PROPOSAL FORM AMENDMENT - EPA NZ
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PROPOSAL FORM AMENDMENT Proposal to amend a new organism approval under the Hazardous Substances and New Organisms Act 1996 Send by post to: Environmental Protection Authority, Private Bag 63002, Wellington 6140 OR email to: noinfo@epa.govt.nz Applicant University of Otago Key contact IBSC secretary ibsc.secretary@otago.ac.nz www.epa.govt.nz
2 Proposal to amend a new organism approval Important This form is used to request amendment(s) to a new organism approval. This is not a formal application. The EPA is not under any statutory obligation to process this request. If you need help to complete this form, please look at our website (www.epa.govt.nz) or email us at noinfo@epa.govt.nz. This form may be made publicly available so any confidential information must be collated in a separate labelled appendix. The fee for this application can be found on our website at www.epa.govt.nz. This form was approved on 1 May 2012. May 2012 EPA0168
3 Proposal to amend a new organism approval 1. Which approval(s) do you wish to amend? APP201858 (importation of genetically modified new organisms) APP201859 (development of genetically modified new organisms) The organism that is the subject of this application is also the subject of: a. an innovative medicine application as defined in section 23A of the Medicines Act 1981. Yes No b. an innovative agricultural compound application as defined in Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997. Yes No 2. Which specific amendment(s) do you propose? We wish to add the organisms listed below to: - Table 1: Genetically modified new organisms approved to be developed in APP201859 - Table 2: Genetically modified new organism approved to be imported in APP201858 All host organisms are Category 2 and are not included on the Prohibited New Organisms list in Schedule 2 of the Hazardous Substances and New Organisms (HSNO) Act 1996. Species to be added: Plants Bryophytes Family Funariaceae Physcomitrella patens (moss) Family Marchantiaceae Marchantia polymorpha (liverwort) Family Anthocerotaceae Anthoceros species# (hornwort) Tracheophytes Family Salviniaceae Azolla species*# (aquatic ferns) Angiosperms Family Poaceae Avena sativa (oat) Bromus species*# (pasture brome) Dactylis species* (cocksfoot) Festuca species*# (tall Fescue) May 2012 EPA0168
4 Proposal to amend a new organism approval Hordeum vulgare (barley) Secale cereale* (rye) Triticum species (wheat) Family Amaryllidaceae Allium sativum (garlic) Allium porrum (leek) Eudicots Family Brassicaceae Arabidopsis lyrata (sandcress) Brassica oleracea (kale/cabbage/broccoli) Brassica napus (swedes/rape) Brassica rapa (turnip) Family Solanaceae Solanum tuberosum (potato) Solanum betaceum (tamarillo) Family Fabaceae Trifolium species* (clover; Trifolium occidentale (Western clover; GMC100243 and GMD101745) and Trifolium repens (white clover; GMD101746 and GMC100244) are already included in APP201858 and APP201859) Lathyrus ororatus (sweetpea) Glycine max (soybeans) Pisum sativum (pea) Family Rosaceae Rubus species*# (rubus berries) Fragaria vesca L (diploid strawberry) Fragaria × ananassa (commercial strawberry) Malus domestica (apple) Family Amaranthaceae Beta vulgaris* (fodder beet) Family Plantaginaceae Plantago lanceolata (narrow-leaved plantain) May 2012 EPA0168
5 Proposal to amend a new organism approval Family Asteraceae Cichorium intybus (forage chicory) Family Gunnerales Gunnera species*#^ Family Actinidiaceae Actinidia deliciosa* (green kiwifruit) Actinidia chinensis (golden kiwifruit) Actinidia arguta (kiwiberry) Family Vitaceae Vitis vinifera* (grapes) Family Ericaceae Vaccinium myrtillus (blueberry) Family Apiaceae Daucus carota (carrot) Insects (Hymenoptera) Family Pteromalidae Nasonia vitripennis Family Braconidae Microctonus aethiopoides Microctonus hyperodae * considered a weed (at least one species) in New Zealand based on Howell 2008 Consolidated list of environmental weeds in New Zealand, DOC. Appendix 1 # New Zealand native (at least one species) ^Gunnera tinctoria is excluded. 3. Why do you want the approval(s) amended? Plants Under APP201858 and APP201859 we currently import and develop genetically modified plants in containment to study plant biochemistry and metabolism along with plant developmental and reproductive biology. We wish to add May 2012 EPA0168
6 Proposal to amend a new organism approval the listed plant species to provide more flexibility and extend our research. This includes incorporating lower land plants and further model species to aid in understanding the diversity and evolution of different genes, gene products and genetic networks. We also wish to add a number of crop and forage plants to test gene function and perform proof-of-concept experiments in plants with current or potential future economic significance in New Zealand. The genetic modifications we wish to perform on these plants will involve either stable or transient transformation and are consistent with modifications described in APP201858 and APP201859. Lower land plants (Bryophytes and Tracheophytes) Lower land plants are an attractive model to study gene function due to their lower number of genes and reduced functional redundancy. We would like to be able to perform gene knock-out experiments along with over expression and expression of higher plant gene homologs in these plants to study gene function. This includes genes involved in metabolism and photosynthesis along with plant growth and reproduction. Additionally, investigating gene function in the lower land plants can aid evolutionary studies. Monocots The grass family (Poaceae) is a large family that contains important forage plants in New Zealand. Several members of this family are already included in APP201858 and APP201859 (Brachypodium distachyon: GMC100231 GMD101733; Lolium multiflorum: GMC100234 GMD101736, Lolium perenne: GMC100235 GMD101737), and we wish to add more to enable us to extend our research and explore