase (Revers et al, 1999).

4.4.19 The production of virus-resistant plants exploits a phenomenon called pathogen-derived resistance. Pathogen-derived resistance occurs when GM plants containing genes or sequences from a pathogen are protected against the adverse effects of that, or a related, pathogen. While the expression of specific viral proteins may play a part in resistance (eg, the expression of viral coat proteins may provide specific resistance to viruses with the same or similar coat proteins), most viral resistance is RNA-mediated RNA interference (Fuchs and Gonsalves, 2007; Prins et al, 2008; Tepfer, 2002).

4.4.20 A number of strategies for developing antiviral resistance in GM plants are under investigation including coat-protein-mediated resistance (Prins et al, 2008; Tepfer, 2002).

Evaluation and Review Report for GMF06002 page 29 of 221 4.4.21 A number of concerns exist with the use of viral sequences in GM plants such as the potential for heteroencapsidation, recombination or transcomplementation to occur. These have been addressed in sections 5.6.15 - 5.6.19.

Insect resistance 4.4.22 The applicant wishes to field test GM alliums resistant to allium insect pests such as the beet armyworm (Spodoptera exigua (Order Lepidoptera; moths)) and onion maggot (Delia antiqua (Order Diptera; flies)). The applicant provided cry genes as an example of the types of genes that would be expressed (page 21 of the application).

Allium insect pests

4.4.23 The onion maggot is a major pest of onions, and is also a pest of garlic, leeks and (Lorbeer et al, 2002). The larvae of the onion maggot feed on the developing seedlings and on the expanding bulb during the later stages of growth, which results in increased rot of bulbs held in storage (Covielli et al, 2007). The beet armyworm larva, known to infest a range of economically important crops such as corn and onion, damages seedlings with early larva damaging young terminal growth and later larva feeding on foliage and other parts of the plant (NSF Center for Integrated Pest Management, no date; USDA, 2006).

Insect-resistant crops

4.4.24 The applicant specifically mentioned the research by Zheng et al (2005) where shallots resistant to the beet armyworm were developed using the cry1Ca or the hybrid H04 (which encodes domains I and II of Cry1Ab and domain III of Cry1Ca) genes (page 21 of the application).

4.4.25 Bacillus thuringiensis foliar sprays (such as Foray and Dipel) are used in New Zealand by growers (including organic growers) for insect control and as part of incursion responses of new pest organisms such as the painted apple moth (Teia anartoides) (Miller and Wansborough, 2002). GM plants expressing Cry insecticidal proteins from B. thuringiensis currently form the basis of commercial insect-resistant crops.

4.4.26 Cry proteins or “crystal” proteins (Bt toxins) are large proteins isolated from B. thuringiensis which have insecticidal activity against certain insect groups. Cry proteins are protoxins that must be ingested and processed by enzymes to yield an active toxin (Schnepf et al, 1998). Cry proteins consist of three structural domains: domain I (pore-forming domain); domain II (membrane binding domain); and domain III (responsible for stability and membrane binding) (Federici, 2003).

4.4.27 To date, over 420 cry (or cry-like) genes are listed on the B. thuringiensis delta-endotoxin list (Crickmore et al, 2007). However, the purpose of the field test application limits the use of cry genes to those which are effective against allium insect pests.

Evaluation and Review Report for GMF06002 page 30 of 221 4.4.28 A number of insect-resistant GM crops carrying various cry genes have been approved for commercial use. For example, insect-resistant cotton (Gossypium hirsutum) has been approved in countries such as , the United States, India and South Africa, and insect-resistant maize (Zea mays) has been approved in countries such as the United States and Canada. Some commercially produced GM plants have stacked traits, eg, glyphosate- tolerant and insect-resistant cotton which has been approved for use in Australia and South Africa (Castle et al, 2006; AgBios, no date). Insect- resistant alliums have yet to be approved for commercial use.

Other strategies for insect resistance

4.4.29 Sap sucking thrips (Thrips tabaci) are a major allium pest (Lorbeer et al, 2002), and are difficult to control by conventional means. Researchers have investigated whether plants that express protease inhibitors or plant-derived lectins (such as from snowdrop (Galanthus nivalis)) can produce thrip- resistant plants (Eady, 2002).

4.4.30 Other strategies to produce insect-resistant plants include GM plants that express: α-amylase inhibitors; Cry fusion proteins (with enhanced binding in the insect gut); chitinases; or other insecticidal toxins such as Vip (vegetative insecticidal proteins from B. thuringiensis) (Christou et al, 2006; Ranjekar et al, 2003; Gatehouse, 2008).

4.4.31 Strategies involving RNAi may be used to develop insect-resistant plants in the future. For example, it has been shown experimentally that RNA interference induced in insects after ingestion of plant-expressed hairpin RNA may be the basis of insect-resistant plants (Gordon and Waterhouse, 2007).

4.4.32 The applicant lists avidin as a protein that may be expressed to produce microbe-resistant alliums. Avidin is a chicken egg white protein that has antibacterial properties, possibly due to sequestering the vitamin biotin which is required for bacterial and yeast growth or by directly binding to bacteria (Korpela et al, 1984). There is no evidence of avidin being expressed in plants for its antimicrobial properties, but instead it is noted that GM maize expressing the avidin protein are being used for the commercial production of avidin (as a diagnostic agent) (Horn et al, 2004). GM avidin maize was found to be resistant to storage insect pests and so avidin could be used in GM crops for its insecticidal acitivity (Kramer et al, 2000; Gatehouse, 2008). The commercial production of avidin is not within the scope of this field test.

Herbicide tolerance 4.4.33 Weed competition can account for yield losses of up to 70% in alliums. The applicant has previously noted that it may be possible to achieve efficient weed control in allium crops by using a single application of low dose glyphosate or phosphinothricin-containing herbicides to tolerant GM alliums (Eady, 2002).

Evaluation and Review Report for GMF06002 page 31 of 221 4.4.34 The applicant wishes to field test alliums tolerant to commonly used herbicides such as those containing glyphosate or phosphinothricin. The applicant has provided examples of the types of genes that would be expressed which include enzymes that degrade the herbicide (bar, gat or gox) or that fail to bind glyphosate (such as CP4 EPSPS or 2mEPSPS) or phosphinothricin (page 21 of the application). The applicant currently holds an approval to field test onions modified to carry the CP4 EPSPS gene (application GMF03001).

4.4.35 Herbicide-tolerant crops have been marketed in North America since 1995 with cotton (tolerant to bromoxynil) and canola (tolerant to glufosinate) among the first crops de-regulated. Since then, glufosinate-tolerant maize, cotton and rice, bromoxynil-tolerant canola, and glyphosate-tolerant soybean, canola, cotton, maize and sugarbeet have been de-regulated in North America and grown elsewhere in the world (Cerdeira and Duke, 2007; ISAAA, 2007; Agbios, no date). No herbicide-tolerant GM crops are approved for release in New Zealand.

4.4.36 Among the current strategies used to produce herbicide-tolerant plants are: (a) for the plant to express an enzyme that detoxifies the herbicide; or (b) for the plant to express a form of the herbicide protein target that is not affected by the herbicide.

Glyphosate tolerance 4.4.37 Glyphosate (N-[phosphomethyl]glycine) is a broad spectrum herbicide that is effective against many grasses and broadleaved weeds. Glyphosate acts by inhibiting the shikimate pathway by binding to and inhibiting the 5-enolpyruvyl-shikimate-3-phosphate synthase (EPSPS) enzyme. This results in reduced protein synthesis and other vital functions and, as a result, plant death occurs. The shikimate pathway is only found in plants, bacteria and fungi but not animals, and so this herbicide has low toxicity to mammals, birds and fish (Cerdeira and Duke, 2007; Mulwa and Mwanza, 2006; Pline- Srnic, 2006). Roundup™ is an example of a glyphosate-containing herbicide available in New Zealand.

4.4.38 The CP4 gene of Agrobacterium spp. encodes a highly efficient, glyphosate- resistant form of EPSPS (Cerdeira and Duke, 2007). Plants which carry this gene can continue to produce aromatic acids in the presence of glyphosate (Cerdeira and Duke, 2007; Pline-Srnic, 2006; Green, 2007; Eady, 2002).

4.4.39 The glyphosate (gox) gene from microbe Ochrobactrum anthropi degrades glyphosate to the non-toxic products glyoxylate and aminomethylphosphonate (Cerdeira and Duke, 2007; Pline-Srnic, 2006; Green, 2007; Eady, 2002). Glyphosate N-acetyl (GAT) is an enzyme from Bacillus licheniformis which, through gene shuffling, was optimized for the ability to acetylate glyphosate to N-acetylglyphosate. As N-acetylglyphosate has low affinity for binding to EPSPS, this molecule no longer acts as an inhibitor of EPSPS (Castle et al, 2004; Siehl et al, 2007; Pline-Srnic, 2006; Green, 2007).

Evaluation and Review Report for GMF06002 page 32 of 221 Glufosinate tolerance 4.4.40 The active ingredient in glufosinate is phosphinothricin - a natural compound from Streptomyces hygroscopicus which inhibits the glutamine synthetase enzyme in plants (Cerdeira and Duke, 2007). As glutamine synthetase is required for nitrogen metabolism and to detoxify ammonia, inhibition causes plant death (AgBios, no date).

4.4.41 Phosphinothricin-N-acetyltransferase (PAT) encoded by the pat or bar genes from Streptomyces hygroscopicus metabolically inactivates both phosphinothricin and its precursor bialaphos (Cerdeira and Duke, 2007; Mulwa and Mwanza, 2006; Eady, 2002). Therefore plants that contain these genes are highly tolerant to glufosinate (Cerdeira and Duke, 2007; Agbios, no date).

Bromoxynil tolerance 4.4.42 The herbicide bromoxynil (3,5-dibromo-4-hydroxybenzonitrile) acts by blocking the electron flow during the light reaction of photosynthesis. This result of this blockage is the production of superoxide which destroys cell membranes and inhibits chlorophyll formation, resulting in plant death (Agbios, no date).

4.4.43 The bromoxynil (BXN) gene from Klebsiella pneumoniae detoxifies bromoxynil by hydrolysing the bromoxynil to 3,5-dibromo-4-hydroxybenzoic acid (a non-phytotoxic compound). GM cotton and canola containing this gene (and that therefore show resistance to bromoxynil) have been developed commercially (Agbios, no date).

ALS herbicide tolerance 4.4.44 Imidazolinones are among five families of chemicals (which include sulfonylureas, triazolopyrimidines, pyrimidinylthiobenzoates and sulphonamino-carbonyl-triazolinones) that block the plant enzyme acetolactate synthase (ALS, acetohydroxyacid synthase, acetolactate pyruvate-). ALS is the first common enzyme in biosynthetic pathways that lead to the production of the amino acids leucine, isoleucine and valine. The herbicide binds to ALS and inhibits activity, which results in a decrease in the production of the amino acids and a build up in α- ketoglutarate which eventually kills the plant. This pathway is present in plants and bacteria but not in animals (Agbios, no date; Mulwa and Mwanza, 2006; Tan et al, 2005; Green, 2007). These herbicides control a wide spectrum of weeds, have low mammalian toxicity and are effective at low application rates (Tan et al, 2005).

4.4.45 Genetically modified cotton and flax plants carrying sulfonylureas-tolerant forms of the ALS gene have been developed commercially (AgBios, no date). Trangenic soybean that carries a mutated imidazolinone-tolerant ALS gene together with GAT have been commercially developed (AgBios, no date).

Evaluation and Review Report for GMF06002 page 33 of 221 Other strategies for herbicide tolerance 4.4.46 The development of herbicide-tolerant crops is an active area of research. A number of mechanisms for resistance are being investigated which may in the future be commercialised. For example, the expression of enzymes involved in the metabolism of herbicides to non-phytotoxic metabolites such as the expression of cytochrome P450 monooxygenase to provide resistance to the herbicide chlortoluron (Shoita et al, 1994), and the expression of the tfdA gene from Ralstonia eutrophus to degrade 2,4-D (Mulwa and Mwanza, 2006; Green, 2007) are currently being investigated.

Inducible flowering 4.4.47 The applicant wishes to field test plants with inducible flowering. The examples of the types of genes that would be modified listed in the application are genes that code for flowering determinancy (eg, wus, lfy, ap1, ft, cal). The applicant wishes to modify flower determinancy genes so that the plants will not be able to flower without the application of an inducing agent (page 21 of the application).

4.4.48 The applicant states that “inducible flowering would be a huge asset to the onion breeding industry as it would enable routine crosses to be made on an annual rather than biannual basis (effectively halving cultivar development times). In addition, it may be able to prevent „bolting‟, which can cause significant crop losses” (page 8 of the application). In addition, the ability to manipulate flowering could help in the production of hybrid seeds as flowering could be synchronised (Eady, 2002), and may be used as a mechanism to prevent transgene spread through pollen.

4.4.49 Enhancing or inhibiting the expression of specific floral regulatory genes can alter if, or when, flowering will occur. For example, plants with increased LFY gene copies or constitutive expression of LFY, flower early, while plants with mutant LFY, produce leaves and associated shoots instead of flowers. Plants with increased FT expression have premature flowering, while conversely the loss of FT function prevents early flowering. The over- expression of AP1 can convert an inflorescence meristem into a terminal flower (Blázquez, 2005; Sablowski, 2007; Parcy, 2005; Komeda, 2004; Vijayraghavan, 2001). Targeted miRNAs against LFY and FT have been used to alter the flowering in the plants (Schwab et al, 2006).

4.5 Description of quality traits applied to be field tested

4.5.1 The applicant wishes to field test alliums with the following quality traits: altered carbohydrate composition, altered colour, and altered sulphur metabolism. The following sections provide a brief background to the traits, whether any crops with similar traits have been commercialised, and the kinds of genetic modifications that may be performed to achieve those traits.

Altered carbohydrate composition 4.5.2 The applicant wishes to field test alliums modified to have altered carbohydrate metabolism and stated that this may be achieved by the

Evaluation and Review Report for GMF06002 page 34 of 221 silencing or over-expression of specific carbohydrate metabolism genes. The applicant has listed genes involved in fructan production and polymerisation (such as 1-SST and 1-FFT) as the types of genes that will be modified (at either the endogenous gene or protein level) (page 21 of the application).

4.5.3 In plants, sugars regulate a broad spectrum of essential genes and can affect developmental and metabolic processes including germination, flowering, growth and photosynthesis (Dai et al, 1999). Carbohydrate metabolism is a vast and complex area, and any alterations can potentially have impacts on a wide range of plant characteristics.

4.5.4 Plants with modified fructans may provide plant products with enhanced health benefits, enhanced storage characteristics, solids content and sweetness (Eady, 2002).

4.5.5 While most plants store sucrose and starch as reserve carbohydrates, approximately 15% of all flowering plants store fructans (linear and branched polymers of fructose). Fructans may act as cryoprotectants, osmoregulatants and a source of stored carbohydrate that can be rapid mobilized during the breaking of dormancy (Eady, 2002).

4.5.6 Research has investigated using GM plants to provide sources of fructan that are qualitatively and quantitatively superior to that found in natural resources or for crop improvement (Cairns, 2003).

4.5.7 A few studies have produced GM plants with altered carbohydrate composition by introducing plant-derived 1-SST or 1-FFT genes into non- fructan accumulating plants. For example, the introduction of the 1-SST gene from Jerusalem artichoke (Helianthus tuberosus) into sugar beet (Beta vulgaris) resulted in a mixture of low molecular weight fructans stored in the taproot (ie, sucrose in the taproot was converted to low molecular weight fructans). This change in storage carbohydrate did not alter the phenotype or growth rate of the taproot (Sévenier et al, 1998). Potato (Solanum tuberosum) that carried the 1-SST and 1-FFT genes from the globe artichoke (Cynara scolymus) (which is known to synthesise inulin molecules with a chain length of up to 200) resulted in production of similar inulin molecules in the potato tubers. No adverse phenotypic effects or reduction in tuber yield was seen (Hellwege et al, 2000).

4.5.8 Some studies have looked at modifying the existing fructan levels of fructan- accumulating plants. For example, in perennial ryegrass (Lolium perenne) that was modified to carry the winter wheat 1-SST and 6-SFT genes, significant increases in fructan content were seen (Hisano et al, 2004). It is noted that chicory (Cichorium intybus), which produces inulins, cannot produce inulin neoseries fructans as it does not possess a 6G-FFT enzyme. Researchers showed that the expression of onion 6G-FFT gene within these plants resulted in the synthesis of inulin neoseries fructan (Vijn et al, 1997).

Evaluation and Review Report for GMF06002 page 35 of 221 Altered sulphur metabolism 4.5.9 The applicant wishes to field test alliums modified to have altered sulphur metabolism which may be achieved through the silencing or over-expression of specific sulphur metabolism genes (page 22 of the application).

4.5.10 The applicant states that genes that encode for proteins involved in sulphur transport (such as ast family of sulphate transporters), enzymes involved in primary sulphur amino acid biosynthetic pathways such as APS and SAT; and enzymes involved in secondary biosynthetic pathways such as alliinase and lachrymatory factor synthase would be modified (at either the endogenous gene or protein level) (page 22 of the application).

4.5.11 Sulphur is an essential nutrient for all organisms. In plants, the sulphur assimilation pathway results in the fixing of inorganic sulphur, sulphate and sulphur dioxide into cysteine (Saito, 2004; Randle and Lancaster, 2002). Altering sulphur levels may improve the health properties, quality or yield of crops.

4.5.12 Onion flavour is dominated by volatile organosulphur compounds (such as the lachrymatory factor and various thiosulphinates). It is proposed that sulphur incorporated through cysteine to glutathione (or other molecules) is then converted to the precursors (Randle, 1997; Jones et al, 2004; Randle and Lancaster, 2002). In onions, the S-alk(en)yl cysteine sulphoxide flavour precursors are trans-S-1-propenyl cysteine sulphoxide (Isoalliin; dominant in onions), S-methyl cysteine sulphoxide (Methiin) and S-propyl cysteine sulphoxide (Propiin). S-allyl cysteine sulphoxide (Alliin) is the predominant precursor in garlic and is not present in onions (Randle, 1997; Randle and Lancaster, 2002; Jones et al, 2004). The differences in the taste and odour of onion, garlic and leek is due to differing amounts of the different precursors (Mehta Luthra and Lutra, 2002).

4.5.13 Propanthial S-oxide is the lachrymatory factor (LF) which is released from onions during chopping and can cause eye irritations. The biochemical pathway that ends in the production of LF begins with trans-S-1-propenyl cysteine sulphoxide which is first converted by the enzyme alliinase to 1-Propenylsulphenic acid, which is then converted by LF synthase to LF. 1-Propenylsulphenic acid also spontaneously breaks down to thiosulphinate which is the flavoring metabolite responsible for the characteristic flavour of fresh onions (Imai et al, 2002; Mehta Luthra and Lutra, 2002).

4.5.14 The applicant has recently developed a “tearless onion” in the laboratory by using RNAi technology to inhibit the production of LF synthase (Crop and Food, 2008). In this press release, the applicant stated that “by shutting down the lachrymatory factor synthase gene, we have stopped valuable sulphur compounds being converted to the tearing agent, and instead made them available for redirection into compounds, some of which are known for their flavour and health properties.”

4.5.15 Volatile sulphur compounds can stimulate dormant fungal sclerotia in soil to germinate, and the applicant has previously investigated whether inhibition

Evaluation and Review Report for GMF06002 page 36 of 221 of a root alliinase could be used to reduce sclerotia germination and so have antifungal inhibitory activity (Eady, 2002).

Altered colour 4.5.16 The applicant wishes to field test alliums modified to have altered colour. The applicant has listed transcription factors that modify the expression of anthocyanin pathway transcriptional regulator genes such as bHLH and Myb as the types of genes that would be modified (at either the gene or protein level) (pages 22-23 of the application).

4.5.17 Flavonoids are a large class of secondary metabolites that are the major red, blue and purple pigments in plants. Flavonoids are a group of aromatic molecules derived from phenylalanine and malonyl coenzyme A (via the fatty acid pathway) (Winkel-Shirley, 2001; Holton and Cornish, 1995). Flavonoids, which include chalcones, flavones, flavonols, flavandiols, anthocyanins and condensed tannins, have proposed roles in pigmentation, signaling between plants and microbes, act as antimicrobial agents, feeding deterrents, and UV protection. It has been reported that flavonoids also have potential health benefits (Winkel-Shirley, 2001; Holton and Cornish, 1995). In onions, cyanidin derivatives are the major anthocyanins that cause the red colour (Kim et al, 2005a; 2007).

4.5.18 Natural onion colour mutants of the anthocyanin biosynthesis pathway enzymes have been observed. For example, a was due to non- functional dihydroflavonol 4-reductase or chalcone synthase genes, while the reduced expression of the anthocyanidin synthase gene resulted in a pink onion (Kim et al, 2005a; 2005b; 2007).

4.5.19 Various GM plants with altered colour have been developed. Plants have been modified by the introduction of genes encoding novel enzymatic activities, for example a white carnation (Dianthus caryophyllus) was modified to carry the dihydroflavonol reductase and flavonoid 3‟, 5‟- hydroxylase enzyme genes from petunia (Petunia х hybrida) which allowed the production of the blue coloured delphinidin anthocyanin pigments resulting in a carnation with blue flowers (Agbios, no date).

4.5.20 Plants with altered pigmentation have been developed by modifying either the activity of endogenous genes or through inhibiting the activity of enzymes in the anthocyanin biosynthesis pathway. For example, by using antisense technology that silences the chalcone synthase (CHS) genes, petunia and rose (Rosa spp.) with flowers with reduced pigmentation have been developed (Holton and Cornish, 1995). Hanumappa et al (2007) showed that by expressing a dominant-negative version of the CHS enzyme (which dimerises with the endogenous CHS) in petunia, reduced anthocyanin levels and altered colour were observed in petunia flowers.

4.5.21 An example provided by the applicant would involve modifying the levels or activities of the transcriptional regulatory genes to control pigment production (Holton and Cornish, 1995). For example, it has been shown that over-expression of the apple MYB transcription factor MdMYB10 in an apple

Evaluation and Review Report for GMF06002 page 37 of 221 cultivar (Malus domestica) enhanced anthocyanin production (Espley et al, 2007), and that the over-expression of a strawberry FaMYB1 transcription factor in tobacco resulted in an decrease of anthocyanidin synthase gene expression and activity of flavonoid-UDP-glucose transferase, and as a result reduced anthocyanin production (Aharoni et al, 2001).

Stacked traits 4.5.22 The applicant wishes to field test GM alliums that contain different events (such as herbicide tolerance and viral resistance) through conventional breeding (page 17 of the application).

4.5.23 “Stacked genes” may either mean that the plants may carry transgenes for more than one different trait (such as for herbicide tolerance and insect resistance) or for one trait with different transgenes (such as viral resistant plants carrying transgenes that target different viruses) (Halpin, 2005). It is noted that a small but growing number of plants carrying multiple stacked genes have been approved for use in countries such as the United States, Canada and Australia and include maize (Zea mays) with herbicide tolerance (EPSPS, gox) and insect resistance (cry1Ab), squash (Cucurbita pepo) which has resistance to three viruses and carnation (Dianthus caryophyllus) which has modified colour and herbicide resistance (Halpin, 2005).

4.6 Donor DNA and regulatory elements, selectable markers and other features

Donor DNA 4.6.1 The applicant has stated that the genetic material used to modify the alliums would come from a variety of plant, bacterial, fungal, or viral sources (page 18 of the application). However, the project team notes that, as the green fluorescent protein (which is listed as an example of a reporter gene) is sourced from the jellyfish Aequorea victoria, animals should also be added to the donor list. Therefore, if this application is approved, the project team proposes that the list of genetic material donors be altered to include animals. It is noted that no genetic material from humans or from native flora and fauna would be used (page 18 of the application). The list of donor genetic material proposed by the project team is listed in Table 2.

Regulatory elements, selectable markers and other features 4.6.2 In page 18-19 of the application, the applicant has requested the use of regulatory elements that would be limited to those that have established use in plant transformation which may include markers that are available to researchers upon requests from research groups or companies. The applicant provided a list of examples of regulatory elements, reporter genes and selectable markers and a list of features associated with protein expression, or the insertion or removal of foreign genetic material.

4.6.3 Previous concerns have arisen about the use of elements such as the CaMV35S promoter (this is addressed in sections 7.8.10 - 7.8.11). No

Evaluation and Review Report for GMF06002 page 38 of 221 concerns were identified by the project team with the use of the regulatory elements, selectable markers and other features listed by the applicant that have established use in plant transformation, and therefore these features have been listed in the proposed organism description in Table 2.

Modifications to the sequences expressed 4.6.4 Transgene sequences inserted into the GM alliums may need to be altered to be plant preferred versions of the genes. The expression of transgenes can be made more efficient by altering the codon usage to make it more similar to the host plant and removing sequences that are likely to be detrimental to expression in plants (Perlak et al, 1991; Strizhov et al, 1996). For example, the reporter green fluorescent protein from jellyfish would be modified for plant codon and splicing use. These modifications however, would not significantly alter the amino acid sequence of the final protein.

4.6.5 The transgenes may also be altered by deletion of nucleotide sequences so that transgene products that are produced as pro-proteins, such as the Cry protein, will be expressed in the GM plant as an active protein. Even if the amino acid sequence is altered by truncation or deletion, the sequence of the final protein would still be known.

4.7 Proposed organism description

Requirements for organism identification under the Act 4.7.1 The current ERMA New Zealand policy (Interpretations and Explanations of Key Concepts (ER-PR-03-21 04/08) states that for identification of organisms for field tests that the GMOs being field tested in containment must be clearly and unambiguously identified, and that the information must be provided that specifies the host organism, the genetic modifications and the phenotypes of the GMOs involved. The specific genetic modifications should be described fully in terms of the organism that the nucleic acid was sourced from, the type of vector (eg, non-conjugative plasmid vectors or Agrobacterium binary vectors), the functional characteristics of the gene constructs, and the range of marker genes and regulatory sequences used. The degree of specification will depend on the inherent characteristics of the organism (ERMA New Zealand, 2008a).

4.7.2 The project team notes that applications with broad organism descriptions such as application GMD02028 (GM cattle) and application GMC03001 (GM mice) have previously been approved. For example, in the outdoor development approval GMD02028, GM cattle with a range of modifications were approved by the Authority. This broad organism description has been scrutinised by the High Court (Mothers Against Genetic Engineering Inc. (MAdGE) versus the Minister for the Environment (2003)).

4.7.3 Under section 20 of the Act, it is stated that the Authority shall keep a register of all applications in which there will be “a sufficient description of the substance or organism to uniquely identify that substance or organism”. The term “identification” is defined in the Act as “(a) clearly identifies the

Evaluation and Review Report for GMF06002 page 39 of 221 chemical or biological nature of the substance or organism: (b) specifies the nature and degree or type of hazard intrinsic to the substance or organism”.

4.7.4 To ensure that the proposed organism description would fulfil the requirements of section 20 of the Act should this application be approved, a control is proposed by the project team that is similar to that seen in the application GMC03001 (GM mice) approval which requires the applicant to submit a unique organism description for the GM allium to be field tested which will be placed on the ERMA New Zealand register (discussed in section 4.7.20).

Proposed organism description 4.7.5 The project team has proposed an organism description for the GM alliums should this application be approved. In this organism description (detailed in Table 2), the host organisms are defined to species level, the donor DNA source is defined, the modifications are listed (eg, decreased susceptibility to allium insect pests), the mechanisms of trait silencing are described (for example the use of RNA silencing-inducing sequences) and the range of regulatory elements are listed. If this application is approved, the applicant would not be limited to specific genes but to specific traits. For example, only GM alliums which have been modified for decreased susceptibilities to allium microbial diseases (as shown by appropriate laboratory or glasshouse tests) would be field tested.

Table 2: Proposed organism description for plants field tested under GMF06002

Host organism: Allium cepa L. (onion), Allium fisulosum L. (spring onion), Allium ampeloprasum L. (leek), Allium sativum L. (garlic), seedlings, bulbs or seeds (Allium cepa only)

Modified using: Standard plasmid vectors used in plant transformation.

Genetic material may be: Genomic or complementary DNA derived from plants, bacteria, fungi, animals and viruses (see exclusions).

Regulatory elements, reporter and selectable marker genes and other features: All elements will be commonly used in plant transformation and include: Promoters (constitutive or inducible) (such as CaMV35S, OCS, NOS, Ubiquitin promoter, Actin promoter, promoters isolated from onion genome) Operators Regulatory elements Binding and enhancer sequences (eg, TMV omega enhancer sequence) derived from plants, bacteria or plant viruses

Other features associated with insertion or removal of foreign genetic material or with gene or protein expression. Limited to the following: Multiple cloning sites

Evaluation and Review Report for GMF06002 page 40 of 221 Polyadenylation signals Splice sites Transcriptional activators Transcriptional responsive elements Transcriptional terminator sequences Secretory and targeting signals Intron signals that function to increase gene expression Recombination sites and flanking sequences Insulator elements

Fluorescent or colourimetric reporter genes such as: green fluorescence protein (gfp) gus

Selectable marker genes such as: antibiotic resistance genes (eg, nptII, hyg) herbicide resistance genes (eg, bar, CP4) nutrient selectable genes (eg, pmi)

Characteristics of the plants field tested: Plants may be field tested if they are modified for the following characteristics (as shown by appropriate laboratory or glasshouse tests): decreased susceptibility to one or more allium insect pest decreased susceptibility to one or more allium fungal or bacterial pathogen decreased susceptibility to one or more allium viral pathogen decreased susceptibility to one or more herbicide altered pungency, colour or carbohydrate metabolism inducible flowering (flowering only after the application of a chemical inducer)

Plants may produce RNA silencing-inducing sequences or short sequences to be used as enzyme inhibitors.

Multiple traits may be stacked as long as the combination of traits does not fall under the exclusions of the organism description.

Null segregant2 offspring of the above GM plants can be used in the field test.

Exclusions : Plants with the following modifications will not be field tested:

Modifications that use DNA from humans or from native flora and fauna. Modifications that would result in the production of known vertebrate toxins or the production of infectious viral particles. Modifications that result in alliums which do not have true-to-type phenotypes in relation to flowering and seed characteristics (except for alliums modified for chemically-induced flowering as described in proposed control 5.4).

2 Plants that are derived from GM plants but shown not to contain the specific genetic modification (eg, transgene). These plants are classed as GM.

Evaluation and Review Report for GMF06002 page 41 of 221

4.7.6 As a broad organism description has been applied for, the corresponding review and assessment must also be broad and exclusions or controls must be imposed to mitigate any identified risks. This identification and assessment can be found in sections 7 and 8.

Explanation of proposed exclusions 4.7.7 The project team proposes that the following types of GM alliums must not be field tested should this application be approved. These are listed in Table 2: Exclusions.

Exclusion of developments that use DNA from humans or from native flora and fauna

4.7.8 The applicant does not intend to use genetic material from humans or from native flora and fauna (page 24 of the application) and therefore, should this application be approved, the project team has excluded this material from the proposed organism description in Table 2.

Exclusion of modifications that would result in the production of known vertebrate toxins or the production of infectious viral particles

4.7.9 As discussed in sections 5.6.20 and 8.1.18, the project team has excluded the following modifications from the proposed organism description: Modifications that result in the production of known vertebrate toxins. Modifications that result in the production of infectious viral particles.

Exclusion of modifications that result in alliums with aberrant (not true-to- type allium) phenotype in relation to flowering or seed characteristics

4.7.10 Modifications that would result in alliums with aberrant (not true-to-type) allium phenotype in relation to flowering or seed characteristics could result in GM alliums with the ability to escape from the containment regime (sections 5.6.104 - 5.6.113). Therefore, should this application be approved, the project team proposes that GM alliums with modifications that have altered the true-to-type phenotype of the allium in relation to flowering or seed characteristics be excluded from the organism description. However, the project team notes that GM alliums modified for inducible flowering (ie, flowering only after the application of a chemical inducer) would fall into this category of plants. Therefore plants with chemically-induced flowering are exempt from this exclusion as long as all other flowering and seed characteristics are true-to-type.

4.7.11 The potential for the genetic modifications to enhance the ability of the alliums to form self-sustaining populations is discussed in section 6.

4.7.12 It is noted that the applicant intends to use the progeny of GM alliums that have been shown not to contain that specific genetic modification eg,

Evaluation and Review Report for GMF06002 page 42 of 221 transgene (called null segregant offspring or non-segregating offspring), as control plants. It is noted that these plants are also regarded as GM alliums for the purposes of this report. The project team proposes that null segregant offspring are permitted to be field tested under the proposed organism description (Table 2) should this application be approved.

The testing of GM alliums prior to field testing 4.7.13 The applicant has stated that each GM allium plant line (with single or multiple traits) to be field tested would be extensively characterised in the laboratory or glasshouse by molecular and biochemical techniques to determine the presence and function of the modified trait prior to planting in the field test, for example by using PCR, Southern blots and trait expression analysis (page 17 of the application).

4.7.14 The applicant has stated that the alliums to be field tested would be essentially true-to-type (eg, would look and behave as alliums except for the key feature modified) (page 25 of the application), and that plants would not be field tested if they do not function as predicted under glasshouse conditions. The applicant states that “only plants with a characterised Southern profile and functioning trait expression will be used in small-scale field test assessment. Only plants that have passed glasshouse and small- scale field trial functionality tests and contain only simple integration profiles (e.g. single or double insertion events only) will be advanced for larger scale testing where appropriate” as GM plants that contain higher number of insertion events are difficult to breed true and rarely perform as expected (page 17 of the application).

4.7.15 The project team also considers that, should this application be approved, the GM alliums must be tested in the laboratory or glasshouse prior to field testing for the reasons discussed in sections 4.7.10 and 4.7.18. As listed in Table 2, the project team proposes that GM alliums with modifications that have altered the typical phenotype of the allium in relation to flowering or seed characteristics are excluded from the field test (with an exception for plants modified for chemically-induced flowering). In addition, should this field test be approved, the following control is proposed by the project team where GM alliums would be evaluated and tested in the laboratory or glasshouse by scientifically validated methods prior to being field tested. The project team notes that, under this proposed control, null segregants (which are also classed as GM alliums) would need to be tested in the laboratory or glasshouse prior to being used in the field test.

4.7.16 Proposed control 5.4: The Operator must ensure that all GM alliums planted in the field containment facility are phenotypically true-to-type with respect to flowering or seed characteristics by the use of scientifically validated methods. GM alliums with modified characteristics for flower induction, eg flowering only after the application of a chemical inducer, are approved for field testing as long as all other flowering and seed characteristics are phenotypically true-to-type.

Evaluation and Review Report for GMF06002 page 43 of 221 4.7.17 For proposed controls 5.4 and 5.5, the project team has considered what would constitute a scientifically validated method for the testing and evaluation of the GM alliums. The project team notes that the specific details of such tests would depend upon the genetic modification and the allium species used, and due to this, should this application be approved, the specific tests undertaken would be agreed by ERMA New Zealand with the applicant prior to the field testing of the specific GM allium.

4.7.18 To comply with the proposed organism description (Table 2), the applicant must confirm that the GM alliums to be field tested conform to the approved organism description. Therefore, should this application be approved, the following controls are proposed to ensure that prior to the field testing of any plants, the GM alliums must be checked for compliance to the approved organism description.

4.7.19 Proposed control 5.5: The Operator must ensure that all GM alliums planted in the field containment facility exhibit the approved traits by the use of scientifically validated methods.

4.7.20 Proposed control 5.6: The Operator must obtain from the MAF Inspector, approval to plant GM alliums in the field containment facility at least 30 working days before the planting takes place. The Operator must provide to the MAF Inspector a written request outlining the nature of the genetic modification, the scientifically validated methods used to assess the phenotype of the GM alliums (in accordance with proposed controls 5.4 and 5.5) and a unique organism description for the GM alliums to be planted. The MAF Inspector must verify the details of the GM alliums against the approved organism description of the approval and confirm this with the Operator. The Operator must provide to ERMA New Zealand a unique organism description of the GM alliums to be field tested for the ERMA New Zealand register.

4.7.21 The project team considers that, should this application be approved, this proposed control would fulfil the requirements under section 20 of the Act (sections 4.7.3 - 4.7.4).

4.7.22 Tissue culture may result in plants with unanticipated characteristics. Therefore, as described in sections 5.6.110- 5.6.113, should this application be approved, the following control is proposed by the project team so that plants regenerated directly from tissue culture would not be planted in the field containment facility (section 5.3).

4.7.23 Proposed control 5.3: The Operator must ensure that all GM alliums planted in the field containment facility are not derived directly from tissue culture.

Evaluation and Review Report for GMF06002 page 44 of 221 Summary 4.7.24 The project team considers that, should the field test be approved, the proposed organism description in Table 2 if combined with the proposed controls listed above,would fulfil the requirements of sections 20 and 40(2)(b)(i) and (iii) of the Act.

Evaluation and Review Report for GMF06002 page 45 of 221 5 Containment of the organism

5.1.1 For the purposes of containment during field tests, containment can only be achieved when the escape of the whole organism or any part of the organism that can reproduce itself or pass a heritable characteristic or trait is prevented.

5.1.2 The Authority may still determine that an organism can be adequately contained even if some material from the organism is lost from the containment facility, provided that the material is not capable of reproducing itself (without human assistance) or of conferring heritable traits to other organisms, and any risks arising from the loss of such material are taken into account and addressed appropriately.

5.1.3 Under section 45A of the Act, an approval must include controls to ensure that, after the end of the field test, the organism and any heritable material from the organism is removed or destroyed and may include controls to ensure that after heritable material is removed or destroyed, some or all of the genetic elements remaining from the organism are removed or destroyed. Destroyed includes leaving genetic elements to break down or become inactive at the site of the field test.

5.1.4 Part I of Schedule 3 of the Act sets out the matters to be addressed by containment controls for importing, developing or field testing GMOs. The project team has reviewed the proposed containment regime and field test design proposed by the applicant, the information provided in submissions and the biological characteristics of the organism. Based on this information, the project team have suggested controls to address containment matters where appropriate should the application be approved (listed in Appendix 1).

5.1.5 It is noted that, under the Act, MAF Inspectors act as authorised agents of the Authority whose role is to ensure compliance with controls imposed by the Authority.

5.2 Summary of Organism Description

5.2.1 The applicant wishes to test allium lines that have been genetically modified to show altered agronomic or quality traits. The proposed organism description for the plants to be field tested is detailed in Table 2.

5.2.2 The applicant seeks to generate field-grown material for evaluation, assess the performance of GM alliums in the field, and investigate specific environmental impacts of these plants.

5.2.3 The proposed field test site would be registered as a containment facility and the field test would be undertaken on a maximum planting area of 2.5 hectares at any one time. Due to its restricted planting area, this is a small scale field test.

5.2.4 The applicant proposes to plant GM onion (A. cepa) bulbs for flowering, pollination and seed production. Such an activity would require additional

Evaluation and Review Report for GMF06002 page 46 of 221 containment measures within the field containment facility to ensure that insects used for pollination do not escape from containment.

5.2.5 Samples of the GM alliums would be removed from the containment facility for biochemical and genetic analysis at PC2 containment facilities such as MAF-registered laboratories or glasshouses.

5.3 Containment facility

5.3.1 It is noted that, if approved, this field test would take place within a field test site that is registered as a containment facility (known as the field containment facility) in accordance with section 39 of the Biosecurity Act 1993, and would be operated in accordance with the MAF/ERMA New Zealand Standard Containment Facilities for Plants: 2007 (the Plant Containment Standard). Therefore, should this application be approved, the following controls are proposed by the project team.

5.3.2 Proposed control 1.1: The containment facility for the field test („the field containment facility‟) must be managed and approved as a containment facility under section 39 of the Biosecurity Act 1993.

5.3.3 Proposed control 1.2: The field containment facility must be operated and maintained in accordance with all of the following controls, including the MAF/ERMA New Zealand Standard Containment Facilities for Plants: 20073 (the Plant Containment Standard) and the following controls.

5.3.4 The applicant proposes that the field test would be undertaken in a maximum planting area of 2.5 hectares at any one time but the exact size and shape of the planting would vary from year to year (page 28 of the application). The boundaries of the field containment facility would contain the 2.5 hectare planting area. Therefore, should this application be approved, the following control is proposed by the project team.

5.3.5 Proposed control 1.4: The planting site is limited to 2.5 hectares in size at any one time. The boundaries of the field containment facility in which the field test is conducted must be marked by a permanent feature (or GPS location details).

5.3.6 It is noted that the Operator of the field containment facility would have the overall responsibility to ensure that all the controls listed in a field test approval are met. Therefore, should this application is approved, the following control is proposed by the project team.

5.3.7 Proposed control 1.3: Responsibility for conducting the field test shall be held by an Operator approved in accordance with section 40 of the Biosecurity Act 1993. The Operator is responsible for ensuring that the field containment facility and authorised staff meet all the relevant requirements

3 Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA New Zealand.

Evaluation and Review Report for GMF06002 page 47 of 221 of the Plant Containment Standard and the controls listed in this Appendix. The field containment facility manual, approved according to the requirements in the Plant Containment Standard, must be updated to incorporate all these controls.

5.4 Transport of allium material to and from the field containment facility

5.4.1 The applicant states that allium material would be transported, with MAF approval, to and from the field containment facility within sealed double bags and within a second sealed container (eg, a vehicle) (pages 29, 36 - 37 of the application).

5.4.2 The project team agrees that the double containment, eg, double-bagging of GM allium material, is an effective containment measure. As such, should this application be approved, the following control is proposed where GM allium material must be transported between the field containment facility and PC2 containment facilities in a secure manner to prevent spills (eg, following events such as a traffic accident). It is noted that section 8.2.7 of the Plant Containment Standard which requires plant material to be packaged in line with Packaging Instruction No. 650 of the IATA Dangerous Goods Regulation would not apply in this instance.

5.4.3 Proposed control 4.2: The Operator must ensure that when transferring GM allium plant material, which includes seeds, seedlings and bulbs, between PC2 containment facilities and the field containment facility, that:

(a) all the GM alliums are secured and double-contained (the packaging requirements listed in section 8.2.7 of the Plant Containment Standard do not apply); and (b) written authorisation is obtained from the MAF Inspector, as the authorised agent of the Authority, in accordance with the procedure specified in the Plant Containment Standard listed in control 1.2.

5.4.4 The applicant proposes to maintain the GM alliums within the PC2 containment facilities, both prior to and after field testing, in accordance with the HSNO Act approvals as listed in section 4.2.1 (pages 36- 37 of the application).

5.4.5 Prior to removing the GM allium material from the PC2 containment facilities, the applicant proposes to organise the material and record the amount of GM allium material that would be transferred to the field containment facility. Records would be kept of all GM allium plant material that has been transferred into or out of the field containment facility (pages 36, 37 and 64 of the application). The project team concurs with the applicant and, should this application be approved, the following proposed control would be appropriate. The register that would record the GM allium material entering and leaving the field containment facility is discussed in sections 5.5.76 - 5.5.77.

Evaluation and Review Report for GMF06002 page 48 of 221 5.4.6 Proposed control 4.3: The Operator must ensure that no GM allium plants escape during the transfer between PC2 containment facilities and the field containment facility by checking on arrival at the receiving facility that all packages are accounted for and that the packaging is closed. If a discrepancy in the number of packages is found or the packaging is opened, the contingency plan must be implemented (control 5.1).

5.4.7 The project team notes in accordance with section 8.2.8 of the Plant Containment Standard, the applicant would need to develop and document a contingency plan which would be implemented on the event of accidental release of GM plant material or other emergencies. The MAF Inspector would be notified if such an event occurred as soon as possible. However, to reiterate the importance of implementing a contingency plan to retrieve or kill any viable material of the organism that has escaped from containment, the following controls proposed by the project team would be appropriate should the application be approved.

5.4.8 Proposed control 5.1: The Operator must ensure the contingency plan for the retrieval or killing of any viable GM allium material that has escaped is implemented immediately in the event of release of viable GM allium material from the field containment facility.

5.4.9 Proposed control 5.2: The Operator must ensure the MAF Inspector, as the authorised agent of the Authority, is informed within 24 hours of the discovery of any interference with the field containment facility or any non- compliance with the controls, whether or not viable GM allium material has escaped from containment.

5.5 Planting

5.5.1 The applicant wishes to field test GM allium plants that have been, or would be developed or imported in accordance with HSNO Act approvals that match the proposed organism description in Table 2 (page 18 of the application).

5.5.2 In most instances, GM plants would not flower within the field containment facility. Any flower heads that do arise would be removed and killed or whole plants would be extracted and transferred back to the PC2 containment facilities (page 30 of the application). However, the applicant wishes for some onion bulbs to be allowed to flower within pollination cages to enable seed production.

Allium plant material 5.5.3 The applicant has proposed to plant GM seedlings and bulbs within the field containment facility. The applicant has also proposed to plant GM A. cepa onion seed directly in the ground.

5.5.4 As discussed in sections 5.6.49 - 5.6.72, the project team considers that, if this application is approved, GM allium seedlings, bulbs and seeds could be

Evaluation and Review Report for GMF06002 page 49 of 221 safely planted within the field containment facility and has included this in the proposed organism description in Table 2.

5.5.5 As discussed in sections 5.6.110 - 5.6.112, plants to be field tested would not be derived directly from tissue culture (page 24 of the application). Therefore, should this application be approved, the following control regarding the type of material planted in the field containment facility is proposed by the project team.

5.5.6 Proposed control 5.3: The Operator must ensure that all GM alliums planted in the field containment facility are not derived directly from tissue culture.

5.5.7 The applicant proposes that all GM allium lines would be extensively characterised in the laboratory or glasshouse by molecular and biochemical techniques including techniques such as PCR, Southern blotting, trait expression analysis and protein function assays prior to field testing. The plants would not be field tested if they do not function in the glasshouse as predicted (page 17 of the application). The project team agrees and, should this application be approved, proposes the following controls.

