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 in the United States where it has become an invasive species in native California grasslands and habitats (CABI, 2019).

Glycine max (soybean or soya bean) 24. A species of legume native to East Asia. This plant is widely grown for its edible bean which has numerous uses as a livestock feed, food for human consumption and medicinal purposes. Traditional unfermented food uses of soybeans include soy milk from which tofu is made from (Riaz, 2005). Soybeans contain significant amount of phytic acid, dietary minerals and B vitamins (Lokuruka, 2010).

Glycine soja (wild soybean) 25. An annual plant in the legume family that is the closest living relative of soybean (Glycine max). This species is native to eastern China, Japan, Korea and far-eastern Russia (Wang et al. 2010).

Helianthus annuus (common sunflower) 26. A large annual forb grown as a crop for its edible oil and fruits. This sunflower species is also used as a wild bird food, as livestock forage (as a meal or silage plant), in some industrial applications and as an ornamental in domestic gardens. Sunflower seeds were brought to Europe from the Americas in the 16th century where, along with sunflower oil, they became a widespread cooking ingredient. This species reaches an average height of three metres with broad and coarsely toothed leaves (Encyclopedia Britannica, 2019).

Hordeum vulgare (barley) 27. A member of the grass family. This species is a major cereal grain grown in temperate climates globally. It was one of the first cultivated grains as early as 10,000 years ago (Zohary & Hopf, 2000). Barley is used as animal fodder and as a source of fermentable material for beer and certain distilled beverages. It is a self-pollinating, diploid species with 14 chromosomes. The wild ancestor of barley, Hordeum vulgare subsp. spontaneum, is abundant in grasslands and woodlands throughout the Fertile Crescent area of Western Asia and northeast Africa and is abundant in disturbed habitats, roadsides and orchards (Thormann et al. 2016).

Lolium multiflorum (Italian ryegrass) 28. A ryegrass species native to temperate Europe though its precise native range is unknown (Umberto, 2006). This herbaceous annual grass is grown for silage as a cover crop and as an ornamental. It readily naturalises in temperate climates and can become a noxious weed in agricultural areas and an invasive species in native habitats (Umberto, 2006). This species is a highly competitive and rapidly growing plant, capable of producing large quantities of seed (CABI.org)

Lolium perenne (perennial ryegrass) 29. Native to Europe, Asia and northern Africa, this species is widely cultivated and naturalised around the world (New Zealand Plant Conservation Network, 2011). Lolium perenne is a low- growing, tufted, hairless grass with a bunching growth habit. The leaves are dark green, smooth and glossy on the lower surface, with untoothed parallel sides and prominent parallel veins on the upper surface. Stems grow up to 90cm and it has a fibrous root system (Agriculture Victoria, 2019). It can be used to prevent erosion and stabilise soils as well as creating a hardwearing turf for lawns and golf courses. The plant has become extremely widespread both as a cultivated species for livestock grazing and for fodder (as hay or silage) (CABI.org).

Lolium temulentum (darnel) 30. An annual plant within the Lolium genus that can reach one metre tall with inflorescence and purple grain. It has a global distribution (Online Atlas of the British and Irish Flora, 2008). Lolium temulentum usually grows in the same production zones as wheat and was a serious weed of cultivation until modern machinery enabled L. temulentum seeds to be separated efficiently from seed wheat.

Lotus corniculatus (common bird’s-foot-trefoil, eggs and bacon, birdsfoot deervetch) 31. A common flowering plant in the pea family, Fabaceae, native to grasslands in temperate Eurasia and North Africa. It is a perennial herbaceous plant similar in appearance to some clovers and has a broad global distribution. The name ‘bird’s foot’ refers to the appearance of the seed pods on their stalk. Five leaflets are present, but, with the central three held conspicuously above the others, hence the commonly used name ‘trefoil’. It is often used as forage for livestock due to its non-bloating properties. The height of L. corniculatus is generally 5-20cm but where supported by other plants, its stems can reach up to 50cm long (Ramirez-Restrepo et al. 2006).

Lotus japonicus 32. A wild legume belonging to the family Fabaceae. Lotus japonicus has become a model plant for genome studies in legumes, particularly in reference to rhizobial and arbuscular mycorrhizal symbiosis. A small genome size of about 470 Mb, diploid genome with six haploid chromosomes, a short life cycle of about two to three months and its perennial nature makes it a convenient plant to study (Sato et al. 2008).