how gene function differs in relation to different phenotypic traits, environmental responses and reproductive biology. This includes adding species that are currently grown, and will potentially increase, as forages in New Zealand, along with model organisms in this family. We also with to add two Allium species. One Allium species (Allium cepa; onion) is already included in APP201858 and APP201859 (GMC100229, GMD101731), and we wish to add Allium sativum (garlic) and Allium porrum (leek) to enable comparative gene function experiments. Eudicots Families Brassicaceae, Solanaceae and Fabaceae These three eudicot families contain many important crop plants, and model plants. APP201858 and APP201859 already contain members of these families (Brassicaceae: Arabidopsis thaliana GMC100230 GMD101732; Solanaceae: Nicotiana benthamiana GMC100240 GMD101742, Nicotiana tabacum GMC100241 GMD101743, Solanum lycoperisum GMC 100242 GMD101744; Fabaceae: Cicer arietinum GMC100232 GMD101734; Lens culinaris GMC100233 GMD101735; Lotus corniculatus GMC100236 GMD101738 Lotus corniculatus Var. japonicus GMC100237 GMD101739, Medicago sativa GMC100238 GMD101740, Medicago truncatula GMC100239 GMD101741,Trifolium occidentale GMC100243 GMD101745, Trifolium repens GMC100244 GMD101746). We wish to add the listed species to extend our studies in these family, exploring conservation of May 2012 EPA0168
7 Proposal to amend a new organism approval gene function along with how genes and genetic pathways have been altered as different family members have adapted to different environments and have altered developmental and reproductive biology. Familes Rosaceae, Amaranthaceae, Plantaginaceae, Asteraceae, Gunnerales, Actinidiaceae, Vitaceae, Ericaceae and Apiaceae We also wish to add a range of plant species in the above families. This includes plants that can be used as models along with plants that are important crop and forage plants in New Zealand. We wish to use these plants to study a range of plant functions such as metabolism including photosynthesis, how these plants respond to different environmental signals along with plant development and reproduction. Insects Nasonia is a chalconid parasitic wasp that is extensively studied overseas. Nasonia is used as a model system to understand Bee and wasp biology, especially due to its haplodiploid sex determination system. Nasonia are poor fliers and easily contained in a laboratory, unlike honeybees. We use non-GM Nasonia to compare with honeybees to understand honeybee biology better. We will use gene editing in Nasonia to test the function of key genes involved in reproduction and development, to gain insight into honeybee biology. Microctonus wasps are Braconid parasitic wasps extensively used in New Zealand to control pest weevils. Biocontrol using these wasps is failing in New Zealand’s pastures and we need to find ways to improve their performance. One critical problem is asexual reproduction (which occurs in M. aethiopoides and M. hyperodae). We wish to carry out gene editing experiments to identify genes that control reproduction in these species to better understand their biology. Microctonus wasps are poor fliers and are easy to contain in a lab setting. 4. Describe why you believe the proposed amendment(s) are minor in effect, or are needed to correct a minor or technical error The hosts we wish to add are all low-risk (Category 2 host organisms and not listed in the Prohibited New Organisms list in Schedule 2 of the Hazardous Substances and New Organisms (HSNO) Act 1996 ), and the proposed modifications are Category B and meet the criteria in APP201858 and APP201859. The listed species could have been included in the initial applications, but we did not envision at the time that we would wish to add them as other model plants or insects in our research. Plants: Many of the plant species listed are in the same genera or family as plants already listed in APP201858 and APP201859: Family Poaceae currently listed: - Brachypodium distachyon: GMC100231 GMD101733 - Lolium multiflorum: GMC100234 GMD101736 - Lolium perenne: GMC100235 GMD101737 Family Amaryllidaceae currently listed: May 2012 EPA0168
8 Proposal to amend a new organism approval - Allium cepa: GMC100229 GMD101731 Family Brassicaceae currently listed: - Arabidopsis thaliana: GMC100230 GMD101732 Family Solanaceae currently listed: - Nicotiana benthamiana: GMC100240 GMD101742 - Nicotiana tabacum: GMC100241 GMD101743 - Solanum lycoperisum: GMC 100242 GMD101744 Family Fabaceae currently listed: - Cicer arietinum: GMC100232 GMD101734 - Lens culinaris: GMC100233 GMD101735 - Lotus corniculatus: GMC100236 GMD101738 - Lotus corniculatus Var. japonicus: GMC100237 GMD101739 - Medicago sativa: GMC100238 GMD101740 - Medicago truncatula: GMC100239 GMD101741 - Trifolium occidentale: GMC100243 GMD101745 - Trifolium repens: GMC100244 GMD101746 Our current PC2 plant growth facility (MAF registration 1268) and current standard operating procedures (Appendix 1) also cover work with the plant species listed. Insects: Our current PC2 invertebrate facility (MAF registration 1268) and QMS Containment and Quarantine Manual v4 (Appendix 2) cover work with the insect species listed. 5. Appendices(s) and referenced material (if any) and glossary (if required) IBSC SOP Plant Growth Room Procedures and Plant Database QMS Containment and Quarantine Manual v1.5 6. Signature of applicant or person authorised to sign on behalf of applicant I request the Authority to waive any legislative information requirements (i.e. concerning the information that shall be supplied in my application) that my application does not meet (tick if applicable). I have completed this application to the best of my ability and, as far as I am aware, the information I have provided in this application form is correct. May 2012 EPA0168
9 Proposal to amend a new organism approval 4 December 2020 Deputy Vice-Chancellor (Research & Enterprise) Signature Date May 2012 EPA0168
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