5.5.8 Proposed control 5.4: The Operator must ensure that all GM alliums planted in the field containment facility are phenotypically true-to-type with respect to flowering or seed characteristics by the use of scientifically validated methods. GM alliums with modified characteristics for flower induction, eg flowering only after the application of a chemical inducer, are approved for field testing as long as all other flowering and seed characteristics are phenotypically true-to-type.

5.5.9 Proposed control 5.5: The Operator must ensure that all GM alliums planted in the field containment facility exhibit the approved traits by the use of scientifically validated methods.

5.5.10 The applicant proposed to forward a list of all lines to be field tested along with an annual field test design to ERMA New Zealand and MAF (page 28 of the application). The project team considers that this information would enable MAF to verify that the GM alliums to be field tested fit within the approved organism description. Therefore, should this application be approved, the following control is proposed by the project team.

5.5.11 Proposed control 5.6: The Operator must obtain from the MAF Inspector, approval to plant GM alliums in the field containment facility at least 30 working days before the planting takes place. The Operator must provide to the MAF Inspector a written request outlining the nature of the genetic modification, the scientifically validated methods used to assess the phenotype of the GM alliums (in accordance with proposed controls 5.4 and 5.5) and a unique organism description for the GM alliums to be planted. The MAF Inspector must verify the details of the GM alliums against the approved organism description of the approval and confirm this with the Operator. The Operator must provide to ERMA New Zealand a unique

Evaluation and Review Report for GMF06002 page 50 of 221 organism description of the GM alliums to be field tested for the ERMA New Zealand register.

Duration of Field Test 5.5.12 The applicant seeks approval for a ten year field test. This period is requested by the applicant to allow for multiple evaluations of the same germplasm and also recognises that the development of transgenic alliums, within the bounds of the approved organism description, would be ongoing through this field test. The applicant considered that ten years would provide sufficient time to achieve the research objective (pages 9 and 27 of the application).

5.5.13 The project team notes that the applicant‟s field test for A. cepa modified to carry the C4 EPSPS gene for herbicide tolerance (application GMF03001) finished 4 years after the approval was granted. However, the project team notes that if approved, this proposed field test would involve four species of alliums with many different traits. Therefore the project team considers that should this application be approved, a ten year period for the field test would be appropriate.

5.5.14 The project team considers that, should this application be approved, the following proposed controls that limit the duration of the field test to ten consecutive calendar years from the date of first planting, and require the approval holder to notify ERMA New Zealand and the MAF Inspector in writing of their intention to use the approval for the first time, would be appropriate.

5.5.15 Proposed additional control 7.1: The Operator must ensure the notification in writing to ERMA New Zealand and the MAF Inspector, as the authorised agent of the Authority, the activation of this approval. This field test must commence within five (5) years of the date of the signing of the decision.

5.5.16 Proposed additional control 7.8: The Operator must ensure that all GM alliums are removed from the field containment facility at completion of the field test, a maximum of ten (10) consecutive calendar years from the activation by Crop and Food Research of the decision, and that final monitoring commences (control 6.5).

Planting Design 5.5.17 Onion seed would be hand planted or planted with a small machine seeder that takes a minimum of 2 g of seed. The seeder delivers seed into a soil depth of 1.5 cm and minimises seed dispersal over a large area. The seeds would be well covered with soil to prevent consumption by birds or dispersal by wind. The applicant states that this machine would be used exclusively in the field site to prevent the release of GM seed that may be trapped in the machine (pages 29 and 30 of the application).

5.5.18 The applicant proposes that seed would be planted at a starting density estimated to give the required plant number per plot based on the germination efficiency and the predicted number of null segregants (plants

Evaluation and Review Report for GMF06002 page 51 of 221 that are derived from GM plants but do not contain the specific genetic modification) (page 34 of the application).

5.5.19 The potential escape of GM seeds has been assessed in sections 5.6.49 - 5.6.65. From that assessment, the following control is proposed by the project team should this application be approved.

5.5.20 Proposed control 5.7: The Operator must not permit the planting of GM allium seeds in the field containment facility when wind is equal to or greater than 4 on the Beaufort Force scale (>20-30 km per hour) at the field containment facility.

5.5.21 The project team considered that equipment used within the field containment facility including machine seeders must be cleaned to prevent release of viable GM allium material from the field containment facility. Therefore, should this application be approved, the following control is proposed.

5.5.22 Proposed control 4.1: The Operator must ensure that no living vegetative GM allium material can escape on equipment removed from the field containment facility.

Buffer rows 5.5.23 The applicant states that the GM allium planting sites would be surrounded by a non-allium buffer4 row of plants (pages 33 and 34 of the application). The project team considered that, to provide clarity for monitoring and disposal, these plants must be morphologically different from the GM alliums. Therefore, should this application be approved, the following control is proposed. The disposal of buffer plants within the field containment facility is discussed in sections 5.5.57 - 5.5.58.

5.5.24 Proposed additional control 7.2: The Operator must ensure that genetically modified alliums are easily recognisable by the planting in the buffer rows of morphologically different species (eg, have different foliage) in the adjacent plots. The Operator must ensure that no genetically modified plants of any species and no GM or non-GM alliums are used in any buffer rows.

Crop Rotation 5.5.25 The applicant proposes to use a three year crop rotation to allow easy identification of volunteers and to ensure the health of the soil is maintained over the field test period (page 33 of the application). Crop rotations of 2 - 3 years should be practiced when growing allium species on one area of land in order to eliminate build up of allium pathogens, resulting in successful plant growth.

4 Plants that are grown around the experimental plots to control for any edge effects. These are planted as part of the experimental design and serve no containment or risk mitigation purposes.

Evaluation and Review Report for GMF06002 page 52 of 221 5.5.26 A rotation similar to that below has been proposed by the applicant (page 33 of the application): Year 1 Alliums Year 2 GM brassicas or other crops Year 3 Fallow Year 4 Alliums 5.5.27 The project team considers that to detect the presence of GM allium volunteers, rotation crops must be morphologically different (eg, have different foliage) from the GM alliums planted at the same location.

5.5.28 The project team considered the use of other GM crops as rotational crops in sections 5.6.114 - 5.6.117. As a result, it was considered that, if this application is approved, GM crops (other than GM alliums) could be used as rotational crops as long as this is permitted under the field test approvals for those specific GM crops. A control to that effect is proposed by the project team should this application be approved. The disposal of rotational crops within the field containment facility is discussed in sections 5.5.57 - 5.5.58.

5.5.29 Proposed additional control 7.3: The Operator must ensure that genetically modified alliums are easily recognisable by the planting of morphologically different species (eg, have different foliage) as rotational crops. The Operator must ensure that the conditions of the relevant approvals are complied with where other GM crops (other than GM alliums) are used as rotational crops. Alliums are prohibited as rotational crops.

Flowering and Seed Production 5.5.30 The applicant proposes to plant onion (A. cepa) bulbs for seed production in the field containment facility. The applicant proposes to plant approximately 80 bulbs per cage at a density of 50 bulbs per m2. These blocks would be planted at least 5 m from the edge of the field containment facility and the plants would be contained within insect-proof double layer mesh cages at least two weeks prior to flower opening. Insects (bees or lab reared flies) would be placed inside the cages in order for pollination to occur (pages 29 and 31 of the application).

5.5.31 The project team does not consider wind-blown pollen to be a pathway for escape of GM allium heritable material and this is discussed in sections 5.6.21 - 5.6.27. As discussed in sections 5.6.28 - 5.6.48, the project team considers that insects carrying pollen are a potential pathway for escape of GM allium heritable material and, should this application be approved, the following controls are proposed to prevent the escape of insects carrying pollen from the pollination cages.

5.5.32 MAF have stated that “MAF supports the use of pollen-cages for effective containment of bee pollinators and Allium pollen in open-field situation” (Appendix 7).

Evaluation and Review Report for GMF06002 page 53 of 221 5.5.33 The project team notes the importance of mesh size to prevent the pollinating insects escaping, and to prevent other insects entering and escaping with viable pollen. Therefore, should this application be approved, the following control is proposed to ensure that no insects can move through the mesh covering the pollination cages.

5.5.34 Proposed control 5.9: The Operator must demonstrate to the MAF Inspector that insects capable of carrying pollen cannot move through the mesh of the pollination cages.

5.5.35 To ensure that plants do not flower outside pollination cages should this application be approved, the following control is proposed by the project team that the A. cepa must be monitored weekly and pollination cages must be placed over these plants at least two weeks prior to flower opening.

5.5.36 Proposed control 5.12: Where GM Allium cepa plants are approved to flower in the field containment facility, the Operator must ensure that all developing flowers are detected at least two weeks before flowers are due to open, by the weekly inspection of the plants that are approved to flower. The Operator must ensure that no pollen escapes from the Allium cepa flowers by placing pollination cages over the flowering plants at least two weeks before flowers are due to open. The Operator must ensure that plants approved to flower and enclosing pollination cages are at least 5 metres from the boundary of the field containment facility.

5.5.37 To ensure the suitability of the pollination cages to contain the pollinating insects should this application be approved, the following control is proposed by the project team requiring that the pollination cages are inspected by MAF before each season of use.

5.5.38 Proposed control 5.8: The Operator must ensure that the MAF Inspector, as the authorised agent of the Authority, inspects and endorses all pollination cages as suitable for the containment of all insects capable of carrying pollen. This must occur at the beginning of each planting season.

5.5.39 Some submitters had concerns about the pollination cages blowing over in the wind (eg, Bleakley, Lees and others). The applicant proposes that pollination cages would be fixed to the ground to prevent them from being blown over (page 31 of the application). The project team concurs and, should this application be approved, proposes the following control.

5.5.40 Proposed control 5.11: The Operator must demonstrate to the MAF Inspector that the pollination cages can not be dislodged. The contingency plan must be immediately implemented in the event that a pollination cage is dislodged in any way that would permit the escape of insects capable of carrying pollen (control 5.1).

5.5.41 To ensure that insects do not escape from the pollination cages when the insects are first introduced into the cages or while live insects are present in the pollination cages should this application be approved, the following controls are proposed by the project team.

Evaluation and Review Report for GMF06002 page 54 of 221 5.5.42 Proposed control 5.13: The Operator must ensure that no insects capable of carrying pollen can escape from the pollination cages containing live insects by conducting a daily inspection of pollination cages.

5.5.43 Proposed control 5.14: The Operator must ensure that no insects escape when they are introduced into the pollination cages. The Operator must ensure that no staff or any other authorised person enters the pollination cages during the period that the cages contain insects capable of carrying pollen.

5.5.44 The applicant states that after pollination has occurred, the insects would be sprayed with insecticide and left to decay inside the cages (page 31 of the application). Therefore, should this application be approved, the following control is proposed by the project team for the applicant to demonstrate to the MAF Inspector that insecticide can penetrate the mesh and kill all insects inside.

5.5.45 Proposed control 5.10: The Operator must demonstrate to the MAF Inspector before the first use of the pollination cages that insecticide can penetrate through the mesh of the pollination cages and kill all the insects contained within the pollination cages.

5.5.46 The applicant states that the seed heads would be harvested once the seed capsule walls start to crack open, and would be transported in double bags to PC2 containment facilities (a control has been proposed to that effect in section 5.5.50 should this application be approved). The applicant states that harvesting would occur approximately one month after pollination and several weeks before seeds are able to fall from the opened seed capsules (page 31 of the application).

5.5.47 The applicant states that pollination cages would remain in place until all the seed heads have been harvested (page 31 of the application). The project team notes the comment from MAF “There is no reason for the pollen-cages to remain in situ once the plants have been pollinated and the bees been euthanised. If the Operator intends to leave pollen-cages in situ…this should be voluntary rather than a mandatory additional control.” (Appendix 7).

5.5.48 It is noted that if all plants flower at the same time, the pollination cages would need to remain in place at least 6 days past the final pollen production as pollen is only viable for 6 days (section 4.1.22). However, if flowering is asynchronous or the environmental conditions prolong the viability of the pollen, the project team cannot be certain that viable GM pollen would not be present within the pollination cage at the time seed heads are to be harvested.

5.5.49 Therefore, should this application be approved, the project team proposes that pollination cages must remain in place until all the seed heads have been harvested, and prior to the harvesting of any seed head, the pollination cages are to be sprayed with insecticide to kill any insects that may have inadvertently entered the pollination cages and may escape with viable GM pollen. Therefore, should this application be approved, the following control is proposed by the project team.

Evaluation and Review Report for GMF06002 page 55 of 221 5.5.50 Proposed control 5.15: The Operator must ensure that no seeds produced in the pollination cages are released in the pollination cages by harvesting all seed heads prior to the shedding of seeds from the seed capsules. The Operator must ensure that all seed heads are collected from the plants approved to flower before authorising the removal of the enclosing pollination cages. The Operator must ensure that pollen does not escape from the pollination cages by the spraying of insecticide in the pollination cages immediately before the harvesting of the seed heads to kill all insects capable of carrying pollen.

5.5.51 The applicant states that if seeds are accidently released from seed heads, they are likely to fall to the ground near the parent plant (pages 31-32 of the application). The project team notes that, if the pollination cages are designed to prevent the transit of insects, such cages would be expected to also prevent the release of seeds outside the pollination cages should premature cracking of the seed capsules occurs.

5.5.52 The applicant notes that an isolation distance of 1000 m is considered to be the accepted international standard for isolation of onion seed (page 35 of the application), but noted that since no flowers would be produced in the open in the field containment facility (the only flowers produced would be within pollination cages), this distance would not be required. The applicant also noted that onion breeders routinely have pollination cages containing different crosses adjacent to each other without suffering contamination between the pollination cages (page 35 of the application).

5.5.53 Given the containment controls proposed regarding onion seed production within the field containment facility, the project team agrees that this isolation distance is not required for this field test should this application be approved. However, if the Authority may wish to consider a control mandating an isolation distance, the project team will investigate this matter further.

Disposal of plant material from the field containment facility 5.5.54 If this application is approved, the project team proposes the following control that all living GM allium vegetative material from the field containment facility that is not retained for research purposes must be either killed on-site by composting or another scientifically validated method, or transferred to a PC2 containment facility for disposal or further research. It is noted that GM allium material retained for research purposes would be subject to the relevant HSNO Act containment approval for the organisms once transferred back into a PC2 containment facility.

5.5.55 Proposed control 5.16: The Operator must ensure that all living GM allium vegetative material from the field containment facility not required for further research is killed on-site by composting or another scientifically validated method or transferred to a PC2 containment facility for further research or to be killed. The Operator must ensure that all GM allium material retained for further research purposes is contained under the relevant

Evaluation and Review Report for GMF06002 page 56 of 221 HSNO Act containment approval for these organisms once they are transferred to the PC2 containment facility.

5.5.56 The project team notes DOC‟s recommendation that “measures be undertaken to ensure that the composting has been effective in rendering the GM plants non-viable and ensure the resulting destruction of material. We also suggest that the contained composting areas are also locked as detailed under the security measures for the field test itself” (Appendix 8). The project team notes that proposed control 5.16 requires a scientifically validated disposal method to be used and that any composting must occur on- site within the field containment facility.

5.5.57 The project team considered that, should this application be approved, all buffer rows and the non GM rotational crops must be disposed of on-site within the field containment facility and that any GM rotational crops must be disposed of as permitted in the field test approvals for those GM crops. Therefore, the following control is proposed by the project team.

5.5.58 Proposed control 5.17: The Operator must ensure that all buffer row plants and any non GM rotational crops planted within the containment facility are composted or ploughed into the ground within the field containment facility for the duration of the field test (including the final post-harvest monitoring period). The Operator must ensure GM rotational crops are disposed of according to the controls approved in the field test decisions for those GM crops.

Monitoring during the field test 5.5.59 The applicant proposes that during the growing season, the field containment facility would be monitored weekly to ensure that GM plants would not flower within the field containment facility, except for those specifically designated for seed production within pollination cages. Any flower heads that do arise would be removed and killed or whole plants would be extracted and transferred back to the PC2 containment facilities (page 30 of the application).

5.5.60 The project team considers that instead of proposing a specific monitoring interval to detect bolting or early flower opening (eg, weekly), that monitoring must be appropriate to the developmental stage of the GM alliums and therefore, should this application be approved, proposes the following control.

5.5.61 Proposed control 6.2: The Operator must ensure the detection of the onset of bolting or early flower opening by monitoring of the field containment facility, during the period when GM alliums are present. The Operator must ensure that scientifically validated methods are used for monitoring and that staff are trained to detect the onset of bolting or early flower opening. The Operator must ensure that if bolting or early flower opening is detected, the entire flower head or the whole plant is disposed of as set out in control 5.16. The only exception to control 6.2 are GM Allium cepa plants approved for seed production and these are subject to controls 5.8 - 5.15.

Evaluation and Review Report for GMF06002 page 57 of 221 5.5.62 Following each annual harvest, the applicant proposes that the field containment facility would be closely monitored every three months in order to identify GM allium volunteers (pages 32 and 38 of the application). However, the project team considers that, should this application be approved, the monitoring must be monthly to ensure that GM allium volunteers are not overlooked. Therefore, should this application be approved, the following control is proposed by the project team.

5.5.63 Proposed control 6.4: The Operator must ensure that all volunteer allium plants are detected by the monthly monitoring, to commence at the end of each growing season, of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road. The Operator must ensure the disposal, in accordance with control 5.16, of all detected allium volunteer plants.

5.5.64 The project team notes DOC‟s comment “The Department would be more comfortable with this approach [use of machine seeder] if there were some element of monitoring……to ensure that no seeds are inadvertently windblown or ingested by birds/animals” (Appendix 8) and considers that monitoring as prescribed in proposed control 6.4 would detect the germination of such seeds.

5.5.65 In addition, the project team considered that a log must be kept detailing all the monitoring activities. To that end, should this application be approved, the following control is proposed by the project team.

5.5.66 Proposed control 6.3: The Operator must ensure a monitoring log is kept and made available for inspection by the MAF Inspector. This log must include:

(a) the date of monitoring inspections and the name of the person undertaking the monitoring; (b) the number of bolting or early flowering plants detected outside pollination cages and the action taken to contain the bolting or early flowering plants; and (c) the date, details and locations of any volunteer alliums found and the action taken.

5.5.67 The project team considered that the MAF Inspector must inspect and audit the field containment facility to ensure compliance at crucial times during plant growth such as when flowering could occur. Therefore, should this application be approved, the following control is proposed by the project team.

5.5.68 Proposed control 6.1: The Operator must ensure that the MAF Inspector, as the authorised agent of the Authority, has access to inspect and audit the field containment facility at any reasonable time to ensure the field containment facility is in full compliance with this approval. The Operator must arrange for inspection of the field containment facility and auditing of its operation to occur:

Evaluation and Review Report for GMF06002 page 58 of 221 (a) twice during the growing season, including at least once during the period when flowering could occur; and (b) once during the winter season if GM alliums are planted in the field containment facility over the winter.

Post harvest monitoring at the end of the field test 5.5.69 The project team notes that at the end of the field test, all GM allium material from the field containment facility must be disposed of and a post-field test monitoring period is required to detect any GM allium volunteers.

5.5.70 The applicant proposes that the field containment facility would be monitored visually (every 3 months) for at least a year following either the completion of the field test or the detection of any GM allium volunteers (pages 32 and 40 of the application).

5.5.71 However, the project team considers that the monitoring should be more frequent to ensure that GM allium volunteers are not overlooked and proposes that, should the application be approved, the final post-harvest monitoring must involve monitoring the field containment facility, the 10 metres surrounding the containment facility and the track from the containment facility to the road monthly for volunteer alliums. The initial monitoring period must be two years which will be extended by at least two more years if allium volunteers are found. Once the final post harvest monitoring has been completed, ERMA New Zealand must be notified that all controls have been met.

5.5.72 The project team notes concerns from submitters that the viability of onion seed may be greater than that described by the applicant (sections 5.6.58 - 5.6.59) and that allium vegetative structures (bulbs, cloves) may persist in the soil for more than the six to eight months without breaking dormancy which is stated in the application (pages 15 - 16 of the application) (section 5.6.67) (Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟ and The Soil and Health Association of New Zealand Inc). The project team recognises these concerns and considers the post harvest monitoring for at least two years would be sufficient to detect such GM bulbs or seeds once dormancy is broken. Therefore, should this application be approved, the project team proposes the following controls.

5.5.73 Proposed additional control 7.8: The Operator must ensure that all GM alliums are removed from the field containment facility at completion of the field test, a maximum of ten (10) consecutive calendar years from the activation by Crop and Food Research of the decision, and that final monitoring commences (control 6.5).

5.5.74 Proposed control 6.5: The Operator must ensure that a monitoring period of a minimum of two (2) calendar years begins at the completion of the field test, and if in that period any allium volunteer plants are detected a new two (2) year monitoring period must begin from the date of the the detection of the most recent detection of an allium volunteer plant. The Operator must ensure that allium volunteer plants are detected by prohibiting the planting of

Evaluation and Review Report for GMF06002 page 59 of 221 any allium plants in the field containment facility for the duration of the final monitoring period. The Operator must ensure the detection of allium volunteer plants by the monthly monitoring of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road for the duration of the final monitoring period. The Operator must ensure, in accordance with control 5.16, the disposal of all detected volunteer allium plants found during the final monitoring period.

5.5.75 Proposed additional control 7.9: The Operator must notify ERMA New Zealand of the completion of the final monitoring of the field containment facility and that all controls have been complied with.

Plant registers 5.5.76 The project team considered that an appropriate records system is required to track GM allium material entering and leaving the field containment facility and therefore, should this application be approved, the following control is proposed by the project team.

5.5.77 Proposed control 5.18: The Operator must ensure that a register of GM allium lines planted and grown in the field containment facility is maintained. The following records must be kept for each plant line:

(a) the identity of the plant line (species, cultivar or breeding line and details of genetic modification); (b) the identity of the authorised person responsible for the plant(s); (c) the date of planting in the field containment facility; (d) the location of rows of the plants within the field containment facility; (e) the date of transfer of plant(s) or viable plant material between PC2 containment facilities and the field containment facility; and (f) the date and method of final disposal of plant(s).

Security Measures 5.5.78 The applicant notes that the field containment facility would be enclosed by fencing, and access to the field containment facility would be restricted to authorised trained personnel. The applicant proposes that the gate to the field containment facility would be locked when authorised persons are not present (page 38 of the application). Further details regarding the security of the field containment facility are included in the Confidential Appendix C1 of the application.

5.5.79 The project team agrees that such requirements would restrict public access to the field containment facility. Therefore, should this application be approved, the following controls are proposed by the project team.

5.5.80 Proposed control 2.1: The Operator must ensure that at all times only persons authorised by the Operator shall have access to the field containment

Evaluation and Review Report for GMF06002 page 60 of 221 facility. The Operator must maintain measures to restrict unauthorised access to the field containment facility that include:

(a) a fence that restricts public access into the field containment facility must enclose the site; (b) gates must be closed at all times and locked whenever there are no authorised persons present; and (c) a record of the entry of authorised personnel into the field containment facility.

5.5.81 Proposed control 3.2: The Operator must ensure that the integrity of the field containment facility boundary fence is maintained at all times.

5.5.82 Proposed control 5.2: The Operator must ensure the MAF Inspector, as the authorised agent of the Authority, is informed within 24 hours of the discovery of any interference with the field containment facility or any non- compliance with the controls, whether or not viable GM allium material has escaped from containment.

Staff experience and training 5.5.83 It is noted that Crop and Food Research has previously conducted field tests approved under the HSNO Act. These include GM potato approvals GMF98007 and GMF98008, the GM onions approval GMF03001 and the recent GM brassicas approval GMF06001.

5.5.84 The applicant states that all authorised staff would be trained in the correct protocols and procedures for the operation of this field test, and all new staff would be trained according to the containment manual for the field containment facility (Appendix 2 of the application) (page 39 of the application). Therefore, should the application be approved, the project team notes the following proposed control would require all personnel involved in the field test to be trained as per the requirements of section 7.1.3 of the Plant Containment Standard and to be informed of any controls required by the Authority.

5.5.85 Proposed control 1.3: Responsibility for conducting the field test shall be held by an Operator approved in accordance with section 40 of the Biosecurity Act 1993. The Operator is responsible for ensuring that the field containment facility and authorised staff meet all the relevant requirements of the Plant Containment Standard and the controls listed in this Appendix. The field containment facility manual, approved according to the requirements in the Plant Containment Standard, must be updated to incorporate all these controls.

5.5.86 Schedule 3, Part I, Matter 7 of the Act specifies that controls may address the qualifications required of the person responsible for implementing those controls. The project team considers that the current Crop and Food Research staff members have relevant training and experience and that new staff would be well trained, and therefore considers that Crop and Food

Evaluation and Review Report for GMF06002 page 61 of 221 Research staff are appropriately qualified to manage the highly technical tasks and responsibilities associated with the field test should this application be approved. Therefore, the project team does not propose any controls related to qualifications of staff.

5.6 Pathways of escape of the organisms from containment

Introduction 5.6.1 Potentially significant pathways are those where it may be possible for heritable GM plant material to escape from containment.

5.6.2 As discussed in sections 5.1.1 - 5.1.2, for the purposes of containment during field tests, containment can be achieved when the escape of the whole organism or any part of the organism that can reproduce itself or pass a heritable characteristic or trait is prevented. The Authority may determine that an organism can be adequately contained even if some material from the organism may be lost from the field containment facility, provided that the material is not capable of reproducing itself (without human assistance) or of conferring heritable traits to other organisms, and any risk arising from the loss of such material are taken into account and addressed appropriately.

5.6.3 “Heritable material” is defined in section 2 of the Act as “viable biological material, including gametes and spores, arising from the organism that can, without human intervention, regenerate the organism or reproduce a new generation of the same species of the organism” while “genetic element” is defined as heritable material and any genes, nucleic acids or other molecules from the organism that can, without human intervention, replicate in a biological system and transfer a character or trait to another organism or to subsequent generations of that organism.

5.6.4 The project team notes that the parts of allium plant material that would be considered to be heritable plant material would be bulbs, seeds, seedlings and cloves (garlic). The project team considered that, as A. cepa pollen is not wind dispersed (as discussed in sections 5.6.21 - 5.6.27), such pollen can only be classed as heritable material under circumstances when pollination can occur (ie, when the pollen is dispersed by insects). Leaves, roots and stalks from allium plants are not heritable material. Therefore the pathways of escape for GM allium bulbs, seeds, seedlings, pollen and genetic elements are identified and assessed in the following sections.

5.6.5 In accordance with section 44A of the Act, the potential for genetic elements from the GM alliums to escape containment via horizontal gene transfer (HGT) was considered. HGT is defined as the transfer of genetic material from one organism to another organism that is outside of the context of parent to offspring reproduction (Heinemann, 2003). Some submitters expressed concern about HGT and the persistence of recombinant DNA in the soil (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), Bleakley, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc, GE Free New Zealand (In Food and Environment) Inc and others).

Evaluation and Review Report for GMF06002 page 62 of 221 5.6.6 ERMA New Zealand has produced a generic issues report “Risk assessment of horizontal gene transfer from GM plants to bacteria and human cells” evaluating the scientific evidence related to the potential for HGT to occur from GM crops (ERMA New Zealand, 2006).

5.6.7 In this report, it is noted that there are a number of biological barriers that would hinder HGT from occurring, and that the transferred genetic material must confer a selective advantage to be retained. It was also noted that no instances of HGT of transgenes from GM organisms to other organisms has been detected under field conditions, such as HGT from GM plants to insects (ERMA New Zealand, 2006). From this information, the project team considers that it would be highly improbable5 that HGT will occur.

5.6.8 However, the project team considered whether genetic material from the GM alliums may provide a selective advantage, and so may enhance the possibility of HGT occurring within the field containment facility.

5.6.9 The project team first considered whether genetic material such as antibiotic or herbicide resistance genes may confer a selective advantage to soil microorganisms. The project team notes that antibiotic or herbicide resistance genes would provide a selective advantage only in the continuous presence of antibiotics or herbicides. As such conditions are not seen in the field, the expression of such genes is not expected to provide a selective advantage under field conditions. Therefore, the project team still considers that should this application be approved, it would be highly improbable for HGT to occur under these circumstances.

5.6.10 A recent study investigated the potential transfer of antibiotic resistance genes to soil bacteria which had been exposed to insect-resistant maize for up to 10 successive years and concluded that the risk of the antibiotic-resistant genes from GM plants to commensual and clinical bacteria should be considered almost null as a plethora of antibiotic resistance genes are already present in soil bacteria and the constant selection pressure to which they are subjected limit the impact of a newly acquired (identical gene) from GM plants would have (Demanèche et al, 2008).

5.6.11 The project team considered whether the antibacterial or antifungal proteins expressed by the GM alliums (sections 4.4.2 - 4.4.11) may confer a selective advantage on soil bacteria and so enhance the likelihood of HGT occurring.

5.6.12 The project team considered that soil microorganisms expressing such proteins may have a selective advantage but only if those proteins specifically kill or inhibit neighbouring microorganisms that compete or suppress the growth of the host organism and do not act against the host organism. However, the project team notes that there would still be significant biological barriers that must first be overcome for the intact antimicrobial coding sequences to be obtained by an organism and the

5 “Highly improbable” is defined as “almost certainty not occurring but cannot be totally ruled out” (see Appendix 3 for further explanation).

Evaluation and Review Report for GMF06002 page 63 of 221 antimicrobial protein produced. The protein must then show the advantageous characteristics as listed above. Therefore, the project team still considers that it would be highly improbable for HGT to occur under these circumstances.

5.6.13 The project team notes that none of the modifications are expected to enhance the virulence, pathogenicity or the infectivity of the soil microorganisms to plants or animals (the production of vertebrate toxins is excluded from the proposed organism description (Table 2)).

5.6.14 Some submitters had concerns about disposal of material on-site (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others). The project team considered whether the proposed disposal methods on-site (such as composting) would enhance the possibility of HGT occurring should this application be approved. Composting has been shown to cause the rapid degradation of transgenic DNA and so was proposed as a safe disposal method of transgenic plant material (Guan et al, 2005). Therefore the project team does not consider that methods such as composting would significantly enhance the chances of HGT occurring should this application be approved.

Escape through the development of novel viruses with altered pathogenicity, vector specificity or altered host range that spread beyond the field containment facility 5.6.15 It was considered whether the field testing of virus-resistant plants could result in the development of novel viruses with altered pathogenicity, vector specificity or host range that would allow the spread of heritable genetic elements outside the field containment facility. Such viruses could theoretically arise through heteroencapsidation, recombination, or transcomplementation. One submitter provided information about transcomplementation (GE Free New Zealand (In Food and Environment) Inc).

5.6.16 Heteroencapsidation is the encapsidation of the genome of one virus by the coat protein of another virus and may theoretically occur if a GM plant that expressed coat proteins was infected with a virus (Fuchs and Gonsalves, 2007; Tepfer, 2002). Recombination is the exchange between the RNA genome of an infecting virus and viral transgene mRNA transcripts (Fuchs and Gonsalves, 2007; Aaziz and Tepfer, 1999; Alejska et al, 2001). Transcomplementation is where the expression of a viral protein by a GM plant increases the susceptibility of the plant to, or enhance or supports, a viral infection and so may theoretically increase the opportunities for recombination to occur (Fuchs and Gonsalves, 2007; Latham and Wilson, 2008).

5.6.17 While with heteroencapsidation and transcomplementation the viral genome is not altered, recombination may produce a virus with an altered genome that can be passed on to its progeny (Prins et al, 2008; Fuchs and Gonsalves, 2007).

Evaluation and Review Report for GMF06002 page 64 of 221 5.6.18 However, for recombination to occur, a number of events must occur in succession: (1) a vector carrying an appropriate virus needs to land or contact the GM plant and then feed/probe and transmit the viral particles; (2) the virions must disassemble and the viral genome must replicate; (3) the genome must recombine with the transgene mRNA and is then encapsidated; (4) these viral particles (which must be viable, have altered biological characteristics compared to the parental virus, be able to evade RNA silencing by the plant and out-compete the parental virus) must cause systemic infection with the plant (Chung et al, 2007); and (5) the recombinant virus must be acquired by a vector or otherwise transmitted to a new plant, infect this plant etc. (Fuchs and Gonsalves, 2007). The project team considers that in light of the information outlined above that the likelihood of such events occurring in succession is highly improbable.

5.6.19 It is noted that no recombination events have been detected in the field and the emergence of recombinant viruses with undesirable properties has not been detected over the last 8-10 years of commercial release or extensive experimental testing of virus-resistant papaya, squash or plum (Fuchs and Gonsalves, 2007).

5.6.20 However, the project team notes that modifications that intentionally produce viral particles (such as the insertion of significant amounts of a viral genome into the plant genome) should be prohibited should this application be approved. Modifications that result in the intentional production of infectious particles are excluded from the proposed organism description in Table 2 (section 4.7.9).

Escape of GM pollen via wind during flowering of GM onions within pollination cages 5.6.21 Many submitters expressed concerns about the potential for GM pollen to spread from the field containment facility. The project team considered whether wind-blown pollen is a pathway of escape for the GM allium heritable material from the field containment facility.

5.6.22 As noted in section 4.1.21, pollination of onions is usually by insects, and studies have shown that wind pollination of onions is unlikely (Woyke, 1981). The project team could not find any additional evidence that A. cepa are wind-pollinated.

5.6.23 As GM A. cepa pollen requires an insect to carry it to receptive A. cepa plants, wind-blown pollen would not be able to transfer the GM allium traits to A. cepa plants outside the field containment facility. Therefore the project team considers that A. cepa pollen should only be classed as heritable material under circumstances when pollination can occur (ie, when dispersed by insects).

5.6.24 The project team notes that, should this application be approved, the following control is proposed so that the pollination cages must be placed at least 5 metres from the boundary of the field containment facility.

Evaluation and Review Report for GMF06002 page 65 of 221 5.6.25 Proposed control 5.12: Where GM Allium cepa plants are approved to flower in the field containment facility, the Operator must ensure that all developing flowers are detected at least two weeks before flowers are due to open, by the weekly inspection of the plants that are approved to flower. The Operator must ensure that no pollen escapes from the Allium cepa flowers by placing pollination cages over the flowering plants at least two weeks before flowers are due to open. The Operator must ensure that plants approved to flower and enclosing pollination cages are at least 5 metres from the boundary of the field containment facility.

5.6.26 The project team considers that any pollen blown from flowers would likely remain inside the pollination cages. However, if any pollen was blown from the pollination cages it would likely remain within the field containment facility (eg, on the ground) and would rapidly lose viability (<6 days). There would be no reason to expect that insects would be attracted to such pollen in the absence of flowers. The potential for HGT has been previously discussed in sections 5.6.5 - 5.6.14.

5.6.27 Therefore the project team considers that the dispersal of pollen by wind is not a pathway of escape of the GM allium heritable material and so is not discussed further. However, the dispersal of GM pollen by insects is a potential pathway for escape. This pathway is discussed in sections 5.6.28 - 5.6.48.

Escape of GM pollen via insects during flowering of GM onions within pollination cages 5.6.28 Many submitters expressed concerns about the potential for GM pollen to accidentally spread from the field containment facility. The project team specifically notes the submission from Federated Farmers Bees (an industry group that represents the New Zealand bee industry) that considers that “field tested plants must not be allowed to flower under any circumstances”.

5.6.29 As discussed in section 5.5.30, the applicant has proposed that, due to the difficulty in producing seeds within PC2 containment facilities, onion bulbs would be planted and allowed to flower within pollination cages within the field containment facility (page 30 of the application). However, no alliums would be allowed to flower outside of the pollination cages in the field containment facility.

5.6.30 The project team considers that given the biological characteristics of alliums, the distinctive nature of allium floral structures and the restricted size of the field containment facility, effective monitoring to detect plants that have begun to flower could be achieved. Therefore, should this application be approved, the following control is proposed by the project team.

5.6.31 Proposed control 6.2: The Operator must ensure the detection of the onset of bolting or early flower opening by monitoring of the field containment facility, during the period when GM alliums are present. The Operator must ensure that scientifically validated methods are used for monitoring and that

Evaluation and Review Report for GMF06002 page 66 of 221 staff are trained to detect the onset of bolting or early flower opening. The Operator must ensure that if bolting or early flower opening is detected, the entire flower head or the whole plant is disposed of as set out in control 5.16. The only exception to control 6.2 are GM Allium cepa plants approved for seed production and these are subject to controls 5.8 - 5.15.

5.6.32 The project team specifically notes in the submission from Federated Farmers Bees, the recommendation that all bulbs are grown within pollination cages to “serve as insurance against the occasional “bolter” to flowering” was proposed. However, the project team considers that, due to the monitoring as described in proposed control 6.2, such a practise would not be required. The project team notes that premature flowering can occur due to vernalisation (cold induction) or stress (pages 13 - 14 of the application). However, proposed control 6.2 would detect such premature flowering occurring.

5.6.33 In addition, the project team considered the proposed genetic modifications, and notes that, while none of these modifications would be expected to promote early or unpredictable flowering, the following proposed control would ensure that the GM alliums to be field tested would be true-to-type in flowering and seed characteristics (with an exception for plants modified for chemically-induced flowering).

5.6.34 Proposed control 5.4: The Operator must ensure that all GM alliums planted in the field containment facility are phenotypically true-to-type with respect to flowering or seed characteristics by the use of scientifically validated methods. GM alliums with modified characteristics for flower induction, eg flowering only after the application of a chemical inducer, are approved for field testing as long as all other flowering and seed characteristics are phenotypically true-to-type.

5.6.35 As discussed in sections 5.5.30 - 5.5.53, should the application be approved, the following controls are proposed by the project team to prevent escape of the insects carrying GM pollen.

5.6.36 Proposed control 5.8: The Operator must ensure that the MAF Inspector, as the authorised agent of the Authority, inspects and endorses all pollination cages as suitable for the containment of all insects capable of carrying pollen. This must occur at the beginning of each planting season.

5.6.37 Proposed control 5.9: The Operator must demonstrate to the MAF Inspector that insects capable of carrying pollen cannot move through the mesh of the pollination cages.

5.6.38 Proposed control 5.10: The Operator must demonstrate to the MAF Inspector before the first use of the pollination cages that insecticide can penetrate through the mesh of the pollination cages and kill all the insects contained within the pollination cages.

5.6.39 Proposed control 5.11: The Operator must demonstrate to the MAF Inspector that the pollination cages can not be dislodged. The contingency

Evaluation and Review Report for GMF06002 page 67 of 221 plan must be immediately implemented in the event that a pollination cage is dislodged in any way that would permit the escape of insects capable of carrying pollen (control 5.1).

5.6.40 Proposed control 5.12: Where GM Allium cepa plants are approved to flower in the field containment facility, the Operator must ensure that all developing flowers are detected at least two weeks before flowers are due to open, by the weekly inspection of the plants that are approved to flower. The Operator must ensure that no pollen escapes from the Allium cepa flowers by placing pollination cages over the flowering plants at least two weeks before flowers are due to open. The Operator must ensure that plants approved to flower and enclosing pollination cages are at least 5 metres from the boundary of the field containment facility.

5.6.41 Proposed control 5.13: The Operator must ensure that no insects capable of carrying pollen can escape from the pollination cages containing live insects by conducting a daily inspection of pollination cages.

5.6.42 Proposed control 5.14: The Operator must ensure that no insects escape when they are introduced into the pollination cages. The Operator must ensure that no staff or any other authorised person enters the pollination cages during the period that the cages contain insects capable of carrying pollen.

5.6.43 The project team notes that, in the submission from Federated Farmers Bees, the placing of insect traps within the pollination cages to trap any insects that may enter the pollination cages was recommended, as well as the use of totally bee-resistant pollination cages. The project team notes that if such traps were placed inside the pollination cages during pollination, the pollinating insects would be trapped, preventing efficient pollination from occurring.

5.6.44 However, the project team notes that, should this application be approved, proposed control 5.9 would mean that the pollinations cages used must not allow the transit of insects capable of carrying pollen into or out of the pollination cages (and therefore will be bee-resistant), and so does not consider that such traps would be required. In addition, as discussed in sections 5.5.46 - 5.5.50, proposed control 5.15 would ensure that prior to the harvesting of any seed heads, the pollination cages must be sprayed with insecticide.

5.6.45 Proposed control 5.15: The Operator must ensure that no seeds produced in the pollination cages are released in the pollination cages by harvesting all seed heads prior to the shedding of seeds from the seed capsules. The Operator must ensure that all seed heads are collected from the plants approved to flower before authorising the removal of the enclosing pollination cages. The Operator must ensure that pollen does not escape from the pollination cages by the spraying of insecticide in the pollination cages immediately before the harvesting of the seed heads to kill all insects capable of carrying pollen.

Evaluation and Review Report for GMF06002 page 68 of 221 5.6.46 The project team notes that, should pollen escape, pollination of alliums outside of the pollination cages within the field containment facility would not occur as no GM alliums would be allowed to flower outside pollination cages (proposed control 6.2) and alliums cannot be used in buffer rows or as rotational crops (proposed additional controls 7.2 and 7.3). The events that would need to occur for insects carrying GM pollen to transfer the trait to plants outside containment are discussed in section 6.2.11.

5.6.47 The applicant states that, if any GM plants should inadvertently flower outside of pollination cages, the Operator would inform any onion seed producers within 1000 m of the field containment facility (page 39 of the application). The project team notes that the contingency plan would be implemented if such an event occurred (proposed control 5.1).

5.6.48 Given the above management regime, the project team considers that, should this application be approved, it would be highly improbable that GM allium plants could escape from containment through flowering and dispersal of pollen by insects.

Escape of GM seeds from the field containment facility through planting of seeds or from seed heads in pollination cages 5.6.49 As described in section 5.5.17, the applicant intends for onion seed to either be hand planted or planted with a small machine seeder (page 30 of the application). The project team notes MAF comments “MAF considers that the use of a small machine seeder in the trial will offer a practical means of planting the trial.” (Appendix 7).

5.6.50 The project team considers that the sowing of seed would be well controlled using a machine seeder or by planting by hand, minimising the risk of seed dispersal, and has therefore not proposed controls around this practice except as described below.

5.6.51 Some submitters had concerns about the planting of GM onion seed (eg, submissions from a number of individuals). Although onion seed lacks wind disperal mechanisms, it is small (3 mm long) and relatively light (300 seeds/gram) (Brewster, 1994) and therefore, should this application be approved, the project team proposes the following control to minimise the effect of wind by prohibiting the planting of seed during conditions where wind could readily disperse seeds. The potential for seed dispersal by animals is discussed in sections 5.6.94 - 5.6.103.

5.6.52 Proposed control 5.7: The Operator must not permit the planting of GM allium seeds in the field containment facility when wind is equal to or greater than 4 on the Beaufort Force scale (>20-30 km per hour) at the field containment facility.

5.6.53 The project team considers that, should this application be approved, the following control would ensure that GM seeds would not be accidentally moved outside the field containment facility on equipment used to plant seeds.

Evaluation and Review Report for GMF06002 page 69 of 221 5.6.54 Proposed control 4.1: The Operator must ensure that no living vegetative GM allium material can escape on equipment removed from the field containment facility.

5.6.55 The applicant has noted that onions and leeks are usually sown in this manner and have not established wild populations (Healy and Edgar, 1980; Roy et al, 2004), indicating that escape and persistence through this route is not an issue (page 30 of the application).

5.6.56 The prevention of escape of GM seed during seed production was discussed in sections 5.5.46 - 5.5.53 and, should this application be approved, the following control is proposed by the project team.

5.6.57 Proposed control 5.15: The Operator must ensure that no seeds produced in the pollination cages are released in the pollination cages by harvesting all seed heads prior to the shedding of seeds from the seed capsules. The Operator must ensure that all seed heads are collected from the plants approved to flower before authorising the removal of the enclosing pollination cages. The Operator must ensure that pollen does not escape from the pollination cages by the spraying of insecticide in the pollination cages immediately before the harvesting of the seed heads to kill all insects capable of carrying pollen.

5.6.58 Onion seeds are not considered long lived and do not have a seed dormancy. The applicant considers that onion seeds are expected to have less than three weeks viability during the Canterbury autumn/winter period (page 15 of the application). The project team notes that some submitters had concerns that onion seed may have longer viability than that stated in the application (Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟ and The Soil and Health Association of New Zealand Inc). Therefore, the project team asked for expert opinions from onion growers.

5.6.59 Onion seed needs moisture to germinate and minimum temperatures of 1-5◦C, so all seeds in the Canterbury region are likely to have germinated by spring (Eamon Balle in litt.). Only in ideal hot and dry conditions (ie, no moisture) will onion seeds remain viable for longer than 12 months (Russell Corfield in litt.).

5.6.60 In the case of seed being carried outside of the field containment facility, it is noted that onion seed requires specific conditions to germinate, grow and thrive. For example A Growers Guide for Growing Onions in Canterbury (McCartney, 1991) describes the conditions to successfully grow onions. For example, requirements for soil type (a well structured free-draining loam free of stones), site preparation (such as weed elimination as onions do not compete with weeds), seed bed preparation (a fine moist seed bed is ideal), sowing depth (must be shallow so that the seeds are in the warmest soil layer), the necessary weed, pest and disease control throughout the life of the plant, and the irrigation requirements.

5.6.61 Further to this, should this application be approved, the following proposed monitoring, both during the field test and at the completion of the field test

Evaluation and Review Report for GMF06002 page 70 of 221 (for at least 2 years), would be sufficient to detect any viable GM seeds that showed delayed germination.

5.6.62 Proposed control 6.4: The Operator must ensure that all volunteer allium plants are detected by the monthly monitoring, to commence at the end of each growing season, of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road. The Operator must ensure the disposal, in accordance with control 5.16, of all detected allium volunteer plants.