Lupinus angustifolius (narrowleaf lupin, narrow-leaved lupin and blue lupin) 33. A species of lupin native to Eurasia and northern Africa and naturalised in parts of Australia and North America. It has been cultivated for over 6,000 years as a food crop for its edible legume seeds (Gladstones et al. 1998), as a fodder for livestock and for green manure. This species is an erect, branching herb that occasionally exceeds one metre in height.

Lycopersicon esculentum (tomato) 34. The tomato is the edible, often red, berry of the plant Solanum lycopersicum, commonly known as a tomato plant. The species originated in western South America and Central America. Its domestication and use as a cultivated food may have originated with the indigenous peoples of Mexico. The Aztecs used tomatoes in their cooking at the time of the Aztec Empire, and the Spanish conquistadors brought the plant to Europe. From there, the tomato was introduced to other parts of the European-colonized world during the 16th century (Encyclopedia of Life, 2019).

35. Numerous varieties of the tomato plant are widely grown in temperate climates across the world, with greenhouses allowing the production of tomatoes throughout the year. Tomato plants typically grow to 1–3m in height. They are vines with a weak stem that sprawls and typically needs support. Indeterminate tomato plants are perennials in their native habitat, but are cultivated as annuals. Determinate, or bush, plants are annuals that stop growing at a certain height and produce a crop all at once. The size of the tomato varies according to the cultivar, with a range of 1–10cm in width (Encyclopedia of Life, 2019).

Medicago sativa (alfalfa, lucerne) 36. A perennial flowering plant in the legume family Fabaceae. It is cultivated as an important forage crop in many countries around the world. It is used for grazing, hay, and silage, as well as a green manure and cover crop. The plant superficially resembles clover (a cousin in the same family), especially while young, when trifoliate leaves comprising round leaflets predominate. In maturity leaflets are elongated. It has clusters of small purple flowers followed by fruits spiraled in two to

5

three turns containing 10–20 seeds. Alfalfa is native to warmer temperate climates. It has been cultivated as livestock fodder since at least the era of the ancient Greeks and Romans (National Lucerne Trust, 2018). 37. Alfalfa normally lives four to eight years, but can live more than 20 years, depending on variety and climate. The plant grows to a height of up to one metre, and has a deep root system (Purves & Wynn-Williams, 1989), sometimes growing to a depth of more than 15m to reach groundwater. Typically the root system grows to a depth of 2–3m depending on subsoil constraints. Owing to deep root system, it helps to improve soil nitrogen fertility and protect from soil erosion. This depth of root system, and perenniality of crowns that store carbohydrates as an energy reserve, makes it very resilient, especially to droughts. Alfalfa is more drought-hardy than drought-tolerant and the persistence of the plant also depends on the management of the stand.

Medicago truncatula (barrelclover, strong-spined medick, barrel medic or barrel medick) 38. A small annual legume native to the Mediterranean region that is used in genomic research (Ellwood et al. 2006). It is a low-growing, clover-like plant 10–60cm tall with trifoliate leaves. Each leaflet is rounded, 1–2cm long, often with a dark spot in the center. The yellow flowers are produced singly or in a small inflorescence of two to five together; the fruit is a small spiny pod. 39. This species is studied as a model organism for legume biology because it has a small diploid genome, is self-fertile, has a rapid generation time and prolific seed production, is amenable to genetic transformation and its genome has been sequenced (Bioinformatics & Evolutionary Genomics, 2011).

Musa genus (bananas and plantains) 40. Musa is a genera in the family Musaceae which includes bananas and plantains. Around 70 species of Musa are known with a broad variety of uses. Though they grow as high as trees, banana and plantain plants are not woody and their apparent "stem" is made up of the bases of the huge leaf stalks. Thus, they are technically gigantic herbs (Australian Government, 2008).

Nicotiana benthamiana 41. A close relative of tobacco, species of Nicotiana are indigenous to Australia (Derevnina et al. 2018). This herbaceous plant is found amongst rocks on hills and cliffs throughout the northern regions of Australia. Variable in height and habit, the species may be up to 1.5m tall. The flowers are white.

