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 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 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 alliums; 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 plant 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 pollen 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