5.6.63 Proposed control 6.5: The Operator must ensure that a monitoring period of a minimum of two (2) calendar years begins at the completion of the field test, and if in that period any allium volunteer plants are detected a new two (2) year monitoring period must begin from the date of the the detection of the most recent detection of an allium volunteer plant. The Operator must ensure that allium volunteer plants are detected by prohibiting the planting of any allium plants in the field containment facility for the duration of the final monitoring period. The Operator must ensure the detection of allium volunteer plants by the monthly monitoring of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road for the duration of the final monitoring period. The Operator must ensure, in accordance with control 5.16, the disposal of all detected volunteer allium plants found during the final monitoring period.

5.6.64 The project team notes comments from MAF “MAF does not envisage problems from un-germinated Allium seed in the field, given the length of the post-harvest monitoring (1 year) concluding each trial.” (Appendix 7).

5.6.65 Given the above management regime, the project team considers that if this application is approved, it would be highly improbable that GM allium plants could escape from containment through dispersal of seed. Therefore the project team proposes that, if this application is approved, the planting of GM seeds directly in the ground be permitted.

Escape from containment through vegetative bulb propagation 5.6.66 As discussed in section 4.1.18, the alliums produce bulbs after their first year of growing, and flower structures during their second year of growth. Apart from the onions that the applicant has proposed to be allowed to flower in pollination cages for seed production, the applicant intends to plant GM allium seeds, seedlings and bulbs which would not be allowed to flower. It is noted that alliums cannot regenerate through leaves, stalks or roots without human intervention (page 14 of the application).

5.6.67 The project team notes concerns from submitters that allium vegetative structures (bulbs, cloves) may persist in the soil for more than the six to eight months without breaking dormancy (this is stated in pages 15 - 16 of the application) (Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟ and The Soil and Health Association of New Zealand Inc). In addition, the

Evaluation and Review Report for GMF06002 page 71 of 221 project team notes that premature flowering can occur due to vernalisation (cold induction) or stress (pages 13 - 14 of the application).

5.6.68 The project team considers that, should the application be approved, the following proposed controls requiring monitoring of plants for bolting would be sufficient to detect plants that aberrantly produce flowering structures, and the monitoring for allium volunteers between growing seasons and at the end of the field test (for at least 2 years) would be sufficient to detect any viable bulbs and prevent the escape of GM allium material.

5.6.69 Proposed control 6.2: The Operator must ensure the detection of the onset of bolting or early flower opening by monitoring of the field containment facility, during the period when GM alliums are present. The Operator must ensure that scientifically validated methods are used for monitoring and that staff are trained to detect the onset of bolting or early flower opening. The Operator must ensure that if bolting or early flower opening is detected, the entire flower head or the whole plant is disposed of as set out in control 5.16. The only exception to control 6.2 are GM Allium cepa plants approved for seed production and these are subject to controls 5.8 - 5.15.

5.6.70 Proposed control 6.4: The Operator must ensure that all volunteer allium plants are detected by the monthly monitoring, to commence at the end of each growing season, of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road. The Operator must ensure the disposal, in accordance with control 5.16, of all detected allium volunteer plants.

5.6.71 Proposed control 6.5: The Operator must ensure that a monitoring period of a minimum of two (2) calendar years begins at the completion of the field test, and if in that period any allium volunteer plants are detected a new two (2) year monitoring period must begin from the date of the the detection of the most recent detection of an allium volunteer plant. The Operator must ensure that allium volunteer plants are detected by prohibiting the planting of any allium plants in the field containment facility for the duration of the final monitoring period. The Operator must ensure the detection of allium volunteer plants by the monthly monitoring of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road for the duration of the final monitoring period. The Operator must ensure, in accordance with control 5.16, the disposal of all detected volunteer allium plants found during the final monitoring period.

5.6.72 Given the above management regime the project team considers that, should this application be approved, it would be highly improbable that GM allium plants could escape from containment through vegetative bulb propagation. Therefore the project team proposes that, should this application is approved, the planting of GM seedlings and bulbs be permitted.

Evaluation and Review Report for GMF06002 page 72 of 221 Escape of GM allium material through irrigation system failure or a flooding event 5.6.73 Within the field containment facility, localised flooding as a result of a burst irrigation pipe or other flooding events may lead to the displacement of allium material. The project team considers that only seed and seedlings are likely to be displaced by flooding as established plants will have more complex root systems anchoring them in the soil. However, as discussed in sections 5.6.58 - 5.6.60, alliums require specific conditions to germinate, grow and thrive.

5.6.74 The project team considers that, should this application be approved, this pathway of escape from containment would be highly improbable as such events would be easily observed by workers in the field containment facility, and localised flooding would be unlikely to cause escape of material from the field containment facility. Furthermore, any displaced allium plants could be retrieved. The project team notes that in the event of flooding, proposed control 5.1 would requires the contingency plan for the retrieval or killing of viable material to be implemented.

Escape of GM allium material by forces of nature (eg, wind, fire) 5.6.75 The potential for loss of GM allium material from the field containment facility by flooding is discussed in sections 5.6.73 - 5.6.74. The potential for GM seed or pollen to be lost from the field containment facility by wind is discussed in sections 5.6.21 - 5.6.27 and 5.6.51 - 5.6.52. In addition, the potential for loss of plant material planted in the field containment facility by the forces of nature such as fire is considered here.

5.6.76 The project team considers that, should this application be approved, natural events such as fire would be likely to significantly reduce the viability of any plant material and that it would be highly improbable to cause an escape of the GM alliums.

Escape of GM allium material through the intentional removal of plants by unauthorised persons 5.6.77 Given the controversial nature of GM field tests, there is a risk of GM allium material being removed from containment as a result of sabotage, theft or vandalism. As discussed in sections 5.5.78 - 5.5.82, the following controls are proposed by the project team should this application be approved. The project team considers that, should this application be approved, these proposed controls would ensure that every reasonable measure would be taken by the applicant to make the escape of plant material by intentional removal by unauthorised person(s) highly improbable.

5.6.78 Proposed control 2.1: The Operator must ensure that at all times only persons authorised by the Operator shall have access to the field containment facility. The Operator must maintain measures to restrict unauthorised access to the field containment facility that include:

(a) a fence that restricts public access into the field containment facility must enclose the site;

Evaluation and Review Report for GMF06002 page 73 of 221 (b) gates must be closed at all times and locked whenever there are no authorised persons present; and (c) a record of the entry of authorised personnel into the field containment facility.

5.6.79 Proposed control 3.2: The Operator must ensure that the integrity of the field containment facility boundary fence is maintained at all times.

Escape of GM allium material through the unapproved removal of allium material by authorised personnel 5.6.80 The project team notes that, if this application is approved, authorised personnel could potentially remove GM allium material from the field containment facility for purposes outside of this approval, but given the training and experience of the people associated with the field test (sections 5.5.83 - 5.5.86), the project team considers that the likelihood of allium material being removed from the field containment facility by authorised person(s) for unapproved use would be highly improbable.

Escape of GM allium material through the unintentional removal by human activity 5.6.81 The project team notes that, if this application is approved, heritable allium material may escape from containment as a result of handling errors by workers or as a result of being caught in machinery in the field containment facility. The potential for removal on equipment used for the planting of seeds has been discussed in sections 5.6.53 - 5.6.54.

5.6.82 Therefore, should this application be approved, the following control is proposed by the project team.

5.6.83 Proposed control 4.1: The Operator must ensure that no living vegetative GM allium material can escape on equipment removed from the field containment facility.

5.6.84 In addition, should this application be approved, the following control is proposed by the project team which would require all personnel involved in the field test to be trained and informed of any controls required by the Authority.

5.6.85 Proposed control 1.3: Responsibility for conducting the field test shall be held by an Operator approved in accordance with section 40 of the Biosecurity Act 1993. The Operator is responsible for ensuring that the field containment facility and authorised staff meet all the relevant requirements of the Plant Containment Standard and the controls listed in this Appendix. The field containment facility manual, approved according to the requirements in the Plant Containment Standard, must be updated to incorporate all these controls.

5.6.86 Given the proposed controls and the experience and training of the staff working in the field containment facility, the project team considers that, if

Evaluation and Review Report for GMF06002 page 74 of 221 this application is approved, the likelihood of plant material being inadvertently removed from containment on equipment would be highly improbable.

Escape of GM allium material during transit 5.6.87 Escape from containment during transit was discussed in section 5.4 and if the application is approved, the following controls are proposed by the project team.

5.6.88 Proposed control 4.2: The Operator must ensure that when transferring GM allium plant material, which includes seeds, seedlings and bulbs, between PC2 containment facilities and the field containment facility, that:

(a) all the GM alliums are secured and double-contained (the packaging requirements listed in section 8.2.7 of the Plant Containment Standard do not apply); and (b) written authorisation is obtained from the MAF Inspector, as the authorised agent of the Authority, in accordance with the procedure specified in the Plant Containment Standard listed in control 1.2.

5.6.89 Proposed control 4.3: The Operator must ensure that no GM allium plants escape during the transfer between PC2 containment facilities and the field containment facility by checking on arrival at the receiving facility that all packages are accounted for and that the packaging is closed. If a discrepancy in the number of packages is found or the packaging is opened, the contingency plan must be implemented (control 5.1).

5.6.90 The project team considers that if escape occurred during transit, it would be likely that most of the plant material would be recovered from the spill site. It is noted that if this application is approved, the following controls proposed by the project team would require a contingency plan to be implemented if the release of GM allium material occurred and for MAF to be notified promptly if such an event occurred.

5.6.91 Proposed control 5.1: The Operator must ensure the contingency plan for the retrieval or killing of any viable GM allium material that has escaped is implemented immediately in the event of release of viable GM allium material from the field containment facility.

5.6.92 Proposed control 5.2: The Operator must ensure the MAF Inspector, as the authorised agent of the Authority, is informed within 24 hours of the discovery of any interference with the field containment facility or any non- compliance with the controls, whether or not viable GM allium material has escaped from containment.

5.6.93 The project team notes comments from MAF BNZ “Seed can be transported more readily to the trial site for planting” (Appendix 7). The project team considers that, should this application be approved, if the above measures were adopted then the escape of GM alliums during transit would be highly improbable.

Evaluation and Review Report for GMF06002 page 75 of 221 Escape of GM allium material through the removal of plant material by animals (such as rodents, rabbits, birds, cattle, sheep) 5.6.94 The project team considered the removal of allium plant material from the field containment facility by animals, including livestock such as cattle and vermin (defined as organisms that are to be excluded from the facility such as rodents, rabbits and birds) removing or consuming parts of the GM allium plants.

5.6.95 The project team notes that the applicant suggested shade cloth as a suitable method for preventing rabbits and other vermin from entering the field containment facility (page 41 of the application). It is noted that, should this application be approved, section 8.6 of the Plant Containment Standard would require an effective vermin control programme to be implemented. The project team notes a concern that arose during the hearing for the previous onion field test (application GMF03001) that pukekos may hoard allium bulbs. The project team notes that, as such behavior was not observed in an indepth study of pukekos in the Manawatu (Fordham, 1983), hoarding by pukekos is not considered further.

5.6.96 The project team considers that, should this application be approved, the following proposed controls would result in the exclusion of undesirable and unwanted organisms from the field containment facility.

5.6.97 Proposed control 2.1: The Operator must ensure that at all times only persons authorised by the Operator shall have access to the field containment facility. The Operator must maintain measures to restrict unauthorised access to the field containment facility that include:

(a) a fence that restricts public access into the field containment facility must enclose the site; (b) gates must be closed at all times and locked whenever there are no authorised persons present; and (c) a record of the entry of authorised personnel into the field containment facility.

5.6.98 Proposed control 3.1: The Operator must ensure that construction and operation of the field containment facility must comply with the requirements of the Plant Containment Standard relating to the exclusion of other organisms from the field containment facility and the control of undesirable and unwanted organisms within the field containment facility.

5.6.99 Proposed control 3.2: The Operator must ensure that the integrity of the field containment facility boundary fence is maintained at all times.

5.6.100 The project team notes DOC‟s recommendation that monitoring for pest activity is undertaken “From the ERMA control requirements in the control manual part 3.2 there is instruction that the Operator should monitor the site for pest damage…The Department endorses this activity and would like to see the detail of this clearly stated for all readers of the current application”

Evaluation and Review Report for GMF06002 page 76 of 221 (Appendix 8) and consider that this would be covered by proposed control 3.1.

5.6.101 It is noted that for livestock, such as sheep or cattle, to be able to remove GM allium material from the containment facility, the animal would need to first enter the field containment facility. For this to occur, a failure in containment would need to take place. Given the proposed containment controls (such as fencing requirements), should this application be approved, it would be considered highly improbable that a breach of containment would occur. Therefore it would be considered that highly improbable that GM allium material would be removed by livestock.

5.6.102 The project team considers that, should this application be approved, with the above containment measures it would be highly improbable that vermin would remove heritable GM allium plant material from the field containment facility.

5.6.103 In addition, the project team considers that even if plant material (including seeds) is consumed by the animals, this would be made non-viable in the animal‟s gut.

Escape of GM allium material through the plants having aberrant phenotypes 5.6.104 Submitters identified aberrant phenotypic expression of the GM plants as a result of genetic modification process as a concern (eg, The Soil and Health Association of New Zealand Inc, GE Free New Zealand (In Food and Environment) Inc and others) and therefore, the possibility of plants in the proposed field test behaving in a way that would result in an escape from containment. For example, if the GM plant were to flower early, then the procedures used to detect and deal with such plants may not be effective, or if the modifications resulted in pollen or seeds that were physically changed to alter the ability to disperse (eg, become wind dispersed) or to enhance hardiness, then this may alter the risks of flowering or planting of seed. The potential for the modifications to unintentionally enhance the ability of the alliums to form a self-sustaining population is discussed in section 6.

5.6.105 Aberrant phenotypic expression could result from either the genetic modification process (eg, from plant tissue culture) or the genetic modification itself. For example, the insertion of transgenes into the plant genome could result in insertion-site mutations such as deletions, chromosomal rearrangements or insertion of superfluous DNA sequences (eg, partial copies of the transgene) which may disrupt or alter the activity of neighbouring genes (Latham et al, 2006; Filipecki and Malepszy, 2006). “Position effect” may occur where the site of integration can influence the transgene expression and stability (Filipecki and Malepszy, 2006).

5.6.106 Aberrant phenotypic expression can also result from altered levels or activities of endogenous proteins such as transcription factors or from the expression of foreign sequences or proteins; either of which may have broad and unanticipated effects on the phenotype. Batista et al (2008) have shown that transformants with inserted genes coding for transcription factors may

Evaluation and Review Report for GMF06002 page 77 of 221 affect the activity of a number of genes whose promoters contain the for that transcription factor.

5.6.107 However, the applicant states that “the genetic modifications will not enhance the ability of the pollen and seed to disperse or escape” (page 26 of the application). The applicant has also stated that the organisms to be field tested would be essentially true-to-type (eg, would look and behave as non- GM alliums except for the key feature modified) (page 25 of the application) and that plants would not be field tested if they do not behave under laboratory or glasshouse conditions as predicted.

5.6.108 The project team proposes that, should this application be approved, GM alliums that have altered phenotypes in relation to flowering and seed characteristics be excluded from the proposed organism description (Table 2). The project team also notes proposed control 5.4 where all GM alliums to be field tested would be evaluated and tested in the laboratory or glasshouse and must be true-to-type in flowering and seed characteristics (with an exception for plants modified for chemically-induced flowering).

5.6.109 Proposed control 5.4: The Operator must ensure that all GM alliums planted in the field containment facility are phenotypically true-to-type with respect to flowering or seed characteristics by the use of scientifically validated methods. GM alliums with modified characteristics for flower induction, eg flowering only after the application of a chemical inducer, are approved for field testing as long as all other flowering and seed characteristics are phenotypically true-to-type.

5.6.110 It is noted that plants regenerated through tissue culture methods may have altered traits such as altered leaf and flower morphology, plant height, fertility, plant vigour, and stress tolerance (called somaclonal variation) (Skirvin et al, 1994; Filipecki and Malepszy, 2006; Latham et al, 2006).

5.6.111 However, the applicant stated that field test material would not be derived directly from tissue culture (page 24 of the application). The project team agrees with this and, should this application be approved, proposes the following control.

5.6.112 Proposed control 5.3: The Operator must ensure that all GM alliums planted in the field containment facility are not derived directly from tissue culture.

5.6.113 Given the above management regime, the project team considers that, should this application be approved, it would be highly improbable that GM allium plants could escape from containment through the GM plants having aberrant flowering or seed characteristics.

Escape of genetic elements through the use of GM rotational crops 5.6.114 The project team considered whether having GM rotational crops planted in the same soil as the GM alliums may increase the chances of HGT occurring.

Evaluation and Review Report for GMF06002 page 78 of 221 The project team could not identify any specific reasons for this to occur and therefore proposes the following control should this application be approved.

5.6.115 Proposed additional control 7.3: The Operator must ensure that genetically modified alliums are easily recognisable by the planting of morphologically different species (eg, have different foliage) as rotational crops. The Operator must ensure that the conditions of the relevant approvals are complied with where other GM crops (other than GM alliums) are used as rotational crops. Alliums are prohibited as rotational crops.

5.6.116 The project team notes that any GM crops used as rotational crops must be handled and disposed of as described in the field test approval for that crop. It should be noted that GMOs could only be used as rotational crops if this activity has been assessed and permitted under that GMO‟s field test approval.

5.6.117 The project team therefore considers that, should this application be approved, escape via this pathway would be highly improbable.

Conclusions on the ability to adequately contain the GM alliums and heritable genetic material 5.6.118 Taking account of the structure and operation of the field containment facility, the training, qualifications and experience of the Crop and Food Research staff, the monitoring and the proposed controls, the project team considers that, should this application be approved, it would be highly improbable that the GM alliums would escape from containment. The project team considers it would be highly improbable that any heritable genetic material from the GM alliums could escape the field containment facility.

Evaluation and Review Report for GMF06002 page 79 of 221 6 Assessment of the ability of the organism to establish a self-sustaining population

6.1 Undesirability of a self-sustaining population

6.1.1 As GM alliums are not approved for release in New Zealand, a self- sustaining population of GM alliums outside of containment would be undesirable.

6.2 Ability to establish a self-sustaining population 6.2.1 GM alliums could potentially form a self-sustaining population either through escape of the whole plant, including bulbs left in the ground at the completion of the field test, and/or through release of genetic material by the dispersal of pollen (via insects) or seed. Potential pathways of escape and the controls proposed to prevent the escape of all GM allium material from the field containment facility are discussed in section 5.6.

6.2.2 As discussed in section 4.1.39, outside of cultivated fields, crop alliums only rarely exist as casual garden outcasts (Roy et al, 2004), are slow growing and susceptible to weed competition and require specific growth conditions to thrive (sections 5.6.58 - 5.6.60). Onions compete poorly with weeds as their foliage gives no shade, and weeds quickly outgrow them (McCartney, 1991).

6.2.3 Wild type onions show few (if any) weedy characteristics. When onions were compared to a known allium weed in New Zealand, three-cornered garlic (A. triquetrum) (onion weed), it was noted that onion weed can grow in damp shaded sections of gardens, stream banks, shaded waste places, roadside banks, shaded gullies and wastelands. The spread of this plant is mainly (but possibly not only) through seed and small offset bulbs carried in water along ditches and drains, in soil for topdressing gardens, and in spoil used as fill or in road making (Healy and Edgar, 1980; Esler, 1988). The spread of this plant seems to be mainly through human activities (ie, the plant does not have specific adaptations to facilitate its own spread).

6.2.4 Therefore, as the wild type alliums applied for should not form a self- sustaining population, it was then considered whether the genetic modification could increase the fitness of the GM plants and enhance the ability to form a self-sustaining population.

6.2.5 The project team firstly considered what characteristics would need to be modified to change a non-weedy plant into a weedy one. The project team notes that the ideal characteristics of weeds include: germination requirements fulfilled in many environments; discontinuous germination and greater longevity of seed; rapid growth through vegetative phase to flowering; adaptations for short- and long-distance dispersal; cross- pollination, when it occurs, by unspecialised visitors or wind; self- compatibility but not complete autogamy or apomixes; and the ability to complete interspecifically by special means (such as rosettes, choking growth, allelochemicals) (Radosevich et al, 2007).

Evaluation and Review Report for GMF06002 page 80 of 221 6.2.6 The applicant considers that none of the agronomic traits would enhance the fitness of the plants outside of cultivated field habitats, and that the quality trait improvements would more likely reduce the fitness of the plants in question (pages 8-9 of the application). The increase in the GM alliums‟ susceptibility to pests is discussed in sections 7.5.9 - 7.5.12.

6.2.7 The project team agrees that herbicide tolerance would confer a selective advantage only in an agricultural setting and only if that specific herbicide is used. It was then considered whether the transfer of virus, disease or insect- resistance genes to allium species could significantly enhance the fitness or weediness of either the wild or domesticated species. It was noted that if the wild plants are not significantly adversely affected by viruses, disease, or insects, such a phenotype would provide only a limited advantage to these plants. In addition, an increase in population size and therefore enhanced weediness of the wild species due to these phenotypes would only occur if the disease or insect is a factor which limits the population size (Prins et al, 2008; Fuchs and Gonsalves, 2007; Tepfer, 2002). The eradication of GM alliums is discussed in section 6.3.

6.2.8 It was then considered whether plants with quality traits may have increased fitness. It was noted that some modifications may result in GM plants which may have enhanced ability to survive under specific circumstances. For example, changes in the levels of fructans may enhance chilling or freezing tolerance (Hisano et al, 2004; Kawakami et al, 2008). However, such traits would only contribute to weediness if sensitivity to frost or freezing temperatures was the only factor that limited the weediness of the alliums.

6.2.9 The applicant considers that “the genetic modifications will not enhance the ability of the pollen and seed to disperse or escape” (page 26 of the application). The project team considered whether the modifications could unintentionally result in a GM plant with characteristics which would enhance its ability to form a self-sustaining population or to escape containment, for example, a GM allium that produces pollen or seeds with increased longevity or wind dispersal characteristics. However, the project team considers that a number of different genes or biochemical pathways would have to be altered simultaneously to result in such plants and that such modifications are unlikely to occur inadvertently. It is also noted that such modifications would be unlawful as they would be beyond the scope of the proposed organism description (Table 2).

6.2.10 The applicant considers that if a GM plant did escape the field containment facility (as a seed, bulb or seedling), it would be unlikely to survive to a flowering stage as crop alliums are slow growing and susceptible to weed competition (Rubin, 1990). Furthermore, the applicant has noted that onions and leek are very susceptible to inbreeding depression such that any selfed seed would be less fit. Garlic, which is exclusively vegetatively propagated in New Zealand, is prone to virus accumulation and therefore decreased fitness (page 43 of the application).

6.2.11 The project team notes in relation to GM pollen, insects carrying pollen (which is only viable for up to 6 days) (Currah, 1990) would need to fly to

Evaluation and Review Report for GMF06002 page 81 of 221 receptive flowers for pollination and seed production to occur. As onions are not expected to cross pollinate any wild species of alliums in New Zealand (sections 4.1.39 - 4.1.46), an insect carrying the pollen would need to find a cultivated flowering A. cepa population. The resulting GM seed would then need to germinate, grow, flower, be pollinated, produce seed for a self- sustaining population to potentially form. The project team notes that for the GM plants to thrive, the plants would need to out-compete with the wild type plant or other plants in the area or colonise a new niche (eg, the trait would need to provide a selective advantage). However, the project team considered that the proposed modifications would not significantly enhance the ability of alliums to form a self-sustaining population.

6.2.12 Therefore the project team considers that, should this application be approved, it would be highly improbable that self-sustaining populations could be established from GM allium material. As concluded in section 5.6.118, with the proposed containment regime in place, the escape of GM alliums or GM allium heritable material was assessed as highly improbable. Therefore, the project team considers with the proposed controls in place, if this application is approved, that it would be at worst highly improbable that the GM alliums would escape from containment and form a self- sustaining population.

6.3 Assessment of the ease of eradication of a self-sustaining population

6.3.1 The applicant notes that the eradication of a self-sustaining population of GM alliums would be easy. The population, once identified, could be eliminated by the application of most broad spectrum herbicides (eg, amitrole or MCPA). An appropriate herbicide (eg, other than glyphosate for glyphosate-tolerant plants) could effectively eliminate such individuals, and the escaped plants could be removed at minimal cost (pages 43 and 44 of the application). The project team concurs with this assessment.

Evaluation and Review Report for GMF06002 page 82 of 221 7 Identification of potentially significant adverse effects and beneficial effects (risks, costs and benefits)

7.1 Introduction

7.1.1 Risks, costs and benefits are identified using the terms adverse and beneficial effects.

7.1.2 Potentially significant adverse and beneficial effects are identified and analysed as described in section 3.2.1 - 3.2.4. Identifying effects requires identifying the sources of effect (eg, the hazards and sources of beneficial effect), the pathways for exposure, and the areas of impact.

7.1.3 The sources of effect are associated with the characteristics of the organism(s) and the type of application, in this case a contained field test, the primary sources of effects are therefore the characteristics of the GM allium plants (along with seed or pollen).

7.1.4 Allium bulbs, seedlings and seeds may also be the source of plants that may cause weed problems in the environment through crossing with other allium plants.

7.1.5 Pollen spread by insects is a potential source of contamination of nearby allium seed crops. It is also a potential source of spread of the agronomic or quality trait to other species.

7.1.6 Genetic elements6 present in allium plant material are also a possible source of transfer of GM traits to other organisms.

7.1.7 The GM alliums themselves may be a selective pressure for the development of resistance of insects and microbes.

7.2 Areas of impact

7.2.1 In accordance with clauses 9 and 10 of the Methodology and Part 2 of the Act, the project team has categorised adverse and beneficial effects in relation to the following areas of impact: the environment, human health and safety, relationship of Māori to the environment, the market economy, and society and the community.

7.3 Identification of potential effects

7.3.1 The project team identified potential effects related to the application by brainstorming (Appendix 9), and through review of the application and

6 Genetic element is defined in the Act as “heritable material” and “any genes, nucleic acids, or other molecules from the organism that can, without human intervention, replicate in a biological system and transfer a character or trait to another organism or to subsequent generations of the organism”.

Evaluation and Review Report for GMF06002 page 83 of 221 public submissions received by ERMA New Zealand. The identification is based on the requirements of the Act and the Methodology.

7.3.2 Potential effects identified are listed in Table 3. These include effects identified by the applicant and effects identified by the project team and submitters.

7.3.3 Those effects that are considered by the project team to be potentially significant are assessed in section 8. Other effects have been discussed in the section below.

Evaluation and Review Report for GMF06002 page 84 of 221 Table 3: Identification of potential effects

ENVIRONMENT

Potentially Non-target effects on soil biodiversity by antimicrobial, significant adverse antifungal or other transgene products effects discussed in Harm to other non-target organisms such as invertebrates section 8. Development of resistance to Bt toxins of target insects

Adverse effects The spread of transgene into wild or domestic onion discussed in sections populations resulting in plants with enhanced weediness 7.5.5- 7.5.21. (fitness) The development of novel viruses with altered pathogenicity,

vector specificity or altered host range Enhanced susceptibility to other pests and diseases Development of herbicide-tolerant weeds through excessive herbicide use Increased pesticide use with pesticide-tolerant crops Contamination of ground water Altered biological characteristics due to HGT from GM alliums to other organisms Unanticipated effects of GM crops Decreased yield of GM crops

Potentially None identified significant beneficial effects.

Beneficial effects Improved disease and weed control strategies, reduction in discussed in sections crop damage, healthier soils and higher productivity 7.6.3 -7.6.7. Decrease in soil erosion due to the use of the herbicide-tolerant crop

Decreased pesticide use due to pesticide-resistant crops

Evaluation and Review Report for GMF06002 page 85 of 221 HUMAN HEALTH and SAFETY

Potentially Toxicity of GM alliums to humans (general public exposure significant adverse and occupational) effects discussed in

section 8.

Adverse effects Development of antibiotic resistant pathogenic bacteria through discussed in sections horizontal transfer of antibiotic resistance genes from GM 7.8.3 - 7.8.13. alliums The use of Agrobacterium has adverse health effects

(occupational effects) Increased exposure to chemical sprays and residues The use of the CaMV 35S promoter has unanticipated effects upon consumption Increased exposure to chemical sprays and residues in food

Potentially None identified significant beneficial effects.

Beneficial effects Reduction in toxicity due to reduced exposure to chemical discussed in sections sprays and residues 7.9.2 - 7.9.5. Enhanced health effects from multifunctional foods

RELATIONSHIP OF MĀORI TO THE ENVIRONMENT AND TREATY OF WAITANGI

Potentially None identified significant adverse effects.

Adverse effects Adverse impact on tikanga and mātauranga Māori through the discussed in sections alteration of whakapapa, mauri and tapu 7.11.1 - 7.11.22 and Adverse impacts on kaitiakitanga caused by a degradation of the 7.14.1 - 7.14.8. integrity of native species and ecosystems Inconsistency with the principles of the Treaty of Waitangi

Potentially None identified significant beneficial effects.

Beneficial effects. None identified

Evaluation and Review Report for GMF06002 page 86 of 221 SOCIETY AND COMMUNITY

Potentially None identified significant adverse effects.

Adverse effects Concern resulting from a general opposition to genetic discussed in section modification 7.17.2 - 7.17.31. Concern that field tests are not in the wider public interest Concern about genetically engineered food, including concern about loss of choice Concern about impact of the field test on home gardening Concerns about the adequacy of containment Concern about uncertainty and potential long term effects, and effects on future generations Concern that we may not be preserving options Concerns about ethical aspects of the application Concern about social costs/liability issues of conducting field tests Concern about effects on ecological health Anxiety expressed in terms of distrust Concern about the involvement of multinational companies

Potentially Enhancing New Zealand‟s ability to preserve options and significant beneficial maintain choices effects discussed in Increased scientific knowledge including knowledge about section 8. environmental impacts, agronomic performance, and the ability to use of GM crops as part of an integrated pest management (IPM) regime Demonstration of the capacity to conduct field tests in New Zealand and enhanced reputation of New Zealand agricultural research

Beneficial effects Upskilling of staff and students (qualifications) and increased discussed in sections experience in working with gene technology in the field 7.18.6 - 7.18.10. Increased understanding of the potential risks and benefits of GM crops for the public, regulators and legislators through environmental impacts research Contribution towards long term benefits to society from genetic engineering technology; and increased public understanding Additional information about cultivar development to assist plant breeders to evaluate novel germplasm, identify lines for advancement and assess performance

Evaluation and Review Report for GMF06002 page 87 of 221

THE MARKET ECONOMY

Potentially None identified significant adverse effects.

Adverse effects Concern about impact of GM pollen on honey production discussed in sections Concern about adverse impacts on trade and potential for loss 7.20.4 - 7.20.30. of clean green image Concern about loss of organic certification for local growers High economic cost Opportunity costs relating to use of research funds Opportunity costs relating to the effects on other growers (reducing options)

Potentially None identified significant beneficial effects.

Beneficial effects Enhanced ability for Crop and Food Research and other discussed in sections agencies to attract research funds (nationally and 7.21.1 -7.21.4. internationally)

7.3.4 In reviewing the information provided and identifying and assessing the adverse and beneficial effects of the organisms and the field test, the project team has taken into account the ethical matters that pertain to the conduct of the field test.

7.4 Potential effects on the environment

7.4.1 The following potential effects on the environment from this proposed field test were identified by the project team and submitters (Table 3).

7.5 Potential adverse effects on the environment

7.5.1 The applicant did not identify any potential adverse effects on the environment from the approval of this application to field test GM alliums. The project team and submitters identified a number of potential adverse effects on the environment (Table 3).

Non-target effects on soil biodiversity by antimicrobial, antifungal or other transgene products 7.5.2 Submitters had concerns about harm to soil biota from the GM alliums should this application be approved (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), Ngati Kahungunu Iwi Incorporated and

Evaluation and Review Report for GMF06002 page 88 of 221 others). The project team considered that non-target effects on soil biodiversity by antimicrobial transgene or other products expressed by the GM alliums could be a potentially significant adverse environmental effect. This has been assessed in sections 8.1.2 -8.1.7.

Harm to other non-target organisms such as invertebrates 7.5.3 Submitters had concerns about harm to non-target organism such as invertebrates from the GM alliums should this application be approved (eg, Ngati Kahungunu Iwi Incorporated, and others). The project team considered that harm to organisms such as invertebrates by the GM alliums could be a potentially significant adverse environmental effect. This has been assessed in sections 8.1.8 - 8.1.12.

Development of resistance to Bt toxins of target insects 7.5.4 Submitters had concerns about the development of insects that are resistant to the GM alliums from the field testing of insect-resistant alliums should this application be approved (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), The Sustainability Council and others). The project team considered that development of resistance to Bt toxins could be a potentially significant adverse environmental effect. This has been assessed in sections 8.1.13 - 8.1.17.

The spread of transgene into wild or domestic onion populations resulting in plants with enhanced weediness (fitness) 7.5.5 The evaluation of whether the proposed genetic modifications may increase the fitness of the GM alliums (ie, enhance the ability of the GM alliums to establish a self-sustaining population) is discussed in section 6.2. In this section, the project team concluded that the proposed modifications would not significantly enhance the weediness of the GM alliums and that it would be highly improbable that self-sustaining populations could be established from GM allium material.

7.5.6 As concluded in section 5.6.118, if this application is approved with the proposed containment regime in place, the escape of GM alliums or GM allium heritable material was assessed as highly improbable. Therefore, the project team considers that, should this application be approved, with the proposed controls in place, it would be at worst highly improbable that the GM alliums could escape from containment and form a self-sustaining population. Therefore this effect was not considered further.

The development of novel viruses with altered pathogenicity, vector specificity or altered host range 7.5.7 It was considered whether the field testing of virus-resistant plants could result in the development of novel viruses with altered pathogenicity, vector specificity or host range that could spread beyond the field containment facility and have a potential adverse effect on the environment.

Evaluation and Review Report for GMF06002 page 89 of 221 7.5.8 However, as discussed in sections, 5.6.15 - 5.6.19, should this application be approved, the likelihood of development of a viable novel virus with enhanced pathogenicity, altered host range or vector specificity arising from the small scale field testing of virus-resistant alliums spreading and establishing beyond the field containment facility would be highly improbable. Therefore, it would be considered at worst highly improbable for such an effect to occur. Therefore this effect was not considered further.

Enhanced susceptibility to other pests and diseases 7.5.9 Some submitters had concerns that the GM alliums may have enhanced susceptibility to pests and diseases (eg, Inta). Some submitters also had concerns that the GM onions from the GMF03001 field test showed enhanced susceptibility to pests (eg, Bleakley, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc, GE Free New Zealand (In Food and Environment) Inc and others).

7.5.10 The applicant considers that “the quality trait improvements are more likely to reduce the fitness of the plants in question by making them more palatable to pests and diseases” (page 8 of the application) and “removing pungency would more likely reduce the ability of the plant to deter animal herbivory” (page 23 of the application).

7.5.11 Some of the proposed modifications may enhance the susceptibility to various pests by interfering with natural plant defences, eg, altering the production of S-alk(en)yl cysteine sulphoxide flavour precursors that may be involved in defence against insect or pathogen attacks (Randle and Lancaster, 2002) or by expressing antimicrobial proteins and peptide may potentially kill beneficial microbes that normally protect the plant against disease. Transcomplementation is discussed in sections 5.6.16 - 5.6.17. The modifications may also result in alliums that are more palatable to insects or microbes eg, increased sweetness.

7.5.12 However, the project team considered that, if this application is approved, a component of assessing the agronomic value of any plants would include testing whether the plants have increased pest susceptibilities when grown under more natural conditions. It was also noted that, if this application is approved, any GM alliums that are extensively predated or diseased could be readily removed from the field containment facility and any effects of these plants would be localised and reversible. This effect was not considered further.

Development of herbicide-tolerant weeds through excessive herbicide use 7.5.13 A number of submitters had concerns about the development of herbicide- tolerant weeds through the use of larger amounts of herbicides or the use of more toxic chemicals to control such weeds should this application be approved (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟ and

Evaluation and Review Report for GMF06002 page 90 of 221 others). The effect of increased herbicide use is assessed in sections 7.5.15 - 7.5.16.

7.5.14 The project team noted that the development of such weeds may need to be considered more fully if this application was for a release of a GM plant. However, as this application is for a small scale field test, any adverse effects due to the development of resistant weeds can only be assessed within the field containment facility. Therefore, if this application is approved, due to the small size of the planting site, the development of resistant weeds would not have a significant impact and therefore this potential effect was not assessed further.

Increased pesticide use with pesticide-tolerant crops 7.5.15 A number of submitters had concerns about increased pesticide use through the use of pesticide-tolerant crops should this application be approved (eg, Bleakley and others). It is noted that there has been much debate as to whether the use of herbicide-tolerant crops has decreased, increased or not changed the amounts of herbicides used (Cerdeira and Duke, 2007).

7.5.16 However, as this application is for a small scale field test, any adverse effects due to increased herbicide use can be assessed only within the field containment facility. If this application is approved, due to the small size of the planting site, any increases in herbicide use would not have a significant impact and therefore this potential effect was not assessed further.

Contamination of ground water 7.5.17 One submitters had concerns about contamination of ground water by the GM alliums should this application be approved (Ngati Kahungunu Iwi Incorporated). If this application is approved, the project team did not consider this effect to be significant as any leaching would only arise from the 2.5 hectare planting site and the effect would only be temporary as such proteins would degrade over time. Therefore this effect was not considered further.

Altered biological characteristics due to HGT from GM alliums to other organisms 7.5.18 Some submitters had concerns about HGT in the field test should this application be approved (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others). If this application was approved, the likelihood of HGT occurring was assessed as highly improbable (sections 5.6.5 - 5.6.14), and considering the size of the field test, this would not have a significant impact. Therefore, this potential effect was not considered further.

Unanticipated effects of GM crops 7.5.19 Some submitters had concerns that the field testing of the GM alliums could result in unanticipated effects should this application be approved (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch) and others).

Evaluation and Review Report for GMF06002 page 91 of 221 7.5.20 It is noted that a reason to field test plants is to determine if any unanticipated effects occur. It is noted that if this application is approved, the GM alliums to be field tested would be tested in the laboratory or glasshouse prior to field testing which should reduce the likelihood of plants showing unanticipated effects from being field tested (proposed control 5.4, Table 2). Therefore, this potential effect was not considered further.

Decreased yield of GM crops 7.5.21 A number of submitters had concerns that GM crops (in particular a GM soybean crop) showed reduced yields (eg, Carapiet, GE Free New Zealand (In Food and Environment) Inc, Lees and others), and therefore such crops are not beneficial should this application be approved. One of the reasons for this field test would be to investigate such matters in the GM alliums. Such effects may need to be considered more fully for an application to release a GM plant. However, as this application is for a small scale field test, this potential effect was not considered further.

7.6 Potential beneficial effects on the environment

7.6.1 The applicant listed the following effects as potential environmental benefits from the approval of this application: increased knowledge of possible environmental impacts of this technology and a greater understanding of the behaviour of the modified trait under field conditions; knowledge of the agronomic impact of altering the quality or agronomic traits, estimations of chemical input savings or costs; initial information on the interactions of the plants with immediate flora and fauna (ie, environmental impact studies); and demonstration of New Zealand‟s capacity to undertake such research as immediate environmental benefits (page 58 of the application). However, as it was considered that these would be society and community effects rather than environmental, these are discussed in sections 7.18 and 8.1.30 - 8.1.48.

7.6.2 The project team identified some potentially beneficial effects on the environment from the approval of this application (Table 3).

Improved disease and weed control strategies, reduction in crop damage, healthier soils and higher productivity 7.6.3 It was considered whether improved disease and weed control strategies, reduction in crop damage, healthier soils and higher productivity are potential beneficial environmental effects should this application be approved. However, these potential benefits are beyond the scope of a field test in containment and were not assessed further.

Decrease in soil erosion due to the use of the herbicide-tolerant crops 7.6.4 A feature of herbicide-tolerant crops has been the adoption of reduced or no- till practices (where dead vegetation is left on the field instead of being ploughed under) which has resulted in reduced soil erosion and reduced fuel costs (Castle et al, 2006; Cerdeira and Duke, 2007).

Evaluation and Review Report for GMF06002 page 92 of 221 7.6.5 However, the project team considered that the realisation of this effect would be contingent on the commercialisation and wide-scale use of the GM alliums. As this potential benefit is beyond the scope of a field test in containment, this effect was not considered further.

Decreased pesticide use due to pesticide-resistant crops 7.6.6 The applicant considered the implementation of GM crops generally has a beneficial environmental effect (page 62 of the application).

7.6.7 If this application is approved, this application is for a small scale field test and any beneficial effects due to reduced pesticide use can be assessed only within the field containment facility. Due to the small size of the planting site, any decreases in pesticide use would not have a significant impact and therefore this potential effect was not assessed further.

7.7 Potential effects on human health and safety

7.7.1 The following potential effects on human health and safety from this proposed field test were identified by the project team (Table 3).

7.8 Potential adverse effects on human health and safety

7.8.1 The applicant did not identify any adverse effects on human health and safety from the field testing of GM alliums. The project team identified a number of potentially adverse effects on human health and safety (Table 3).

Toxicity of GM alliums to humans (general public exposure and occupational) 7.8.2 Submitters had concerns about harm to humans from the GM alliums should this application be approved (eg, Carapiet, GE Free New Zealand (In Food and Environment) Inc, Lees and others). The project team considered that harm to the public or field test personnel could be a potentially significant adverse effect on human health and safety. This has been assessed in sections 8.1.18 - 8.1.27.

Development of antibiotic resistant pathogenic bacteria through horizontal transfer of antibiotic resistance genes from GM alliums 7.8.3 The project team notes previous concerns regarding the potential for the antibiotic-resistance marker genes used in the development of the GM alliums to contribute to antibiotic resistance of human pathogenic bacteria.

7.8.4 ERMA New Zealand‟s policy states that the use of antibiotic resistance marker genes is acceptable in the developmental or field testing stage as the exposure to the GM organism is limited (ERMA New Zealand, 2008a; Read, 2000). HGT is discussed in sections 5.6.5 - 5.6.14 where it was considered that if this application is approved, it would be highly improbable to occur during this field test. Therefore this effect was not considered further.

Evaluation and Review Report for GMF06002 page 93 of 221 The use of Agrobacterium has adverse health effects (occupational effects) 7.8.5 A number of submitters have listed concerns about a potential relationship between Morgellons disease and Agrobacterium tumefaciens should this application be approved (eg, Carapiet, GE Free (in Food and Environment) Inc, Lees and others). Morgellons disease is described as a disorder involving fibre-like strands extruding from the skin with other dermatologic and neuropsychiatric signs and symptoms. While Agrobacterium has been tentatively linked to this disease, further investigation is required to prove a definitive link (Savely and Stricker, 2007).

7.8.6 Crop and Food Research personnel would only be exposed to the disarmed strains of GM A. tumefaciens during the initial production phase of the GM alliums, and the safe handling and disposal of GM bacteria would be prescribed in the MAF/ERMA Standard Facilities for Microorganisms and Cell Cultures: 2007.

7.8.7 The GM disarmed strains of A. tumefaciens that would be used to transform the alliums would be killed during the production of the GM alliums (page 24 of the application). If this application is approved, none of the plant material field tested would carry GM disarmed strains of A. tumefaciens and therefore no effects on either the public or field test personnel would arise. This effect was not considered further.

Increased exposure to chemical sprays and residues 7.8.8 A number of submitters have concerns that the field testing of GM alliums would result in an increase in pesticide use should this application be approved (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others). Therefore it was considered whether the field testing of pest-resistant alliums may result in an increase in the amounts of pesticides used which could have a toxic effect on the public.

7.8.9 If this application is approved, given the scale of the contained field test compared with the land used for allium production in New Zealand, any increases in exposure to chemical sprays and residues would be limited to those authorised personnel within the field containment facility. This effect was not assessed further. All commercially applied chemicals are regulated under the Act and must be used according to strict controls to protect the environment and human health.

The use of the CaMV 35S promoter has unanticipated effects upon consumption 7.8.10 A number of submitters have concerns about the use of viral promoters such as the CaMV 35S promoter if this application is approved, as it has been previously suggested that this promoter has the ability to integrate into the genome of organisms that eat GMOs (eg, Carapiet, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc, GE Free New Zealand (In Food and Environment) Inc, Lees and others). There is no evidence that the CaMV 35S promoter is mobile, and it is also noted that humans eat cabbages infected by CaMV and

Evaluation and Review Report for GMF06002 page 94 of 221 material containing DNA from other vegetables, animals and microbes with no ill effects (Tepfer, 2002).

7.8.11 This application is for a contained field test, and, should this application be approved, GM alliums would not enter the food chain or be used for human taste testing trials without further approvals. This effect was not considered further.

Increased exposure to chemical sprays and residues in food 7.8.12 A number of submitters have concerns that the field testing of GM alliums would result in an increase of pesticide levels (such as glyphosate) in food should this application be approved (eg, Carapiet, GE Free Northland (In Food and Environment) and others).

7.8.13 If this application is approved, as this application is for a contained field test and GM alliums would not enter the food chain or be used for human taste testing trials without further approvals, this effect was not considered further.

7.9 Potential beneficial effects on human health and safety

7.9.1 The applicant identified the two beneficial effects on human health and safety listed below from the field testing of GM alliums (Table 3). The project team did not identify any further beneficial effects.

Reduction in toxicity due to reduced exposure to chemical sprays and residues 7.9.2 The applicant listed the reduction in toxicity due to reduced exposure to chemical sprays and residues as a potential long term benefit to human health and safety from the approval of this application (pages 59 and 62 of the application).

7.9.3 If this application is approved, given the scale of the contained field test compared with the land used for allium production in New Zealand, the potential for a reduction in exposure to chemical sprays and residues would not be an immediate benefit of the field test. The potential beneficial effect was not considered further.