42. The plant was used by people of Australia as a stimulant — it contains nicotine and other alkaloids — before the introduction of commercial tobacco (Nicotiana tabacum and N. rustica). 43. Nicotiana benthamiana has been used as a model organism in plant research. For example, the leaves are rather frail and can be injured in experiments to study ethylene synthesis. Due to the large number of plant pathogens able to infect it, N. benthamiana is widely used in the field of plant virology (Goodin et al. 2008).

Nicotiana tabacum (tobacco) 44. Cultivated tobacco is an annually-grown herbaceous plant. It is the most commonly grown of all plants in the genus Nicotiana and its leaves are commercially grown in many countries to be processed into tobacco. It grows to a height between one and two metres. Research is ongoing into its ancestry among wild Nicotiana species, but it is believed to be a hybrid of Nicotiana sylvestris, Nicotiana tomentosiformis and possibly Nicotiana otophora (Nan et al. 2001).

45. Nicotiana tabacum is a native of tropical and subtropical America but it is now commercially cultivated worldwide. Other varieties are cultivated as ornamental plants or grow as a weed.

Oryza sativa (Asian rice) 46. The plant species the most commonly referred to in English as rice. This species is a grass with a genome consisting of 430Mb across 12 chromosomes. It is renowned for being easy to genetically modify and is one of the best model organisms for plant genomic research (Rensink & Buell, 2004). 47. Oryza sativa contains two major subspecies: the sticky, short-grained japonica or sinica variety, and the non-sticky, long-grained indica variety. Japonica varieties are usually cultivated in dry fields in temperate East Asia, upland areas of Southeast Asia, and high elevations in South Asia, while indica varieties are mainly lowland rices, grown mostly submerged, throughout tropical Asia. Rice occurs in a variety of colours such as brown, white, black, red, white and black (Mohammadi Shad & Atungulu, 2019).

Paspalum vaginatum (seashore paspalum, biscuit grass, saltwater couch, silt grass, and swamp couch) 48. A species of grass native to the Americas where it grows in tropical and subtropical regions. It is found throughout the other tropical areas of the world where it is an introduced species and sometimes an invasive weed. It is also cultivated as a turfgrass in many countries.

49. This grass has been bred into cultivars which are used for golf course turf and landscaping. It can grow in lawns that receive rain on 250 days per year and it can survive being waterlogged or submerged for several days at a time. It tolerates foot traffic and the main advantage of this grass is that it is highly salt-tolerant. It can be irrigated with non-potable water, such as greywater, an important advantage in a time when there are increasing restrictions on water use.

Petunia hybrida 50. A Petunia plant hybrid which encompasses all hybrid species of petunia between Petunia axillaris and P. integrifolia (United States National Plant Germplasm System, 2019). Most of the petunias sold for cultivation in home gardens belong to this hybrid species. 51. Petunia hybrida plants were originally produced by hybridisation between P. axillaris and P. integrifolia. P. axillaris bears night-fragrant, buff-white blossoms with long, thin tubes and somewhat flattened openings. The scent molecules emitted by the hybrids are generally similar to those from P. axillaris.

52. Petunia seeds germinate in 5 to 15 days. Petunias can tolerate relatively harsh conditions and hot climates. They need at least five hours of sunlight every day. They grow well in low humidity and moist soil. Young plants can be grown from seeds. Maximum growth occurs in late spring. Petunias may readily be cultivated in tubs, window boxes, hanging baskets and other containers.

Pisum sativum (pea) 53. A plant that produces pods containing several small spherical seeds, called peas, which can be green or yellow. Botanically, pea pods are fruit, since they contain seeds and develop from the ovary of a (pea) flower. 54. Pisum sativum is an annual plant. It is a cool-season crop grown in many parts of the world; planting can take place from winter to early summer depending on location (Purdue University, 1997). The immature peas (and in snow peas the tender pod as well) are used as a vegetable, fresh, frozen or canned; varieties of the species typically called field peas are grown to produce dry peas like the split pea shelled from the matured pod.

