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APP203937 EPA Staff Advice Memorandum.Pdf MEMORANDUM File Ref: APP203937 To: HSNO Decision Making Committee From: Advisor New Organisms Date: 26 February 2020 Subject: Information to support the consideration of application APP203937 Purpose 1. This memorandum provides information to support your consideration of Application APP203937 and guidance around the proposed controls. It is intended to be read in conjunction with the draft decision. The application 2. The applicant, AgResearch Limited, seeks to import 42 genetically modified (GM) plant species into containment for research and development of new knowledge, practices and products relevant to primary production systems. 3. The application was formally received on 31 January 2020. It was decided by the Acting General Manager, Hazardous Substances and New Organisms that the application did not warrant public notification as it did not meet the threshold of ‘significant’ public interest. 4. The decision path for this application can be found in Appendix 1 of this memorandum. Comments from external agencies 5. The Department of Conservation (DOC) and the Ministry for Primary Industries (MPI) were given the opportunity to comment on the application. 6. DOC stated that the importation into containment or development in containment of low-risk GMOs to carry very low risks to biodiversity. Therefore, they are not opposed to the approval of this application. 7. MPI stated that the information provided by the applicant relating to the proposed containment of new organisms (physical and operational) is vague and, to some extent contradictory. MPI noted that the applicant indicated that all experiments will be conducted using PC2 or higher conditions yet, the applicant also indicated that the modified plants will be maintained in a PC1 or PC3 facility. 8. MPI noted that while the applicant made reference to the AgResearch Plant Molecular Genetics Facility’s Transitional and Containment Facility Manual for details and protocols for handling imported material, no further specific information is provided on how the applicants propose to contain the organisms after taking into account their ability to escape from containment. 9. MPI stated that the possibility of accidental release of disease associated with the imported plant material does not seem to have been considered as a risk in the application. If the way in which 1 the source plant material is produced manages this risk then this could be stated. Consequently, it is very difficult to determine whether their proposed containment is adequate. 10. MPI suggests that the GM plants should be imported into, and held within, a containment facility approved in accordance with the requirements of MPI/EPA Standard: Containment Facilities for Plants, 2007 (‘the Plant Standard’) at a minimum containment level of PC2. However, the EPA should consider that the level of containment proposed by the applicants may not be suitable for all the listed species e.g. Solanum tuberosum (potato) there is a requirement in the schedule in the import health standard (seed for sowing) for seeds to be held in Level 3B post-entry quarantine (PEQ) to manage specific hitchhiker risks that may be associated with the pollen of this species. The Draft Decision 11. We evaluated this application as being relatively low risk and straightforward, and therefore elected to prepare a draft decision and this memorandum to support your consideration, in place of a full Staff Assessment Report. 12. The draft decision is just that, a draft. Alterations, inclusions or deletions to the content may well be appropriate or necessary following your consideration of the application. Organism descriptions 13. The 42 GM for import into containment are listed in Table 1. Table 1: Table of the proposed 42 GM plant species. Species Agrostis stolonifera, Linnaeus Lolium perenne, Linnaeus Pisum sativum, Linnaeus Arabidopsis thaliana, (L.) Heynh Lolium temulentum, Linnaeus Poa annua, Linnaeus Brachypodium distachyon, (L.) P. Beauvois Lotus corniculatus, Linnaeus Poa pratensis, Linnaeus Brassica nigra, Linnaeus Lotus japonicus, Linnaeus Sesamum indicum, Linnaeus Brassica oleracea, Linnaeus Lupinus angustifolius, Linnaeus Sesamum orientale, Linnaeus Brassica rapa, Linnaeus Lycopersicon esculentum, Solanum tuberosum, Linnaeus Linnaeus Camelina sativa, (L.) Crantz Medicago sativa, Linnaeus Trifolium arvense, Linnaeus Carthamus tinctorius, Linnaeus Medicago truncatula, Gaertner Trifolium occidentale, D.E. Coombe Festuca arundinacea, Schreber Musa genus, Linnaeus Trifolium pratense, Linnaeus Glycine max, (L.) Merrill Nicotiana benthamiana, Domin Trifolium repens, Linnaeus Glycine soja, Siebold & Zuccarini Nicotiana tabacum, Linnaeus Trifolium semipilosum, Fresen Helianthus annuus, Linnaeus Oryza