Enhanced health effects from multifunctional foods 7.9.4 The applicant listed that GM alliums may offer enhanced long term health benefits to humans as a potential beneficial effect on human health and safety if this application was approved (pages 59 and 62 of the application).

7.9.5 If this application was approved, as GM alliums would not enter the food chain without further approvals, the project team considers that this potential effect is outside the scope of this field test application, and so this effect was not considered further.

Evaluation and Review Report for GMF06002 page 95 of 221 7.10 Potential effects on relationship of Māori to the environment

7.10.1 Potential effects on relationship of Māori to the environment from this proposed field test were identified by the project team (Table 3). The consultation undertaken by the applicant is summarised in Appendix 10.

7.11 Potential adverse effects on relationship of Māori to the environment

7.11.1 The applicant did not identify any potentially adverse effects from the approval of this field test on the relationship of Māori to the environment.

7.11.2 The project team identified two potential adverse effects on the relationship of Māori to the environment if this application is approved: an adverse impact on tikanga and mātauranga Māori through the alteration of whakapapa, mauri and tapu; and adverse impacts on kaitiakitanga caused by a degradation of the integrity of native species and ecosystems (Table 3). These are discussed and analysed below.

Tikanga and Mātauranga Māori 7.11.3 Mātauranga Māori is essentially a system of knowledge and understanding about Māori beliefs relating to creation, and the relationships between entities. It is developed, like any other body of knowledge, through experience. The primary mechanism for organising this knowledge and a key determinant of the relationships between entities is whakapapa - the genealogical descent of all things. Literally whakapapa means „to lay one thing upon another‟ as, for example, to lay one generation upon another (Barlow, 1994). It is this relationship or whakapapa that determines the way people behave in the context of their environmental ethical practices.

7.11.4 Inherent to whakapapa is mauri and tapu. Mauri is the indivisible quality of the totality of an organism enabling it to move and live in accordance with the conditions and limits of its existence (Durie, 2003). It is the mauri that binds the physical and spiritual essence of things together. At the point of death the mauri is no longer able to bind the two essences together and the spiritual essence is released. The mauri is therefore a form of energy, generating, regenerating, upholding creation and ensuring harmony and balance to the processes of the Earth‟s ecosystems.

7.11.5 Tapu relates to the sacred quality afforded by the atua or gods (through the relationship of all things to the atua), and is linked to ensuring healthy practices and social regulation intended to protect mauri and mana (Durie, 2003). Māori believe that any imbalance to mauri and tapu through the interference with whakapapa may cause adverse effects to the physical and spiritual health of the affected organisms or ecosystems, including Māori themselves.

7.11.6 Tikanga is a set of ethics expressed as customs and traditions handed down through generations. They have been developed as a result of experience and

Evaluation and Review Report for GMF06002 page 96 of 221 are accepted as appropriate ways or methods of fulfilling certain objectives and goals.

7.11.7 Many Māori assert that genetic modification, the alteration of whakapapa and mauri, and the disregard for tapu, is in direct conflict with tikanga and mātauranga Māori disrupting the basic structure of relationships between generations and between species. The potential long term effects of this disruption remain unknown. This has been widely recognised, including by government agencies. The Ministry for the Environment noted in its 1996 report on „Genetically Modified Organisms and Māori Cultural and Ethical Issue‟ that “genetic manipulation of the human genome may be seen by Māori as interference with the basic structure of relationships between generations and between species, which is central to both the practical and spiritual aspects of Māori life” (Gibbs, 1996).

7.11.8 Te Mana Taiao Environmental Trust noted these concerns in their response to consultation, specifically referring to potential effects to the integrity of whakapapa.

7.11.9 Te Rūnanga o Ngāi Tahu also referred to whakapapa in their submission confirming that it “provides guidance to decision-making through providing a framework to assess the cultural acceptability of the degree of genetic modification associated with an activity or proposal”.

7.11.10 The project team notes that these concerns are relevant to this application though consider that, should this application be approved, the contained nature of the proposed field test limits the risks posed to tikanga and mātauranga Māori. In addition, because the modified species are not native or considered taonga species, any potential for adverse effect to Māori is likely to be minimal and short term.

Kaitiakitanga 7.11.11 The role of Māori as kaitiaki has been formally recognised including in the Resource Management Act 1991 as guardians and/or stewards of New Zealand‟s natural resources. Kaitiakitanga is the undertaking of duties and obligations inherited from the atua over the realms of those atua in accordance with tikanga Māori (ERMA New Zealand, 2004). Understanding the whakapapa relationships of the natural world and the dynamics of mauri, including being able to recognise and address issues, are key to the role of kaitiaki.

7.11.12 As noted above the potential long term effects of the disruption of whakapapa, mauri and tapu remain unknown placing increased pressure on kaitiaki in terms of their ability to continue to oversee the natural resources within their region. In addition, because of the new nature of the technology, the relative levels of uncertainty, and the lack of kaitiaki experience in this area, there is significant concern about the ability of kaitiaki to recognise or address issues as they arise.

Evaluation and Review Report for GMF06002 page 97 of 221 7.11.13 Over and above the metaphysical effects, kaitiaki are also concerned with potentially adverse biophysical effects to native or valued species or ecosystems. Māori consultees and submitters raised concern about the potential for transgene escape into the soil environment and native or valued flora and fauna species impacting on their intrinsic value or having other deleterious effects. As highlighted in other parts of this report, the applicant notes that the plants being field tested would either be removed from the field before flowering, or would use cages that limit the ability of pollen from escaping.

7.11.14 Having regarded the information available, the project team considers that due to the contained nature of the field test and the controls proposed, the potential for adverse effect to the role of Māori as kaitiaki will be minimal. This takes into account the assessments made in section 8 regarding the potential adverse effects of transgene escape considering it highly improbable that any effect would occur. In addition, the small scale size of the field test site will limit any effect that did occur reducing any requirement on the kaitiaki in the region.

7.11.15 The project team also took into account that Ngāi Tahu, the acknowledged kaitiaki and mana whenua in the broad geographical region of the proposed field test, chose not to oppose the application.

7.11.16 However, in their submission Te Rūnanga ō Ngāi Tahu did make two recommendations: that the safety and security measures be increased due to the long length of the field tests; and that the role of Te Taumutu Rūnanga be recognised through accurate and timely information, opportunities for further participation and visits to observe the field tests and providing the rūnanga with the location of the field containment facility for future reference if requested. 7.11.17 On considering these recommendations the project team notes that the first is adequately covered by controls suggested in this report. In addition, the project team suggests that should this application be approved, the addition of a control requiring the applicant to provide an annual update of the progress of the field test to both Te Rūnanga ō Ngāi Tahu and Te Taumutu Rūnanga as kaitiaki over the location of the field test (proposed additional control 7.6). The project team also proposes a control should this application be approved requiring the applicants to continue their endeavours to meet with Te Taumutu Rūnanga to discuss the field test and to determine their desired level of participation in the project (proposed additional control 7.7).

7.11.18 Proposed additional control 7.6: The Operator must provide a specifically written annual update to Te Rūnanga o Ngāi Tahu and Te Taumutu Rūnanga by 31 July of each year of the operation of the field containment facility. The Operator must ensure that the update provides information on the progress of the field test and explain how Crop and Food Research is addressing any cultural issues raised by Ngāi Tahu in relation to the field test

Evaluation and Review Report for GMF06002 page 98 of 221 research. The Operator must ensure that a copy of this update is provided to Ngā Kaihautū Tikanga Taiao.

7.11.19 Proposed additional control 7.7: Crop and Food Research must ensure the continued engagement and participation in the field test programme of Te Taumutu Rūnanga to a mutually agreed level. Crop and Food Research must provide a copy of the finalised agreement between Crop and Food Research and Te Taumutu Rūnanga to ERMA New Zealand.

7.11.20 Ngāti Kahungunu Iwi Incorporated also provided a submission noting a number of environmental concerns that could impact on their ability to continue to fulfil their role as kaitiaki. These concerns included the potential for adverse effects to soil environments, ground water contamination, insects and birds, other crop and wild species and increase the palatability of alliums to pests. These concerns are addressed in sections 6, 7 and 8 of this report.

7.11.21 Ngāti Kahungunu Iwi Incorporated also expressed concern that the manipulation of quality traits might impact adversely on the medicinal and other characteristics of allium species. They contend that the integrity of these naturally occurring properties should be protected.

7.11.22 Again the project team assessed these concerns and considered that, should this application be approved, any likely risk posed to be minimal given the contained nature of the field test proposal.

7.12 Potential beneficial effects on relationship of Māori to the environment

7.12.1 Neither the applicant nor the project team identified any specific beneficial effects of the field testing of GM alliums on the relationship of Māori to the environment.

7.13 Potential effects on the Principles of the Treaty of Waitangi

7.13.1 Potential effects on the principles of the Treaty of Waitangi from the approval of this proposed field test were identified by the project team (Table 3). The effects that the project team considered to be not potentially significant are discussed and analysed below.

7.14 Potential adverse effects on the Principles of the Treaty of Waitangi

7.14.1 The project team identified inconsistency with the principles of the Treaty of Waitangi as a potential adverse effect from the approval of this field test.

7.14.2 As there is no single point of reference defining the principles of the Treaty of Waitangi (Te Tiriti o Waitang), the Methodology outlines the principles defined by the Court of Appeal decision in New Zealand Māori Council v Attorney General 1987. Of these, two are of particular relevance to this application.

Evaluation and Review Report for GMF06002 page 99 of 221 Active Protection 7.14.3 The principle of active protection was defined as “not merely passive but extends to active protection of Māori people in the use of their lands and waters to the fullest extent practicable” (Cooke P, New Zealand Māori Council, p664). This principle is applicable both in terms of:

mātauranga and tikanga Māori as it relates to the knowledge developed and established about the relationship of Māori to the environment; and kaitiakitanga as a tangible expression of the rights of Māori over their traditional lands, waters and other natural resources. 7.14.4 On considering the impact of the proposed field test, the project team determined that the application of containment controls that restrict the exposure of the environment and people to be consistent with the principle of active protection.

Redress 7.14.5 This principle describes the obligation on the Crown to not unduly impede or diminish its capacity to provide redress where a valid Treaty grievance is established. Though no such grievance has been established to date, a number of relevant claims have been lodged in accordance with the Treaty of Waitangi Act 1975 with the Waitangi Tribunal.

7.14.6 Of particular moment is the WAI262 claim (known as the Flora and Fauna Claim) which asserts specific rights over native and valued flora and fauna, including their genetic make up. Claimant evidence includes assertions about the inability of the Act decision making framework to deal effectively with cultural issues, particularly in regard to genetic modification.

7.14.7 Though the outcome of this claim is yet to be decided upon, the project team consider it useful to bring to the Authority‟s attention. In particular, with regard to the principle of redress, claimants may consider that a field test of GM plants poses unnecessary risk to native flora and/or fauna species limiting the options for redress.

7.14.8 The project team having considered this issue notes that, should this application be approved, due to the contained nature of the field test application and the specific measures proposed to avoid environmental exposure, that any potential adverse effect in terms of the principle of redress would be minimal.

7.15 Potential beneficial effects on the Principles of the Treaty of Waitangi

7.15.1 The project team did not identify any specific beneficial effects of the field testing of GM alliums on the principles of the Treaty of Waitangi.

Evaluation and Review Report for GMF06002 page 100 of 221 7.16 Potential effects on society and community

7.16.1 Crop and Food Research has undertaken over 10 separate field tests of GMOs approved under the Act (including IAG approvals transferred under the Act) and Crop and Food Research has spoken about their work on a number of occasions to local community groups and schools. The local community is aware of Crop and Food Research‟s history of undertaking field tests of GMOs.

7.16.2 The ethical procedural standards of honesty and integrity, transparency and openness, and community and expert consultation listed in section 3.3.5 are relevant to this application.

7.16.3 Whilst acknowledging that there is no legal requirement for neighbours to be advised, the project team considers that as a matter of good practise, the applicant should advise neighbours of the field test. As part of its stakeholder notification, the applicant advised landowners adjacent to the site of the field containment facility.

7.16.4 There are no animal welfare issues nor are any human genes involved in this application, and no particular issues have been identified that raise novel or specific ethical issues.

7.16.5 The project team did identify effects on society and community (Table 3). These are discussed below.

7.17 Potentially adverse effects on society and community

7.17.1 The applicant did not identify any direct potentially significant adverse effects on society and community from the field test. Submitters identified a range of concerns about the approval of this field test. From these concerns the following adverse effects on society and community from this proposed field test were identified (Table 3).

Concern resulting from a general opposition to genetic modification 7.17.2 This concern was expressed by a number of submitters. In some cases the concern was expressed in general terms in statements such as “There is no need for GM with its possible risks” (Wakelam). In other cases the objection was to field tests in general, or to this particular field test. For example one submitter was not opposed to genetic modification of crops in general, but was opposed to genetic modification for onions because it was not necessary (Ellis). Others were opposed to genetic modification of onions but did not state whether this was a more general concern or simply related to concern about modification of alliums.

7.17.3 The project team acknowledges the genuine concern and resulting anxiety that is felt by submitters that object to genetic modification. There are two aspects to this concern, the concern about genetic modification in general, and concern about the proposed field test, and the additional concern that the field test raises. The project team respects the view of the submitters which

Evaluation and Review Report for GMF06002 page 101 of 221 was expressed by a significant number of submitters. The field test is a small scale activity (maximum size in any one year of 2.5 hectare) and all viable material associated with the field test will be removed at its conclusion. The degree of concern that is specific to the field test is therefore a short to medium term effect. The project team concludes that the marginal concern specific to the field test is not potentially significant.

Concern that field tests are not in wider public interest 7.17.4 A number of submitters expressed concern that the field tests are not in the wider public interest and that there are no credible public benefits. One submitter stated that in their view “A field trial is a release to the environment…” (Moorhouse). The validity of field tests as an activity is not an effect in itself, but concern about this validity is an appropriate effect for consideration. At a more specific level, a submitter noted that he was not opposed to all genetic modification for crop production, but was of the view that the purpose of these particular trials was not valuable (Thompson).

7.17.5 The project team accepts this concern, but considers that it is a wider issue that was addressed by the Royal Commission on Genetic Modification, and that it is not potentially significant in a national sense in the context of this field test.

Concern about genetically engineered food, including concern about loss of choice 7.17.6 A large number of submissions expressed concern about GM food both from the perspective that this was not what New Zealanders want (“..GM crops which the citizens of New Zealand … have indicated that they do not want and wil not willingly eat” (Royal Forest and Bird Protection Society (Nelson/Tasman Branch)), and from the international perspective that there is no interest worldwide in GE crops (eg, Griffiths and Royal Forest and Bird Protection Society (Nelson/Tasman Branch)) and “much of the world‟s population does not want to consume genetically altered foods” (Harris). Other aspects related to food security and the concept that “food is sacred” (Drueckler).

7.17.7 This concern was both generic and specific to alliums and was expressed by individuals, onion growers and onion exporters. Another aspect of concern about genetically modifying food crops was the concept of choice; and that genetically modifying food crops “destroys people‟s right to buy GE-free food” (Gaughan) and that the “market message is very loud and clear” (Brasell), “NZ must remain GE free to maintain its place as a niche producer of high quality safe food” (Schofield). These aspects are more generally captured in the concern about maintaining options.

7.17.8 While a number of submitters have expressed this concern about GM foods, there is no intention that the alliums that are subject of the proposed field test should enter the food chain, nor is there any clear path that would see such products going on the market in the foreseeable future. This is a research field test, and any further development of the products will require extensive testing (including food safety testing) and further public consultation.

Evaluation and Review Report for GMF06002 page 102 of 221 Therefore, the project team does not consider that this adverse effect is potentially significant for this field test application. Such an effect may need to be considered more fully for an application to release a GM plant.

Concern about impact of the field test on home gardening 7.17.9 Several submitters were concerned about the effect of the field test on home gardening and in particular their own activities (eg, Inta). The project team is of the view that the proposed controls for the field test should alleviate any such concern and that it is not potentially significant.

Concerns about the adequacy of containment 7.17.10 Concerns were expressed about the adequacy of containment: “Field trials cannot contain securely the GE material” (eg, Postelnik & Postelnik); “Previous controls have seen slack controls and accidental spreading has occurred” (Cieraad); “Whether it be rabbits or insects, there is no secure way of keeping these crops isolated” (Treadwell); and “Accidents happen! Allowing plants to flower inside insect proof cages presents a risk of contaminating GE free status in the area” (Carapiet). 7.17.11 The reference to accidental spreading may refer to field tests conducted prior to Royal Commisssion on Genetic Modification, but since that time there have been no substantiated cases of accidental spreading. However, the perception that this occurred has clearly raised concerns. Other submitters noted that allium crops would require large separation distances to prevent pollen spread (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others).

7.17.12 The project team accepts these concerns and notes that adequacy of containment is addressed in other section of this E&R report and concludes that while submissions have shown that there is an outstanding aspect of concern about adequacy of containment, there is limited evidence for this concern and it is not potentially significant.

Concern about uncertainty and potential long term effects, and effects on future generations 7.17.13 Submitters expressed concern that humans don‟t understand what will happen in the long term with the potential effects of genetic modification and possible effects on future generations (eg, Church). Statements included references to looking at what had changed in the last 100 years (Williams) and the comment that “We cannot be certain what effect this will have in 10 or 20 years time” (Thomas). These concerns were articulated in the context of genetic modification in general rather than the effects of the field test. The project team agrees with the submitters that we cannot have full knowledge of the long term effects of GM organisms, but notes that this is a

Evaluation and Review Report for GMF06002 page 103 of 221 contained field test and that no material will be left on the site in the longer term.

7.17.14 Other related statements included “we do not yet fully understand the implications to the health of soil microflora and fauna and subsequently to human health of releasing genetically engineered plant material into the environment” (Schofield), and “for the benefit of future generations of NZers it is vital to keep NZ GE free” (Shaw).

7.17.15 The project team notes that at this stage there is no intention of releasing plant material into the environment (a different approval would be required for that activity), and that all viable material will be removed from the field containment facility at the end of the field test. The project team acknowledges the concerns of submitters about the containment of a field test and considers that this is addressed in other parts of the report. In terms of the benefits to future generations of a GE free New Zealand, the project team notes that the submitter is making a value judgement that GE free is „better‟ than a future where GE crops are used. The project team refers to the consideration of the concept of preserving options (sections 8.1.28 - 8.1.29), and believes that this field test is consistent with the Royal Commission‟s recommendations of preserving options.

Concern that we may not be preserving options 7.17.16 The Royal Commission on Genetic Modification considered carefully how best to preserve New Zealand‟s future options and concluded that it would be “be unwise to pin ourselves irretrievably to any one approach at this time as this would limit our future options”. This statement was in the context of the range of technologies available including selective use of genetic modification, as well as technologies that do not depend on genetic modification.

7.17.17 A number of submitters discussed the concept of preserving options in a range of areas (and referred to the Royal Commission on Genetic Modification), but focussed mainly on the idea that, by allowing field testing of GM crops, New Zealand could be foregoing an opportunity. A part of this view was that, by allowing field tests of GMOs, we would be compromising the ability of organic growers to produce and sell high value products. Some of the statements included:

that we need to retain the ability to grow unmodified crops to satisfy the premium customer (Bradley)”; that New Zealand has a “unique opportunity to go ahead with organic products” because of our relative geographical isolation (Sutherland), that consumers will “pay a premium for produce they believe is safer, GM free, Organic or with added health benefit” (Stiefel), and that “..it is paramount that we safeguard NZ‟s unique position as solitary GE free first world ag[ricultural] producer” (Stiefel). 7.17.18 The project team notes that the Royal Commission on Genetic Modification report concludes (Chapter 13, paragraph 24) “The four categories

Evaluation and Review Report for GMF06002 page 104 of 221 [genetically modified crops, conventional farming, Integrated Pest Management (IPM) and organics] are not mutually exclusive, but each has a particular place.” Thus preserving options does not preclude contained field tests.

7.17.19 The project team concludes that some submitters are concerned that, by allowing field tests, we are cutting off future options of being GE free. However, that concern while understandable, is not consistent with the Royal Commission on Genetic Modification arguments regarding preserving options. The project team acknowledges the concern felt by submitters. The Royal Commission on Genetic Modification explicitly acknowledged the place of GM crops within a range of options available to New Zealand as part of preserving options. The project team further recognises that fears about field testing of GM organisms are associated with the view that this will lead to future release of such organisms, which will in turn have a serious impact on organic production. However, the project team notes that this field test is a small scale activity (maximum size in any one year of 2.5 hectare) and that all viable material associated with the field test will be removed at its conclusion. In the context of this field test, the project team concludes that this effect is not potentially significant.

Concerns about ethical aspects of the application 7.17.20 Some submitters also expressed a view in relation to the ethical aspects of genetic modification. For example, submitters stated that “it is against my spiritual beliefs to genetically modify matter in humans or plants” (Bentham). Others disapproved of the ethics of the Act and ERMA New Zealand‟s process for assessing such applications, for example that it would be “unethical for ERMA to continue to make approvals under the current HSNO Act which does not require testing for negative effects” (Mohr), and that “ERMA should recognise its moral responsibility to be more than a rubber stamp machine for biotech investors” (Trott). Submitters also criticised as “offensive” a perceived suggestion in the application that international fair trade concerns might force New Zealand to grow GM, stating that “this is an absolutely inconceivable loss of democracy and sovereignty, and is also called high treason”(Graffeuille).

7.17.21 The project team recognises and respects that some people find it ethically unacceptable to alter the genetic makeup of living organisms. Under the Act, applicants are entitled to apply for approval to carry out such activities. In terms of the implications of free trade rules, any decision on whether or not to release GMOs into the New Zealand environment would be made by ERMA New Zealand on the basis of whether the benefits of such a release would outweigh the risks. While trade implications may be taken into account, they would not themselves be determinative.

Concern about social costs/liability issues of conducting field tests 7.17.22 The Royal Commission on Genetic Modification explored liability issues and concluded that it was “unnecessary to recommend legislation providing special remedies for third parties, where they may have been affected by the

Evaluation and Review Report for GMF06002 page 105 of 221 release of a genetically modified organism” and expressed the view that common law is adequate to address any matters that may arise. The Royal Commission on Genetic Modification noted that “strict liability can be a barrier to innovation and progress, and the weight of international precedent is against setting up such a regime”. Importantly the Commission placed emphasis on the use of field tests to develop information that would help prevent damage or injury. The Royal Commission on Genetic Modification noted that in adopting this approach “there is the potential for some socialisation of unforeseen or unanticipated loss or damage”.

7.17.23 Submitters were concerned about what might happen if something went wrong during the field test and there were adverse effects on the surrounding environment or people, and submitters who expressed concern about the social costs of conducting field tests were of the view that the Royal Commission on Genetic Modification‟s conclusion about the socialisation of some loss or damage was unacceptable.

“Socialising the risk on the public is unacceptable …. As such, under the current flawed HSNO Act to approve the trial would be unethical” (Moorhouse); “Crop and Food will not compensate us if our (own grown) onions/leeks/garlic become contaminated by their experiments” (Moorhouse); “To impose risks on a public who now has been opposing GE trials in the environment is unfair” (Wakelam); and “I object to the applicant and ERMA not taking the responsibility of the liability for any adverse impacts of the proposed trials” (Harrington). 7.17.24 While the project team notes the conclusions and recommendation of the Royal Commission on Genetic Modification (Recommendation 12.2: that for the time being there be no change in the liability), it recognises the concern expressed by submitters. The project team notes that this application is for a contained field test, and while some members of the public may be very concerned about liability issues and the social cost of GM crops, in the context of a field test where all material will be removed from the site at the end of the field test, this effect is not potentially significant.

Concern about effects on ecological health 7.17.25 Some submitters expressed concern about damage to ecological health resulting from the field test. This was expressed as a concern about the “contamination” of the surrounding environment. Over 60 GM field tests have been conducted in New Zealand and no adverse effects on the surrounding environment or any specific ecosystems have been reported. The project team recognises that the lack of reported evidence does not mean that such effects have not occurred, and does not reduce the real concern expressed by the submitters. However, given the non specific nature of the concern the project team is not able to analyse this effect.

Evaluation and Review Report for GMF06002 page 106 of 221 Anxiety expressed in terms of distrust 7.17.26 Submitters exhibited anxiety about genetic modification of crops, expressed as mistrust of crops and of ERMA:

“GE crops are distrusted, they are not wanted by the public” (Myers); “GE crops tie farmers to ruthless companies” (Myers); and “I have no confidence in ERMAS [sic] ability to manage this situation and put adequate safeguards in place” (Aiken). 7.17.27 The project team notes this concern. ERMA New Zealand has confidence in the controls that it places on field tests.

7.17.28 The project team acknowledges the anxiety of people who do not want GM crops to be grown either in New Zealand or internationally. However, in the context of this field test, the project team does not consider that such an effect is potentially significant.

Concern about the involvement of multinational companies 7.17.29 Some submitters voiced concerns that any benefits associated with the field test would only accrue to offshore commercial interests and not to the people of New Zealand (eg, Bleakley).

7.17.30 Others stated that: “NZ is just another poor sucker nation tagging along, afraid to stand up for its people and say “We value our people and present biodiversity above the extent that bullying corporations can push us” (Inta); and “GM crops and the chemical applications required to grow them make money for American corporations while adversely effecting both the health of those who eat it/grow it and the land on which they are grown on”( Mclennan). 7.17.31 The project team considers that, while offshore investors may benefit from the application, ERMA‟s assessment of the benefits is based on benefits that accrue to New Zealand. This means that if the risks to New Zealand are not outweighed by the benefits to New Zealand, then the application would be declined, irrespective of any benefits to offshore commercial interests. For these reasons the project team considers that this concern is not potentially significant in terms of the social effects of the application.

7.18 Potentially beneficial effects on society and community

7.18.1 The applicant listed the following effects as potential environmental benefits: increased knowledge of possible environmental impacts of this technology and a greater understanding of the behaviour of the modified trait under field conditions; knowledge of the agronomic impact of altering the quality or agronomic traits; estimations of chemical input savings or costs; initial information on the interactions of the plants with immediate flora and fauna (ie, environmental impact studies); and demonstration of New Zealand‟s capacity to undertake such research as immediate environmental benefits

Evaluation and Review Report for GMF06002 page 107 of 221 (page 58 of the application). However, it was considered that these are effects on society and community rather than on the environment. These are discussed below or in section 8.

7.18.2 The following beneficial effects on society and community from this proposed field test were identified (Table 3).

Enhancing New Zealand’s ability to preserve options and maintain choices 7.18.3 The project team considered whether enhancing New Zealand‟s ability to preserve options and maintain choices could be a potentially significant beneficial effect from the approval of this field test on society and the community. This has been assessed in sections 8.1.28 - 8.1.29.

Increased scientific knowledge including knowledge about environmental impacts, agronomic performance and impact, and the ability to use GM crops as part of an integrated pest management (IPM) regime 7.18.4 The project team considered whether increased scientific knowledge including knowledge about environmental impacts, agronomic performance and impact, and the ability to use GM crops as part of an integrated pest management (IPM) regime could be a potentially significant beneficial effect from the approval of this field test on society and the community. This has been assessed in sections 8.1.30 - 8.1.43.

Demonstration of the capacity to conduct field tests in New Zealand and enhanced reputation of New Zealand agricultural research

7.18.5 It was considered whether the demonstration of the capacity to conduct field tests in New Zealand and enhanced reputation of New Zealand agricultural research is a potentially significant beneficial effect from the approval of this field test on society and community. This has been assessed in sections 8.1.44 - 8.1.48.

Upskilling of staff and students (qualifications) and increased experience in working with gene technology in the field 7.18.6 The applicant and project team identified a beneficial effect from upskilling of staff and students (ie, gaining qualifications) and increased experience in working with gene technology in the field should this application be approved. The project team considers that, while this effect is additional, the effect of increased scientific knowledge is a benefit that would accrue to only a very few individuals. However, the broader benefit to increased knowledge is addressed in sections 8.1.30 - 8.1.43.

Increased understanding of the potential risks and benefits of GM crops for the public, regulators and legislators through environmental impacts research

7.18.7 The applicant has identified that the approval of the field test would result in increased understanding of the potential risks and benefits of GM crops for

Evaluation and Review Report for GMF06002 page 108 of 221 the public, regulators and legislators. The project team acknowledges the existence of this effect but does not consider that it is potentially significant.

Contribution towards long term benefits to society from genetic engineering technology and increased public understanding

7.18.8 Submitters identified that the field test could make a long term contribution in the form of benefits to society from increased understanding and knowledge of genetic engineering technology. This includes improved understanding of GM field tests in general and allium species trials in particular, and information about the potential effects of GM alliums (supporting informed debate and discussion about the value of GM alliums). Submitters considered that such knowledge could assist in reducing pesticide use, resulting in healthier soils and decreased carbon footprint as well as allowing for protection of natural habitats as a result of higher production on less acreage (eg, AgResearch Ltd, Walter, SCION, Federated Farmers of New Zealand and Horticulture and Food Research Institute). While such effects are possible if the organisms were approved for release or conditional release at a future time, these long term future benefits are not relevant to the consideration of the effects of this field test and have not been addressed further.

7.18.9 There may be potentially significant benefits to society and community arising from the provision and dissemination of information about potential effects if this application is approved. Crop and Food Research undertakes outreach activities as part of their everyday business. While there might be some information specific to this proposed field test, the project team considered that the marginal effect that could be attributed to the field testing of the alliums would be small, and because of its indirect nature there is no recognised way of measuring the size of the effect or the likelihood of it occurring. Thus, given the indirect nature of the effect and the small scale of the field test, it is expected that any potential benefit from the approval of this application would be very small and therefore this effect is not considered further.

Additional information about cultivar development to assist plant breeders to evaluate novel germplasm, identify lines for advancement and assess performance 7.18.10 The proposed field test will provide researchers with additional information about cultivar development that might be used in the future to assist plant breeders to evaluate novel germplasm, identify lines for advancement and assess performance if approved. This effect is directly related to the field test and the organisms that are to be field tested. It is also likely that such an effect will eventuate. However, in the context of effects on New Zealand society and communities, the size of the effect is difficult to determine. The project team therefore concludes that such benefits will be captured under increased scientific knowledge (assessed in section 8.1.30 - 8.1.43) and therefore this specific aspect has not been assessed further.

Evaluation and Review Report for GMF06002 page 109 of 221 7.19 Potential effects on the market economy

7.19.1 Submitters identified a range of concerns about the field test. From these concerns the following effects on market economy from this proposed field test were identified (Table 3). Each of these effects is discussed and analysed below.

7.20 Potentially adverse effects on the market economy

7.20.1 Relevant effects on the market economy are those arising directly from the operation of the field test. The direct financial costs of conducting the field test are internal to the applicant organisation.

7.20.2 The applicant and the project team did not identify any direct potentially significant adverse effects on the market economy from the field test. Submitters raised the concerns regarding effects on the market economy (Table 3).

7.20.3 The project team agrees with the applicant that, should this application be approved, since the plants would be grown in a controlled field test environment and that strict accounting procedures would be part of the containment regime, it would be at worst highly improbable that the plants or heritable material could leave the field containment facility (section 5.6.118). The consideration of adverse effects on the market economy from the approval of this application confines itself to those effects associated with the plants in a contained environment, but discusses submitters‟ concerns about potential impact of the organisms were to escape from containment.

Concern about impact of GM pollen on honey production 7.20.4 Some submitters raised concerns about effects on bees and honey production (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc, Federated Farmers of New Zealand and a number of individuals). Federated Farmers Bees noted that the application “is of particular concern due to the pollination release from the genetically modified plants” because of the threat to the GM free status of New Zealand honey. Federated Farmers Bees supports the use of pollination cages with an additional insect proof mesh, but request that these cages be “totally bee resistant” and “do not allow pollination at any point”. Federated Farmers Bees recommend an additional safety measure in the form of traps within the cages to capture any insects. These recommendations are discussed in sections 5.6.32 and 5.6.43 - 5.6.44.

7.20.5 The project team also considered whether the contamination of honey could be a potential adverse effect on human health and safety or the environment. However, the project team considered that it is appropriate for these effects to be assessed together in this section.

7.20.6 The project team acknowledges the submitters‟ concerns and the suggestions offered by the Federated Farmers Bees group. The project team agrees with submitters that the impact of GM pollen on honey production would be

Evaluation and Review Report for GMF06002 page 110 of 221 significant in terms of any future application to conditionally release or release the GMOs. In the context of a field test this potential effect is not considered to be potentially significant and therefore has not been addressed further.

Concern about adverse impacts on trade and potential for loss of the clean green image 7.20.7 Submitters expressed concern that genetic engineering (of crops) poses a risk to “Brand NZ” image and export reputation and increases the risk of contamination of non GE crops (including vegetable crops). For example: “The moment it is known, or merely suspected that NZ is GE contaminated the consequences for our economy could be catastrophic. Our Trading partners still regard us as GE Free. To put that reputation at risk would be utterly foolish. Any kind of field testing of GE organisms involves that risk” (Dane).

7.20.8 Submitters were of the view that perceptions of a field test could have an adverse effect. “The name of New Zealand as a green and clean country producing high quality produce will get tainted [as a result of the field test], because there is a close relationship in people‟s perception between healthy clean and green and non-GM” (Volker).

7.20.9 The project team notes that in 2001 a report commissioned by the Ministry for the Environment (MfE, 2001) concluded that:

New Zealand‟s “clean green image” has value in terms of the way in which particular New Zealand exports benefit from positive perceptions about our environment; the „image‟ is worth at least hundreds of millions of dollars (per year); New Zealand is relatively “clean and green”; and there are risks including the uncontrolled release of GMOs would adversely impact on New Zealand‟s profit (or premium) in particular for kiwifruit and apples. 7.20.10 Submissions on previous applications for field tests of GMOs have argued that there are economic costs to New Zealand from adverse effects associated with changing perceptions about New Zealand‟s „clean green‟ image, and that even small scale field tests of this nature may have an adverse effect on overseas markets.

7.20.11 However, a study conducted in 2003 at the University of Otago concluded that there was no evidence that the presence of GM food crops in a country caused negative perceptions, in general, of food from that country (Knight et al, 2003). A later study looking specifically at country of origin and choice of food imports found that country of origin factors appeared largely irrelevant to large food retailers (Knight et al, 2007). Consumers do show high willingness to purchase from a country where the country image is an important positive characteristic for the product category and it may therefore mean that sales of New Zealand apples benefit from image perceptions reinforced by scenery shown in movies. However, a high

Evaluation and Review Report for GMF06002 page 111 of 221 percentage of New Zealand food exports are unbranded and country of origin is unknown. A further factor is that country of origin labelling can be negative, with consumers being concerned about „food miles‟ and also food quality (having travelled that far).

7.20.12 Survey results show that quality may be a more important factor than image, and that trust remains an important factor. This relates to traceability, which is becoming an increasingly important market factor. Looking specifically at perceptions around GM food, an interesting result from Knight‟s research is that the origin of GM food is not an issue, and the key concern for people concerned about this is that food should be GE free, not where the food comes from.

7.20.13 One submitter to the GM brassicas field test application (GMF06001) noted that Zespri had stated that “The image of New Zealand as „clean, green‟ and therefore „safe‟ is considered to be a benefit to kiwifruit sales particularly in Europe, and also in Japan”. This is consistent with the MfE report quoted above.

7.20.14 The project team notes that, notwithstanding the results discussed above, international market perceptions may be affected by release of GMOs, particularly where they are food products. However, this application is for a field test and there is no intention of releasing the GM products. The field test is small scale and able to be contained. The project team does not consider that the existence of such a small scale field test will have any impact (either positive or negative) on international perceptions of New Zealand or New Zealand products.

7.20.15 The project team does not consider that this effect is potentially significant, and therefore it has not been assessed further.

Concern about loss of organic product certification for local growers

7.20.16 The project team identified a possible adverse effect that local allium growers might lose organic product certification as a result of the field test. This issue was also raised by submitters; [the field test] “threatens our status and the way we want to live and grow crops” (Tschirky).

7.20.17 The project team notes that the alliums will not be allowed to flower in the open outside pollination cages, and therefore no pollen will be able to be transmitted to other allium crops in the area via insects. Thus the project team does not consider that there is any realistic chance that local allium growers would lose organic certification as a result of the small scale field test. The project team concluded that this effect is not potentially significant and has not been assessed further. The project team has also considered a potential adverse effect in terms of the concern felt by organic growers.

High economic cost 7.20.18 Submitters noted that the cost of the field test will be very high because of the containment requirements; thirty years of trials on onions will have cost

Evaluation and Review Report for GMF06002 page 112 of 221 millions “with no high performing, commercially viable cultivars at the end” – it would be better to go with traditional onion breeding (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟ and The Soil and Health Association of New Zealand Inc). The project team notes that the cost of the field test is an internal cost incurred by the applicant, and that the applicant has made a commercial decision regarding whether or not to submit an application.

Opportunity costs relating to the effects on other growers (reducing options) and opportunity costs relating to use of research funds 7.20.19 A number of submitters raised concerns about opportunity costs associated with growing GM alliums. Particular concerns articulated were associated with growing foods for which there may never be a market, additional costs to (organic) farmers of staying GE free, and the opportunity costs that the application poses to other research (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), GE Free Northland (In Food and Environment) and others).

7.20.20 The Act (section 6e) requires that matters to be taken into account in making decisions under the Act include “the economic and related benefits and costs of using a particular hazardous substance or new organism”. ERMA New Zealand has clarified the way in which it will address economic benefits and costs in the Technical Guide “Assessment of Economic Risks, Costs and Benefits: consideration of impacts on the market economy” (ERMA New Zealand, 2007). The context is established by reference to a set of „Decision Principles‟. In addition, clauses 13(a) and 14 of the Methodology also describe which benefits and costs are relevant to decision making.

7.20.21 ERMA New Zealand recognises that opportunity costs are an important aspect of economic benefits and costs. A common definition of opportunity cost7 is “a measure of the economic cost of using scarce resources to produce one particular good or service in terms of the alternatives thereby foregone”.

7.20.22 There are two aspects to opportunity cost: lost opportunity costs relating to the effects on other growers (reducing options); and opportunity cost of capital opportunity costs relating to use of research funds.

Opportunity costs relating to the effects on other growers (reducing options) 7.20.23 Submitters expressed their concerns in the following manner: “Growers have the right to grow GE free products” (eg, Gaughan, Sutherland and Rowson);

7 Collins Reference Dictionary of Economics” 1988.

Evaluation and Review Report for GMF06002 page 113 of 221 “Don‟t want (my) organically grown onions, garlic and leeks to be cross contaminated” (Astarte); “NZ organic growers have a unique advantage with consumers who are rejecting GM food” (Falls); and [the field test] “threatens our status and the way we want to live and grow crops” and will “open the door to unknown harm that would cripple organic growing and seed saving” (Elphick). 7.20.24 In this context opportunity cost is demonstrated by showing that by undertaking an activity some other activity has been precluded. In this sense opportunity cost may be complete or partial. The project team is of the view that the concept of opportunity cost as lost opportunity is not pertinent to the case of a field test as undertaking a field test does not preclude other activities (complete) or influence other activities to the extent that they are limited (partial). That is, if a field test is approved, then it does not prevent others undertaking activities that may have similar intent or be alternative ways of achieving similar objectives. Thus the project team is satisfied that, if this field test is approved, then if someone wants to adopt a different approach to undertaking this activity they will be able to do so. One submitter noted that “better spending 10 years researching organic methods” (Curnow). The project team notes that the field test would not preclude this occurring.

7.20.25 In general, ERMA New Zealand is of the view that where approvals are given at the laboratory or field test level, this does not preclude anyone else from undertaking the activity and, therefore, there is no opportunity cost to others. However, in the case of an approval for conditional release, there may well be opportunity costs in terms of lost opportunities. This conclusion is consistent with Principle 9 of the Technical Guide (ERMA New Zealand, 2007) referred to above.

7.20.26 In reaching this conclusion, the project team recognises the real concerns that have been expressed by submitters and does not wish to detract from these concerns and beliefs which are strongly held.

Opportunity costs relating to use of research funds

7.20.27 Submitters expressed concern about opportunity costs relating to the use of research funds. Examples of the expression of this concern are:“GE is a bad use of research funds” and it would be “better to spend research funding on climate change” or “better to research reduction of use of chemical sprays” (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch) and a number of individuals).

7.20.28 Other statements included:

“Research comes at cost of investing in research into more sustainable production measures” (Gaughan); “Use money for something good” (Dubalar Orchard); and

Evaluation and Review Report for GMF06002 page 114 of 221 “Funding should be put into alternative research for long-term reduction of pesticide sprays in crops that will also make them more attractive to the export market” (Inta). 7.20.29 With respect to the second case or the opportunity cost of capital, the investment strategies of funders such as FRST, CRIs, or commercial investors are matters for those organisations. Taking the example of FRST funding, the criteria for allocating FRST funding are complex: they are broad and are not specific to the objectives of the research. Thus the allocation of funding is not a reflection of the market value of the project, nor is there any evidence that funding work in one area precludes the funding or work in areas using different approaches to achieve similar objectives.

7.20.30 This latter concern focuses on the opportunity cost that the pursuit of this research poses on alternative approaches to achieving similar objectives. The submission from the Sustainability Council specifically refers to application GMF03001 noting that the decision making Committee “addressed the opportunity costs that pursuit of GM approaches incurred on other methods of achieving the same agronomic goals.” While the project team acknowledges in this instance consideration was given to opportunity costs, the discussion did not influence the outcome. The project team considers that this issue is not relevant to the ERMA New Zealand consideration except in circumstances where the funding of research is considered to have a potentially significant impact on the market economy. In the case of a contained, small scale field test, the project team does not consider that any such effect is potentially significant and therefore it has not been addressed further.

7.21 Potentially beneficial effects on the market economy

7.21.1 As noted above in reference to the identification of adverse effects on the market economy, relevant beneficial effects on the market economy are those arising directly from the operation of the field test.

7.21.2 The applicant identified the enhanced ability for Crop and Food Research and other agencies to attract research funds (nationally and internationally) as a potential beneficial effect on the market economy from the approval of this application. This is discussed in sections below. The project team did not identify any further beneficial effects.

Enhanced ability for Crop and Food Research and other agencies to attract research funds (nationally and internationally) 7.21.3 The applicant noted that, should this field test be approved, the field test would enhance Crop and Food Research‟s ability to attract research funds both from New Zealand and possibly overseas, noting that the previous onions field test (application GMF03001) contributed to securing overseas funding (page 60 of the application).

7.21.4 The project team acknowledges this beneficial effect should this application be approved and notes that the direct economic effect accrues to Crop and

Evaluation and Review Report for GMF06002 page 115 of 221 Food Research. There will be a flow-on indirect effect to the New Zealand economy, but the project team considered that this indirect effect will not be potentially significant at this stage. That is, while such benefits are very likely to be realised, the national economic component of the size of the effect is considered to be very small. The social and community aspects of upskilling and knowledge gain have been addressed in sections 8.1.30 - 8.1.43 and 7.18.6. Noting that the size of the effect is small and that it is a benefit arising from the field test rather than the organism, the project team concludes that it is not potentially significant and has not assessed it further.

7.22 Conclusion – effects on the market economy

7.22.1 This application is for a small scale contained field test to be conducted over a fixed time period, after which all plants will be removed. The project team notes that, should this application be approved, the significant adverse and beneficial effects associated with this application are not economic in nature, and therefore this is not an application for which a full assessment of economic effects is relevant.

Evaluation and Review Report for GMF06002 page 116 of 221 8 Assessment of potentially significant adverse and beneficial effects

8.1.1 The beneficial and adverse effects identified in section 7 as being potentially significant are assessed in this section.

Non-target effects on soil biodiversity by antimicrobial, antifungal or other transgene products 8.1.2 Some submitters had concerns about the effect of the GM alliums on soil biota should this application be approved (eg, Royal Forest and Bird Protection Society (Nelson/Tasman Branch), Schofield, Ngati Kahungunu Iwi Incorporated and others). Therefore, it was considered whether non- target effects on soil biodiversity by antimicrobial transgene or other products expressed by the GM alliums could occur through field testing.

8.1.3 Microorganisms can interact with GM plants by: (a) transgene products released through plant roots from sloughed and damaged cells and root exudation; (b) if no tillage, plants will decompose on the surface and residue is concentrated on the cell surface (therefore exposure is limited to microorganisms on the cell surface); and (c) if conventional tillage, plants decomposition in the soil will mean that an increased number of microorganisms will be exposed (reviewed in Dunfield and Germida, 2004).

8.1.4 GM plants that express broad spectrum antibacterial, antifungal or other transgene products have the potential to cause undesirable effects on non- target or potentially beneficial microbial communities in close proximity to those GM plants.

8.1.5 A number of studies have been performed monitoring the effect of GM plants modified for herbicide tolerance, insect resistance (expressing Bt gene), pathogen resistance (expressing antimicrobial peptides or proteins) or viral resistance on specific groups of ecologically important soil microorganisms or on the whole microbial soil community. While microbial diversity can sometimes be altered when associated with GM plants, these effects were minor in comparison with factors such as the field site, sampling date, soil type, plant genotype, vegetation stage and pathogen exposure and that changes to soil microorganisms due to GM crops were found to be more variable and transient compared to those caused by agricultural practices such as crop rotation, tillage, irrigation, and use of herbicides (Dunfield and Germida, 2004; Fuchs and Gonsalves, 2007; O‟Callaghan et al, 2005; O‟Callaghan et al, 2008; Rasche et al, 2006; Stotzky, 2002; Van Overbeek and van Elsas, 2008).