Poa annua (annual meadow grass) 55. A widespread low-growing turfgrass found in temperate climates. Though P. annua is commonly considered a solely annual plant due to its name, perennial bio-types do exist. Poa is Greek for "fodder". This grass may have originated as a hybrid between Poa supina and Poa infirma (CABI, 2019). 7

56. The vivid green leaves are short and blunt at the tips, shaped like the prow of a small canoe. They are soft and drooping. Long sheaths clasp the stem. The leaves are smooth above and below with finely serrated edges. Occasionally the leaves are serrated transversely. 57. It is in flower all year around except for severe winters. The seeds ripen and are deposited eight months of the year. The plant grows rapidly from seed, flowering within six weeks, seeding and then dying.

Poa pratensis (Kentucky bluegrass, blue grass, smooth meadow-grass, common meadow-grass) 58. A perennial species of grass native to Europe, North Asia and the mountains of Algeria and Morocco. Although the species is spread over all of the cool, humid parts of the United States, it is not native to North America. The Spanish Empire brought the seeds of Kentucky bluegrass to the New World in mixtures with other grasses. Poa pratensis forms a valuable pasture plant, characteristic of well-drained, fertile soil. It is also used for making lawns in parks and gardens and is common in cool moist climates like the north-eastern United States. When found on native grasslands in Canada, however, it is considered an unwelcome exotic plant, and is indicative of a disturbed and degraded landscape (Vujnovic, 1997).

59. Poa pratensis is a herbaceous plant 30–70cm tall. The leaves have boat-shaped tips, narrowly linear, up to 20cm long and 3–5mm broad, smooth or slightly roughened, with a rounded to truncate ligule 1–2mm long. They are in flower from May to July (Massey University, 2019).

Sesamum indicum syn. Sesamum orientale (sesame) 60. Sesame is a flowering plant in the genus Sesamum. Numerous wild relatives occur in Africa and a smaller number in India, and is widely naturalised in tropical regions. It is cultivated for its edible seeds, which grow in pods. 61. Sesame indicum, the cultivated type, originated in India and is tolerant to drought-like conditions, growing where other crops fail. Sesame has one of the highest oil contents of any seed. With a rich, nutty flavor, it is a common ingredient in cuisines across the world. Like other nuts and foods, it can trigger allergic reactions in some people. Sesame seeds are sometimes sold with the seed coat removed; this variety is often present on top of baked goods.

62. Sesame seed is considered to be the oldest oilseed crop known to humanity. The genus has many species and most are wild species native to sub-Saharan Africa (Bedigian, 2014).

63. Sesame is an annual plant growing 50-100cm tall, with opposite leaves 4-14cm long. The flowers are white, tubular, 3-5cm long, with a four-lobed mouth. The flowers may vary in colour with some being white, blue, or purple. Sesame seeds occur in many colours depending on the cultivar. The most traded variety of sesame is off-white coloured.

Solanum tuberosum (potato) 64. A perennial plant in the family Solanaceae, native to the Americas. The potato is a root vegetable with a starchy tuber.

65. Wild potato species can be found from the United States to southern Chile (Hijmans & Spooner, 2001). The potato was originally believed to have been domesticated by indigenous peoples of the Americas independently in multiple locations, but later genetic testing of the wide variety of cultivars and wild species traced a single origin for potatoes. Potatoes were domesticated approximately 7,000 – 10,000 years ago in present-day, southern Peru and extreme northwestern Bolivia, from the Solanum brevicaule species complex. In the Andes region of South America, where the species is indigenous, some close relatives of the potato are cultivated (Francis, 2005).

66. Potatoes were introduced to Europe from the Americas in the second half of the 16th century by the Spanish. Today they are a staple food in many parts of the world and an integral part of much of the world's food supply. As of 2014, potatoes were the world's fourth-largest food crop after maize (corn), wheat and rice.

67. Following millennia of selective breeding, there are now over 1,000 different types of potatoes. Over 99% of presently cultivated potatoes worldwide descended from varieties that originated in the lowlands of south-central Chile, which have displaced formerly popular varieties from the Andes.

Trifolium arvense (hare's-foot clover, rabbitfoot clover, stone clover, oldfield clover) 68. A flowering plant in the bean family Fabaceae. This species of clover is native to most of Europe, excluding the Arctic zone, and western Asia (Plants of the World, 2019), in plain or mid-mountain habitats up to 1,600 metres altitude. It grows in dry sandy soils, both acidic and alkaline soils with dry-mesic conditions. It is typically found at the edge of fields, in wastelands, at the side of roads, on sand dunes, and opportunistically in vineyards and orchards when they are not irrigated.