sativa, Linnaeus Triticum aestivum, Linnaeus Hordeum vulgare, Linnaeus Paspalum vaginatum, Swartz Triticum durum, Desfontaines Lolium multiflorum, Lamarck Petunia hybrid, (Sweet) D. Don ex Zea mays, Linnaeus W.H. Baxter 14. All of the species proposed in APP203937 are commonly cultivated plant species in agricultural systems around the world. Agrostis stolonifera (creeping bentgrass, creeping bent, carpet bentgrass) 15. A perennial grass species with stems reaching a height of one metre. Native to Eurasia and North Africa (Algeria, Morocco and Tunisia). This species inhabits a variety of environments from woodlands, grasslands, meadows, wetlands and riparian zones. Agrostis stolonifera has been widely introduced and naturalised in North America. It is the most commonly used species of Agrostis for turf in gardens and landscapes, particularly on golf courses (Kubik et al. 2011). Arabidopsis thaliana (thale cress, mouse-ear cress or arabidopsis) 16. A small flowering plant usually growing 20-25cm tall. It is native to Eurasia, Asia and Africa but has been introduced and naturalised worldwide. It is considered to be a weed and is found by roadsides and on disturbed land. It is a winter annual with a relatively short lifecycle. Arabidopsis thaliana is a popular model organism in plant biology and genetics and was the first plant to have its genome sequenced (Arabidopsis.org, 2010; Kramer, 2015). Brachypodium distachyon (purple false brome or stiff brome) 17. A grass species native to southern Europe, northern Africa and southwestern Asia. It is related to the major cereal grain species wheat, barley, oats, maize, rice, sorghum and millet. The species’ small genome, small physical stature, self-fertility, short lifecycle and simple growth requirements make it an excellent model organism for functional genomics and molecular biology (Vogel & Hill, 2008). Brassica nigra (black mustard) 18. A plant cultivated widely for its black or dark brown seeds which are commonly used as a spice. It is native to tropical regions of North Africa, temperate regions of Europe and parts of Asia. Brassica nigra reaches 80-90cm tall in most fertile soil (United States National Plant Germplasm System, 2019). It blooms in summer with flowers having four yellow petals which are twice as long as the sepals. It is considered an invasive species along the Pacific coast of North America (Los Angeles Times, 2019) and has been used as a condiment for over 2,000 years. Brassica oleracea (cabbage) 19. A plant species that includes many common foods in cultivar groups such as cabbage, broccoli, cauliflower, kale and Brussels sprouts. It is a tall, biennial plant that forms a stout rosette of large leaves in the first year. In the second year, it uses the stored nutrients to produce a flower spike one to two metres tall with numerous yellow flowers. Brassica oleracea has become established as an important human food crop plant and has been cultivated for several thousands of years (Snogerup et al. 1990). Brassica rapa (turnip rape, field mustard, bird rape) 20. A plant species consisting of various widely cultivated subspecies including turnip, napa cabbage and bok choy (United States National Plant Germplasm System, 2019). The oil made from the seed is sometimes called canola. The oilseeds known as canola are sometimes particular varieties of Brassica rapa but usually the related species Brassica napus (rapeseed) and Brassica juncea (mustard greens and mizuna) (Canola Encyclopedia, 2017). Camelina sativa (camelina, gold-of-pleasure or false flax) 21. A flowering plant in the Brassicaceae family and is native to Europe and Central Asian areas (Eynck & Falk, 2013). It is cultivated as oilseed crop mainly in Europe and North America. As an annual plant, C. sativa grows to a height of up to 90cm with branching stems which become woody at maturity (Fleenor, 2011). Leaves and stems may be partially hairy and produce seeds that are brown or orange. Carthamus tinctorius (safflower) 22. A highly branched, herbaceous, thistle-like annual plant. It is commercially cultivated for vegetable oil extracted from the seeds and was used by the early Spanish colonies along the Rio Grande as 3 a substitute for saffron. Plants are 30-150cm tall with globular yellow, orange or red flower head. Each branch will typically have from one to five flower heads containing 15 to 20 seeds per head. It is native to arid environments having seasonal rain and has a deep taproot which enables it to thrive in such environments (Dajue & Mundel, 1996). Festuca arundinacea (tall fescue) 23. A significant forage grass throughout Europe with many cultivars used in agriculture. In its native European environment, tall fescue is found in damp grasslands, river banks and in coastal seashore locations. It was introduced
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