8.1.6 The field test methodology indicates that the field containment facility will have different cover crops over the life of the field test and that the planting site will be a maximum of 2.5 hectares at any one time. Therefore, the soil microbial communities will not be exposed to GM alliums continuously. These circumstances should also discourage the selection of microbes which show resistance to antimicrobial peptides or proteins.

Evaluation and Review Report for GMF06002 page 117 of 221 8.1.7 Taking the above information into account, should this application be approved, if any toxicity effects did arise, then they would be highly localised and contained to the soil area surrounding the plant, and any adverse effects will cease once the plant is removed. There will be no discernible ecosystem impact. Therefore the project team considers that, if this application is approved, this effect would be of minimal8 magnitude. As the likelihood of the adverse effect was considered to almost certainly not occur but could not be totally ruled out, the likelihood was considered to be highly improbable9. As the level of effect is therefore A10, this effect was considered by the project team to be negligible11. The project team considers that any effects on soil biodiversity would have to be addressed fully if this application was for the release of a GMO.

Harm to other non-target organisms such as invertebrates 8.1.8 Some submitters had concerns about the effect of the GM alliums on non- target organisms should this application be approved (eg, Ngati Kahungunu Iwi Incorporated and others). For example, some submitters have referred to articles in the popular press reporting the death of sheep in India after grazing on fields previously planted with Bt cotton. This information was unable to be verified. It is noted that livestock would need to consume the GM alliums for toxic effects, if any, to occur. However, should this application be approved, as it would be highly improbable that livestock could enter the field containment facility (sections 5.6.94 - 5.6.101), it would be at worst highly improbable that the GM alliums would have an adverse effect on livestock and this effect was not considered further.

8.1.9 It was considered whether direct and indirect harm to non-target organisms such as invertebrates could result from the field testing of the GM alliums. In addition, the potential for indirect toxic effects on parasitoids and predators by changing the availability or the quality of the prey/hosts consumed through effects of the GM plants themselves or due to management practises of those GM plants was considered.

8.1.10 The proteins expressed by the GM alliums (such as the Cry protein) could potentially be directly toxic to non-target invertebrates, some of which may be beneficial, native or valued organisms. Non-target organisms include pests which feed on alliums, parasitoids and natural enemies of allium pests, and other organisms such as bees that may visit these plants and could potentially enter the field containment facility.

8 “Minimal” in terms of the environment can mean “highly localised and contained environmental impact, affecting a few (less than ten) individuals of communities of flora and fauna, no discernible ecosystem impact” (see Appendix 3 for further explanation). 9 “Highly improbable” means “almost certainly not occurring but cannot be totally ruled out” (see Appendix 3 for further explanation). 10 “A” in most circumstances is equivalent to „negligible‟ (see Appendix 3 for further explanation) 11 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in terms of their likelihood and effect that they do not require active management and/or after the application of risk management can be justified by very small levels of benefits”.

Evaluation and Review Report for GMF06002 page 118 of 221 8.1.11 Other existing pest control methods, including the use of insecticides such as Bt-based insecticides, may also be expected to exhibit a similar adverse effect on the populations of parasitoids and predators. Another example is the study by Butler et al (2007) which showed that the use of herbicide- tolerant sugarbeets and oilseed rape, which is likely to cause a long term reduction in above-ground invertebrates and seed in the cropped fields due to changes in weed populations, had a limited effect on bird populations when compared to the conventional agricultural systems.

8.1.12 Taking the above information into account, should this application be approved, harm to non-target organisms, if any, would be highly localised and limited to those organisms that enter the field containment facility and interact with the GM alliums (eg, eat). Any effects would cease once the plants are removed and there would be no discernible ecosystem impact. Therefore the project team considers that, if this application was approved, this effect would be of minimal magnitude. As the likelihood of the adverse effect was considered to almost certainly not occur but could not be totally ruled out, the likelihood was considered to be highly improbable. As the level of effect is therefore A, this effect was considered by the project team to be negligible. The project team considers that any effects on non-target organisms would have to be considered more fully if this application was for the release of a GMO.

Development of resistance to Bt toxins of target insects 8.1.13 Some submitters had concerns about the development of insects that are resistant to the GM alliums should this application be approved (eg, submissions Royal Forest and Bird Protection Society (Nelson/Tasman Branch), The Sustainability Council, and others). The presence of GM alliums which continually express high levels of activated Bt toxins may expose insect pests feeding on these plants to a greater selection pressure than that encountered with the use of foliar insecticidal Bt sprays12. This could potentially accelerate the development of resistance to Bt toxins in insect pests.

8.1.14 It was noted that refuge (or refugia) are area(s) of habitat where susceptible pests can survive and are used as a strategy to retard the development of insects that are resistant to the Bt plants (Miller and Wansbrough, 2002; Ranjekar et al, 2003). The project team notes that there may be concerns about the effectiveness of refugia, but the results from monitoring the field resistance to commercial Bt crops in Australia, China, Spain and the United States suggest that refuges can delay resistance of insects to Bt crops (Tabashnik et al, 2008).

8.1.15 As the field containment facility will be in the Canterbury region, the surrounding land will act as refugia.

12 Bt foliar sprays consist of a mixture of the Bacillus thuringiensis bacterium and spores which have to be ingested, solubilised and proteolytically processed in the insect gut to yield the active toxin in susceptible insects.

Evaluation and Review Report for GMF06002 page 119 of 221 8.1.16 It is considered that, should this application be approved, the development of resistant insects, if any, would be highly localised and limited only to those insects that enter the field containment facility, consume the GM alliums and then show innate resistance to the Bt toxin (eg, survive after consumption of Bt plants). However, once the selection pressure towards those insects ceases (eg, once the plants are removed or if Bt sprays are not used), the selective advantage would cease. The presence of the refugia (with Bt toxin- sensitive mates) would retard the development of a Bt-resistant population and so there would not expect to be any discernible ecosystem impact. The development of such resistant population may also be hindered by the use of non-Bt insecticides.

8.1.17 Therefore the project team considers that, if this application is approved, this effect would be of minimal magnitude. As the likelihood of the adverse effect was considered to almost certainly not occur but could not be totally ruled out, the likelihood was considered to be highly improbable. As the level of effect is therefore A, this effect was considered by the project team to be negligible. So although the development of resistant insects may need to be considered if Bt crops are ever released in New Zealand, such concerns are not within the scope of this field test application.

Toxicity of GM alliums to humans (general public exposure and occupational) 8.1.18 It was considered whether the GM alliums could have an adverse (toxic) physical effect on public or on Crop and Food Research personnel. The applicant has stated that, should this application be approved, the GM alliums field tested would be imported or developed under other HSNO approvals. These would all be approvals under sections 42, 42A, or 42B given in accordance with the Hazardous Substances and New Organisms (Low Risk Genetic Modification) Regulations 2003 (the Low Risk Regulations). This would mean that developments specified in the Schedule of the Low Risk Regulations (such as alliums with modifications that would result in the production of vertebrate toxins) would not be field tested. The project team proposes that such modifications be excluded from the proposed organism description should this application be approved (Table 2) (section 4.7.9).

8.1.19 Some submitters listed various reports that some Bt-expressing crops have caused allergic or toxic reactions in humans (eg, Lees and others). For example pollen produced by GM maize fields in the Philippines has been suggested as a cause of fevers, respiratory illnesses and skin reactions in nearby residents (Vidal, 2004) or in India, Bt cotton fibres may cause allergic reactions on contact (Gupta et al, 2005). Some submitters also had concerns about the potential allergenic properties of the GM alliums listing the GM peas modified to carry a bean α-amylase inhibitor by CSIRO as an example (Prescott et al, 2005; CSIRO Plant Industry, 2006; Editor, 2006) (eg, Carapiet, GE Free New Zealand (Food and Environment) Inc, Lees and others). In addition, the submission from GE Free New Zealand provided information about various animal feeding trials involving GM-derived products or information about the potential survival of recombinant DNA after consumption.

Evaluation and Review Report for GMF06002 page 120 of 221 Toxic and allergic reactions in the general public 8.1.20 The project team considered that, should this application be approved, unauthorised persons would not have access to the field containment facility and therefore it would be highly improbable that any member of the public would be directly adversely affected (ie, through direct contact) by GM allium plants within the field containment facility.

8.1.21 With regard to the GM pollen and potential allergenic reactions, as the GM pollen is insect-dispersed (not wind) and of limited viability (sections 4.1.21 - 4.1.22), and due to the limited contained flowering (proposed control 6.2) and proposed placement of pollination cages at least 5 metres from the boundary of the field containment facility (proposed control 5.12), the project team considered that the general public would not be exposed to wind-blown GM pollen. As discussed in sections 5.6.24 - 5.6.26, the project team considers that, should this application be approved, any GM pollen blown from the pollination cages would likely to stay within the field containment facility. Therefore, this effect was not considered further.

8.1.22 A large number of submitters identified the consumption of GM foods as a potential cause of adverse effects on human health. Submitters also had concerns about the lack of safety testing related to the GM alliums (such as animal feeding trials) (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc, GE Free New Zealand (Food and Environment) Inc and others). This application is for a contained field test and, should this application be approved, GM alliums would not enter the food chain or be used for human taste testing trials without further approvals. It is further noted that a number of safety considerations would have to be fulfilled before GM plant material can be approved for general public consumption such as immunogenicity (van‟t Hof et al, 2001).

8.1.23 As it is highly improbable that the viable GM alliums would escape from containment (section 5.6.118), the project team considered that, should this application be approved, it would be at worst highly improbable for an adverse effect on the general public.

8.1.24 The project team considered that, should this application be approved, potential allergic or toxic effects, if any, on the general public due to GM alliums would be mild, reversible, short term health effects to individuals in highly localised areas and therefore would be of minimal13 magnitude. As the likelihood of the adverse effect was considered to almost certainly not occur but could not be totally ruled out, the likelihood was considered to be highly improbable. As the level of effect is therefore A, this effect was considered by the project team to be negligible.

13 “Minimal” in terms of human health and safety can mean “mild reversible short term adverse health effects to individuals in highly localised area” (see Appendix 3 for further explanation).

Evaluation and Review Report for GMF06002 page 121 of 221 Toxic and allergic reactions in the field test personnel 8.1.25 The project team considered that, should this application be approved, any allergenic or toxic reactions would be highly localised and affect only those personnel within the field containment facility. It is noted that exposure to this risk is voluntary as, in accordance with the proposed controls, only authorised persons would have access to the GM allium plants in the field containment facility. Furthermore, any adverse health effects would likely to be of short duration, as any person suffering a reaction could be rapidly isolated from the source of the allergen or toxin should it be suspected or found to be the GM allium plants. Any adverse allergic or toxic effects would be readily treatable.

8.1.26 Therefore, the project team considered that, should this application be approved, potential allergic or toxic effects, if any, on field test personnel due to GM alliums would be mild, reversible, short term health effects to individuals in highly localised areas and therefore would be of minimal magnitude. As the likelihood of the adverse effect was considered to almost certainly not occur but could not be totally ruled out, the likelihood was considered to be highly improbable. As the level of effect is therefore A, this effect was considered by the project team to be negligible.

8.1.27 The magnitude of an allergic or toxic effect on field test personnel is uncertain. However, given the potentially small number of people who may have access to the GM alliums and their training, this uncertainty is insignificant.

Enhancing New Zealand’s ability to preserve options and maintain choices 8.1.28 The Royal Commission on Genetic Modification concluded that it is important for New Zealand to preserve its options in terms of future agricultural systems and that research such as that associated with field tests of GMOs is an important foundation that maintains options. While some submitters expressed concern that, by conducting field tests, we might not be preserving options, others noted that it is important to apply biotechnology to keep pace with international developments and that this research will provide information on efficacy and environmental impacts. A further comment from submitters was that New Zealand cannot afford to ignore technology that has brought considerable benefit to farmers in other countries (Walter).

8.1.29 The project team concludes that this field test is important in terms of assisting New Zealand to maintain options should this application be approved. The benefit is associated with the specific genetic modification and is therefore associated with the organism. The project team considers that should this application be approved, that a minor14 beneficial effect

14 “Minor” in terms of society and community can mean “minor localised community benefit” (see Appendix 3 for further explanation).

Evaluation and Review Report for GMF06002 page 122 of 221 would be likely15. The rationale for this assessment is that every field test can make a contribution, and the size of this effect is incremental. The level of beneficial effect is E and this effect was considered by the project team to be non-negligible.

Increased scientific knowledge including knowledge about environmental impacts, agronomic performance and impact, and the ability to use GM crops as part of an integrated pest management (IPM) regime 8.1.30 The project team considered whether increased scientific knowledge including knowledge about environmental impacts, agronomic performance and impact, and the ability to use GM crops as part of an integrated pest management (IPM) regime could be a potentially significant beneficial effect of this field test on society and the community if this application is approved.

8.1.31 On page 9 of the application, the applicant intends for the field test to “answer questions about the impact of particular genes when expressed in alliums, particularly in relation to the physiology of the plant, plant interactions with particular pests or pathogens and the implications for crop agronomy as well as the requirement for chemical applications”.

8.1.32 On page 27 of the application, the applicant lists the data that would be collected during the field test:

environmental impact assessments (eg, chemical application requirements and amounts, flora and fauna assessments); economic impact assessments (eg, extrapolations of potential dollar savings on chemical application costs); cultivar development (eg, selection and advancement of elite germplasm); equivalency testing (eg, comparative biochemical analysis of transgenic and control transgenic lines); and agronomy assessments (eg, assessment of growth and physiology of the lines compared to control material). 8.1.33 The applicant states on page 64 of the application that “with respect to the two major thrusts of the research have been designed around the monitoring such impacts. The first will determine the chemicals, for example, fungicides and pesticides, that must be applied to the field site. The second involves some monitoring of soil microorganisms and fauna associated with the trial site. Precise details of what can and cannot be undertaken are not available until we receive the outcome the recent FRST funding round to determine resources that can be put towards these components, and the size of the field trials we can plant in coming seasons.”

15 “Likely” means “a good chance that it may occur under normal operating conditions” (see Appendix 3 for further explanation).

Evaluation and Review Report for GMF06002 page 123 of 221 8.1.34 In addition, the information listed on page 63 of the application describes a collaboration (funding dependent) which involves the development of logical stepwise risk assessments based primarily on the trait, the properties of the host plant and interactions with flora and fauna. The project team notes that submitters have disagreed whether some aspects of this research (such as the economic impact assessment) would be beneficial (eg, Carapiet and others).

8.1.35 The applicant has described the testing that has been carried out in the GM onions (application GMF03001) field test site. For example, soil samples were tested for the presence of the CP4 EPSPS transgene (none have been found) and differences in the microbial flora and fauna around the root rhizosphere is being investigated (page 50 of the application).

8.1.36 If this application is approved, there are tangible benefits to individual researchers, research organisations and the country as a whole that are directly associated with the conduct of a field test.

8.1.37 If this application is approved, there would likely to be intangible benefits in the form of facts and experience gained through the scientific process (Medawar, 1979). These intangible benefits which accrue to individual researchers, research organisations and the country as a whole can be measured in terms of increased capacity (individual and institutional), numbers of publications, invitations to international fora, and research funding.

8.1.38 Some submitters expressed support for this benefit, but others expressed concern about benefits of this nature and expressed their concern in statements reflecting that they do not believe that the minor benefits to researchers and the research organisation justify risks (ie, submitters consider that such benefits only accrue to individuals and the organisation but are not of public benefit). Associated views included “The US collaborators are just using this test as a seed multiplication exercise… There is no scientific benefit to NZ people” (Bleakley).

8.1.39 There was a view that the benefits to researchers were no different to those that would result from non-GM crop field tests: “Scientific and employee benefit to NZ science – as the GE seeds are imported from the collaborator are as the skills of spraying and weed control can be got working with conventional crops” (Bleakley). The project team notes that working with GM crops does provide researchers with additional skills on top of normal agronomic practices.

8.1.40 Expressions that the benefits from previous tests have not been realised included: “Publication of robust data are yet to be realized. This can be better gained by going to University”; (Bleakley) and “True Science has robust and valid data after testing, this will have neither” (Bleakley).

8.1.41 Some submitters were of the view that knowledge about agronomic performance is not relevant in the specific application because of the time to market for such a crop (The Sustainability Council). Others stated that New Zealand needs to apply biotechnology to keep pace with international

Evaluation and Review Report for GMF06002 page 124 of 221 developments, and that this research would provide information on efficacy and environmental impacts (AgResearch Ltd).

8.1.42 Notwithstanding the integrity of these views and the concerns behind their expression, the project team considers that the specific benefits from this research, including information on the agronomic performance and impact of the alliums, and the environmental effects of growing GM alliums in New Zealand, are potentially significant.

8.1.43 If the field test application is approved, the project team considers that this would result in a minor beneficial effect accruing to both the staff immediately involved with the field test and the wider scientific community. This potential benefit would include an understanding of the agronomic performance of the GM plants and the effects of growing these plants under New Zealand conditions. This beneficial effect would be associated with the genetic modification and would therefore be a benefit of the organism. It would be considered likely to occur. The level of effect is E and this effect was considered by the project team to be non-negligible.

Demonstration of the capacity to conduct field tests in New Zealand and enhanced reputation of New Zealand agricultural research

8.1.44 It was considered whether the demonstration of the capacity to conduct field tests in New Zealand and enhanced reputation of New Zealand agricultural research would be a potentially significant beneficial effect should this application be approved. The project team concluded that since the conduct of the field test is specific to the particular organisms, this is a valid effect

8.1.45 Crop and Food Research has undertaken over 10 field tests of GMOs approved under the Act, and has demonstrated an ability to conduct these tests both from an administrative and scientific capacity including the attracting and retention of scientists. This proposed field test is therefore seen as a continuation of these activities and reinforcement of Crop and Food Research‟s capacity and capability.

8.1.46 Reputational benefits (accruing to a public sector organisation) would have an indirect national reputational benefit accruing to New Zealand.

8.1.47 The project team also notes that, contrary to views held by some individuals, research from previous Crop and Food Research field tests has been published in peer reviewed scientific journals. An example is the recent paper published in the journal Soil Biology and Biochemistry by O‟Callaghan et al (2008) investigating the microbial and nematode communities associated with potatoes genetically modified to express the antimicrobial peptide magainin and unmodified potato cultivars that were grown as part of the GMF98007 field test.

Evaluation and Review Report for GMF06002 page 125 of 221 8.1.48 If this field test application is approved, the project team considers that this would result in a minimal16 to minor beneficial effect accruing to the staff and organisation immediately involved with the field test, and it would be considered to be likely to occur. The level of effect is D – E and this effect was considered by the project team to be non-negligible.

16 “Minimal” in terms of society and community can mean “no social effect” (see Appendix 3 for further explanation).

Evaluation and Review Report for GMF06002 page 126 of 221 9 Evaluation of additional matters

9.1 Additional matters 9.1.1 Section 44A of the Act requires the Authority, in deciding whether to approve or decline an application to field test in containment a GMO, to take into account: (a) any adverse effects of developing or field testing the organism on human health and safety; and the environment, in particular ecosystems and their constituent parts; (b) any alternative method of achieving the research objective that has fewer adverse effects on the matters referred to in paragraph (a) than the development or field test; and (c) any effects resulting from the transfer of any genetic elements to other organisms in or around the site of the development or field test. 9.1.2 All potential adverse effects of the proposed field test have been examined in sections 7 and 8.

9.2 Evaluation of alternative methods to achieve the research objective

9.2.1 As per the ERMA New Zealand policy (ERMA New Zealand, 2008a), when evaluating alternative methods the following questions should be addressed:

can the research objectives be achieved by non-transgenic methods? If “yes”, will these methods have lower overall risk than the transgenic method proposed?; and can the research objective be achieved using alternative transgenic methods? if “yes”, will these methods have lower risks? 9.2.2 In looking for alternative methods, it was investigated whether there is an alternative to the testing of the GM alliums outside a containment structure and whether there are any viable alternatives to achieve alliums with altered agronomic or quality straits.

Alternative to the outdoor testing of GM plants 9.2.3 A number of submitters have questioned whether it is necessary to carry out this proposed research in outdoor containment (ie, the research should be performed in a contained glasshouse) (eg, Carapiet, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others).

9.2.4 However, the purpose of this field test is to assess the performance of the GM alliums in the field and investigate environmental impacts of these plants. Genetically modified plants often exhibit subtle phenotypic differences that only become apparent during field tests (ie, are not evident under contained glasshouse conditions), and the project team considers that

Evaluation and Review Report for GMF06002 page 127 of 221 there are no viable alternative methods of achieving the primary goals of this field test as stated above.

Alternative pest management systems 9.2.5 The project team notes that alternatives exist for achieving the goal of reducing pest damage in an allium cropping system, such as the use of Integrated Pest Management (IPM) strategies. As an example of such a system, forecasting systems for disease outbreaks or insect pest infestations, plant inspections and insect pest scouting missions may allow for the more judicious use of pesticides in allium production (Lorbeer et al, 2002). For onion bacterial diseases, the current control measures may include specific practices to dry onion tops and necks prior to harvest, the use of sanitation programmes for equipment and storage facilities, and the possible use of copper biocides (Mark et al, 2002). Fungal pathogens are currently controlled by rotation, fungicides and curing and storage regimes (Eady, 2002).

9.2.6 However, control of fungal pathogens using fungicides is becoming increasingly difficult. In addition, bacterial rot can occur in the field during wet seasons and, due to the opportunistic nature of the diseases, the development of spray-based control strategies against bacterial diseases has been difficult (Eady, 2002).

9.2.7 Other strategies to produce antimicrobial-resistant plants are being investigated, for example using chemicals or microbes to activate the plant defence pathways to induce disease resistance in plants. As an example, applications of the active ingredient probenazole have been used to protect against rice blast disease (Kogel and Langen, 2005).

Alternative methods for producing alliums with altered agronomic or quality traits 9.2.8 It was considered whether there are alternative methods to genetic modification to produce alliums with the specific agronomic or quality traits that the applicant proposes to field test.

9.2.9 Alternative methods have been attempted to produce crops with altered agronomic or quality traits with mixed success. Plant breeders have attempted to use mutagenesis (eg, by using radiation or mutagens) and/or the selection of specific traits or the breeding of natural variants to develop crops with specific agronomic or quality traits.

Mutagenesis and/or chemical selection 9.2.10 The continuous growth of plant cell cultures in specific herbicides induced spontaneous mutations, gene amplifications or selection of pre-existing herbicide-tolerant variants which includes glyphosate tolerance (Mulwa and Mwanza, 2006; Tan et al, 2005; Pline-Srnic, 2006).

9.2.11 Some herbicide-tolerant plants have been produced through chemical mutagenesis (such as using ethyl methanesulfonate) of seeds, pollen, microspores or cell culture and then selection with an herbicide (Mulwa and

Evaluation and Review Report for GMF06002 page 128 of 221 Mwanza, 2006). By this method a soybean that contained a mutated version of the ALS gene was developed which had enhanced resistant to sulfonylureas. These beans (called STS soybeans) have been sold commercially since 1992 (Gianessi and Carpenter, 2000). Chemical mutagenesis has also generated other herbicide-resistant plants including imidazolinone-tolerant maize, rice, wheat and canola (Tan et al, 2005; Green, 2007).

9.2.12 A naturally occurring ALS mutation which conferred imidazolinone tolerance was found in a wild population of sunflowers adjacent to an herbicide-sprayed field. Conventional breeding techniques introduced this trait into the sunflower germplasm with these imidazolinone-tolerant plants commercialised in 2003 in USA, and Turkey (Tan et al, 2005). When triazine tolerance was found in a birdsrape mustard (Brassica rapa), conventional breeding was used to move this trait into canola (Green, 2007).

Natural variants or spontaneous mutations and conventional breeding 9.2.13 A number of submitters have queried why conventional breeding cannot be used to produce alliums with the specified quality or agronomic traits (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others).

9.2.14 It was noted that that virtually all existing crop plants have some form of disease resistance. For example over 200 plant viral resistance (R) genes have been reported in crops, wild relatives and Arabidopsis thaliana which act through strategies such as limiting or inhibiting viral replication, limiting virus movement cell-to-cell or systemically (Kang et al, 2005; Punja, 2001). Conventional breeding and screening techniques have been used to produce specific disease-resistant alliums, for example Fusarium basal rot-resistant intermediate- and long-day onions have been developed using this strategy (Cramer, 2000).

9.2.15 It was noted that yellow and pink onion (that contain spontaneous mutations in the anthocyanin biosynthesis pathway enzymes) have been bred (Kim et al, 2005a; 2005b; 2007).

Discussion 9.2.16 While non-genetic modification methods could potentially be used to produce some of the GM alliums proposed to be field tested, for example screening for plants with specific virus resistance, such experiments are laborious, time-consuming and the production of a robust stable plant may be ultimately unsuccessful. It was noted that for some of the traits, it may never be possible to reproduce by non-genetic modification means.

9.2.17 Conventional breeding of pest-resistant cultivars and the extensive use of pesticides are currently used as strategies to combat plant pathogens. However, the development of pesticide-resistant microbes or insects is becoming an increasing problem in agriculture and so new strategies to fight these diseases are being explored (Vilcinskas and Gross, 2005). It was also

Evaluation and Review Report for GMF06002 page 129 of 221 noted that microorganisms can rapidly evolve to counter disease resistance mechanisms, and new strategies will be required to rapidly and specifically produce plants that can resist these mutated microorganisms.

9.2.18 When producing herbicide-tolerant plants by herbicide selection (as described in sections 9.2.10 - 9.2.11), the stability of such tolerance can vary considerably in the absence of the herbicide, and the lack of heritable robust tolerance in plants derived from tissue culture limits the use of this method to develop such plants (Pline-Srnic, 2006). While some non-bacteria-derived glyphosate-tolerant traits (such as the maize EPSPS double mutant) have been shown to provide commercially acceptable glyphosate tolerance levels, the bacterial CP4 EPSPS gene was ultimately found to be more efficient (Green, 2007).

9.2.19 Although plants developed using methods such as mutagenesis or selection are not regulated under the Act, the same concerns about GM plants, such as the transfer of herbicide-tolerance genes to weeds or other species may still be applicable to these plants (Tan et al, 2005).

9.2.20 The project team notes that the safety of plants with altered traits developed using non-genetic modification methods compared to GM plants has been questioned (SCION). For example, research by Batista et al (2008) which compared plants that had been mutated using radiation versus those developed through genetic engineering showed that GM plants showed fewer genetic modifications than the mutagenised plants. From these results the authors suggested that all “improved” plants should undergo safety assessment on a case-by-case basis, regardless of how they were developed.

Conclusion 9.2.21 The project team considers that non-transgenic methods will not be able to produce alliums with the range of traits applied for in this application and as the adverse effects (risks) of field testing the GM alliums are not significant, a further evaluation of alternative transgenic or non-transgenic methods is not warranted.

Evaluation and Review Report for GMF06002 page 130 of 221 10 Monitoring of effects

10.1.1 It is noted that a number of submitters consider that food safety testing of the GM alliums should be conducted prior to the field test commencing or the effects of the GM alliums on organisms such as pollinating insects should be investigated during the field test (eg, Aoraki (Canterbury) Province of „The Green Party of Aotearoa‟, The Soil and Health Association of New Zealand Inc and others). A number of submitters also consider that such adverse effects testing cannot be imposed for a field test under the Act (eg, Carapiet and others). It should be noted that it is the policy of the Authority to examine with every GMO application, but especially outdoor developments and field tests, the practicality of monitoring for possible effects or other factors. The Authority‟s position is to encourage applicants to take full advantage of the field test to conduct monitoring which will provide an assurance that risks are being effectively managed and/or provide information that will assist the consideration of any future release application. Where the Authority decides that such monitoring is appropriate as a risk mitigation measure, it will be imposed as a mandatory condition on an approval (ERMA New Zealand, 2008b).

10.1.2 The project team does not consider that mandatory controls for monitoring are required for this contained field test should this application be approved. The applicant intends to perform some environmental impact testing. The applicant states on page 64 of the application that “with respect to the two major thrusts of the research have been designed around the monitoring such impacts. The first will determine the chemicals, for example, fungicides and pesticides, that must be applied to the field site. The second involves some monitoring of soil microorganisms and fauna associated with the trial site. Precise details of what can and cannot be undertaken are not available until we receive the outcome the recent FRST funding round to determine resources that can be put towards these components, and the size of the field trials we can plant in coming seasons.”

10.1.3 The project team considers that, should this application be approved, an annual report must be submitted to ERMA New Zealand that may include details on the activities that have occurred in the field test, if any unanticipated events have occurred, if there are any scientific publications, key findings or results from impacts research, and therefore proposes the following control.

10.1.4 Proposed additional control 7.5: The Operator must ensure that a written, annual, progress report of the field test is provided to ERMA New Zealand by 31 July of each year of the operation of the field containment facility and the subsequent monitoring period. The Operator must ensure content of the progress report is as agreed with ERMA New Zealand at the beginning of each new financial year (1 July to 30 June), and may include, but is not limited to, the following:

(a) field test activities; (b) any unanticipated events;

Evaluation and Review Report for GMF06002 page 131 of 221 (c) any issues with controls; (d) proposed activities for the next year where relevant; (e) any relationship development and management initiatives undertaken with Te Rūnanga o Ngāi Tahu and Te Taumutu Rūnanga; (f) all educational and public awareness activities undertaken with Māori more generally; (g) all educational and public awareness activities undertaken with community groups; and (h) all scientific publications, conference presentations and key findings resulting from this field test, including impacts research. 10.1.5 The applicant has described the effects testing that have been carried out during the GM Onion (application GMF03001) field test. For example, soil samples were tested for the presence of the EPSPS CP4 transgene (none have been found) and the differences in the microbial flora and fauna around the root rhizosphere are being investigated (page 50 of the application).

10.2 Transfer of genetic elements

10.2.1 For the purposes of section 44A(2)(c) of the Act, the potential effects of genetic transfer to non-GM organisms of the same species and to related species were considered. Potential effects arising from the transfer of genetic elements to other allium crops or wild relatives by hybridisation, should this application be approved, are discussed in sections 4.1.39 - 4.1.46, 7.5.5 - 7.5.6 and 6.2. The potential effects resulting from the transfer of any genetic elements, should this application be approved, are discussed in sections 5.6.5 - 5.6.19.

Evaluation and Review Report for GMF06002 page 132 of 221 11 Previous similar applications

11.1 Previous field tests in New Zealand 11.1.1 The Authority must consider each application on its merits and is therefore not bound by the stance it has taken in previous decisions. However, the Authority may wish to reflect on statements it has made in previous decisions where similar issues are raised in this application.

11.1.2 Crop and Food Research currently hold an approval to field test onions modified to carry the C4 EPSPS gene (glyphosate resistance) was approved in 2003 (application GMF03001). This current application differs from application GMF03001 in that the applicant has applied: to field test four allium species with a range of altered quality and agronomic traits; to plant onion seed directly in the ground; and to allow limited flowering of onions in insect-proof cages for seed production.

11.1.3 Genetically modified organisms with traits similar to that applied for in this application have previously been approved for field testing under the Act such as brassicas modified to carry cry genes (insect resistance) (application GMF06001), petunia modified for altered plant form or pigmentation (application GMF98002), sugar beet modified for glufosinate resistance (pat gene) (application GMF98004) and potatoes modified with cecropin B, magainin 2 and lysozyme for resistance to bacterial soft rots (application GMF98007).

11.1.4 From late 1988 until early 1998, the GMO Interim Assessment Group for Field Testing (IAG) approved field tests involving GMOs in New Zealand under the Environment Act 1986. While no approvals for GM alliums were granted by IAG, GMOs with traits similar to that applied for in this application have previously been approved including potatoes modified for resistance to potato virus Y (Coat protein gene)17.

11.2 Consideration of the organism by another country

11.2.1 Field tests have been carried out in the United States involving onions with either glyphosate-tolerance, resistance to the fungal pathogens Fusarium oxysporum and Phoma terrestris (via expression of garlic Chitinase genes), or carrying the Green Fluorescent Protein from Aequorea victoria (Information Systems for Biotechnology, no date). The risk assessment by the Animal and Plant Health Inspection Service (APHIS) on the fungal pathogen-resistant onions found no significant impact on the environment (USDA-APHIS, 1996).

17 See the following ERMA New Zealand websites for details: http://www.ermanz.govt.nz/no/compliance/gmapprovals/iagcarried.html and http://www.ermanz.govt.nz/no/compliance/gmapprovals/iagcompleted.html.

Evaluation and Review Report for GMF06002 page 133 of 221 11.3 Information on other jurisdictions

11.3.1 The project team is not aware of GM alliums commercially released elsewhere in the world.

Evaluation and Review Report for GMF06002 page 134 of 221 12 Associated approvals 12.1.1 If this application is approved, the GM alliums to be field tested would be either developed or imported into New Zealand under a HSNO Act approval. While the applicant currently holds approvals for applications GMD07033, GMD01086 and GMC04019 to import or develop GM alliums, if this application is approved, the alliums to be field tested would not be limited to those developed or imported under these approvals (ie, any GM allium could be field tested provided that they comply with the approved organism description).

12.1.2 The applicant currently holds an approval to field test onions that carry the C4 EPSPS gene (application GMF03001).

12.1.3 If this application is approved, any GM alliums transferred from the field containment facility back to a PC2 containment facility would be subject to the original development or import approvals.

Evaluation and Review Report for GMF06002 page 135 of 221 13 International obligations 13.1.1 For the purposes of consistency with New Zealand‟s international obligations, under section 6(f) of the Act, the project team has considered whether there are any international obligations that may be affected by the field testing of the GM alliums should the Authority decide to approve the application.

13.1.2 It is ERMA New Zealand‟s responsibility as the focal point to notify the Biological Clearing House of this field test, if approved, under the Cartagena Protocol. Under this Protocol, the exportation of any living modified organisms from New Zealand must comply with the Imports and Exports (Living Modified Organisms) Prohibition Order 2005.

13.1.3 The project team notes that, if this application is approved, the applicant must ensure that all international obligations are met prior to field testing.

Evaluation and Review Report for GMF06002 page 136 of 221 14 Overall evaluation 14.1.1 The project team has assessed the risks, costs and benefits of the proposed field test of GM alliums should it be approved, taking into account the controls proposed by the project team and has reached the following conclusions.

14.1.2 Containment measures have been proposed by the project team should this application be approved. It is concluded that, if these measures were adopted, it would be highly improbable that the GM alliums heritable material or genetic elements would escape from the field containment facility.

14.1.3 The project team considers that, should this application be approved, the presence of GM alliums in the field test site would pose a negligible risk on the environment.

14.1.4 The project team considers that, should this application be approved, the health risks of GM alliums to humans and animals through toxicity or allergenicity would be negligible.

14.1.5 The project team considers that, should this application be approved, the risks to the relationship of Māori to the environment, particularly with regard to mātauranga and tikanga Māori, and kaitiakitanga would be negligible. In making this assessment, the project team gave particular weight to the position taken by Te Rūnanga ō Ngāi Tahu, the iwi most affected by this proposal, who chose not to oppose the application.

14.1.6 The project team considers that, should this application be approved, the risks to the principles of the Treaty of Waitangi would be negligible, given the contained nature of the field test and the position taken by Te Rūnanga ō Ngāi Tahu.

14.1.7 The project team considers that, should this application be approved, there would be no significant adverse effects on society and the community or the market economy from the proposed field test.

14.1.8 The project team considers that, should this application be approved, the benefits to be derived from the proposed field test would be enhancing New Zealand‟s ability to preserve options and maintain choices, increased scientific knowledge including knowledge about environmental impacts, agronomic performance and impact, the ability to use of GM crops as part of an IPM regime and the demonstration of the capacity to conduct field tests in New Zealand; and enhanced reputation of New Zealand agricultural research. The benefits considered by the project team to be significant are summarised in Table 4.

Evaluation and Review Report for GMF06002 page 137 of 221

Table 4: Summary of significant beneficial effects on society and community

Description Magnitude Likelihood Effect Uncertainty and Comments Sections of level report

Enhancing New Zealand‟s ability to minor likely E There is little uncertainty about the realisation 8.1.28 - preserve options and maintain choices of this effect. However, it is noted that while 8.1.29 each field test conducted contributes to New Zealand‟s ability to preserve options, the measure of the size of the effect is incremental.

Increased scientific knowledge minor likely E There is little uncertainty about this effect since 8.1.30 - including knowledge about it is independent of the agronomic performance 8.1.43 environmental impacts, agronomic of the plants. performance and impact, and the ability to use of GM crops as part of an IPM regime

Demonstration of the capacity to minimal likely D Since it is difficult to measure the size of this 8.1.44 - conduct field tests in New Zealand; and effect the project team has chosen to account for 8.1.48 enhanced reputation of New Zealand uncertainty by bounding the magnitude of the minor likely E agricultural research effect giving it an upper and lower bound. The same likelihood is applied in both cases.

Evaluation and Review Report for GMF06002 page 138 of 221

References

Aaziz, R, Tepfer, M 1999. Recombination in RNA viruses and in virus-resistant transgenic plants. Journal of General Virology 80: 1339-1346.

Agbios GM Crop Database (no date) http://www.agbios.com/dbase.php?action=ShowForm Agrawal, N, Dasaradhi, PVN, Mohmmed, A, Malhotra, P, Bhatnagar, RK, Mukherjee, SK 2003. RNA interference: biology, mechanism, and applications. Microbiology and Molecular Biology Reviews 67: 657-685.

Aharoni, A, De Vos, ACR, Wein, M, Sun, Z, Greco, R, Kroon, A, Mol, JNM, O‟Connell, AP 2001. The strawberry FaMYB1 transcription factor suppresses anthocyanin and flavonol accumulation in transgenic tobacco. The Plant Journal 28: 319-332.

Alejska, M, Kurzňska-Kokorniak, A, Broda, M, Kierzek, R, Figlerowicz, M 2001. How RNA viruses exchange their genetic material. Acta Biochimica Polonica 48: 391-407.

Alvarez, JP, Pekker, I, Goldschmit, A, Blum, E, Amsellem, Z, Eshed, Y 2006. Endogenous and synthetic microRNAs stimulate simultaneous, efficient, and localized regulation of multiple targets in diverse species. Plant Cell 18: 1134-1151.

Barlow, C 1994. Tikanga Whakaaro Key Concepts in Māori Culture. Oxford University Press, Australia. Batista, R, Saibo, N, Lourenço, T, Oliveira, MM 2008. Microarray analyses reveal that plant mutagenesis may induce more transcriptomic changes than transgene insertion. Proceedings of the National Academy of Sciences USA 105: 3640-3645. Baulcombe, D 2004. RNA silencing in plants. Nature 431: 356-363.

Baum, JA, Bogaert, T, Clinton, W, Heck, GR, Feldmann, P, Ilagan, O, Johnson, S, Plaetinck, G, Munyikwa, T, Pleau, M, Vaughn, T, Roberts, J 2007. Control of coleopteran insect pests through RNA interference. Nature Biotechnology 25: 1322- 1326. Bierhuizen, JF, Wagenvoort, WA 1974. Some aspects of seed germination in vegetables. 1. The determination and application of head sums and minimum temperature for germination. Scientia Horticulturae, 2: 213-219.

Blázquez, MA 2005. The right time and place for making flowers. Science 309: 1024- 1025.

Brewster, JL 1994. Onions and other vegetable alliums. CABI Publishing. Oxon, UK.

Brookes, G, Barfoot, P 2006. Global impact of biotech crops: socio-economic and environmental effects in the first ten years of commercial use. AgBioForum 9: 139-151.

Evaluation and Review Report for GMF06002 page 139 of 221

Brunt, AA, Crabtree, K, Dallwitz, MJ, Gibbs, AJ, Watson, L, Zurcher, EJ (eds.) 1996. onwards. Plant Viruses Online: Descriptions and Lists from the VIDE Database. Version: 20th August 1996. http://image.fs.uidaho.edu/vide/refs.htm

Butler, SJ, Vickery, JA, Norris, K 2007. Farmland biodiversity and the footprint of agriculture. Science 315: 381-383.

Cairns, AJ 2003. Fructan biosynthesis in transgenic plants. Journal of Experimental Botany 54: 549-567.

Capon, B 1990. Botany for Gardeners: An Introduction and Guide. Timber Press Incorporated, Oregon

Castle, LA, Siehl, DL, Gorton, R, Patten, PA, Chen YH, Bertain S, Cho, HJ, Duck, N, Wong, J, Liu, D, Lassner, MW 2004. Discovery and directed evolution of a glyphosate tolerance gene. Science 304: 1151-1154. Castle, LA, Wu, G, McElroy, D 2006. Agricultural input traits: past, present and future. Current Opinion in Biotechnology 17: 105-112. Cerdeira, AL, Duke, SO 2007. Environmental impacts of transgenic herbicide-resistant crops. CAB reviews: Perspectives in Agriculture, Veterinary Science, Nutrition and Natural Resources doi: 10.1079/PAVSNNR20072033. Chen, X 2005. microRNA biogenesis and function in plants. FEBS Letters 579: 5923- 5931.

Christou, P, Capell, T, Kohli, A, Gatehouse, JA, Gatehouse, AMR 2006. Recent developments and future prospects in insect pest control in transgenic crops. Trends in Plant Science 11: 302-308.

Chung, B-N, Canto, T, Palukaitis, P 2007. Stability of recombinant plant virus containing genes of unrelated plant viruses. Journal of General Virology 88: 1347- 1355.

Cooke, P 1987. New Zealand Māori Council vs Attorney General, p664.

Coviello RL, Chaney, WE, Orloff, S, Poole, GJ 2007. Onion and Garlic Maggots. UC IPM Pest Management Guidelines. UC ANR Publication 3453. http://www.ipm.ucdavis.edu/PMG/r584300211.html Retrieved May 2008.

Cramer, CS 2000. Breeding and genetics of Fusarium basal rot resistance in onions. Euphytica 115: 159-166.

Crickmore, N, Zeigler, DR, Schnepf, E, Van Rie, J, Lereclus, D, Baum, J, Bravo, A, Dean, DH 2007. Bacillus thuringiensis toxin nomenclature. http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt/ Retrieved May 2008.

Evaluation and Review Report for GMF06002 page 140 of 221

Crop and Food Research 2008. Media release - International magazine announces New Zealand “Tearless onion” breakthrough http://www.crop.cri.nz/home/news/releases/1201749913200.php Retrieved April 2008.

CSIRO Plant Industry 2006. Effective risk assessment of GM field peas. http://www.pi.csiro.au/GMpeas/PI_info_GMpeas.pdf Retrieved May 2008. Currah, L 1990. Pollination biology. In:Rabinowitch, HD, Brewster, JL. Onions and Allied Crops Volume II. CRC Press Boca Raton, Florida pp. 135-149.

Dai, N, Schaffer, A, Petreikov, M, Shahak, Y, Giller, Y, Ratner, K, Levine, A, Granot, D 1999. Overexpression of Arabidopsis hexokinase in tomato plants inhibits growth, reduces photosynthesis, and induces rapid senescence. The Plant Cell 11: 1253-1266.

Davis, RM, Aegerter, BJ 2007. Onion Yellow Dwarf. UC IPM Pest Management Guidelines: Onion and Garlic. UC ANR Publication 3453. http://www.ipm.ucdavis.edu/PMG/r584101511.html Retrieved May 2008.

Demanèche, S, Sanguin, H, Poté, J, Navarro, E, Bernillon, D, Mavingui, P, Wildi, W, Vogel, TM, Simonet, P 2008. Antibiotic-resistant soil bacteria in transgenic plant fields. Proceedings of the National Academy of Sciences USA 105: 3957-3962. Dunfield, KE, Germida, JJ 2004. Impact of genetically modified crops on soil- and plant-associated microbial communities. Journal of Environmental Quality 33: 806- 815.

Durie, M 2003. „Mana Tangata: Culture, Custom and Transgenic Research‟. Massey University, Palmerston North.

Düring, K, Porsch, P, Fladung, M, Lörz, H 1993. Transgenic potato plants resistant to the phytopathogenic bacterium E. carotovora. Plant Journal 3: 587-598.

Düring, K, Porsch, P, Mahn, A, Brinkmann, O, Gieffers, W 1999. The non-enzymatic microbicidal activity of lysozymes. FEBS Letters 449: 93-100 .

Eady, C 2002. Genetic transformation of onions. In:Rabinowitch, HD. Currah, L (eds.) Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 119 - 142.

Eady, C, Davis, S, Catanach, A, Kenel, F, Hunger, S 2005. Agrobacterium tumefaciens- mediated transformation of leek (Allium porrum) and garlic (Allium sativum). Plant Cell Reports 24: 209-215.

Eady, C, Davis, S, Farrant, J, Reader, J, Kenel, F 2003a. Agrobacterium tumefaciens- mediated transformation and regeneration of herbicide resistant onion (Allium cepa) plants. Annals of Applied Biology 142: 213-217.

Eady, CC, Reader, J, Davis, S, Dale, T 2003b. Inheritance and expression of introduced DNA in transgenic onions plants (Allium cepa). Annals of Applied Biology 142: 219- 224.

Evaluation and Review Report for GMF06002 page 141 of 221

Eady, CC, Weld, RJ, Lister, CE 2000. Agrobacterium tumefaciens-mediated transformation and transgenic-plant regeneration of onion (Allium cepa L.). Plant Cell Reports 19: 376-381.

Editor 2006. Genetically modified mush. Nature Biotechnology 24: 2.

ERMA New Zealand 2003. Evaluation and Review Report - Application for approval to field test in containment any genetically modified organism. Application code: GMF03001. ERMA New Zealand, Wellington. http://www.ermanz.govt.nz/appfiles/execsumm/pdf/GMF03001-003.pdf Retrieved May 2008.

ERMA New Zealand 2004. Incorporating Māori Perspectives in Part V Decision Making ER-PR-01-02 11/04. ERMA New Zealand, Wellington, New Zealand. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-PR-01-02.pdf - Retrieved June 2008.