69. It is a small erect herbaceous annual or sometimes biennial plant, growing to 10–40cm tall. Like all clovers, it has leaves divided into three sessile leaflets which are slender, 1–2cm long and 3– 5mm broad, and sometimes edged with small hairs and finely serrated. The flowers are grouped in a dense inflorescence rosy white in colour, and characterised by the many silky white hairs which tip the five sepals, which are much larger than the petals. Pollination is carried out by bees, or via autogamy, since the plant is hermaphroditic. The flowering season is from mid-spring to late summer. The fruit is a small pod containing a single seed.

Trifolium occidentale (western clover) 70. A clover plant belonging to the genus Trifolium in the legume family, Fabaceae. Its flowers are white, similar to white clover (Trifolium repens), with which it has long been confused. The species was first described in 1961 (Coombe, 1961). 71. Trifolium occidentale is a self-compatible, diploid, stoloniferous1 perennial herb, found only within 100m of the coast in Western Europe. It inhabits sandy dunes including dry short coastal grasslands and sea cliffs, especially around rock outcrops (Kazimierska, 1997). Its range extends from the east coast of Ireland and the southern British Isles such as Cornwall, the Channel Islands and Isle of Scilly in particular, to the northwest of the Iberian Peninsula, although much less common. In France, it is found on the shores of the Armorican Massif, Normandy and Brittany. It was discovered in Ireland in June 1979 and in Wales in 1987. It appears earlier in the season than white clover and is more compact with more opaque leaves - often a blue-green.

Trifolium pratense (red clover) 72. A herbaceous species of flowering plant in the bean family Fabaceae, native to Europe, Western Asia and Northwest Africa, but planted and naturalised in many other regions.

73. Red clover is a short-lived perennial plant, variable in size, growing to 20–80cm tall. It has a deep taproot which makes it tolerant to drought and gives it a good soil structuring effect. The leaves are alternate, trifoliate (with three leaflets), green with a characteristic pale crescent in the outer half of the leaf; with two basal stipules that are abruptly narrowed to a bristle-like point. The dark pink with a paler base flowers are produced in a dense inflorescence (Van Der Kooi et al. 2015).

74. The red clover was brought to Argentina and Chile over 100 years ago, although it is not clear how exactly it was introduced. It has become an increasingly important source of economic stability in Chile, which has made the need for pollinators even more important. One important pollinator, which was also brought from Europe, is Bombus ruderatus, or the large garden

1 Stoloniferous: having stolons – horizontal, above-ground, creeping stems with roots and shoots forming at the nodes and the tip. 9

bumblebee. This bumblebee has been one of the important pollinators of red clover in South America and other countries such as New Zealand.

Trifolium repens (white clover) 75. A herbaceous perennial plant in the bean family Fabaceae native to Europe including the British Isles (Clapham et al. 1968) and central Asia. It is one of the most widely cultivated types of clover. It has been widely introduced worldwide as a forage crop and is now also common in most grassy areas of North America and New Zealand (Porsild & Cody, 1980). The species includes varieties often classed as small, intermediate and large, according to height, which reflects petiole length. 76. Trifolium repens is low growing, with heads of whitish flowers, often with a tinge of pink or cream that may come on with the aging of the plant. The heads are generally 1.5–2cm wide and are at the end of 7cm inflorescence stalks. The flowers are mostly visited by bumblebees and honey bees.

Trifolium semipilosum (Kenya clover, Kenya white clover) 77. A herbaceous perennial plant species native to Africa. It occurs naturally in the humid and equatorial high altitude areas of Kenya, Uganda, Tanzania, Yemen and Ethiopia. Now it is cultivated elsewhere in the high altitude tropics and subtropics. Kenya white clover grows in the low altitude subtropics and elevated tropics (1,000-3,000m). In its natural habitat in East Africa, annual rainfall is 550-1,400mm.

78. Temperature requirements for growth are intermediate between those of most tropical legumes and white clover. It grows very well in Papua New Guinea at sites with a diurnal temperature range of 10-20°C and at elevations as low as 1,300m, provided the soil is fertile. It can flower and set seed on the equator and also at latitudes in excess of 30°C. In the subtropics, flowering occurs mainly during the cooler months

Triticum aestivum (bread wheat, common wheat) 79. A cultivated wheat species. About 95% of wheat produced worldwide is common wheat; it is the most widely grown of all crops and the cereal with the highest monetary yield. 80. Numerous forms of wheat have evolved under human selection. This diversity has led to confusion in the naming of wheats, with names based on both genetic and morphological characteristics. 81. Common wheat was first domesticated in Western Asia during the early Holocene and spread from there to North Africa, Europe and East Asia in the prehistoric period. Naked wheats (including Triticum aestivum, T. durum and T. turgidum) were found in Roman burial sites ranging from 100BCE to 300CE (Rottoli & Castiglioni, 2011).

82. Globally, bread wheat has proved well adapted to modern industrial baking, and has displaced many of the other wheat, barley and rye species that were once commonly used for bread making particularly in Europe.

Triticum durum (durum wheat, pasta wheat, macaroni wheat) 83. This plant is the second most cultivated species of wheat after common wheat, although it represents only 5% to 8% of global wheat production (World-Grain.com, 2017). It was developed by artificial selection of the domesticated emmer wheat strains formerly grown in Central Europe and the Near East around 7000BC, which developed a naked, free-threshing form. Like emmer, durum wheat is awned2 (with bristles). It is the predominant wheat that grows in the Middle East.

2 Awned: a slender bristle, especially one at the tip of a glume or lemma in a grass spikelet. 84. Durum in Latin means "hard" and the species is the hardest of all wheats. This refers to the resistance of the grain to milling, in particular of the starchy endosperm, implying dough made from its flour is weak or "soft". This makes durum favorable for semolina and pasta and less practical for flour, which requires more work than with hexaploid wheats like common bread wheats. Despite its high protein content, durum is not a strong wheat in the sense of giving strength to dough through the formation of a gluten network. Durum contains 27% extractable wet gluten, about 3% higher than in common wheat (T. aestivum) (Zilic et al. 2011).

85. Durum wheat is a tetraploid wheat, having 4 sets of chromosomes for a total of 28, unlike hard red winter and hard red spring wheats which are hexaploid (6 sets of chromosomes) for a total of 42 chromosomes each.

Zea mays (corn, maize) 86. A cereal grain first domesticated by indigenous peoples in southern Mexico about 10,000 years ago (Benz, 2001). The leafy stalk of the plant produces pollen inflorescences and separate ovuliferous3 inflorescences called ears that yield kernels or seeds which are fruits.

87. Maize has become a staple food in many parts of the world with the total production of maize surpassing that of wheat or rice. However, little of this maize is consumed directly by humans: most is used for corn ethanol, animal feed and other maize products, such as corn starch and corn syrup. Sugar-rich varieties called sweet corn are usually grown for human consumption as kernels, while field corn varieties are used for animal feed, various corn-based human food uses (including grinding into cornmeal or masa, pressing into corn oil and fermentation and distillation into alcoholic beverages like bourbon whiskey) and as chemical feedstocks.

88. Maize is widely cultivated throughout the world, and a greater weight of maize is produced each year than any other grain (International Grains Council, 2013).

89. The maize plant is often 3m in height though some natural strains can grow 13m. The stem is commonly composed of 20 internodes of 18cm length. A leaf, which grows from each node, is generally 9cm in width and 120cm in length.

Proposed controls 90. Section 45(2) of the HSNO Act specifies that an approval must include controls that provide for the matters specified in Schedule 3, and may include controls that provide for any other matters that give effect to the purpose of the Act. 91. The proposed controls are primarily outcome focused, specifying outcomes that must be achieved, rather than prescribing a set method by which the outcome must be achieved. This enables the approval user to update their containment measures (design, construction, and management of the facility) to reflect best practice and any new information about the biology of the organisms being contained.

92. Appendix 2 sets out the proposed controls against the matters specified in Part 2 of Schedule 3 (Matters to be addressed by containment controls for new organisms excluding genetically modified organisms).