ERMA New Zealand 2005. Ethics Framework ER-PR-05-1 12/05. ERMA New Zealand, Wellington. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-PR-05-1.pdf Retrieved May 2008.

ERMA New Zealand 2006. Risk assessment of horizontal gene transfer from GM plants to bacteria and human cells ER-GI-05-1 07/06. ERMA New Zealand, Wellington.

ERMA New Zealand 2007. Decision Making: A Technical Guide to Identifying, Assessing and Evaluating Risks, Costs and Benefits ER-TG-05-02 09/07. ERMA New Zealand, Wellington. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-TG- 05-02%2009%2007.pdf

ERMA New Zealand 2008a. Interpretations and Explanations of Key Concepts ER-PR- 03-21 04/08. ERMA New Zealand, Wellington. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-PR-03-21%2004-08.pdf Retrieved May 2008.

ERMA New Zealand 2008b. Making an Application to field test in Containment any Genetically Modified Organism under the HSNO Act 1996 ER-UG-NO-04-3 02/08. ERMA New Zealand, Wellington. Esler, AE 1988. The naturalisation of plants in urban Auckland, New Zealand. 6. Alien plants as weeds. New Zealand Journal of Botany 26: 585-618.

Espley, RV, Hellens, RP, Putterill, J, Stevenson, DE, Kutty-Amma, S, Allan, AC 2007. Red colouration in apple fruit is due to the activity of the MYB transcription factor, MdMYB10. The Plant Journal 49: 414-427.

FAO/IPGRI 1997. Alliums spp. FAO/IPGRI Technical Guidelines for the Safe Movement of Germplasm No 18 Diekmann, M (ed). http://www.bioversityinternational.org/publications/pdf/469.pdf Retrieved May 2008.

Evaluation and Review Report for GMF06002 page 142 of 221

Federici, B 2003. Effects of Bt on Non-Target Organisms. In Matthew Metz (ed) Bacillus thuringiensis A Cornerstone Of Modern Agriculture. Haworth Press, Washington, DC. pp. 11-31.

Filipecki, M, Malepszy, S 2006. Unintended consequences for plant transformation: a molecular insight. Journal of Applied Genetics 47: 277-286.

Fordham, RA 1983. Seasonal dispersion and activity of the pukeko Porphrio p. melanotus (Rallidae) in swamp and pasture. New Zealand Journal of Ecology 6: 133- 142.

Free, JB 1993. Insect pollination of crops. (2nd Ed) pp 115-121. Academic Press, London.

Fuchs, M, Gonsalves, D 2007. Safety of virus-resistant transgenic plants two decades after their introduction: lessons from realistic field risk assessment studies. Annual Review of Phytopathology 45: 173-202.

Gatehouse, JA 2008. Biotechnological prospects for engineering insect-resistant plants. Plant Physiology 146: 881-887.

Gent, DH, du Toit, LJ, Fichtner, SF, Mohan, SK, Pappu, HR, Schwartz, HF 2006. Iris yellow spot virus: An emerging threat to onion bulb and seed production. Plant Disease 90:1468-1480.

Gianessi, LP, Carpenter, JE 2000. Agricultural biotechnology: benefits of transgenic soybean. National Center for Food and Agricultural Policy. http://www.ncfap.org/reports/biotech/rrsoybeanbenefits.pdf Retrieved April 2008. Gibbs, N 1996. Genetically Modified Organisms and Maori Cultural and Ethical Issues. Background paper presented to the Royal Commission on Genetic Modification, commissioned by the Ministry for the Environment June 1996.

Goldberg, N 2005. Iris yellow spot virus. Guide H-255 http://www.cahe.nmsu.edu/pubs/_h/H-255.pdf Retrieved May 2008. Gordon, KHJ, Waterhouse, PM 2007. RNAi for insect-proof plants. Nature Biotechnology 25: 1231-1232.

Green, JM 2007. Review of glyphosate and ALS-inhibiting herbicide crop resistance and resistant weed management. Weed Technology 21: 547-558.

Guan, J, Spencer, JL, Ma, B-L 2005. The fate of the recombinant DNA in corn during composting. Journal of Environmental Science and Health Part B 40: 463-463.

Gupta, A, Gandoloi. A, Nidhi, A 2005. Impact of Bt cotton on farmers‟ health (in Barwani and Dhar District of Madhya Pradesh – Investigation report. http://www.indiagminfo.org/Independent%20studies%20&%20papers%20on%20GM %20crops%20in%20India/On%20BT%20Cotton%20&%20Health%20impacts/BT_He alth_Report-NBA-JSA.pdf Retrieved May 2008.

Evaluation and Review Report for GMF06002 page 143 of 221

Halpin, C 2005. Gene stacking in transgenic plants – the challenge for 21st century plant biotechnology. Plant Biotechnology Journal 3: 141-155.

Hanumappa, M, Choi, G, Ryu, S, Choi, G 2007. Modulation of flower colour by rationally designed dominant-negative chalcone synthase. Journal of Experimental Botany 58: 2471-2478. Healy, AJ, Edgar, E 1980. Flora of New Zealand Volume III. P.D. Hasselberg, Government Printer, Wellington, New Zealand. Heinemann, JA 2003. Is horizontal gene transfer the Cinderella of genetics? NZ BioScience (May): 18-20.

Hellwege, EM, Czapla, S, Jahnke, A, Willmitzer, L, Heyer, AG 2000. Transgenic potato (Solanum tuberosum) tubers synthesize the full spectrum of inulin molecules naturally occurring in globe artichoke (Cynara scolymus) roots. Proceedings of the National Academy of Sciences USA 97: 8699-8704.

Hisano, H, Kanazawa, A, Kawakami, A, Yoshida, M, Shimamoto, Y, Yamada, T 2004. Transgenic perennial ryegrass plants expressing wheat fructosyltransferase genes accumulate increased amounts of fructan and acquire increased tolerance on a cellular level to freezing. Plant Science 167: 861-868.

Holton, TA, Cornish, EC 1995. Genetics and biochemistry of anthocyanin biosynthesis. The Plant Cell 7: 1071-1083.

Horn, ME, Woodard, SL, Howard, JA 2004. Plant molecular farming: systems and products. Plant Cell Reports 22: 711-720.

Howlett, BG, Donovan, BJ, McCallum, JA, Newstrom, LE, Teulon, DAJ 2005. Between and within field variability of New Zealand indigenous flower visitors to onions. New Zealand Plant Protection 58:213-218

Imai, S, Tsuge, N, Tomotake, M, Nagatome, Y, Sawada, H, Nagata, T, Kumagai, H 2002. An onion enzyme that makes the eyes water. Nature 419: 685.

Information Systems for Biotechnology no date. http://www.isb.vt.edu/cfdocs/fieldtests3.cfm Retrieved May 2008.

ISAAA 2007. Brief 37 - Global Status of Commercialized Biotech/GM Crops: 2007 http://www.isaaa.org/resources/publications/briefs/37/executivesummary/pdf/Brief%20 37%20-%20Executive%20Summary%20-%20English.pdf Jones, MG, Hughes, J, Tregova, A, Milne, J, Tomsett, AB, Collin, HA 2004. Biosynthesis of the flavour precursors of onion and garlic. Journal of Experimental Botany 55: 1903-1918.

Jones, HA, Mann, LK 1963. Onions and their allies: botany, cultivation, and utilization. Leonard Hill (Books) Limited, Interscience Publishers, Inc, .

Evaluation and Review Report for GMF06002 page 144 of 221

Kamenetsky, R, Fritsch, RM 2002. Ornamental Alliums. In: Rabinowitch, HD, Currah, L (eds). Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 81- 100.

Kamenetsky, R, Rabinowitch, HD, 2006. The genus Allium: a developmental and horticultural analysis. Horticultural Reviews, 32:329-337.

Kang, B-C, Yeam, I, Jahn, MM 2005. Genetics of plant virus resistance. Annual Review of Phytopathology 43: 581-621.

Kawakami, A, Sato, Y, Yosida, M 2008. Genetic engineering of rice capable of synthesizing fructans and enhancing chilling tolerance. Journal of Experimental Botany 59: 793-802.

Kik, C 2002. Exploitation of wild relatives for the breeding of cultivated Allium species. In: Rabinowitch, HD, Currah, L (eds). Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 81-100.

Kim, S, Bang, H, Yoo, K-S, Pike, LM 2007. Marker-assisted genotype analysis of bulb colors in segregating populations of onions (Allium cepa). Molecules and Cells 23: 573- 578.192-197.

Kim, S, Yoo, K-S, Pike, LM 2005a. Development of a codominant PCR-based marker for allelic selection of the pink trait in onions (Allium cepa), based on the insertion mutation in the promoter of the anthocyanidin synthase gene. Theoretical Applied Genetics 110: 573-578.

Kim, S, Yoo, K-S, Pike, LM 2005b. The basic color factor, the C locus, encodes a regulatory gene controlling transcription of chalcone synthase genes in onions (Allium cepa). Euphytica 142: 273-282.

Knight, J, Holdsworth, D, Mather, D 2003. Trust and Country Image. University of Otago. Knight, J. Holdsworth, D, Mather, D 2007. Country of origin and choice of food imports. Journal of International Business Studies 38: 107-125.

Kogel, KH, Langen, G 2005. Induced disease resistance and gene expression in cereals. Cellular Microbiology 7: 1555-1564.

Komeda, Y 2004. Genetic regulation of time to flower in Arabidposis thaliana. Annual Review of Plant Biology 55: 521-535.

Komochi, S 1990. Bulb dormancy and storage physiology. In:Rabinowitch, HD, Brewster, JL (eds). Onions and Allied Crops Volume II. CRC Press Boca Raton, Florida pp. 89-111.

Evaluation and Review Report for GMF06002 page 145 of 221

Korpela, J, Salonen, E-M, Kuusela, P, Sarvas, M, Vaheri, A 1984. Binding of bacteria and to the outer membrane porin of Escherichia coli. FEMS Microbiology Letters 2: 3- 10.

Kramer, KJ, Morgan, TD, Throne, JE, Dowell, FE, Bailey, M, Howard, JA 2000. Transgenic avidin maize is resistant to storage insect pests. Nature Biotechnology 18: 670-674.

Latham, JR, Wilson, AK 2008. Transcomplementation and synergism in plants: implications for viral transgenes? Molecular Plant Pathology 9: 85-103.

Latham, JR, Wilson, AK, Steinbrecher, RA 2006. The mutational consequences of plant transformation. Journal of Biomedicine and Biotechnology 25376: 1-7.

Lorbeer, JW, Kuhar, TP, Hoffmann, MP 2002. Monitoring and forecasting for disease and insect attack in onions and Allium crops within IPM strategies. In:Rabinowitch, HD. Currah, L (eds.) Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 293-309.

Lu, G 2003. Engineering Sclerotinia sclerotiorum resistance in oilseed crops. African Journal of Biotechnology 2: 509-516.

Lu, S, Shi, R, Tsao, CC, Yi, X, Li, L, Chiang, VL 2004. RNA silencing in plants by the expression of siRNA duplexes. Nucleic Acid Research 32: e171

Mao, Y-B, Cai, W-J, Wang, J-W, Hong, G-J, Tao, X-Y, Wang, L-J, Huang, Y-P, Chen, X-Y 2007. Silencing a cotton bollworm P450 monooxygenase gene by plant-mediated RNAi impairs larval tolerance of gossypol. Nature Biotechnology 25: 1307-1313.

Mark, GL, Gitaitis, RD, Lorbeer, JW 2002. Bacterial diseases of onion. In:Rabinowitch, HD. Currah, L (eds.) Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 267-292.

McCartney, P 1991. A growers guideline for growing onions in Canterbury. New Zealand Department of Scientific and Industrial Research Crop Research Agricultural Bulletin No.16..

Medawar, PB 1979. Advice to a Young Scientist. Pan Books, London.

Mehta Luthra, P, Luthra, R 2002. Propanthial S-oxide synthase: Potential target to develop flavoursome, nonlachrymatory user-friendly onions. Current Science 83: 1439- 1440.

Miller, C, Wansbrough, D 2002. Towards a strategy for using Bt toxins in New Zealand. A response to recommendation 7.1 of the Royal Commission on Genetic Modification. MAF Technical Paper No: 2002/20. http://www.maf.govt.nz/mafnet/rural-nz/research-and- development/biotechnology/using-bt-toxins-in-new-zealand/ Retrieved May 2008.

Evaluation and Review Report for GMF06002 page 146 of 221

Ministry for the Environment, 2001. Valuing New Zealand‟s “Clean Green Image”. Mulwa, RMS, Mwanza, LM 2006. Biotechnology approaches to developing herbicide tolerance/selectivity in crops. African Journal of Biotechnology 5: 396-404. NSF Center for Integrated Pest Management no date. Beet Army Worm http://ipm.ncsu.edu/ag271/soybeans/beet_armyworm.html Retrieved May 2008.

O‟Callaghan, M, Gerard, EM, Bell, NL, Waipara, NW, Aalders, LT, Baird, DB, Conner, AJ 2008. Microbial and nematode communities associated with potatoes genetically modified to express the antimicrobial peptide magainin and unmodified potato cultivars. Soil Biology and Biochemistry 40: 1446-1459. O‟Callaghan, M, Glare, TR, Burgess, EPJ, Malone, LA 2005. Effects of plants genetically modified for insect resistance on nontarget organisms. Annual Review of Entomology 50: 271-92. Ocamb, CM, Gent, DH 2007. Onion (Allium cepa) – Iris Yellow Spot. http://plant- disease.ippc.orst.edu/factsheet.cfm?RecordID=1368&rec_type=disease Retrieved May 2008. Ockey, SC, Thomson, SV no date. Iris Yellow Spot Virus (IYSV). Exotic Pest Monitoring Series EPMS-002. http://utahpests.usu.edu/plantdiseases/files/uploads/PestMonitoring/iris_yellow_spot_vi rus.pdf Retrieved May 2008. OEPP/EPPO 2000. EPPO Standard PP 2/4(2) Guidelines on good plant protection practice Allium Crops. EPPO, Paris, France. Parcy, F 2005. Flowering: a time for integration. International Journal of Developmental Biology 49: 585-593.

Parizotto, EA, Dunoyer, P, Rahm, N, Himber, C, Voinnet, O 2004. In vivo investigation of the transcription, processing, endonucleolytic activity, and functional relevance of the spatial distribution of a plant miRNA. Genes Development 18: 2237- 2242. Perlak, FJ, Fuchs, RL, Dean, DA, McPherson, SL, Fishhoff, DA 1991. Modification of the coding sequence enhances plant expression of insect control protein genes. Proceedings of the National Academy of Sciences USA 88: 3324-3328. Pline-Srnic, W 2006. Physiological mechanisms of glyphosate resistance. Weed Technology 20: 290-300. Pollock, M, Griffiths, M 2005. The Royal Horticultural Society: Illustrated Dictionary of Gardening. The Penguin Group, London. Prescott, VE, Campbell, PM, Moore, A, Mattes, J, Rothenberg, ME, Foster, PS, Higgins, TJV, Hogan, SP 2005. Transgenic expression of bean α-amylase inhibitor in peas results in altered structure and immunogenicity. Journal of Agriculture and Food Chemistry 53: 9023-9030.

Evaluation and Review Report for GMF06002 page 147 of 221

Prins, M, Laimer, M, Noris, E, Schubert, J, Wassenegger, M, Tepfer, M 2008. Strategies for antiviral resistance in transgenic plants. Molecular Plant Pathology 9: 73- 83.

Punja, ZK 2001. Genetic engineering of plants to enhance resistance to fungal pathogens – a review of progress and future prospects. Canadian Journal of Plant Pathology 23: 216-235. Qu, J, Ye, J, Fang, R 2007. Artificial microRNA-mediated virus resistance in plants. Journal of Virology 81: 6690-6699.

Radosevich, SR, Holt, JS, Ghersa, CM 2007. Ecology of Weeds and Invasive Plants. Relationship to Agriculture and Natural Resource Management Third Edition. John Wiley & Sons, Inc. New Jersey, USA p 5. Randle WM 1997. Chapter 5 Onion flavor chemistry and factors influencing flavor intensity. In: Risch, SJ, Ho, C-T (eds.) Spices: Flavor Chemistry and Antioxidant Properties. American Chemical Society.

Randle, WM, Lancaster. JE 2002. Sulphur compounds in alliums in relation to flavour quality. In:Rabinowitch, HD. Currah, L (eds.) Allium Crop Science: Recent Advances. CABI Publishing, Oxon, UK pp 329 - 356.

Ranjekar, PK, Patankar, A, Gupta, V, Bhatnagar, R, Bentur, J, Kumar, PA 2003. Genetic engineering of crop plants for insect resistance. Current Science 84: 321-329.

Rasche, F, Hödl, V, Poll, C, Kandeler, E, Gerzabek, MH, van Elsas, JD, Sessitsch, A 2006. Rhizosphere bacteria affected by transgenic potatoes with antibacterial activities compared with the effects of soil, wild-type potatoes, vegetation stage and pathogen exposure. FEMS Microbiology Ecology 56: 219-23.

Read, D 2000. Use of Antibiotic Resistance Marker Genes in Genetically Modified Organisms. ERMA New Zealand, Wellington. http://www.ermanz.govt.nz/resources/Publications/pdfs/ER-GI-01-1.pdf Retrieved May 2008. Revers, F, Le Gall, O, Candresse, T, Maule, AJ 1999. New advances in understanding the molecular biology of plant/potyvirus interactions. Molecular Plant-Microbe Interactions 12: 367-376.

Roy, B, Popay, I, Champion, P, James, T, Rahman, A 2004. An Illustrated Guide to Common Weeds of New Zealand (2nd Ed). New Zealand Plant Protection Society.

Rubin, B 1990. Weed competition and weed control in Allium crops. In:Rabinowitch, HD, Brewster, JL(ed). Onions and Allied Crops Volume II, CRC Press Boca Raten, Florida pp 63-81.

Sablowski, R 2007. Flowering and determinancy in Arabidopsis. Journal of Experimental Botany 58: 899-907.

Evaluation and Review Report for GMF06002 page 148 of 221

Saito,K 2004. Sulfur assimilatory metabolism. The long and smelling road. Plant Physiology 136: 2443-2450.

Savely, VR, Stricker, RB 2007. Morgellons disease: the mystery unfolds. Expert Review in Dermatology 2: 585-591. Schnepf, E, Crickmore, N, van Rie, J, Lereclus, D, Baum, J, Eielson, J, Zeigler, DR, Dean, DH 1998. Bacillus thuringiensis and its Pesticidal Crystal Proteins. Microbiology and Molecular Biology Reviews 62:775-806.

Schwab, R, Ossowski, S, Riester, M, Warthmann, N, Weigel, D 2006. Highly specific gene silencing by artificial microRNAs in Arabidopsis. Plant Cell 18: 1121-1133.

Sévenier, R, Hall, RD, van der Meer, IM, Hakkert, HJC, van Tunen, AJ, Koops, AJ 1998. High level fructan accumulation in a transgenic sugar beet. Nature Biotechnology 16: 843-846.

Shiota, N, Nagasawa, A, Sakaki, T, Yabusaki, Y, Ohkawa, H 1994. Herbicide-resistant tobacco plants expressing the fused enzyme between rat cytochrome P4501A1 (CYP1A1) and yeast NAPDH-cytochrome P450 oxidoreductase. Plant Physiology 106: 17-23.

Siehl, DL, Castle, LA, Gorton, R, Keenan, RJ 2007. The molecular basis of glyphosate resistance by an optimized microbial acetyltransferase. The Journal of Biological Chemistry 282: 1146-11455.

Simon, PW, Jenderek, MM 2003. Flowering, seed production, and the genesis of garlic breeding. Plant Breeding Reviews 23: 211-244.

Skirvin, RM, McPheeters, KD, Norton, M 1994. Sources and frequency of somaclonal variation. HortScience 29: 1232-1237.

Slater, A, Scott, NW, Fowler, MR 2008. Chapter 2 Plant Tissue Culture In: Plant biotechnology – the genetic manipulation of plants. pp 37-53. Oxford University Press.

Smith, NA, Singh, SP, Wang, MB, Stoutjesdijk, PA, Green, AG, Waterhouse, PM 2000. Total silencing by intron-spliced hairpin RNAs. Nature 407: 319-320.

Stephens, JM 1994. Onion, Welsh – Allium fistulosum L. Horticultural Sciences Department, Florida Cooperative Extension Service, Institute of Food and Agricultural Sciences, University of Florida. http://edis.ifas.ufl.edu/MV102 Retrieved 15 May 2008.

Stotzky, G 2002. Release, persistence, and biological activity in soil of insecticidal proteins from Bacillus thuringiensis. In: Letourneau, DK, Burrows, BE (eds) Genetically Engineered Organisms. Assessing Environmental and Human Health Effects. CRC press, U.S.A. pp.187-222.

Evaluation and Review Report for GMF06002 page 149 of 221

Strizhov, N, Keller, M, Mathur, J, Koncz-Kálmán, Z, Bosch, D, Prudovsky, E, Schell, J, Sneh, B, Koncz, C, Zilberstein, A 1996. A synthetic cryIC gene, encoding a Bacillus thuringiensis δ-endotoxin, confers Spodoptera resistance in alfalfa and tobacco. Proceedings of the National Academy of Sciences USA 93: 15012-15017.

Tabashnik, BE, Gassmann, AJ, Crowder, DW, Carrière, Y 2008. Insect resistance to Bt crops: evidence versus theory. Nature Biotechnology 26: 199-202.

Tan, S, Evans, RR, Dahmer, ML, Singh, BK, Shaner, DL 2005. Imidazolinone-tolerant crops: history, current status and future. Pest Management Science 61: 246-257.

Tepfer, M 2002. Risk assessment of virus-resistant transgenic plants. Annual Review of Phytopathology 40: 467-491.

USDA 2006. Beet/ Fall Armyworm. http://www.ars.usda.gov/Research/docs.htm?docid=7596 Retrieved May 2008.

USDA-APHIS 2006. Environmental assessment and finding of no significant impact. APHIS Number 96-129-02r http://www.isb.vt.edu/biomon/releapdf/9612902r.ea.pdf Retrieved May 2008.

Van Overbeek, L, van Elsas, JD 2008. Effects of plant genotypes and growth stage on the structure of bacterial communities associated with potato (Solanum tuberosum L.). FEMS Microbiology Ecology 64: 283-296.

van Raamsdonk, LWD, Ensink, W, van Heusden, AW, Vrielink-van Ginkel, M, Kik, C 2003. Biodiversity aassessment based on cpDNA and crossability analysis in selected species of Allium subgenus Rhizirideum. Theoretical and Applied Genetics 107 (6) pp 1048 - 1058.

van‟t Hof, W, Veerman, ECI, Helmerhorst, EJ, Nieuw Amerongen, AV 2001. Antimicrobial peptides: properties and applicability. Biological Chemistry 382: 597- 619.

Vidal, J 2004. Scientists suspect health threat from GM maize. The Guardian. http://www.guardian.co.uk/science/2004/feb/27/gm.science Retrieved May 2008.

Vigne, E, Komar, V, Fuchs, M 2004. Field safety assessment of recombination in transgenic grapevines expressing the coat protein gene of Grapevine fanleaf virus. Transgenic Research 13: 165-179.

Vijayraghavan, U 2001. How plants pattern flowers: Lessons from molecular genetic studies of flowering in Arabidopsis thaliana a model plant. Current Science 80: 233- 243.

Vijn, I, van Dijken, A, Sprenger, N, van Dun, K, Weisbeek, P, Wiemken, A, Smeekens, S 1997. Fructan of the inulin neoseries is synthesized in transgenic chicory plants

Evaluation and Review Report for GMF06002 page 150 of 221

(Cichorium intybus L.) harbouring onion (Allium cepa L.) fructan: fructan 6G- fructosyltransferase. Plant Journal 11: 387-398.

Vilcinskas, A, Gross, J 2005. Drugs from bugs: the use of insects as a valuable source of transgenes with the potential in modern plant protection strategies. Journal of Pest Science 78: 187-191.

Voss, RE, Murray, M, Bradford, K, Mayberry, KS, Miller 1999. Onion seed production in . University of California, Division of Agriculture and Natural Resources. http://anrcatalog.ucdavis.edu/pdf/8008.pdf Retrieved 24 May 2008.

Walker, TW 1992. Vegetable Gardening with “Prof‟ Walker. David Bateman Ltd. Auckland.

Wang, M-B, Metzlaff, M 2005. RNA silencing and antiviral defence in plants. Current Opinion in Plant Biology 8: 216-222.

Waterhouse, PM, Graham, MW, Wang, M-B 1998. Virus resistance and gene silencing in plants can be induced by simultaneous expression of sense and antisense RNA. Proceedings of the National Academy of Sciences USA 95: 13959-13964.

Winkel-Shirley, B 2001. Flavonoid biosynthesis. A colorful model for genetics, biochemistry, cell biology, and biotechnology. Plant Physiology 126: 485-493.

Woyke, HW 1981. Some aspects of the role of the honeybee in onion seed production in Poland. Acta Horticulture, 111: 91-98.

Wright, PJ, Clark, RG, Hale, CN 1993. A storage soft rot of New Zealand onions caused by Pseudomonas gladioli pv. alliicola. New Zealand Journal of Crop and Horticultural Science 21: 225-227.

Zheng, S-J, Henken, B, de Maagd, RA, Purwito, A, Krens, FA, Kik, C 2005. Two different Bacillus thuringiensis toxin genes confer resistance to beet armyworm (Spodoptera exigua Hübner) in transgenic Bt-shallots (Allium cepa L.). Transgenic Research 14: 261-272.

Evaluation and Review Report for GMF06002 page 151 of 221

Glossary

Act, The: The Hazardous Substances and New Organisms (HSNO) Act 1996. Agrobacterium tumefaciens: A soil bacterium that infects plants and contains a plasmid that forms plant galls. Strains of this bacterium can be used to introduce foreign DNA into plant cells. Agronomic trait: A characteristic that confers a benefit to the growing and production of the allium such as tolerance to herbicides, resistance to fungal, bacterial or viral diseases of alliums or inducible flowering. Allergen: Any substance (antigen) that is recognised by the immune system and causes an allergic reaction. Amino acids: Amino acids are the building blocks of proteins. There are 20 known amino acids found in living organisms. The sequence of amino acids in a protein determines its function. This sequence of amino acids is determined by the sequence of bases found in the DNA coding for that protein. Antibiotic resistance: An inheritable change in a microorganism that confers the ability to withstand the effects of an antibiotic drug. Autoclave: A pressurised container for heating water above boiling point to sterilise the container‟s contents. Autoclaving destroys organisms but will not destroy DNA. Bacillus thuringiensis (Bt): A gram positive, soil-dwelling bacterium. B. thuringiensis also occurs naturally in the caterpillars of some moths and butterflies. Biota: The total collection of organisms present in a specific region or area. Soil biota include an incredible diversity of organisms including microorganisms (bacteria, fungi and algae), and soil „animals‟ (protozoa, nematodes, mites, springtails, spiders, insects and earthworms). Bt-modified: Plants that have been engineered to express one or more cry genes from Bt. This term is used interchangeably with Bt-expressing, Bt-alliums, Bt- containing, Bt-crops, Bt-transgenic. Bt-spray: Bt foliar sprays consist of a mixture of B. thuringiensis bacteria and spores. Bt toxin Cry protein. BNZ: Biosecurity New Zealand. A division of MAF, hence MAF BNZ. Bolting: The rapid growth of an elongated stem with flowers, which arises from within the main stem of a plant. Codon: The basic unit of the genetic code, comprising three-nucleotide sequences of messenger ribonucleic acid (mRNA), each of which is translated into one amino acid in protein synthesis. Conditional release: Release of an organism with controls determined under section 38 of the HSNO Act 1996. Containment: Restricting an organism to a secure location or facility to prevent escape. Containment facility: A place approved in accordance with section 39 of the Biosecurity Act 1993 for holding of organisms that should not, whether for the time being or ever, become established in New Zealand. Containment glasshouse: A containment structure registered under the Biosecurity Act. Containment structure: A containment facility that is a vehicle, room, building, or other structure, set aside and equipped for the development of genetically modified organisms registered under the Biosecurity Act. Controls: Containment conditions imposed by the Authority under section 45(2) of the Act.

Evaluation and Review Report for GMF06002 page 152 of 221

CRIs Crown Research Institutes such as Crop and Food Research Cry protein: Crystals of proteinaceous insecticidal δ-endotoxins which are encoded by cry genes from Bacillus thuringiensis. Active Cry toxins are produced from Cry proteins through enzymatic cleavage in the gut of susceptible insects (also known as Bt toxin). cry genes: Genes encoding a crystalline protein from Bacillus thuringiensis with insecticidal activity. DNA: Deoxyribonucleic acid. A molecule of DNA consists of a long chain of nucleotides that are composed of deoxyribose, a 5-carbon sugar, a phosphate group linked to the bases (nucleotides) adenine, thymine, cytosine and guanine. DNA contains the genetic code of organisms. DOC: Department of Conservation. Encapsidation Enclosure of a virus's genetic material; with a protein shell (called the capsid). Endemic: Found only in New Zealand. E&R: Evaluation and Review. ERMA New Zealand: Environmental Risk Management Authority. Fallow: Land left uncultivated, or ploughed but not sown. Field containment facility The field test site. Field test: The carrying on of trials on the effects of the organisms under conditions similar to those of the environment into which the organisms are likely to be released, but from which the organisms, or any heritable material arising from them, could be retrieved or destroyed at the end of the trials. Field test site: The area of land in which the field test is to be conducted, and the whole of which is registered as a containment facility in accordance with the provisions of the Act. The field test site is known in this report as“the field containment facility”. Food chains, food webs: Describe the feeding relationships and pathways of energy flow between species in an ecosystem. FRST Foundation for Research, Science and Technology GE: Genetic engineering: heritable, directed alteration of genetic elements of an organism (= GM). Gene: The unit of heredity that carries inherited information. Gene expression: The process by which the information coded within a gene is converted into proteins that ultimately control all the operations in a cell. Genetic element: (a) Heritable material (see below); and (b) any genes, nucleic acids, or other molecules than can, without human intervention, replicate in a biological system and transfer a character or trait to another organism or to subsequent generations of the organism. Gene flow: The transfer of alleles of genes from one population to another. Genome: The entire inherited genetic material of an organism. Genetic marker: A sequence of DNA that has a known location on a chromosome and is known to be associated with a particular gene or trait. Genotype: The genetic make-up of an organism. GM: Genetically modified (or genetic modification): heritable, directed alteration of genetic elements of an organism (= GE). GMO: Genetically Modified Organism - An organism in which any of the genes or other genetic material (a) have been modified by in vitro techniques; or (b)

Evaluation and Review Report for GMF06002 page 153 of 221

are inherited or otherwise derived, through any number of replications, from any genes or genetic material which has been modified by in vitro techniques. ha: Hectare. Heritable material: Viable biological material, including gametes and spores, arising from the organism that can, without human intervention, regenerate the organism or reproduce a new generation of the same species of the organism. HGT: Horizontal gene transfer: transfer of genetic material from one organism to another that is outside the context of parent to offspring reproduction. HSNO Act 1996: Hazardous Substances and New Organisms (HSNO) Act 1996. Hybridisation: The process of crossing different species, varieties or cultivars to create a hybrid. IAG: Interim Assessment Group for the Field Testing and Release of Genetically Modified Organisms. The IAG assessed applications to field test GMOs or perform large scale fermentations involving GMOs before the HSNO Act 1996 came into force. The IAG was established under the Environment Act 1986. IBSC: Institutional Biological Safety Committee. Inbreeding depression: The reduced fitness in a given population as a result of breeding of related individuals. Insect resistance: See „Resistance to insecticides‟ [or „Resistance to insects‟] below. Integrated Pest Management (IPM) A pest control strategy that uses an array of complementary methods: natural predators and parasites, pest-resistant varieties, cultural practises, biological controls, various physical techniques, and pesticides as a last resort. In vitro: In an artificial environment, rather than inside a living organism (which = in vivo). Low-risk genetic modification: Modifications defined in the HSNO Low-Risk (Genetic Modification) Regulations 2003. The field testing of GMOs is not considered low-risk under the Regulations as field tests are not contained within a containment structure. Marker gene: A detectable genetic trait or segment of DNA that can be identified and tracked. A marker gene can serve as a flag for another gene, sometimes called the target gene. A marker gene must be on the same chromosome as the target gene and near enough to it so that the two genes (the marker gene and the target gene) are genetically linked and are usually inherited together. MAF: Ministry of Agriculture and Forestry. Methodology, the: Hazardous Substances and New Organisms (Methodology) Order 1998. mRNA: Messenger RNA - an RNA molecule (see below) whose nucleotide sequence is translated into an amino acid sequence during polypeptide synthesis. Morphology The form and structure of an organism. Non target organisms: Include organisms not targeted by the transgene or modification which feed on alliums plants and may be affected by the transgene product. These may include parasitoids and natural enemies of brassica pests, other organisms such as bees, flies and beetles which may visit these plants, and larger animals such as rabbits and birds. NPTII: Neomycin phosphotransferase gene - confers resistance to neomycin antibiotics e.g. kanamycin.

Evaluation and Review Report for GMF06002 page 154 of 221

Null segregant A plant derived originally from GM plants but shown not to contain the specific genetic modification or trait, may be used as control plants in the proposed field test. Under the Act, such plants are still classed as GM. Parasitoid: An insect, especially a wasp, which completes its larval development within the body of another insect eventually killing it and is free-living as an adult. Pathogenic: Causing disease. Post translational modification: Chemical modification of a protein after its translation, which extends the range of functions of the protein by attaching to it other biochemical functional groups, by changing the chemical nature of the amino acid and/or by making structural changes to the protein PC1: Physical Containment Level 1 as specified in the Australian/New Zealand Standard 2243.3:2002. Safety in laboratories. Part 3: Microbiological aspects and containment facilities. 5th ed. PC2: Physical Containment Level 2 as specified in the Australian/New Zealand Standard 2243.3:2002. Safety in laboratories. Part 3: Microbiological aspects and containment facilities. 5th ed. PCR: Polymerase chain reaction: a technique for generating, in vitro, an increased quantity of a target segment of DNA. Phenotype: The observable characteristics of an organism, produced by the interaction of the organism‟s genotype and the environment. Plant Containment Standard: MAF/ERMA New Zealand Standard Containment Facilities for of Plants: 2007. Plasmid: A small, self-replicating molecule of DNA which contains a specific origin of replication. Plasmids are often used as vectors (see below). Predator: An animal that lives by preying on other animals. Promoter: A DNA sequence that enables a gene to be transcribed. The promoter is recognised by RNA polymerase, which then initiates transcription. Promoters are typically upstream from the gene in question on the DNA strand. The 35S promoter of the cauliflower mosaic virus (CaMV) is a general, a strong plant promoter. It has been used to secure expression of transgenes in most genetically engineered (GE) crop plants. Proteolytically processed: A process by which a protein such as the Cry protein is enzymatically cleaved at certain sites to produce the final product, in this instance, an activated Cry protein which is toxic to susceptible insects. Quality trait A characteristic that confers a consumer or processing benefit to the allium such as altered pungency, heath and flavour, altered sweetness or altered colour. Recombinant: An organism, cell, or virus that contains recombinant DNA. Recombinant DNA: DNA formed by joining, in vitro, segments of DNA from the same or different organisms. Refugia: An area close to the GM crop site. A refugia is used to reduce selection pressure for the development of insect resistance. Release (full): In relation to new organisms, to allow an organism to move within New Zealand free of any restrictions other than those imposed in accordance with the Biosecurity Act 1993 or the Conservation Act 1987. Reporter gene: A gene attached experimentally to another gene or regulatory element such as a promoter of interest. Certain genes are chosen as reporters because the characteristics they confer on organisms expressing them are easily identified and measured. Reporter genes are generally used to determine whether the gene of interest has been taken up by or expressed in the cell or organism population.

Evaluation and Review Report for GMF06002 page 155 of 221

Resistance to antibiotics: See „antibiotic resistance‟ above. Resistance to insecticides: An inheritable change in the ability of insects to withstand exposure to insecticides. Resistance to insects: An inheritable change in the ability of organisms (eg allium) to withstand attack by insects. Rhizosphere: The zone that surrounds the roots of plants. RNA: Ribonucleic acid: a chemical similar to DNA, except that in RNA molecules, the 5-carbon sugar is ribose and uracil is substituted for thymine. RNA delivers the DNA's genetic message to the cytoplasm of a cell where proteins are made. Seed set: Time when seed matures and becomes viable, usually occurs on the parent plant. Segregating non-transgenic progeny Plants derived from crossing GM plants to themselves or to non-GM plants. These plants however, do not contain the transgenes (see below). Selectable markers: Gene sequences that are used to distinguish cells that have been successfully transformed. Selection pressure: Environmental pressure for evolutionary selection for a particular trait. Southern blot: A technique to transfer DNA molecules, which have been separated by gel electrophoresis, onto a membrane for detection by hybridisation. Stacked traits: Transgenic plants engineered to have multiple potentially valuable traits. Inspector: An inspector appointed under the Biosecurity Act, with duties and functions as set down in the MAF/ERMA New Zealand Standard: Containment Facilities for Plants: 2007. T-DNA: Transferred DNA (see „Transformation‟ below). Terminator: (= polyadenylation signal) A part of a gene which specifies the addition of a tail of adenosine residues to the end of an mRNA. The polyadenosine (poly- A) tail protects the mRNA molecule from degradation, and is important for export of mRNA from the nucleus, and for protein biosynthesis. The Act: Hazardous Substances and New Organisms (HSNO) Act 1996. Translation: Formation of polypeptide chain on specialised cellular structures called ribosomes, using the sequence that is contained in the mRNA. The Authority: Environmental Risk Management Authority. The Methodology: HSNO (Methodology) Order 1998. Toxin: A poisonous substance produced by micro-organisms, fungi, plants or animals. Trait: A character or feature of an organism. Transcription: The transfer of genetic information encoded in the nucleotide sequence of DNA into a single-stranded molecule of RNA. Transformation: The genetic alteration of a cell resulting from the introduction, uptake and expression of foreign genetic material (DNA). Transgene: A gene or genetic material which has been transferred, by any of a number of genetic engineering techniques, from one organism to another. Transgenic plants: Plants in which the genetic material has been modified using recombinant DNA techniques. Vector: 1. a self-replicating agent (e.g. plasmid or virus) used to transfer foreign DNA into a host cell.

Evaluation and Review Report for GMF06002 page 156 of 221

2. An organism that transmits a parasite or pathogen from one host to another. Viable genetic material: Biological material that can be resuscitated to grow into tissues or organisms. Volunteer: A plant from the previous year's crop that has become established as a weed in the current crop.

Evaluation and Review Report for GMF06002 page 157 of 221

Appendix 1: Proposed containment controls for GMF06002

In order to provide for the matters detailed in Part I of the Third Schedule to the Act, Containment Controls for Importing, Developing or Field Testing of Genetically Modified Organisms, the project team has proposed the following controls should this application be approved.

In this Appendix:

1. References to providing information or reports to ERMA New Zealand shall mean the Chief Executive of ERMA New Zealand or any such other person nominated by the Authority for this purpose.

2. The terms Operator and Inspector have the meanings given in the MAF/ERMA New Zealand Standard Containment Facilities for Plants:2007 (the Plant Containment Standard).

3. The terms „containment structure‟ and „containment facility‟ have the same meaning as defined in section 2(1) of the Act, namely:

“Containment facility” means,- (a) in relation to new organisms (other than genetically modified organisms), a facility registered as a containment facility under the Biosecurity Act 1993: (b) in relation to genetically modified organisms, a facility which complies with the controls imposed by an approval granted under any of sections 42, 42A, 42B, or 45. “Containment structure” means a containment facility that is a vehicle, room, building, or other structure, set aside and equipped for the development of genetically modified organisms.

1 To limit the likelihood of any accidental release of any organism or any viable genetic material18: Field containment facility

1.1 The containment facility for the field test („the field containment facility‟) must be managed and approved as a containment facility under section 39 of the Biosecurity Act 1993.

1.2 The field containment facility must be operated and maintained in accordance with all of the following controls, including the MAF/ERMA New Zealand Standard

18 Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can be defined to mean biological material capable of growth even though resuscitation procedures may be required, for example, when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by chemicals.

Evaluation and Review Report for GMF06002 page 158 of 221

Containment Facilities for Plants: 200719 (the Plant Containment Standard) and the following controls.

1.3 Responsibility for conducting the field test shall be held by an Operator approved in accordance with section 40 of the Biosecurity Act 1993. The Operator is responsible for ensuring that the field containment facility and authorised staff meet all the relevant requirements of the Plant Containment Standard and the controls listed in this Appendix. The field containment facility manual, approved according to the requirements in the Plant Containment Standard, must be updated to incorporate all these controls. 1.4 The planting site is limited to 2.5 hectares in size at any one time. The boundaries of the field containment facility in which the field test is conducted must be marked by a permanent feature (or GPS location details). 2 To exclude unauthorised people from the field containment facility: 2.1 The Operator must ensure that at all times only persons authorised by the Operator shall have access to the field containment facility. The Operator must maintain measures to restrict unauthorised access to the field containment facility that include:

(a) a fence that restricts public access into the field containment facility must enclose the site; (b) gates must be closed at all times and locked whenever there are no authorised persons present; and

(c) a record of the entry of authorised personnel into the field containment facility.

3 To exclude other organisms from the field containment facility and to control undesirable and unwanted organisms within the field containment facility: 3.1 The Operator must ensure that construction and operation of the field containment facility must comply with the requirements of the Plant Containment Standard relating to the exclusion of other organisms from the field containment facility and the control of undesirable and unwanted organisms within the field containment facility.

3.2 The Operator must ensure that the integrity of the field containment facility boundary fence is maintained at all times. 4 To prevent unintended release of the organism by experimenters working with the organism: 4.1 The Operator must ensure that no living vegetative GM allium material can escape on equipment removed from the field containment facility.

19 Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA New Zealand.

Evaluation and Review Report for GMF06002 page 159 of 221

Transfer of GM allium between the field containment facility and PC2 containment facilities 4.2 The Operator must ensure that when transferring GM allium plant material, which includes seeds, seedlings and bulbs, between PC2 containment facilities and the field containment facility, that: (a) all the GM alliums are secured and double-contained (the packaging requirements listed in section 8.2.7 of the Plant Containment Standard do not apply); and (b) written authorisation is obtained from the MAF Inspector, as the authorised agent of the Authority, in accordance with the procedure specified in the Plant Containment Standard listed in control 1.2. 4.3 The Operator must ensure that no GM allium plants escape during the transfer between PC2 containment facilities and the field containment facility by checking on arrival at the receiving facility that all packages are accounted for and that the packaging is closed. If a discrepancy in the number of packages is found or the packaging is opened, the contingency plan must be implemented (control 5.1). 5 To control the effects of any accidental release or escape of an organism: 5.1 The Operator must ensure the contingency plan for the retrieval or killing of any viable GM allium material that has escaped is implemented immediately in the event of release of viable GM allium material from the field containment facility.

5.2 The Operator must ensure the MAF Inspector, as the authorised agent of the Authority, is informed within 24 hours of the discovery of any interference with the field containment facility or any non-compliance with the controls, whether or not viable GM allium material has escaped from containment. The GM allium material planted in the field containment facility 5.3 The Operator must ensure that all GM alliums planted in the field containment facility are not derived directly from tissue culture.

5.4 The Operator must ensure that all GM alliums planted in the field containment facility are phenotypically true-to-type with respect to flowering or seed characteristics by the use of scientifically validated methods. GM alliums with modified characteristics for flower induction, eg flowering only after the application of a chemical inducer, are approved for field testing as long as all other flowering and seed characteristics are phenotypically true-to-type.

5.5 The Operator must ensure that all GM alliums planted in the field containment facility exhibit the approved traits by the use of scientifically validated methods.

5.6 The Operator must obtain from the MAF Inspector, approval to plant GM alliums in the field containment facility at least 30 working days before the planting takes place. The Operator must provide to the MAF Inspector a written request outlining the nature of the genetic modification, the scientifically validated methods used to assess the phenotype of the GM alliums (in accordance with proposed controls 5.4 and 5.5) and a unique organism description for the GM alliums to be planted. The MAF Inspector must verify the details of the GM alliums against the approved organism description of the approval and confirm this with the Operator. The

Evaluation and Review Report for GMF06002 page 160 of 221

Operator must provide to ERMA New Zealand a unique organism description of the GM alliums to be field tested for the ERMA New Zealand register.

Planting of seeds

5.7 The Operator must not permit the planting of GM allium seeds in the field containment facility when wind is equal to or greater than 4 on the Beaufort Force scale (>20-30 km per hour) at the field containment facility. Seed production within pollination cages 5.8 The Operator must ensure that the MAF Inspector, as the authorised agent of the Authority, inspects and endorses all pollination cages as suitable for the containment of all insects capable of carrying pollen. This must occur at the beginning of each planting season. 5.9 The Operator must demonstrate to the MAF Inspector that insects capable of carrying pollen cannot move through the mesh of the pollination cages. 5.10 The Operator must demonstrate to the MAF Inspector before the first use of the pollination cages that insecticide can penetrate through the mesh of the pollination cages and kill all the insects contained within the pollination cages. 5.11 The Operator must demonstrate to the MAF Inspector that the pollination cages can not be dislodged. The contingency plan must be immediately implemented in the event that a pollination cage is dislodged in any way that would permit the escape of insects capable of carrying pollen (control 5.1).