93. In addition to those controls addressing the matters in Schedule 3, it is proposed that controls 3 and 4 be imposed. Control 3 requires that the approval user document the technical and operational policies and procedures that they will implement to meet the controls and the quality control measures they will use to ensure those policies and procedures are effective in achieving

3 Ovuliferous: one of a group of large woody specialised leaves that form the female cone of conifers and related trees. It bears the ovules which develop into seeds. 11

the outcomes set out in the controls (i.e., containment of genetically modified plants). Control 4 requires that the containment facility where the genetically modified plants are held be operated in compliance with the documentation specified in control 3.

Risks and benefits 94. In the decision document, the EPA assessed the risks, costs and benefits of the release of the 42 GM plant species in the context of the environment, market economy, people and communities, public health and on the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna, and other taonga. 95. We considered that the risks associated with having the 42 GM plant species in containment are not significant. In addition, the benefits of having these genetically modified plant species in containment are likely to occur and are potentially significant.

Conclusion 96. There are no issues we would like to bring to the attention of the Committee. 97. We recommend that this application meets the requirements of section 45, and therefore, can be approved, subject to the controls set out in Appendix 1 of the draft decision.

26 February 2020

Advisor, New Organisms Date

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Appendix 1: Decision path for applications to import any GMO into containment

Context This decision path describes the decision-making process for applications to import any GMO into containment. These applications are made under section 40 of the HSNO Act, and determined under section 45 of the Act. Applications to import a GMO into containment require consideration of section 44 (section 37 plus ability to escape). 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 HSNO decision maker4 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 HSNO decision maker 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 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.

4 The HSNO decision maker refers to either the EPA Board or any committee or persons with delegated authority from the Board. 17

Figure 1: Flowchart Decision path for applications to import into containment any NO (non GMO) (application made under section 40 of the Act and determined under section 45 of the Act)

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 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?

15 Yes Taking into account controls, Yes do positive effects outweigh adverse effects? 16 Confirm scope of organism description Confirm and set controls No

Decline Approve (section 45(1)(b)) (section 45(1)(a))

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. 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 EPA staff 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 HSNO decision maker in evaluating applications shall be that which is appropriate and relevant to the application. While the HSNO decision maker 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 EPA staff 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 HSNO decision maker 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 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 HSNO decision maker may approve the importation of a new organism. If the application is not for one of the purposes listed under section 39(1) then it must be declined.

Item 6: Identify scope of organism description Clearly identify the scope of the organism description. 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-negligible5 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

5 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. 19

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 Methodology and sections 5 and 6 of the Act6. 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 negligible7, 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 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 II). The HSNO decision maker may consider other controls to give effect to the purpose of the Act. The impact of these controls also needs to be considered. Section 45(1)(a)(iii) requires the HSNO decision maker 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 HSNO decision maker 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 three 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).

6 Effects on the natural environment, effects on human health and safety, effects on Māori culture and traditions, effects on society and community, effects on the market economy.

7 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”. 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. 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 HSNO decision maker’s approach to risk (clause 33 of the Methodology) or how risk averse the HSNO decision maker 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: Exposure to the risk is involuntary: (a) The risk will persist over time: (b) The risk is subject to uncontrollable spread and is likely to extend its effects beyond the immediate location of incidence: (c) The potential adverse effects are irreversible: (d) 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 of estimating the magnitude of the effect or where this is not relevant, it may be done separately. Where the HSNO decision maker 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.

The assessment includes consideration of how cautious the HSNO decision maker 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 21

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) 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 10: Undertake combined consideration of all risks and costs, cognisant of 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 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 11: Are all risks with controls in place negligible? 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?

Yes Clause 26

(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 demonstrate existence of internal or private net benefit, and therefore total benefits outweigh total costs. 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 HSNO decision maker 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 14: Assess benefits 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 HSNO decision maker’s approach to uncertainty or how cautious the HSNO decision maker 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 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 HSNO decision maker will in particular look to identify those situations where the beneficiaries of an application are different from those who bear the costs8. 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 HSNO decision maker 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 15: Taking into account controls, do positive effects outweigh adverse effects? 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 16: Confirm scope of organism description 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.

8Clause 13 of the Methodology 23

Controls have been considered at the earlier stages of the process (items 8, 9 and 15). 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.

Appendix 2: Proposed containment regime9

Any persons importing the approved organisms under the approval granted by this decision must ensure compliance with the controls set out below in respect of any activity they carry out under this approval in a facility under their control.