5.12 Where GM Allium cepa plants are approved to flower in the field containment facility, the Operator must ensure that all developing flowers are detected at least two weeks before flowers are due to open, by the weekly inspection of the plants that are approved to flower. The Operator must ensure that no pollen escapes from the Allium cepa flowers by placing pollination cages over the flowering plants at least two weeks before flowers are due to open. The Operator must ensure that plants approved to flower and enclosing pollination cages are at least 5 metres from the boundary of the field containment facility. 5.13 The Operator must ensure that no insects capable of carrying pollen can escape from the pollination cages containing live insects by conducting a daily inspection of pollination cages. 5.14 The Operator must ensure that no insects escape when they are introduced into the pollination cages. The Operator must ensure that no staff or any other authorised person enters the pollination cages during the period that the cages contain insects capable of carrying pollen. 5.15 The Operator must ensure that no seeds produced in the pollination cages are released in the pollination cages by harvesting all seed heads prior to the shedding of seeds from the seed capsules. The Operator must ensure that all seed heads are collected from the plants approved to flower before authorising the removal of the enclosing pollination cages. The Operator must ensure that pollen does not escape from the pollination cages by the spraying of insecticide in the pollination cages immediately before the harvesting of the seed heads to kill all insects capable of carrying pollen.

Evaluation and Review Report for GMF06002 page 161 of 221

Disposal of plant material from the field containment facility 5.16 The Operator must ensure that all living GM allium vegetative material from the field containment facility not required for further research is killed on-site by composting or another scientifically validated method or transferred to a PC2 containment facility for further research or to be killed. The Operator must ensure that all GM allium material retained for further research purposes is contained under the relevant HSNO Act containment approval for these organisms once they are transferred to the PC2 containment facility. 5.17 The Operator must ensure that all buffer row plants and any non GM rotational crops planted within the containment facility are composted or ploughed into the ground within the field containment facility for the duration of the field test (including the final post-harvest monitoring period). The Operator must ensure GM rotational crops are disposed of according to the controls approved in the field test decisions for those GM crops. Register of GM alliums within the field containment facility 5.18 The Operator must ensure that a register of GM allium lines planted and grown in the field containment facility is maintained. The following records must be kept for each plant line: (a) the identity of the plant line (species, cultivar or breeding line and details of genetic modification); (b) the identity of the authorised person responsible for the plant(s); (c) the date of planting in the field containment facility; (d) the location of rows of the plants within the field containment facility; (e) the date of transfer of plant(s) or viable plant material between PC2 containment facilities and the field containment facility; and (f) the date and method of final disposal of plant(s). 6 Controls addressing inspection and monitoring requirements including any inspection required before, during and after the field containment facility: 6.1 The Operator must ensure that the MAF Inspector, as the authorised agent of the Authority, has access to inspect and audit the field containment facility at any reasonable time to ensure the field containment facility is in full compliance with this approval. The Operator must arrange for inspection of the field containment facility and auditing of its operation to occur:

(a) twice during the growing season, including at least once during the period when flowering could occur; and

(b) once during the winter season if GM alliums are planted in the field containment facility over the winter.

6.2 The Operator must ensure the detection of the onset of bolting or early flower opening by monitoring of the field containment facility, during the period when GM alliums are present. The Operator must ensure that scientifically validated methods are used for monitoring and that staff are trained to detect the onset of bolting or early flower opening. The Operator must ensure that if bolting or early flower opening is detected, the entire flower head or the whole plant is disposed of as set

Evaluation and Review Report for GMF06002 page 162 of 221

out in control 5.16. The only exception to control 6.2 are GM Allium cepa plants approved for seed production and these are subject to controls 5.8 - 5.15. 6.3 The Operator must ensure a monitoring log is kept and made available for inspection by the MAF Inspector. This log must include: (a) the date of monitoring inspections and the name of the person undertaking the monitoring; (b) the number of bolting or early flowering plants detected outside pollination cages and the action taken to contain the bolting or early flowering plants; and (c) the date, details and locations of any volunteer alliums found and the action taken. 6.4 The Operator must ensure that all volunteer allium plants are detected by the monthly monitoring, to commence at the end of each growing season, of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road. The Operator must ensure the disposal, in accordance with control 5.16, of all detected allium volunteer plants. 6.5 The Operator must ensure that a monitoring period of a minimum of two (2) calendar years begins at the completion of the field test, and if in that period any allium volunteer plants are detected a new two (2) year monitoring period must begin from the date of the the detection of the most recent detection of an allium volunteer plant. The Operator must ensure that allium volunteer plants are detected by prohibiting the planting of any allium plants in the field containment facility for the duration of the final monitoring period. The Operator must ensure the detection of allium volunteer plants by the monthly monitoring of the field containment facility, a 10 metre wide strip immediately around the field containment facility and the track from the field containment facility to the road for the duration of the final monitoring period. The Operator must ensure, in accordance with control 5.16, the disposal of all detected volunteer allium plants found during the final monitoring period. 7 Additional controls:

7.1 The Operator must ensure the notification in writing to ERMA New Zealand and the MAF Inspector, as the authorised agent of the Authority, the activation of this approval. This field test must commence within five (5) years of the date of the signing of the decision.

7.2 The Operator must ensure that genetically modified alliums are easily recognisable by the planting in the buffer rows20 of morphologically different species (eg, have different foliage) in the adjacent plots. The Operator must ensure that no genetically modified plants of any species and no GM or non-GM alliums are used in any buffer rows. 7.3 The Operator must ensure that genetically modified alliums are easily recognisable by the planting of morphologically different species (eg, have different foliage) as

20 Plants that are grown around the experimental plots to control for any edge effects. These are planted as part of the experimental design and serve no containment or risk mitigation purposes.

Evaluation and Review Report for GMF06002 page 163 of 221

rotational crops. The Operator must ensure that the conditions of the relevant approvals are complied with where other GM crops (other than GM alliums) are used as rotational crops. Alliums are prohibited as rotational crops. 7.4 The Operator must ensure that ERMA New Zealand and the MAF Inspector is promptly informed of any matters which may affect the long term management of the field containment facility including: (a) changes in the key personnel such as Operator of the field containment facility or the principal investigator responsible for the field test; (b) changes in the management structure of the applicant, (Crop and Food Research) that may affect the management of the field test; (c) any event or circumstance that would affect the capacity of the applicant to meet the requirements of any controls set out in this Appendix; and (d) changes in the use of land immediately surrounding the field containment facility or ownership of the field containment facility site. 7.5 The Operator must ensure that a written, annual, progress report of the field test is provided to ERMA New Zealand by 31 July of each year of the operation of the field containment facility and the subsequent monitoring period. The Operator must ensure content of the progress report is as agreed with ERMA New Zealand at the beginning of each new financial year (1 July to 30 June), and may include, but is not limited to, the following: (a) field test activities; (b) any unanticipated events; (c) any issues with controls; (d) proposed activities for the next year where relevant; (e) any relationship development and management initiatives undertaken with Te Rūnanga o Ngāi Tahu and Te Taumutu Rūnanga; (f) all educational and public awareness activities undertaken with Māori more generally; (g) all educational and public awareness activities undertaken with community groups; and (h) all scientific publications, conference presentations and key findings resulting from this field test, including impacts research. 7.6 The Operator must provide a specifically written annual update to Te Rūnanga o Ngāi Tahu and Te Taumutu Rūnanga by 31 July of each year of the operation of the field containment facility. The Operator must ensure that the update provides information on the progress of the field test and explain how Crop and Food Research is addressing any cultural issues raised by Ngāi Tahu in relation to the field test research. The Operator must ensure that a copy of this update is provided to Ngā Kaihautū Tikanga Taiao. 7.7 Crop and Food Research must ensure the continued engagement and participation in the field test programme of Te Taumutu Rūnanga to a mutually agreed level. Crop and Food Research must provide a copy of the finalised agreement between Crop and Food Research and Te Taumutu Rūnanga to ERMA New Zealand. 7.8 The Operator must ensure that all GM alliums are removed from the field containment facility at completion of the field test, a maximum of ten (10)

Evaluation and Review Report for GMF06002 page 164 of 221

consecutive calendar years from the activation by Crop and Food Research of the decision, and that final monitoring commences (control 6.5). 7.9 The Operator must notify ERMA New Zealand of the completion of the final monitoring of the field containment facility and that all controls have been complied with.

Evaluation and Review Report for GMF06002 page 165 of 221

Appendix 2: Decision pathway FIGURE 11: Decision path for applications to develop or field test any GMO in containment

Context

This decision path describes the decision-making process for applications to develop or field test any GMO in containment. These applications are made under section 40 of the HSNO Act, and determined under section 45 of the Act. Applications to develop a GMO in containment require consideration of section 43 (including sections 41 and 37), and applications to field test a GMO require consideration of sections 44 (section 37 plus the ability of the organism to escape from containment) and 44A (alternative research methods with lesser adverse effects and effects of transfer of genetic elements). Section 37 refers to the ability of the organism to form an undesirable self-sustaining population and ease of eradication.

Introduction

The purpose of the decision path is to provide the Authority with guidance so that all relevant matters in the HSNO Act and the Methodology have been addressed. It does not attempt to direct the weighting that the Authority may decide to make on individual aspects of an application.

In this document „section‟ refers to sections of the HSNO Act, and „clause‟ refers to clauses of the ERMA New Zealand Methodology.

The decision path has two parts –

. Flowchart (a logic diagram showing the process prescribed in the Methodology and the HSNO Act to be followed in making a decision), and . Explanatory notes (discussion of each step of the process).

Of necessity the words in the boxes in the flowchart are brief, and key words are used to summarise the activity required. The explanatory notes provide a comprehensive description of each of the numbered items in the flowchart, and describe the processes that should be followed to achieve the described outcome.

For proper interpretation of the decision path it is important to work through the flowchart in conjunction with the explanatory notes.

Evaluation and Review Report for GMF06002 page 166 of 221

FIGURE 11 FLOWCHART

Decision path for applications to develop or field test any GMO in containment (application made under section 40 of the Act and determined under section 45 of the Act). For proper interpretation of the decision path it is important to work through the flowchart in conjunction with the explanatory notes

1 Review the content of the application and all relevant information

2 3 4 Is this information sufficient No Seek additional Sufficient? to proceed? information

Yes Yes

5 Is the application for a proper No Decline No purpose? (section 45(1)(b)

6 Identify scope of organism description

7 Identify all risks, costs and benefits that are potentially non-negligible

8 Consider extent and impact of mandatory and additional controls under section 45(2) and 45A and whether the organism(s) can be adequately contained

9 Assess each risk assuming controls in place.

10 Undertake combined consideration of all risks and costs, cognisant of proposed controls

11 Clause 27 13 Are all risks with controls in place No Establish position on risk averseness negligible? and appropriate level of caution

Clause 26 Yes

12 14 Is it evident that benefits outweigh No Assess benefits costs?

Yes 15 Taking into account controls, Yes do positive effects outweigh adverse 16 effects? Confirm scope of organism description Confirm and set controls No

Decline Approve (section 45(b)) (section 45(a))

Evaluation and Review Report for GMF06002 page 167 of 221

Figure 11 EXPLANATORY NOTES

An application may be for a single new organism, or for a variety or range of new organisms where the boundaries of the extent of modifications envisaged are well defined (see ERMA New Zealand Protocol: Interpretations and Explanations of Key Concepts interpretation „Identification of New Organisms‟). In both of these cases organisms having similar risk profiles should be grouped into categories. Each category should be considered separately via the path below.

Item 1: Review the content of the application and all relevant information

Review the application, the E&R Report (or draft decision and Agency advice),, and information received from experts and that provided in submissions (where relevant) in terms of section 40(2) of the Act and clauses 8, 15, 16 and 20 of the Methodology.

Item 2: Is this information sufficient to proceed?

Review the information and determine whether or not there is sufficient information available to make a decision.

The Methodology (clause 8) states that the information used by the Authority in evaluating applications shall be that which is appropriate and relevant to the application. While the Authority will consider all relevant information, its principal interest is in information which is significant to the proper consideration of the application; ie information which is “necessary and sufficient” for decision- making.

Item 3: (if no) Seek additional information

If there is not sufficient information then additional information may need to be sought from the applicant, the Agency or other parties/experts under section 58 of the Act (clause 23 of the Methodology).

Item 4: Sufficient?

When additional information has been sought, has this been provided, and is there now sufficient information available to make a decision?

If the Authority is not satisfied that it has sufficient information for consideration, then the application must be declined under section 45(1)(b).

Under section 40(4) of the Act the applicant may choose to withdraw the Evaluation and Review Report for GMF06002 page 168 of 221

application at any time.

Item 5: (If ‘yes’ from item 2 or from item 4) Is the application for a proper purpose?

Section 39(1) of the Act specifies the purposes for which the Authority may approve the importation, development or field testing of a new organism. Specifically section 39(1)(a) refers to the development of any new organism, and 39(1)(b) to the field testing of any new organism.

If the application is not for one of these purposes then it must be declined.

Item 6: Identify scope of organism description

Clearly identify the scope of the organism. Particular attention should be paid to whether the application is for a single new organism or a variety of new organisms as referenced in the Introduction to these notes. Exclusions may be used to sets bounds on the scope of the organism description where a range or variety of new organisms is being considered.

Item 7: Identify all risks, costs and benefits that are potentially non-negligible21

Costs and benefits are defined in the Methodology as the value of particular effects (clause 2). However, in most cases these „values‟ are not certain and have a likelihood attached to them. Thus costs and risks are generally linked and may be addressed together. If not, they will be addressed separately. Examples of costs that might not be obviously linked to risks are direct financial costs that cannot be considered as „sunk‟ costs (see footnote 1). Where such costs arise and they have a market economic effect they will be assessed in the same way as risks, but their likelihood of occurrence will be more certain (see also item 12).

Identification is a two step process that scopes the range of possible effects (risks, costs and benefits).

Step 1: Identify all risks and costs (adverse effects) and benefits (beneficial effects) associated with the approval of the organism(s), and based on the range of areas of impact described in clauses 9 and 10 of the

21 Relevant effects are marginal effects, or the changes that will occur as a result of the organism(s) being available. Financial costs associated with preparing and submitting an application are not marginal effects and are not effects of the organism(s) and are therefore not taken into account in weighing up adverse and positive effects. These latter types of costs are sometimes called „sunk‟ costs since they are incurred whether or not the application is successful. Evaluation and Review Report for GMF06002 page 169 of 221

Methodology and sections 5 and 6 of the Act22.

Effects arising from the transfer of genetic elements, as set out in section 44A(2)(c) of the Act, must also be considered if the application is

. for a development that does not take place in a containment structure, or . for a field test. Relevant costs and benefits are those that relate to New Zealand and those that would arise as a consequence of approving the application (clause 14).

Consider short term and long term effects.

Identify situations where risks and costs occur in one area of impact or affect one sector and benefits accrue to another area or sector; that is, situations where risks and costs do not have corresponding benefits.

Step 2: Document those risks, costs and benefits that can be readily concluded to be negligible23, having regard to the characteristics of the organism and the circumstances of the application, and eliminate them from further consideration.

Note that where there are costs that are not associated with risks some of them may be eliminated at this scoping stage on the basis that the financial cost represented is very small and there is no overall effect on the market economy.

Item 8: Consider extent and impact of mandatory and additional controls under sections 45(2) and 45A and whether the organism(s) can be adequately contained.

Section 45(2) requires the application of controls for all applicable matters specified in the 3rd Schedule (Part I).

Mandatory controls for certain developments (those that do not take place in a containment structure) and all field tests are set out in section 45A of the Act. These relate to removal and/or destruction of material from the site. The Authority must set controls for the removal of the organisms and any heritable material and

22 Effects on the natural environment, effects on human health and safety, effects on Maori culture and traditions, effects on society and community, effects on the market economy. 23 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in terms of their likelihood and effect that they do not require active management and/or after the application of risk management can be justified by very small levels of benefits”. Evaluation and Review Report for GMF06002 page 170 of 221

may set controls for the removal or destruction of genetic elements (this is a matter for the discretion of the Authority).

The Authority may consider other controls to give effect to the purpose of the Act. The impact of all these controls needs to be considered.

Section 45(1)(a)(iii) requires the Authority to be satisfied that the organism can be “adequately contained”. The concept of adequate containment includes the satisfactory biological and/or physical containment of the organism and also the ability of the applicant to apply and maintain all the controls satisfactorily.

Item 9: Assess each risk assuming controls in place

The assessment of potentially non-negligible risks and costs should be carried out in accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. Most of these risks and costs will relate to matters in sections 5 and 6 of the Act. In undertaking this assessment the Authority must take into account the principles of the Treaty of Waitangi (section 8, and clause 9(c)(iv)).

The assessment is carried out with the controls in place. It should consider the following four matters that have particular relevance for this type of application.

(1) The ability of the organism to escape from containment (section 44)

Although strictly speaking, this requirement applies only to field test applications and not to development applications (see section 45(1)(a)(ii)), it is prudent and good practice to consider it anyway. This element must be considered in an integrated way in the assessment process because the ability to escape depends on the containment controls set.

(2) Self-sustaining population (section 37).

Section 37 of the Act requires the consideration to have regard to the ability of the organism to establish an undesirable self sustaining population and the ease of eradication if it were to establish such a population. Undesirable means (in effect) able to create significant risks.

(3) Alternative research methods (section 44A(2)(b))

For certain developments (those that do not take place in a containment structure) and for all field tests, section 44A of the Act requires alternative means of achieving research objectives to be taken into account.

The following actions apply:

. Consideration of whether there are any other ways of achieving the research objectives which pose less risk (taking account of the

Evaluation and Review Report for GMF06002 page 171 of 221

mitigating impact of controls as well as the absence of controls). . Consideration of whether the difference between possible approaches is sufficient to justify declining the application. (4) Additional matters

Other matters to be considered in the assessment are:

. the extent to which the risk will be mitigated by the setting of containment and other controls, including the mandatory controls in the Act; and . the extent to which the risk will be mitigated by the ability to eradicate the organism if it becomes established. Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it should occur and the likelihood of it occurring considering also the level of risk if containment or other controls fail, as well as the probability of such a failure. In estimating the magnitude of the adverse effect take into account the extent to which the risk might be mitigated by how or whether it might be possible to eradicate the organism if a significant adverse effect eventuated (section 37). When estimating the likelihood of the effect occurring, consider the full pathway, that is, all the possible steps that must occur before the final identified effect is realised. Estimating the likelihood requires combining (multiplying) all of the individual likelihoods for each link in the chain of events.

Where there are non-negligible financial costs that are not associated with risks then the probability of occurrence (likelihood) may be close to 1. Relevant information provided in submissions should be taken into account.

The distribution of risks and costs should be considered, including geographical distribution and distribution over groups in the community, as well as distribution over time. This information should be retained with the assessed level of risk/cost.

Approach to risk and approach to uncertainty Consider the Authority‟s approach to risk (clause 33 of the Methodology) or how risk averse the Authority should be in giving weight to the residual risk, where residual risk is the risk remaining after the imposition of controls.

The risk characteristics set out in clause 33 are:

(a) Exposure to the risk is involuntary: (b) The risk will persist over time: (c) The risk is subject to uncontrollable spread and is likely to extend its effects beyond the immediate location of incidence: (d) The potential adverse effects are irreversible: (e) The risk is not known or understood by the general public and there is little experience or understanding of possible measures for managing the potential adverse effects. Consider each non-negligible risk in terms of the factors listed and decide whether to be risk averse by giving additional weight to that risk. This may be done as part Evaluation and Review Report for GMF06002 page 172 of 221

of estimating the magnitude of the effect or where this is not relevant, it may be done separately.

Where the Authority chooses to be risk averse, and there is uncertainty as well, the approach to risk may be consolidated with the approach to uncertainty by adopting a conservative approach such as the worst feasible case scenario.

See the ERMA New Zealand report „Approach to Risk‟ for further guidance24.

The assessment includes consideration of how cautious the Authority will be in the face of uncertainty (section 7 and clauses 29-32). Where there is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the adverse effect as a means of identifying the range of uncertainty (clause 32). It is also important to bear in mind the materiality of the uncertainty and how significant the uncertainty is for the decision (clause 29(a)).

For each component (magnitude and likelihood) consider the degree of uncertainty associated with the estimation of each component. In some cases it may be clear that the uncertainty could be reduced by gathering further information (undertaking more scientific tests, or extending the literature search). Before requesting or seeking further information it is important to consider how important the uncertainty is in terms of the decision (clause 29(a) – materiality), and to essentially consider the cost-effectiveness of gathering further information.

Another approach to addressing uncertainty is to look at a range of scenarios and consider a best feasible-worst feasible scenario range. However, where there is a large degree of uncertainty, this may not be particularly meaningful for calculating the level of risk. In other cases, calculating the level of risk for each end of the range may result in a fairly similar level of risk. Where this does not occur, rather than presenting a wide range in the level of risk it may be better to concentrate on analysing why the uncertainty occurs and whether or not there is any obvious way of resolving it.

Additional controls Controls additional to those mandated in section 45(2) and 45A of the Act (see item 8) may need to be considered, in order to mitigate risks to whatever level is considered to be appropriate, and to provide adequate containment.

Item Undertake combined consideration of all risks and costs, cognisant of 10: proposed controls

Once the risks and costs have been assessed individually, if appropriate consider all risks and costs together as a „basket‟ of risks/costs. This may involve

24 http://www.ermanz.govt.nz/resources/publications/pdfs/ER-OP-03-02.pdf Evaluation and Review Report for GMF06002 page 173 of 221

combining groups of risks and costs as indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or using other techniques as indicated in clause 34(b). The purpose of this step is to consider the interactions between different effects and determine whether these may change the level of individual risks.

Item Are all risks with controls in place negligible? 11: At this point the decision path branches. Looking at individual risks in the context of the „basket‟ of risks, consider whether all of the residual risks are negligible. Consider also the cumulative effect of the assessed risks.

Where all risks are negligible, and the cumulative effect of the risks is considered to be negligible then take the clause 26 option and move to item 12. If one or more of the risks is considered to be non-negligible, or the cumulative sum of the risks is non-negligible, then take the clause 27 option and move to item 13.

Item 12:

11 Are all risks with controls in place negligible?

Clause 26 Yes

(from item 11 - if ‘yes’) Is it evident that benefits outweigh costs?

Risks have already been determined to be negligible (item 11), therefore the decision must be made under clause 26 of the Methodology. In the unusual circumstance where there are non-negligible costs that are not associated with risks they have been assessed in item 9.

Costs are made up of two components: internal costs or those that accrue to the applicant, and external costs or those that accrue to the wider community.

Consider whether there are any non-negligible external costs that are not associated with risks.

If there are no external non-negligible costs then external benefits outweigh external costs. The fact that the application has been submitted is deemed to

Evaluation and Review Report for GMF06002 page 174 of 221

demonstrate existence of internal or private net benefit, and therefore total benefits outweigh total costs25. As indicated above, where risks are deemed to be negligible, and the only identifiable costs resulting from approving an application are shown to accrue to the applicant, then a cost-benefit analysis will not be required. The act of an application being lodged will be deemed by the Authority to indicate that the applicant believes the benefits to be greater than the costs.

However, if this is not the case and there are external non-negligible costs then all benefits need to be assessed (via item 14).

Item 13:

11 Clause 27 Are all risks with controls in place No negligible?

(from item 11 - if ‘no’) Establish position on risk averseness and appropriate level of caution

Although „risk averseness‟ (approach to risk, clause 33) is considered as a part of the assessment of individual risks, it is good practice to consolidate the view on this if several risks are non-negligible. This consolidation also applies to the consideration of the approach to uncertainty (section 7).

Item Assess benefits 14: Assess benefits or positive effects in terms of clause 13 of the Methodology.

Since benefits are not certain, they are assessed in the same way as risks. Thus the assessment involves estimating the magnitude of the effect if it should occur and the likelihood of it occurring. This assessment also includes consideration of the Authority‟s approach to uncertainty or how cautious the Authority will be in the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the positive effect.

An understanding of the distributional implications of a proposal is an important

25TECHNICAL GUIDE ‘RISKS, COSTS AND BENEFITS’ PAGE 6 - NOTE THAT, WHERE RISKS ARE NEGLIGIBLE AND THE COSTS ACCRUE ONLY TO THE APPLICANT, NO EXPLICIT COST BENEFIT ANALYSIS IS REQUIRED. IN EFFECT, THE AUTHORITY TAKES THE ACT OF MAKING AN APPLICATION AS EVIDENCE THAT THE BENEFITS OUTWEIGH THE COSTS. SEE ALSO PROTOCOL SERIES 1 ‘GENERAL REQUIREMENTS FOR THE IDENTIFICATION AND ASSESSMENT OF RISKS, COSTS, AND BENEFITS’.

Evaluation and Review Report for GMF06002 page 175 of 221

part of any consideration of costs and benefits, and the distribution of benefits should be considered in the same way as for the distribution of risks and costs.

The Authority will in particular look to identify those situations where the beneficiaries of an application are different from those who bear the costs26. This is important not only for reasons related to fairness but also in forming a view of just how robust any claim of an overall net benefit might be. It is much more difficult to sustain a claim of an overall net benefit if those who enjoy the benefits are different to those who will bear the costs. Thus where benefits accrue to one area or sector and risks and costs are borne by another area or sector then the Authority may choose to be more risk averse and to place a higher weight on the risks and costs.

As for risks and costs, the assessment is carried out with the default controls in place.

Item Taking into account controls, do positive effects outweigh adverse effects? 15: In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where possible combine groups of risks, costs and benefits or use other techniques such as dominant risks and ranking of risks. The weighing up process takes into account controls proposed in items 8 and 9.

Where this item is taken in sequence from items 13 and 14 (i.e. risks are not negligible) it constitutes a decision made under clause 27 of the Methodology.

Where this item is taken in sequence from items 12 and 14 (i.e. risks are negligible, and there are external non-negligible costs) it constitutes a decision made under clause 26 of the Methodology.

Item Confirm scope or organism description 16: Confirm and set controls

At this step the scope of the organism description for generic applications should be reviewed. If changes are made to the organism description, items 7-15 above should be repeated for the revised organism description. Then the weighing up process in this item for the revised organism description should also be repeated.

The scope of the organism description has been identified in item 6. This step in the decision-making process confirms the scope of the organism description in such a way that the risk boundaries are defined. Controls have been considered at

26 This principle derives from Protocol Series 1, and is restated in the Technical Guide „Risks, Costs and Benefits‟. Evaluation and Review Report for GMF06002 page 176 of 221

the earlier stages of the process (items 8, 9 and 16). The final step in the decision- making process brings together all the proposed controls, and reviews them for overlaps, gaps and inconsistencies.

Once these have been resolved the controls are confirmed.

Evaluation and Review Report for GMF06002 page 177 of 221

Appendix 3: Qualitative descriptors for risk/benefit assessment

Qualitative descriptors for risk/benefit assessment

Modified from the ERMA New Zealand Technical Guide to Decision Making. This section describes how the Agency staff and the Authority address the qualitative assessment of risks, costs and benefits. Risks and benefits are assessed by estimating the magnitude and nature of the possible effects and the likelihood of their occurrence. For each effect, the combination of these two components determines the level of the risk associated with that effect, which is a two dimensional concept. Because of lack of data, risks are often presented as singular results. In reality, they are better represented by „families‟ of data which link probability with different levels of outcome (magnitude).

The magnitude of effect is described in terms of the element that might be affected. The qualitative descriptors for magnitude of effect are surrogate measures that should be used to gauge the end effect or the „what if‟ element. Tables 1 and 2 contain generic descriptors for magnitude of adverse and beneficial effect. These descriptors are examples only, and their generic nature means that it may be difficult to use them in some particular circumstances. They are included here to illustrate how qualitative tables may be used to represent levels of adverse and beneficial effect.

Table 1 Magnitude of adverse effect (risks and costs)

Descriptor Examples of descriptions - ADVERSE

Minimal Mild reversible short term adverse health effects to individuals in highly localised area

Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact

Local/regional short-term adverse economic effects on small organisations (businesses, individuals), temporary job losses

No social disruption

Minor Mild reversible short term adverse health effects to identified and isolated groups

Localised and contained reversible environmental impact, some local plant or animal communities temporarily damaged, no discernible ecosystem impact or species damage

Regional adverse economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job losses

Potential social disruption (community placed on alert)

Evaluation and Review Report for GMF06002 page 178 of 221

Moderate Minor irreversible health effects to individuals and/or reversible medium term adverse health effects to larger (but surrounding) community (requiring hospitalisation)

Measurable long term damage to local plant and animal communities, but no obvious spread beyond defined boundaries, medium term individual ecosystem damage, no species damage

Medium term (one to five years) regional adverse economic effects with some national implications, medium term job losses

Some social disruption (e.g. people delayed)

Major Significant irreversible adverse health effects affecting individuals and requiring hospitalisation and/or reversible adverse health effects reaching beyond the immediate community

Long term/irreversible damage to localised ecosystem but no species loss

Measurable adverse effect on GDP, some long term (more than five years) job losses

Social disruption to surrounding community, including some evacuations

Massive Significant irreversible adverse health effects reaching beyond the immediate community and/or deaths

Extensive irreversible ecosystem damage, including species loss

Significant on-going adverse effect on GDP, long term job losses on a national basis

Major social disruption with entire surrounding area evacuated and impacts on wider community

.

Table 2 Magnitude of beneficial effect (benefits)

Descriptor Examples of descriptions -BENEFICIAL

Minimal Mild short term positive health effects to individuals in highly localised area

Highly localised and contained environmental impact, affecting a few (less than ten) individuals members of communities of flora or fauna, no discernible ecosystem impact

Local/regional short-term beneficial economic effects on small organisations (businesses, individuals), temporary job creation

No social effect

Evaluation and Review Report for GMF06002 page 179 of 221

Minor Mild short term beneficial health effects to identified and isolated groups

Localised and contained beneficial environmental impact, no discernible ecosystem impact

Regional beneficial economic effects on small organisations (businesses, individuals) lasting less than six months, temporary job creation

Minor localised community benefit

Moderate Minor health benefits to individuals and/or medium term health impacts on larger (but surrounding) community and health status groups

Measurable benefit to localised plant and animal communities expected to pertain to medium term.

Medium term (one to five years) regional beneficial economic effects with some national implications, medium term job creation

Local community and some individuals beyond immediate community receive social benefit.

Major Significant beneficial health effects to localised community and specific groups in wider community

Long term benefit to localised ecosystem(s)

Measurable beneficial effect on GDP, some long term (more than five years) job creation

Substantial social benefit to surrounding community, and individuals in wider community.

Massive Significant long term beneficial health effects to the wider community

Long term, wide spread benefits to species and/or ecosystems

Significant on-going effect beneficial on GDP, long term job creation on a national basis

Major social benefit affecting wider community

Likelihood in this context applies to the composite likelihood of the end effect, and not either to the initiating event, or any one of the intermediary events. It includes:

. the concept of an initiating event (triggering the hazard), and . the exposure pathway that links the source (hazard) and the area of impact (public health, environment, economy, or community).

Evaluation and Review Report for GMF06002 page 180 of 221

Thus, the likelihood is not the likelihood of an organism escaping, or the frequency of accidents for trucks containing hazardous substances, but the likelihood of the specified adverse effect27 resulting from that initiating event. It will be a combination of the likelihood of the initiating event and several intermediary likelihoods28. The best way to determine the likelihood is to specify and analyse the complete pathway from source to impact.

Likelihood may be expressed as a frequency or a probability. While frequency is often expressed as a number of events within a given time period, it may also be expressed as the number of events per head of (exposed) population. As a probability, the likelihood is dimensionless and refers to the number of events of interest divided by the total number of events (range 0-1).

Table 3 Likelihood

Descriptor Description

1 Highly improbable Almost certainly not occurring but cannot be totally ruled out

2 Improbable Only occurring in very exceptional circumstances. (remote)

3 Very unlikely Considered only to occur in very unusual circumstances

4 Unlikely Could occur, but is not expected to occur under normal operating (occasional) conditions.

5 Likely A good chance that it may occur under normal operating conditions.

6 Very likely Expected to occur if all conditions met

7 Extremely likely Almost certain

Using the magnitude and likelihood tables a matrix representing a level of risk can be constructed.

In the example shown in Table 4, six levels of risk are allocated: A, B, C, D, E and F. These terms have been used to avoid confusion with the descriptions used for likelihood and magnitude, and to emphasise that the matrix is a tool to help decide which risks (benefits) require further analysis to determine their significance in the decision making process.

27 The specified effect refers to scenarios established in order to establish the representative risk, and may be as specific as x people suffering adverse health effects, or y% of a bird population being adversely affected. The risks included in the analysis may be those related to a single scenario, or may be defined as a combination of several scenarios. 28 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included. Evaluation and Review Report for GMF06002 page 181 of 221

The lowest level (A) is, in most circumstances, equivalent to „negligible‟. In this table „A‟ is given to three combinations; minimal impact and an occurrence of improbable or highly improbable, and minor impact with a highly improbable occurrence.

For negative effects, the levels are used to show how risks can be reduced by the application of additional controls. Where the table is used for positive effects it may also be possible for controls to be applied to ensure that a particular level of benefit is achieved, but this is not a common approach. The purpose of developing the tables for both risk and benefit is so that the risks and benefits can be compared.

Table 4 Level of risk

Magnitude of effect

Likelihood Minimal Minor Moderate Major Massive

Highly A A B C D improbable

Improbable A B C D E

Very B C D E E unlikely

Unlikely C D E E F

Likely D E E F F

Very likely E E F F F

Extremely E F F F F likely

Evaluation and Review Report for GMF06002 page 182 of 221

Appendix 4: Government Departments and other agencies notified of application

AgResearch Ltd Ministry of Health Ashburton District Council Ministry of Pacific Island Affairs Ministry of Research, Science & Technology Banks Peninsula District Council (MoRST) Buller District Council Museum of New Zealand - Te Papa Tongarewa National Institute of Water & Atmospheric Canterbury Regional Council Research Limited (NIWA) Central Otago District Council Nelson City Council New Zealand Institute for Crop and Food Research Chatham Islands Council Limited Christchurch City Council Northland Regional Council Clutha District Council Otago District Health Board Department of Internal Affairs Otago Regional Council Dunedin City Council Queenstown-Lakes District Council Environment Bay of Plenty Rangitikei District Council Far North District Council SCION Fish & Game Council of New Zealand Selwyn District Council Fish & Game Council Otago South Taranaki District Council Fish & Game Nelson/Marlborough Southland District Council Food Standards Australia New Zealand Southland Regional Council Gore District Council Tairawhiti District Health Grey District Council Taranaki Regional Council Horizons Regional Council Tasman District Council Horowhenua District Council Taupo District Council Horticulture and Food Research Institute Television New Zealand (HortResearch Auckland) Horticulture and Food Research Institute Thames Coromandel District Council (HortResearch) Human Rights Commission Timaru District Council Hurunui District Council University of Auckland Institute of Environmental Science & Research University of Canterbury Limited (ESR) Invercargill City Council University of Otago Kaikoura District Council University of Waikato Kaipara District Council Victoria University of Wellington Landcare Research New Zealand Limited Waimakariri District Council

Evaluation and Review Report for GMF06002 page 183 of 221

Landcorp Farming Limited Waimate District Council Mackenzie District Council Wairoa District Council MAF Biosecurity New Zealand (MAFBNZ) Waitakere City Council Marlborough District Council Waitaki District Council Massey University West Coast Regional Council Matamata-Piako District Council Westland District Council Minister of Conservation Whangarei District Council Ministry for the Environment

Evaluation and Review Report for GMF06002 page 184 of 221

Appendix 5a: Submitters who indicated that they wished to be heard (alphabetically by surname)

Submission ID Organisation First Name Surname

9993 GE Free Northland (in Shushila Ajani Food and Environment)

10000 Shushila Ajani

9971 Claire Bleakley

9988 GE Free New Zealand Claire Bleakley (In Food and Environment) Inc

9983 DM Palmer David Brasell

9928 Jon Carapiet

9986 The Soil and Health Elvira Dommisse Association of New Zealand Inc

9899 Charles Drace

10011 Dido Dunlop

10015 Lisa Er

9981 Aoraki (Canterbury) Ryan Garland Province of „The Green Party of Aotearoa‟

10022 Neville Gillespie

9997 Zelka Grammer

9938 Lois Griffiths

9959 Frida Inta

9996 Scott Lawson

10009 Susie Lees

10010 GE Aware Nelson Susie Lees

9985 Sustainable Future Wendy McGuinness

9994 David Moorhouse

9995 Letitia Moorhouse

9910 Stephen Reeve

9901 Simon Riddell

Evaluation and Review Report for GMF06002 page 185 of 221

Submission ID Organisation First Name Surname

9991 Ngati Kahungunu Iwi Aramanu Ropiha Incorporated

9954 Frank Rowson

9951 James Samuel

10001 Brian Sandle

9998 Federated Farmers of Carly Sluys New Zealand (Incorporated)

10012 Sustainability Council Simon Terry

9935 Michael P. Trott

10006 Martina Tschirky

10007 Pedro Tschirky

9926 SCION Christian Walter

9952 Te Runanga o Ngai Frania Zygadlo Tahu

Evaluation and Review Report for GMF06002 page 186 of 221

Appendix 5b: Submitters who indicated that they did not wish to be heard (alphabetically by surname)

Submission ID Organisation First Name Surname

9950 Tony Achtzehner

9909 Leo Adler

9978 Gail Aiken

9960 Pip Andrews

9963 James Andrews

10023 Guy Armstrong

9937 Astarte

10004 Nadine Autet

9939 Rick Bazeley

10014 Glenys Bean

10020 John Bentham

9944 Royal Forest and Bird Jocelyn Bieleski Protection Society (Nelson/Tasman Branch)

9913 Christine Bradley

9922 Clara Brouwer

9964 Christine Bruce

9974 Jarad Bryant

9990 Kathlyn Cardiff

9941 A.J. Church

9973 Ellen Cieraad

9929 Anna Curnow

9900 Peter and Gabi Dane

9916 Terry Dare

9977 Brett and Jane Dewar Brett Dewar Partnership

9943 Sabine Drueckler

9957 C Ebisu

9949 Sophie Edwards

Evaluation and Review Report for GMF06002 page 187 of 221

Submission ID Organisation First Name Surname

9970 Sarah Ellis

9966 Sara Elphick

9972 John Falls

10021 Horticulture and Food Ian Ferguson Research Institute (HortResearch Auckland)

9989 Michael Fleck

9920 Karen Forno

9945 David Gaughan

9921 Alana Gerrand

10018 Judi Gilbert

10019 Adrian Gilbert

9925 Christian Graffeuille

9976 Christine Grieder

9955 Fiona Guyan

10003 G Hamilton

9979 Cathy Harrington

9992 Lynda Harris

9906 Isabel Heymanns

9932 Judith Holtebrinck

9927 Stan Jones

10016 Bob Jones

9907 Leanne Lassman

9919 Peter Laufkotter

9975 Bill Leonard

9999 A. O. MacLennan

9924 Steve Marshall

9917 Cecelia Martin

10013 Matthew McGinty

9958 Juanita McKenzie

Evaluation and Review Report for GMF06002 page 188 of 221

Submission ID Organisation First Name Surname

9980 Gairn Mclennan

9918 Mandy McMullin

9940 Daniel Mohr

9948 Paul Moreham

9956 Bridget Myers

10008 Asphodel Myhre

9968 Denis Postelnik

9969 Sumitra Postelnik

9933 Judy Reinken

9946 Steven Roigard

9947 Tina Sailer

9911 Rod Sandle

9936 Ingrid Schloemer

9984 Phillip Schofield

9923 Carolyn Shaw

9942 David Stewart

9982 DMPalmer Heidi Stiefel

9967 Sam Stockman

10017 Julia Struyck

9953 Sharna Sutherland

9965 Carol Taylor

10005 Susie Thomas

9908 Peter Thompson

9930 Joe Thompson

9931 Gaylene Melody Thompson

9934 Colin Thomson

10002 Hannie Treadwell

9987 Peter Volker

9961 Yannick Wakelam

9962 Henry George Wakelam

Evaluation and Review Report for GMF06002 page 189 of 221

Submission ID Organisation First Name Surname

9904 Anya Walkington

9905 Christian Walter

9902 AgResearch Ltd Andrew West

9912 Dubalar Orchard Jon Wichers

9914 Nicola Williams

9915 Helen Wiseman-Dare

Evaluation and Review Report for GMF06002 page 190 of 221

Appendix 6: Summary of Public Submissions The environment

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

1) Concern that insects will become resistant to GM crops Development of insects that are resistance to 9938, 9944, 9945B, 9997#,10012, 10017B and will need more pesticides to kill. Bt alliums is addressed in sections 8.1.13 - 8.1.17.

2) Concern that the use of GM crops will increase or Increased pesticide use due to GM crops is 9899, 9907#, 9908, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, change herbicide and pesticide use which may have addressed in sections 7.5.15– 7.5.16. 9923#, 9924#, 9935#, 9936#, 9939#, 9945B, 9959#, 9971, 9974#, 9979#, 9981#, effects on soil, ecosystems etc. 9986#, 9988, 9993#, 9994#, 9995#, 9997#, 9999, 10000#, 10006, 10007, 10009#, 10015#, 10016#, 10017B, 10018#, 10019#

3) Concern that the use of GM crops will result in weeds Development or selection of herbicide- 9899, 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, 9923#, with resistance to herbicides/ traits that may pose a risk tolerant weeds is addressed in sections 9924#, 9935#, 9936#, 9938, 9939#, 9944, 9959#, 9971, 9974#, 9979#, 9981#, 9991, for effectively controlling wild allium populations. 7.5.13 – 7.5.14. 9993#, 9994#, 9995#, 9997#, 10000#, 10015#, 10016#, 10018#, 10019#

The ability of the GM alliums to form a self- sustaining population and ease of eradication is discussed in section 6.

Evaluation and Review Report for GMF06002 page 191 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

4) Concern that GM pollen/ GM crops/GM material will Escape of GM allium material is addressed 9899, 9900, 9901, 9906#, 9909#, 9911#, 9915#, 9916#, 9918#, 9921#, 9922#, escape and contaminate environment/ wild alliums or in section 5.6. 9923#, 9924#, 9925, 9928#, 9935#, 9936#, 9937, 9938, 9943, 9944, 9945B, 9950, other plants/ contamination of organically grown 9951, 9953, 9954, 9955, 9956, 9959#, 9960, 9961#, 9964, 9965, 9966, 9968, 9969, produce/ loss of old varieties or heritage plants/ opposed Taking into account the structure and 9971, 9973, 9974#, 9977, 9978, 9979#, 9981#, 9982, 9986#, 9987, 9988, 9991, to flowering/ provided information on research that operation of the field containment facility, showed that a mechanism of recombinant DNA spread in 9993#, 9994#, 9995#, 9997#, 9998S, 10000#, 10001, 10002, 10003#, 10004#, the environment from GM sugar beets is the dispersal of the training, qualifications and experience of 10005, 10009#, 10011, 10015#, 10016#, 10017B, 10018#, 10019# pollen. the field test personnel and the proposed containment regime; it is considered that it is highly improbable for the GM alliums to escape containment (section 5.6.118).

5) Concern about contamination of ground water from the Contamination of the ground water is 9991 GM alliums. addressed in section 7.5.17.

6) Concern that soil, bacteria, fungi and mycorrhiza systems Potential adverse effects on soil biota are 9944, 9959#, 9971, 9981#, 9984, 9986#, 9991, 9999, 10009#, 10013 will be adversely affected by GM crops/ develop addressed in sections 8.1.2– 8.1.7. resistance. 7) Concern about harm to organisms such as insects and Potential adverse effects on non-target 9933, 9940#, 9959#, 9971, 9988, 9989#, 9991, 9992#, 10009#, 10014, 10023# birds from GM pollen or plants. organisms are addressed in sections 8.1.8 – 8.1.12.

8) Concerns that GM crops can kill animals/ provides Potential adverse effects on livestock are 9899, 9945B, 9971, 9981#, 9986#, 9988, 10009#, 10011, 10017B information of studies into the potential adverse effects addressed in section 8.1.8. of GM food on animals.

Evaluation and Review Report for GMF06002 page 192 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

9) Concern that GM crops will have adverse effects on New Escape of GM allium material is addressed 9906#, 9934, 9944, 9959#, 9965, 9967, 9971, 9978, 9988, 9989#, 9994#, 9995#, Zealand‟s ecosystems or result in loss of biodiversity, in section 5.6. 9997#, 9999, 10005, 10009# species extinction, environmental damage etc. Taking into account the structure and operation of the field containment facility, the training, qualifications and experience of the field test personnel, and the proposed containment regime, it is considered that it is highly improbable for the GM alliums to escape containment (section 5.6.118).

The ability of the GM alliums to form a self- sustaining population is discussed in section 6.

10) Concerns that the GM crops will create new pests, The potential for the formation of novel 9944, 9959# diseases, etc. viruses is addressed in sections 5.6.15 – 5.6.20.

11) Concern that vectors used in the genetic modifications The potential environmental effects of the 9959#, 10022 are dangerous in our environment. GM alliums have been assessed in sections 7 and 8.

12) Concern that the genetic modification will make the The potential for increased susceptibility to 9959#, 9971, 9981#, 9986#, 9988, 9991, 9993# alliums more palatable to pests or prone to disease, that disease is addressed in sections 7.5.9 – GM onions are genetically and phenotypically inferior to 7.5.12. non-GM counterparts (from application GMF03001 field test).

Evaluation and Review Report for GMF06002 page 193 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

13) Concern that the genetic modifications will reduce allium Decreased yield of GM crops is addressed in 9899, 9907#, 9908, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, yield, or yield of other crops. section 7.5.21. 9923#, 9924#, 9928#, 9935#, 9936#, 9938, 9939#, 9940#, 9949, 9959#, 9971, 9974#, 9979#, 9981#, 9988, 9989#, 9992#, 9993#, 9994#, 9995#, 9997#, 10000#, 10006, 10007, 10009#, 10014, 10015#, 10016#, 10018#, 10019#, 10023#

14) Concern about unanticipated long-term effects of GM on Unanticipated effects are addressed in 9909#, 9941, 9942, 9944, 9948, 9959#, 9960, 9966, 9971, 9973, 9979#, 9981#, soil, microflora and human health, long term effects, the sections 7.5.19 - 7.5.20. 9984, 9986#, 9988, 9997#, 10002, 10005, 10006, 10007 GM process producing aberrant plants with phenotypic abnormalities/ the introduction of genes can change other Escape of GM allium material through genes‟ expression or produce unintended molecules or aberrant phenotypes is addressed in 5.6.104 - proteins/unanticipiated CaMV-induced silencing. 5.6.113.

15) Consider that there is relatively lack of wild species so The potential for hybridisation of the GM 9902S low probability of transference of transgenes from GM alliums is addressed in sections 4.1.39 - alliums. 4.1.46 and 6.2.11.

16) Consider that New Zealand experiments show GM plants The potential environmental effects of this 9926S are no threat to environment, in particular to insects and field test are evaluated in sections 7 and 8. microorganisms and that no HGT detected. HGT is discussed in section 5.6.

17) Consider that the use of GM crops may result in the Reduction in pesticides due to the use of GM 9902S, 9926S, 9998S, 10021S reduction in pesticide and herbicide use/ more crops is addressed in sections 7.6.6 - 7.6.7. sustainable practices.

18) Consider that GM crops may protect natural habitats due Potential environmental benefits of the field 9905S, 9926S, 9998S, 10021S to higher production on less acreage, or result in healthier test are addressed in section 7.6. soil, decreased agricultural carbon footprints or other agricultural benefits.

Evaluation and Review Report for GMF06002 page 194 of 221

B. Human health and safety

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

19) Concern that GM crops may be toxic, allergenic or The potential of GM alliums to be toxic to 9899, 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, 9923#, detrimental to humans (CSIRO GE peas, antisense DNA humans is addressed in section 8. 9924#, 9928#, 9935#, 9936#, 9939#, 9945B, 9954, 9959#, 9967, 9971, 9974#, eg, Flavr Savr tomatoes)/ provides information of studies 9981#, 9986#, 9988, 9993#, 9994#, 9995#, 9997#, 10000#, 10009#, 10011, 10013, into the potential adverse effects of GM food on animals. 10015#, 10016#, 10017B, 10018#, 10019#

20) Concern about increased exposure of consumers to The potential for increased exposure of the 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, pesticide residues (such as glyphosate) in food or to public or consumers to pesticides or 9928#, 9935#, 9936#, 9939#, 9940#, 9961#, 9971, 9974#, 9979#, 9980, 9981#, increased amounts of pesticides which may lead to absorbed herbicides in food is addressed in 9986#, 9988, 9989#, 9992#, 9993#, 9994#, 9995#, 9997#, 9998, 10000#, 10003#, increased disease or other human health issues. sections 7.8.8 – 7.8.9 and 7.8.12 – 7.8.13. 10004#, 10009#, 10015#, 10016#, 10018#, 10019#, 10023#

21) Concern that GM will decrease the nutritional value of As GM alliums will not enter the food chain, 9965 crops. this effect is beyond the scope of the field test application.

22) Concerns about disease related to the use of CaMV 35S The use of Agrobacterium is addressed in 9906#, 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, 9923#, promoter or Agrobacterium. sections 7.8.5 – 7.8.7. The use of the CaMV 9924#, 9928#, 9935#, 9936#, 9939#, 9955, 9974#, 9981#, 9986#, 9988, 9993#, 35S promoter is addressed in sections 7.8.10 9994#, 9995#, 9997#, 10001, 10009#, 10015#, 10016#, 10018#, 10019# – 7.8.11.

23) Concerns about HGT/ use of antibiotic-resistance HGT is addressed in section 5.6. The use of 9928#, 9944, 9945B, 9954, 9959#, 9971, 9981#, 9986#, 9993#, 9997#, 10001, markers. antibiotic-resistance markers in the GM 10013, 10017B alliums is addressed in sections 7.8.3 – 7.8.4.

24) Consider that the GM plants to be field tested are low The adverse effects of the GM alliums are 9926S, 9902S risk/not harmful as the genes in the field test are not evaluated in sections 7 and 8 of the report. known to be toxic, allergenic, derived from humans of valued NZ flora or fauna/ unlikely to increase weediness.

Evaluation and Review Report for GMF06002 page 195 of 221

C. Effects on Māori culture

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

25) Concern over inadequacies of consultation. Consultation is summarised in Appendix 10 9971, 9988, 9991 and discussed in section 7.11.

26) Considers that the claims of benefits to Māori stated in Potential beneficial or adverse effects are 9988, 9991, 9997# the application should be rejected/ effect on cultural addressed in sections 7.10 - 7.15. beliefs/ implications on taonga/ other concerns.

27) Does not oppose the field test. Recommend the role of This is addressed in section 7.11. 9952 Te Taumutu Rūnanga is recognized through accurate, timely information, further participation and field visits, an increase in security and safety measures, the site of the field test, further research into quantifying environmental benefits if GM alliums are to be released.

Evaluation and Review Report for GMF06002 page 196 of 221

D. The Market economy

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

28) Considers that the field test will have adverse effects on Concern about adverse impacts on trade and 9900, 9904, 9907#, 9909#, 9910#, 9911#, 9913#, 9914, 9915#, 9916#, 9917, 9918#, primary trade/ concern the field test will harm New the potential for loss of clean green image is 9921#, 9922#, 9923#, 9924#, 9928#, 9929, 9933, 9934, 9935#, 9936#, 9939#, Zealand‟s “clean green” image/ concern that “GE free" addressed in sections 7.20.7 – 7.20.15. 9940#, 9945B, 9948, 9949, 9950, 9953, 9954, 9957, 9959#, 9961#, 9963, 9966, country status will be adversely affected/ there will be a Concern about loss of organic product 9967, 9968, 9969, 9972, 9973, 9974#, 9976, 9977, 9978, 9981#, 9982, 9983, 9984, loss of opportunity to promote organic food or GE free produce world wide/ affect organic markets. certification for local growers is addressed in 9985, 9986#, 9987, 9988, 9989#, 9992#, 9994#, 9995#, 9996, 9997#, 10000#, sections 7.20.16 – 7.20.17. 10003#, 10004#, 10006, 10007, 10009#, 10011, 10013, 10014, 10015#, 10016#, 10017B, 10018#, 10019#, 10023#

29) Concern that New Zealand may be forced to grow GM This is discussed in sections 7.17.20 – 9909#, 9911#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, 9925, 9927, 9928#, crops under „free trade agreements” or that this has been 7.17.21.. 9936#, 9959#, 9971, 9974#, 9979#, 9981#, 9986#, 9988, 9993#, 9994#, 9995#, implied. 9997#, 9998, 10000#, 10008#, 10009#, 10015#, 10016#, 10018#, 10019#

30) Concern over losing status of GM free honey/ Concerns about the impact of GM pollen on 9909#, 9911#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, 9928#, 9935#, 9936#, contamination of honey by GM pollen. honey production are addressed in sections 9945B, 9955, 9959#, 9961#, 9974#, 9981#, 9986#, 9988, 9993#, 9994#, 9995#, 7.20.4 - 7.20.6. 9997#, 9998S, 10000#, 10003#, 10004#, 10009#, 10015#, 10016#, 10017B, 10018#, 10019#

31) Consider that there is no or minimal financial or The potential benefits on the market 9917, 9925 economic benefits for this research for New Zealand. economy are identified and assessed in section 7.21.

32) Concern that GM crops will increase production costs. As this application is for a contained field 9899 test and not for a commercial release, this is beyond the scope of this field test.

33) Consider that the money spent on this research would be Opportunity costs are discussed in sections 9910#, 9912, 9917, 9933, 9938, 9944, 9945B, 9953, 9954, 9956, 9959#, 9972, better spent elsewhere/effect on growers of reducing 7.20.19 – 7.20.30. 9981#, 9982, 9984, 9986#, 9987, 9988, 9990, 9993#, 9994#, 9995#, 9997#, 10000#, options/ opportunity costs. 10006, 10007, 10011, 10012, 10017B

Evaluation and Review Report for GMF06002 page 197 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

34) Consider that there are economic benefits to GM/ The potential benefits on the market 9902S, 9926S considerable use and investment in GM crops overseas. economy from this field test are addressed in section 7.21.

35) Consider that there is a high economic cost of this field The high economic cost of the field test is 9971, 9981#, 9986# test. addressed in section 7.20.18.

36) Consider there is no market or a limited market for GM This is discussed in sections 7.20.19 - 9906#, 9914, 9917, 9920, 9935#, 9938, 9944, 9945B, 9956, 9959#, 9971, 9981#, crops 7.20.22. 9982, 9983, 9986#, 9988, 9992#, 9993#, 9994#, 9995#, 9997#, 10012, 10013, 10017B, 10022

Evaluation and Review Report for GMF06002 page 198 of 221

E. Society and community

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

37) Stated opposition to GE (for ethical, spiritual or other General opposition to GM is addressed in 9901, 9919, 9920, 9930, 9931, 9941, 9942, 9946, 9959#, 9975, 9990, 9997#, 10005, reasons) sections 7.17.2 – 7.17.3. Concerns over 10020 ethical aspects are addressed in sections 7.17.20 – 7.17.21.

38) Consider that clear danger and adverse effects from Adverse effects have been identified and 9927, 9929, 9938, 9943, 9945B, 9946, 9953, 9959#, 9963, 9965, 9968, 9969, GMOs have been illustrated abroad. assessed in sections 7 and 8. 9974#, 10017B

39) Opposed to GM food, concerned for people's right to buy Concern about GM food is addressed in 9906#, 9920, 9927, 9932, 9943, 9945B, 9947, 9950, 9953, 9958, 9959#, 9963, GM free food/ consider that as it is currently not section 7.17.6 – 7.17.8. 9966, 9976, 9988, 9990, 9994#, 9995#, 10009#, 10013, 10017B, 10023# compulsory to label food as containing GM or trace GM food it is unethical to continue field tests/ concerned over long term food security.

40) Support GE, consider that no substantiated harm has Adverse and beneficial effects of this field 9905S, 9926S been reported from GM crops; consider that non-GM test have been identified and assessed in breeding for traits much less precise. sections 7 and 8.

41) Concern over GM liability issues / concern that the cost GM liability issues are discussed in sections 9909#, 9911#, 9912, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, 9925, 9928#, of GM contamination will be borne by the public/ 7.17.22 – 7.17.24. 9935#, 9936#, 9940#, 9945B, 9947, 9955, 9959#, 9961#, 9974#, 9979#, 9981#, concern over lack of government or developer liability if 9986#, 9988, 9989#, 9993#, 9994#, 9995#, 9997#, 10000#, 10003#, 10004#, things go wrong/ concern that risks are imposed on the 10009#, 10010, 10013, 10015#, 10016#, 10017B, 10018#, 10019#, 10023# public/ concerned about the monetary cost of clean-ups/ consider that insurance is needed against adverse economic impacts.

42) Consider that GM is not the answer to world hunger/ This issue is beyond the scope of this field 9918#, 9943, 9951, 9956, 10009# consider GM has a not lived up to promises/consider GM test. is a failure.

Evaluation and Review Report for GMF06002 page 199 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

43) Concerns about coexistence of GM and non GM As this application is for a contained field 9920, 9959#, 9987, 9997#, 10010 crops/concerned about right to choose to have GE free test, co-existence is beyond the scope of this zones/ consider that GE and organics are incompatible. field test.

44) Consider that this field test is not „preserving Concern that we may not be preserving 9909#, 9911#, 9914, 9915#, 9916#, 9918#, 9921#, 9922#, 9923#, 9924#, 9928#, opportunities‟ (RCGM) or is foreclosing on future options is addressed in sections 7.17.16 – 9936#, 9945B, 9953, 9954, 9959#, 9972, 9973, 9974#, 9976, 9979#, 9981#, 9982, opportunities in organic or conventional farming. 7.17.19. 9984, 9986#, 9987, 9988, 9990, 9993#, 9994#, 9995#, 9997#, 10000#, 10006,

10008#, 10009#, 10011, 10015#, 100016#, 10017B, 10018#, 10019#, 10020, 10022

45) Consider that such field tests will allow New Zealand to The potential benefit of enhancing of New 9902S, 9905S, 9926S, 9998S, 10021S keep its options open or allow New Zealand to keep pace Zealand‟s ability to preserve options and with adoption of biotechnology/ consider that farmers maintain choices is addressed in sections should be able to choose production and technology 8.1.28 – 8.1.29. systems. 46) Considers that there is no to little public benefit for New Potential benefits of this contained field test 9907#, 9908, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9918#, 9921#, 9922#, Zealand from this field test/ considers that this field test are identified and assessed in sections 7 and 9923#, 9924#, 9925, 9928#, 9933, 9935#, 9936#, 9939#, 9940#, 9949, 9950, 9955, is a data gathering or seed multiplication exercise for 8. 9959#, 9970, 9971, 9974#, 9978, 9979#, 9981#, 9986#, 9987, 9988, 9989#, 9993#, overseas seed company. 9994#, 9995#, 9997#, 10000#, 10009#, 10013, 10015#, 10016#, 10018#, 10019#,

10023#

47) Submission from commercial onion or allium growers Noted. 9912, 9933, 9983, 9996, 10006, 10007 against the field test.

Evaluation and Review Report for GMF06002 page 200 of 221

Effects; Issues; Topics Sections in E&R report where this point has Raised in submissions – submission numbers been addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

48) Considers that this field test will provide information, Potential benefits of increased scientific 9902S, 9905S, 10021S including developing GM cultivars, the efficacy and knowledge from this contained field test are environmental impacts on agronomic and quality traits, addressed in sections 8.1.30 – 8.1.43. and scientific knowledge of GM plants in economic, Increased understanding of the potential risk health and sustainability perspectives and data to inform future decisions to use or no use GM crops in New and benefits of GM crops for the public, Zealand. regulators and legislators is addressed in sections 7.18.7. The contribution towards long term benefits to society from genetic engineering technology and increased public understanding is addressed in sections 7.18.8 - 7.18.9. Information about cultivar development to assist plant breeders to evaluate novel germplasm, identify lines for advancement and assess performance is addressed in section 7.18.10.

49) Consider that such research is required to attract high Potential benefits of this contained field test 9998S quality scientists. are identified and assessed in section 8.1.44 - 8.1.48.

50) Consider there are benefits from GM to farmers and These benefits are beyond the scope of a 9902S, 9905S, 9926S, 9998S, 10021S societies such as developing crops that are better adapted contained field test. when climate changes/ consider that GM will benefit consumer with greater choice and health benefit or higher quality.

51) Concern about the involvement of multinationals/ Concern about the involvement of 9956, 9959#, 9963, 9971, 9980, 9981#, 9986#, 9989#, 9990, 9993#, 10009# foreign companies. multinationals is addressed in sections 7.17.29 – 7.17.31.

Evaluation and Review Report for GMF06002 page 201 of 221

F. Additional Matters; Process; Project aims, design

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

52) Concerns about deficiencies in application or proposed The project team considers that the application 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, research: meets the requirements of section 40 of the Act 9927, 9928#, 9935#, 9936#, 9939#, 9945B, 9952, 9955, 9959#, 9971, 9974#, that not enough information provided on what flora which sets down the requirements for 9979#, 9981#, 9986#, 9988, 9991, 9993#, 9994#, 9995#, 9997#, 9999, 10000#, and fauna will be assessed/ there is no safety data or applications for field testing of GMOs. The 10009#, 10012, 10015#, 10016#, 10017B, 10018#, 10019# description of previous existing field tests/ new health risks not mentioned by applicant/ no audit or cost application is reviewed in this report.

benefit analysis of previous work provided or available/ an inadequate peer review need independent peer review/ environmental effects are only partially considered/ there is insufficient molecular characterisation or organism description/ there is no meaningful data on additional risks of machine sowing or applicant‟s objections to previous controls/ no clear description of "Quality" assays provided/ how will the quality traits enable researchers to study the precise effect of that trait on consumer‟s choice or benefits?/ concerns over increase in fitness of GM alliums/ adverse effects taken lightly/ it is unclear how pest infestation or other agronomic test factors applied/ there is uncertainty about how genes will be expressed, including whether they will be expressed at all/ concern over synergistic and environmental effects/ consider that it is not up to submitter to prove to ERMA that application is flawed/ the applicant only considers risk of vertical gene transfer not horizontal/ consider that field test applications need documented proof of laboratory-based safety testing/ the provision for protection and containment of accidental modification insufficient/ biosafety issues poorly researched/ responsibility of applicant to address these issues in application or research/ why will GM Brassica be grown in the plots too?/ why are

Evaluation and Review Report for GMF06002 page 202 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

transgenic plants used as controls?/ safety and security need to be increased due to long 10 year field test/ Southern blotting should be conducted to determine number of trans-gene copies/ a promoter from the relevant species should be used rather than from a virus or other species/ environmental effect such as reduced herbicide use and vs. organic agriculture should be quantified/ GM plants and animals should be tested as per HS work on pesticides testing groups with same active ingredient for long term safety/ no safety tests of new trait at any point/ growing GM alliums in same soil as GM Brassica will confound results/ why flower induction by GE rather than cold treatment?/ insect vectors not adequately managed at the site/ cross-breeding within GM lines could result in unintended gene combinations or expression/ question whether a gene could be differentially expressed, eg, only where plant is under attack, only when plant is sprayed, only in foliage and not in bulb/ whether differential expression will avoid having GE in food/ question the value of using outmoded GM technology or GM at all to improve scientists skill and status/ consider that inadequate technology or resources to find gene transfer, soil contamination, so why risk it?/ need to state what the limits of detection are/ multiple gene insertions may be overlooked in phenotypically „normal‟ plants/ the molecular and biochemical techniques like PCR, Southern blots and trait expression analysis may only help determine the presence and function of the modified trait prior to field test/ they will not test for other impacts including consumer health/ unexpected changes in plant development should be identified first/ precise details of genes needed/ why are null segregants used as controls?/ why field test an onion that is still in

Evaluation and Review Report for GMF06002 page 203 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

development phase?/ no details on HGT experiments/ CaMV-induced silencing not identified as a risk/ insufficient information to demonstrate a net benefit/ no assurance that environmental research of significance will occur/ insufficient experimental detail supplied/ risks not sufficiently evaluated to enable appropriate mitigation measures to be imposed/ letting onion seed growers know after planting has occurred is short sighted/ many environmental factors overlooked/ lightly referenced/ reject claims that all risks of this application are covered by previously applications/ it is wrong for past approvals to be used to apply for further broad ranging vectors unproven in humans and environmental terms.

53) Consider that statements in application on viability of This is discussed in sections 5.6.58 – 5.6.59 9981#, 9986# seed and bulbs are incorrect. and 5.6.67.

54) Concerns about robustness of pollinator cages/ As discussed in sections 5.5.30 - 5.5.53, a 9928#, 9935#, 9971, 9988, 9998S, 10009# concern about wind or other damage to containment number of controls have been proposed to structures/ concern if structures may be washed away. ensure that the pollination cages are

constructed to contain insects and to be well secured to the ground.

55) Recommend that all bulbs should be covered with bee- These recommendations are discussed in 9998S resistant pollination cages as insurance against “bolters sections 5.6.32 and 5.6.43 - 5.6.44. and insect kill traps should be placed within pollination cages.

56) Concern about no separation distance to isolate GM The project team notes that a physical 9964, 9981#, 9986# crop/ pollen doesn‟t stop at1000m distance. separation distance would only be required if a breach of containment occurred.

Evaluation and Review Report for GMF06002 page 204 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

Taking into account the structure and operation of the field containment facility, the training, qualifications and experience of the field test personnel, and the proposed containment regime, it is considered that it is highly improbable for the GM alliums to escape containment (section 5.6.118).

57) Concern about the sowing of seeds/ concerns about The sowing of seeds has been discussed in 9901, 9974#, 9981#, 9988, 9993#, 9994#, 9995#, 9997#, 10000#, 10010, 10015#, using machines for sowing (could spread material if sections 5.6.49 – 5.6.65. 10016#, 10018#, 10019# not cleaned)/ reject reasons for not using seed tape.

58) Concern that composting GM material on-site will HGT is addressed in section 5.6. Composting 9981#, 9986#, 9988, 9899 result in GE DNA persisting in soil/ GMOs stay in soil is discussed in section 5.6.14. for over 10 years/provided information on research that showed that recombinant DNA from pollen from GM sugar beets can persist in the field for at least one year.

59) Concerns that a failure in containment could occur/ The escape of the GM alliums from the 9900, 9909#, 9911#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, 9927, 9928#, concerns over inadequate controls and monitoring/ proposed containment regime (which includes 9929, 9935#, 9936#, 9937, 9943, 9944, 9945B, 9959#, 9964, 9965, 9968, 9969, consider that material can‟t be controlled or auditing of controls) is discussed in sections 9971, 9973, 9974#, 9978, 9979#, 9981#, 9982, 9983, 9986#, 9988, 9991, 9993#, contained/unidentified changes in plant development 5.6 and 7.17.10 – 7.17.12. 9994#, 9995#, 9997#, 9998S, 10000#, 10002, 10009#, 10015#, 10016#, 10017B, must be identified first to prevent spread of genetic material/ “Accidents happen”. 10018#, 10019#, 10020

60) Consider that management procedures will ensure the The proposed containment of this field test and 9902S, 9905S safety of field test and that traits not spread to other potential pathways of escape is discussed in plants section 5.

61) Considers that historical breaches of isolation for other Points noted. The proposed containment and 9935#, 9973, 9988 GM plants or animals have occurred. potential pathways of escape for this proposed

Evaluation and Review Report for GMF06002 page 205 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

field test is discussed in section 5.

62) Consider that such research cannot take place in Alternative methods (such as performing the 9902S glasshouses. research indoors) are discussed in section 9.2.

63) Consider that research or testing for adverse effects Alternative methods (such as performing the 9906#, 9909#, 9911#, 9915#, 9916#, 9921#, 9922#, 9923#, 9924#, 9928#, 9933, and flowering/seed production etc. should only research indoors) are discussed in section 9.2. 9935#, 9936#, 9945B, 9968, 9969, 9974#, 9977, 9981#, 9986#, 9988, 9993#, permitted in contained laboratories or glasshouses/ 9994#, 9995#, 9997#, 9998S, 10000#, 10009#, 10013, 10015#, 10016#, 10017B, results from containment need to be peer reviewed and 10018#, 10019# published before proceeding to outside field tests. 64) Concern that the field test may ending early and no This is not within the scope of this field test. 9971, 9988 results will ever be published.

65) Consider that there is limited value in the testing The information that the applicant proposes to 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9918#, 9921#, 9922#, 9923#, described in the application as not all aspects will be collect from this field test is discussed in 9924#, 9925, 9928#, 9935#, 9936#, 9939#, 9955, 9971, 9974#, 9979#, 9981#, 9988, tested eg, effects on pollinators/ consider that there is sections 8.1.30 – 8.1.43. 9993#, 9994#, 9995#, 9997#, 10000#, 10001, 10009#, 10012, 10014, 10015#, no guarantee that ecological or environmental effects 10016#, 10018#, 10019# will be studied or monitored/ consider that there is no credible research on negative effects..

66) Consider that ERMA should require testing for The project team did not identify any risks that 9906#, 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9917, 9921#, 9922#, negative effects (effects on non-target organisms)/ would need to be mitigated by imposing 9923#, 9924#, 9925, 9928#, 9935#, 9936#, 9939#, 9940#, 9945B, 9954, 9955, concern that there will be no investigation of human controls for adverse effect testing (section 10). 9959#, 9971, 9974#, 9979#, 9981#, 9986#, 9988, 9989#, 9993#, 9994#, 9995#, health impacts (such as farm workers, consumer health 9997#, 9999, 10000#, 10009#, 10010, 10012, 10013, 10014, 10015#, 10016#, safety testing)/ consider small-scale releases are not capable of identifying the full range of environmental 10017B, 10018#, 10019# effects.

67) Consider that alternative research should be Alternative methods are discussed in section 9910#, 9929, 9944, 9945B, 9956, 9958, 9959#, 9981#, 9986#, 9990, 9993#, 9994#, performed. 9.2. 9995#, 9997#, 9999, 10006, 10007, 10017B

68) Consider that this research is not need: because The benefits for this field test have been 9904, 9906#, 9908, 9912, 9920, 9929, 9933, 9944, 9954, 9959#, 9962, 9970, 9971, sufficient herbicides and chemicals available so don't identified and assessed in sections 7 and 8.

Evaluation and Review Report for GMF06002 page 206 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

need GM induced resistance/ alliums grow quite well Alternative methods are discussed in section 9981#, 9986#, 9988, 9990, 9993#, 9997#, 10002, 10006, 10007 in New Zealand when not using herbicides or 9.2. fertilisers or if using organic farming methods or sustainable practices/ allium species already provide health benefits and don't need to be improved/ alliums are not a staple food/ the world‟s population won't benefit from increased production/ “alliums naturally resistant [to herbicides]”/ consider that a better understanding of ecological effects of Bt crops is not sufficient reason to conduct field tests/ consider that this research is not helping the environment or mitigating effects on the environment/ considers that as we don't want to eat GM foods therefore field test unnecessary/ opposes the aim to increase chemical resistance and considers that increased nutrition or palatability should be researched/ considers that cross fertilization with endangered species should be performed instead/ considers that this research could achieved by non GM methods such as marker-assisted breeding/ consider that cold can be used to achieve vernalisation/ considers that IPM methods should be used instead.

69) Considers that this application has dubious scientific The benefits for this field test have been 9906#, 9907#, 9909#, 9910#, 9911#, 9913#, 9915#, 9916#, 9917, 9918#, 9921#, and commercial benefits which are outweighed by risk identified and assessed in sections 7 and 8. 9922#, 9923#, 9924#, 9927, 9928#, 9933#, 9935#, 9940#, 9945B, 9948, 9950, to environment and New Zealand consumers/ rejects 9957, 9971, 9974#, 9979#, 9981#, 9985, 9986#, 9988, 9992#, 9993#, 9994#, 9995#, the claims of benefits of GM crops/ considers that 9997#, 10000#, 10005, 10009#, 10012, 10015#, 10016#, 10018#, 10019#, 10023# farmer‟s knowledge produces better results long-term/ considers that there is no benefit to modifying plants/

considers that reductions in pesticide use through GM would need to exceed 50-65% to have similar net benefit to integrated pest management/ considers that there are no credible benefits/ considers that the harm outweighs the benefits/ queries the benefit of the “economic impact assessment”/ considers if there is no

Evaluation and Review Report for GMF06002 page 207 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

safety data from the existing field test then there are no benefits to this application/ queries benefits of knowledge of agronomic performance or performance of GM food crops/ considers that there is no assurance that any environmental research of significance will occur/ considers that there is insufficient evidence to demonstrate a net benefit.

70) Considers that the HSNO Act does not allow field tests Under the HSNO Act, controls are imposed to 9928#, 9935#, 9940#, 9955, 9959#, 9971, 9981#, 9988, 9989#, 9992#, 9994#, to look into negative effects/ considers that ERMA mitigate risks. Controls requiring adverse 9995#, 9997#, 10010, 10023# claims to be unable to place limits on research effects testing can be imposed on a field test methods or ensure testing of adverse effects on only if such controls are deemed necessary to ecosystem or public health/ considers that it is unethical to continue field tests if not testing for mitigate a risk (section 10). adverse effects.

71) Considers that the HSNO Act is flawed/ considers the Opinions noted. 9928#, 9940#, 9974#, 9981#, 9985, 9993#, 9994#, 9995#, 9997#, 10000#, 10009#, Sustainable Future (2008) review of Royal 10010, 10015#, 10016#, 10018#, 10019#, 10023# Commission on GM highlights gaps in public rights/ considers a lack of progress on issues raised by Sustainable Futures/ considers that councils not allowed to determine direction of GM in local area.

72) Considers that there is no confidence in ERMA to Anxiety expressed in terms of distrust is 9945B, 9971, 9978, 9985, 9988, 9994#, 9995#, 10009#, 10010, 10017B manage situation or manage risks (eg, to protect New addressed in sections 7.17.26 - 7.17.28. Zealand‟s clean green image)/ loss of faith in the process.

73) Considers that there is insufficient public notification The project team notes that as described in 10013 of application in an aim to try to avoid public section 1.8, the receipt of this application was attention. listed onto the ERMA New Zealand website, advertised in the four major newspapers, and notification was sent to a list of interested persons (which include NGOs and any

Evaluation and Review Report for GMF06002 page 208 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

individuals who request to be put on the list) and Government agencies. A press release was also released to the media. The project team considers that this process is sufficient to notify the public of the receipt of such applications and allow for public input into the process.

74) Concerns that ERMA is biased or not objective/ There are procedures are in place to declare 9917, 9928#, 9959#, 9971, 9989#, 10006, 10007, 10009# considers that ERMA may have a conflict of interests any conflicts of interest prior to the selection of as some members are also involved in the an Authority member to a decision-making biotechnology field/ considers that ERMA act as Committee. “enablers” or“kowtow to agribusiness”.

75) Considers that this application will be approved The project team notes that all applications are 9935#, 9959#, 10000# regardless/ rubber stamped. carefully evaluated and if the risks outweigh the benefits, the application cannot be approved.

76) Concerns about expertise of ERMA New Zealand The project team notes that this E&R report has 9971 staff. been reviewed by an expert to ensure that the report is balanced and technically correct.

77) Considers that that future benefits cannot be included The benefits and risks assessed in this E&R 9928#, 9986#, 10012 in assessing applications for field tests/ considers that report must fall within the scope of a contained if potential future benefits are taken into consideration field test. then potential future adverse effects or risks should also be taken into account/ considers that ERMA must evaluate potential benefits in a rigourous and commonsense manner/ considers that commercial benefits cannot be taken into account.

78) Considers that GM methods may add untested quality Adverse and beneficial effects are identified 9988 risks to the field test and that ERMA needs to

Evaluation and Review Report for GMF06002 page 209 of 221

Effects; Issues; Topics Sections in E&R report where this point has been Raised in submissions – submission numbers addressed or the project team comments # = Submission based in part or whole on a pro forma template B = Submission based in part or whole on Brassica application submission S = Submission in support of application

recognise this. and assessed in sections 7 and 8.

79) Queries ERMA‟s interpretation of 'market economy' Market economy and opportunity costs are 10012 and consideration of opportunity costs. discussed in section 7.20.

80) Considers that ERMA uses the HSNO Act selectively/ The “Annotated Methodology” sets out how 9971, 10009# ignores or not preserves the precautionary principle. the Authority deals with information, makes determinations, deals with uncertainty, identifies and assesses risks, costs and benefits and presents decisions.

81) Concerns about applicant (lack of investment in Opinion noted. 9981#, 9986# facilities).

82) Considers that this research does not need to be Points noted. 9900, 9912, 9927, 9987, 9991 performed in New Zealand/ considers that New Zealand can import GM crops if needed in the future.

83) Considers that broad applications will keep submission Point noted. 9902S transaction costs down.

Evaluation and Review Report for GMF06002 page 210 of 221

Appendix 7: Comments from Ministry of Agriculture and Forestry Biosecurity New Zealand (received 23 May 2008)

Submission Form to ERMA New Zealand for New Organism Applications

Application Code: GMF06002

Applicant Name: Crop & Food Research

Application Category: To field test in containment any genetically modified organism under Section 40 of the Hazardous Substances and New Organisms Act 1996.

Application Title: Field test of genetically modified onions, garlic and leeks with altered agronomic or quality traits.

ERMA Applications Brenda Pottinger Contact:

Date: 23/05/08

MAF Response Liz Phillips Coordinator:

Option to Speak in Yes Support of this Submission:

BASIS ON WHICH COMMENT IS PROVIDED

MAF submits these comments for consideration to ERMA New Zealand on the following:

MAF considers the field-test in containment is consistent with the recommendations of the Royal Commission on Genetic Modification (RCGM)29, which aimed to encourage the coexistence of all forms of agriculture, including GM. MAF supports the use of pollen-cages for the effective containment of bees and pollen in an open-field situation. If pollen-cages are to remain in situ once the bees have pollinated the plants and been exterminated, this should be a voluntary measure rather than mandated as a control.‟

29 http://www.mfe.govt.nz/publications/organisms/royal-commission-gm/ Evaluation and Review Report for GMF06002 page 211 of 221

MAF does not provide comments in this submission on the scientific merit, validity or rationale of purpose of the application. These comments, if deemed necessary, will be provided via a separate submission.

Reference Comment

1. General MAF considers that this field-test in containment application for GM Alliums to be consistent with the government‟s approach to “proceed with caution while preserving opportunities”. This position is in line with the recommendations of the Royal Commission on Genetic Modification (RCGM)30, which aimed at encouraging the coexistence of all forms of agriculture, including GM.

2. Biosecurity GM Allium seedlings or bulbs planted into the field-test site Considerations must be derived from seeds, either imported or produced within the containment suites. Imported Allium bulbs and tissue cultures need to undertake a quarantine period for up to six months, and be verified free of pests and diseases of concern to New Zealand, before they can be cleared for planting in the field-test.

3. Pollen cages MAF supports the use of pollen-cages for the effective containment of bee pollinators and Allium pollen in an open- field situation. Pollen-cages are used globally in seed breeding and production nurseries to maintain effective separation of insect-pollinated crop species. They both contain pollinator bees and exclude foraging bees from accessing the GM Allium plants - effecting pollination while preventing movement of pollen to other Allium which might be in flower at the same time in the surrounding area.

There is no reason for the pollen-cages to remain in situ once the plants have been pollinated and the bees have been euthanized. If the Operator intends to leave pollen-cages in situ, to simplify field management operations, this should be voluntary rather than a mandatory additional control.

4. Use of small machine MAF considers that the use of a small machine seeder in the seeder trial will offer a practical means of planting the trial. Seed can

30 http://www.mfe.govt.nz/publications/organisms/royal-commission-gm/ Evaluation and Review Report for GMF06002 page 212 of 221

be transported more readily to the trial site for planting than sprouted onion seedlings, and establishment is likely to be more successful. MAF does not envisage problems from un- germinated Allium seed in the field, given the length of post- harvest monitoring (1 year) concluding each trial.

5. Research into MAF has identified onion production as requiring one of the sustainable highest inputs of chemical applications in vegetable production alternatives for New in New Zealand. (http://www.maf.govt.nz/mafnet/rural- Zealand onion nz/sustainable-resource-use/resource-management/pesticide- production use-trends/pestrends-09.htm#P653_49781).

There is a need for research into alternative production systems (both GM and organic) to improve sustainability and ensure the ongoing viability of commercial onion production in New Zealand.

Evaluation and Review Report for GMF06002 page 213 of 221

Appendix 8: Comments from Department of Conservation (received 1 May 2008)

GMF06002 Field test of genetically modified onions, garlic and leeks with altered agronomic or quality traits

Application no: GMF06002

Applicant: Crop and Food Research Ltd

Thank you for the opportunity to comment on the application from Crop and Food Research Limited to field test, over 10 consecutive years, the vegetable allium species onion, garlic and leek with genetically modified agronomic and quality traits in order to assess their performance in the field and investigate the environmental impacts of these plants.

Summary

The Department has reviewed this application and the following discussion includes some areas where we see the application can be improved. Overall, we consider that the risks to indigenous flora and fauna are minimal and therefore we would not oppose the approval of this application

Previous application to field trial GM onions.

The Department has provided comment on a previous application relating to genetically modified onion trials (GMF03001). The concerns that we raised at that time have been adequately addressed in the current application. The differences between GMF03001 and the current application lies in the addition of garlic and leeks to the trials, the size of the trial, use of seed (and its production), and the trialling of additional gene constructs. We consider that the scale of the trials could be perceived to pose a greater risk to the environment and we suggest that the applicants ensure that their security and containment provisions are rigorous and appropriate for the scale of the experiment.

Risk to Native Biota

The Department is aware that there are no closely related New Zealand native species to those being considered in this application, and that the risk of horizontal gene transfer has been previously assessed as being low. The Department notes that in this application that assessment of the soil biota is being undertaken (page 51), which we view as being important in assessing the risk of transfer of genetic material via this pathway and was a key point in our earlier submission.

However, as much of New Zealand‟s biodiversity continues to be under threat from the impacts of introduced species, the Department takes a precautionary approach to the introduction of new organisms [including the development of genetically modified organisms (GMO)] and the risks that they may pose in the potential development of a new weed. The

Evaluation and Review Report for GMF06002 page 214 of 221

Department has some concerns in the development of plants where there may be a resulting increase in tolerance to herbicides, pathogenic fungi, bacteria, viruses or insect pets and where these plants have the potential to become new weed species. Both onions and leeks are sometimes found as casual garden escapes, and there are closely related exotic Allium species present in New Zealand including A. triquetrum , an environmental weed. We concur that the potential for hybridisation between the GM onions and exotic species is low but are of the view that every possible precaution should be put in place to mitigate against this risk. To strengthen these aspects in the current application, the Department has the following recommendations:

1. Composting

That assessment of composting is undertaken. Due to the possible scale of some trials, our preference would be for waste material from this trial to be autoclaved where possible. GM material should only be disposed of if it has first been rendered non-viable. However, we realise that with large amounts of material - such as in a field trial of this nature - that this may be challenging. We suggest that measures are undertaken to ensure that the composting has been effective in rendering the GM plants non-viable and ensure the resulting destruction of material. We also suggest that the contained composting areas are also locked as detailed under the security measures for the field test site itself.

2. Pests The Department is concerned that rodents may access the onions and we endorse that that monitoring for pest activity is undertaken. The applicants have stated that the requirements for vermin control in standard 155.04.09 will be applied31. From the ERMA control requirements in the control manual part 3.2 there is instruction that the Operator should monitor the site for pest damage]. The Department endorses this activity and would like to see the detail of this clearly stated for all readers of the current application. Although we accept the results from the earlier trials, again the applicant must ensure that the proposed larger scale trials do not engender greater risks which aren‟t appropriately mitigated for. 3. Seed Distribution Mitigation of inadvertent seed distribution. The Department recognises that the previous use of seed tape has been unsatisfactory in terms of experimental use as well as monitoring seed distribution (page 30 of the application). The applicants suggest that the method of sowing by which the seeds are covered in soil is sufficient. The Department would be more comfortable with this approach if there were some element of monitoring, or an indication as to the depth of planting that would be undertaken to ensure that no seeds are inadvertently wind blown or ingested by birds/animals. 4. Emergency Contingency Plans

31 155.04.09 states that: ‘The organisation shall have an effective insect and rodent control program. Depending on the assigned physical containment level the containment manual shall describe how vermin such as rodents, birds and invertebrates are to be excluded (where such exclusion is relevant for the purposes of containment), how surveillance for their presence is to be maintained and what control activities will be undertaken if detected. Evaluation and Review Report for GMF06002 page 215 of 221

The Department would have a greater level of confidence in the proposed contingency plans (page 38) if more detail were included to indicate the extent of the survey area, and the number of times that the survey would be undertaken. 5. Non-Onion Buffer Zone Finally, it is not clear how wide the non-onion buffer around the trial would be. Including this information in the figures (page 33-34) would be useful.

Conclusion

The Department of Conservation has no significant concerns in the approval of this application, however we have made some suggestions that we believe will ensure the robustness of the proposal.

Comments provided on behalf of the Department of Conservation by:

Gail Shuttleworth PhD

Biosecurity National Advisor:

30th April, 2008

Evaluation and Review Report for GMF06002 page 216 of 221

Appendix 9: Brainstorming

Possible pathways that GM material could get out of field test site:

GM pollen transferred onto people‟s clothes GM seeds blown out by wind Rabbits, mice (other small animals) takes GM plants out Machinery taking GM plant material out People sabotaging site/ theft of material Fence taken out by tree falling – due to lightening, animals get onto site and move GM material Composting on-site (loss of material) Crash of vehicle carrying GM material GM plants taken out by scientists working on site Floods etc moving GM material (Act of God) Fire – does not fully destroy material and it gets dispersed by wind Horizontal Gene Transfer

Concerns identified:

Size and location of the site Planting of GM seeds (more easily escape through wind, birds eating or transporting) Rotation using GM crops (cumulative concerns) GM plants producing toxins Potential transfer of infectious particles to other plants Safe disposal of GM material Effectiveness of containment system for seed, pollen, GM plant material Effectiveness of pollination cages Contamination of GM honey by GM pollen Non-target effects – soil, pollinators and other insects Long term adverse effects – could these be cumulative as it is a 10 year field test What happens at the end of the field test? Is there a benefit for New Zealand? Could this affect New Zealand‟s reputation? What effect will this have on the Organics section? Public perception of rubber stamping Funding (what happens if this is lost?) Public needs to be well informed about the decision-making process

Evaluation and Review Report for GMF06002 page 217 of 221

Benefits identified:

Will learn about growing in a field test environment (ie, we can‟t replicate the natural environment exactly indoors) Training for scientists Royal Commission recommendations – environmental impacts research

Assurances:

NZ has world experts = one reason why they are doing the field test here The applicant is a world class onion expert

Evaluation and Review Report for GMF06002 page 218 of 221

Appendix 10: Summary of consultation

Consultation Consultation with Māori occurs in order to give effect to section 6(d) of the Act. This section requires the Authority, when exercising functions under the Act, to specifically take into account the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga.

Accordingly the Authority policy on consultation with Māori requires that consultation be undertaken by the applicant in the first instance, enabling the effective exchange of information between applicant and iwi/hapū group as appropriate. In accordance with ERMA New Zealand policy the applicant conducted level 1 national consultation with iwi/Māori. In addition the applicant, following the advice of ERMA New Zealand, sought to undertake „kanohi ki te kanohi‟ consultation with Te Rūnanga ō Ngāi Tahu and Te Taumutu Rūnanga as the iwi and hapū most affected by the field test proposal.

Ngāi Tahu The applicant provided information about the proposed field trial and met with the HSNO committee of Te Rūnanga ō Ngāi Tahu on two occasions to present and discuss the application proposal. In their responses, Te Rūnanga ō Ngāi Tahu noted that their tribal policy has been to oppose genetic modification and release until such time as any cultural risks associated with the technology can be fully understood. However they also acknowledged that the policy provides for case by case consideration of applications and on assessing the information Te Rūnanga o Ngāi Tahu chose not to oppose the application for the following reasons:

Knowledge gained from previous trials; The species used are not native or taonga species and are considered low risk; and There is no intention to release genetically modified material into the environment. The response did however raise some concerns about aspects of the proposed field trial including the length of the trial, security issues with regard to natural disaster mitigation, the risk of escape through bird or animal routes, knowledge and understanding about the manipulation of quality traits and clarification about the long term outcomes of the research. Te Rūnanga ō Ngāi Tahu also requested assurance that Te Taumutu Rūnanga would be specifically consulted. The applicant responded directly to these issues through various correspondences and also in the body of the application itself. These are further outlined in the assessment of environmental effects and pathways of escape (sections 7, 8 and 9).

The applicant made a number of attempts to undertake „kanohi ki te kanohi‟ consultation with Te Taumutu Rūnanga, but had not received a response at the time of submitting their application with ERMA New Zealand. Information about the proposal was provided to the rūnanga, but again no response was received.

National Consultation As a requirement of a level 1 national consultation, the applicant distributed an information pack to rūnanga and other contacts nationally. The pack provided information on the field trial proposal including potential risks, costs and benefits. It also outlined the mechanisms to Evaluation and Review Report for GMF06002 page 219 of 221

be implemented to address any risks. Responses were received from four iwi groups (excluding Te Rūnanga o Ngāi Tahu). Three of the respondents (Hokunui Rūnanga, Ngāti Rarua Iwi Trust and Ngāti Tama Manawhenua ki Te Tauihu Trust) did not raise further issues. Te Mana Taiao Environmental Trust opposed the application raising a number of concerns including that the proposal: diminishes the integrity of whakapapa and tikanga Māori; includes the modification of quality traits that could be addressed through traditional horticultural methods; may lead to the development of genetically modified foods for human consumption; is too long; may lead to the contamination of the soil environment; and may lead to the contamination of other crop species. Te Mana Taiao Environmental Trust requested that these issues be addressed and that an independent peer review of the application be conducted prior to its submission to ERMA New Zealand. The applicant responded addressing each of the issues raised and noted that the ERMA New Zealand process would serve as an independent review of the application.

In addition to the applicant‟s response to these issues the project team has assessed them in this and other sections of this report.

The project team consider the consultative effort undertaken by the applicant to be consistent with the ERMA New Zealand Consultation Policy requirements.

Partnerships in research The project team has previously noted, by way of comment, that field tests of this nature offer the prospect of working in partnership to incorporate or contribute to the development of knowledge and understanding with regard to Māori cultural and spiritual concerns. Crop and Food Research, though not incorporating this recommendation for this particular field trial, have approached Te Rūnanga o Ngāi Tahu about future research proposals involving genetic modification. The project team is pleased to see this progress.

In addition, Crop and Food Research has worked with Te Rūnanga o Ngāi Tahu to develop a relationship agreement that clarifies the bounds and protocols for their mutual engagement. The Agency has been kept informed throughout the development of this relationship and continues to provide support where appropriate. Again the project team is pleased with this progress and considers the measures taken to provide a useful platform for future partnership opportunities.

Evaluation and Review Report for GMF06002 page 220 of 221

Appendix 11: Details of onion experts used in this report

Eamon Balle

Eamon is Production Manager at Balle Bros Group, Pukekohe. Balle Bros currently produce 800ha bulb onions (around 40,000t onions) for domestic and export markets. He has worked full time in the industry for 12 years as a grower/agronomist in his current role.

Russell Corfield

Russell is the Technical Services Manager for AS Wilcox and Sons Ltd. He has worked in the onion industry in New Zealand for the last 18 months, and has a background in agriculture based in the UK. He has a BSc Hons in Agriculture (specialising in cropping and agrochemicals) as well as the Dr. Norman Gill Crop Science Award and Farm Planner of the Year 2005.

Evaluation and Review Report for GMF06002 page 221 of 221