Requirement for the containment of approved organisms

1. The approved organism(s) must be contained.

Requirements for accountability for compliance with controls

2. The organisation, entity or person(s) responsible for the ownership, control and management of the containment facility where the approved organisms are held (including Board members and/or directors) must ensure compliance with the controls of this approval.

Requirement to specify how controls will be met

3. Procedures that specify how the controls will be implemented must be documented, and these procedures must be reviewed at least annually to ensure they:

a. are effective in maintaining containment and achieving their purpose, b. reflect any relevant changes in the facility and its operation, and c. incorporate any improvements to best practice.

4. The containment facility must be operated in compliance with the documentation specified in control 3.

Requirements for the containment regime

5. The containment facility where the approved organisms may be held must be clearly defined, described, and documented, including the location and boundaries.

6. The containment facility must be designed, constructed, managed, and maintained to prevent the approved organism(s) from escaping.

7. Persons entering and exiting the containment facility must do so in a way that does not adversely affect containment of the approved organism(s).

8. The approved organism(s) must be identifiable as a new organism and be able to be linked to the relevant HSNO Act approval.

Requirements for notification to the EPA and/or MPI

9. Notification must be given to MPI of any movement of approved organisms outside of the facility, or any proposed modification to the containment regime which may affect the integrity of containment of the approved organism(s), before the modifications are undertaken.

9Compliance with the controls imposed in this decision does not affect the requirements of the Biosecurity Act 1993 including any authorisations or approvals that may be required under that Act (such as approvals of containment facilities by MPI). 25

10. The EPA and MPI must be notified in writing before this HSNO Act approval is used for the first time.

11. MPI must be notified as soon as possible, and within 24 hours, of any escape and/or breach of containment and the actions taken in response to that incident.

Requirements for moving approved organisms

12. The approved organism(s) must be contained during movement within, to, or from the containment facility.

13. When being moved outside of a containment facility, within New Zealand, the approved organism(s) must be accompanied by documentation stating the:

a. Identity of the approved organism(s); b. Containment requirements; c. Details of the sender; and d. Details of the receiving facility.

Requirements to limit access to the containment facility

14. Unauthorised persons must be excluded from the containment facility.

15. All containment facility entrances must be clearly identified including specifying who has the right of access.

16. The number and location of entrances to the containment facility where the approved organism(s) are held must be identified and documented.

Requirements for removing equipment and waste from the containment facility

17. Any waste (including biological material) that may harbour the approved organism(s), or heritable material from the approved organism, must be treated to ensure that the approved organism or any heritable material is killed prior to disposal.

18. Any equipment, that may harbour the approved organism(s) or heritable material from the approved organism, must be treated to ensure that the approved organism or any heritable material is killed prior to the equipment being used for another purpose or being removed from the containment facility.

Requirement for dealing with undesirable organisms

19. The containment facility must be secured and monitored to ensure the exclusion of undesirable organisms that might compromise the containment of the approved organism(s).

Requirements for instruction and training

20. Any person (including contractors, staff, students, visitors, and volunteers) entering the containment facility must have received sufficient instruction on the containment regime to enable the person to meet their responsibilities in relation to containment. Requirements for contingency plans

21. There must be a documented contingency plan for each approved organism held in the containment facility.

22. The contingency plan must be implemented immediately if there is any reason to believe that an approved organism has escaped or been released from the containment facility, or any other breach of containment has occurred.

Requirements for internal inspections and monitoring

23. To ensure containment is being achieved, containment measures must be: a. Inspected, monitored and reviewed, as appropriate b. Inspected as soon as possible after any event that could compromise the containment regime, such as an Act of God (such as flood, earthquake) or any unauthorised attempt to enter the containment facility.

24. Any remedial requirements identified under control 22, or by any other means, must be actioned as soon as possible.

Interpretation 25. In these controls, unless otherwise specified below, a word has the same meaning as it is defined in the HSNO Act (if any).

26. Unless the context otherwise requires:

Term Definition

approved New organisms approved under APP203503 (as described in Appendix 3) for organism development in containment for research and teaching purposes.

audit A systematic documented review or examination and evaluation of evidence to determine the extent to which specific criteria are fulfilled.

authorised Authorised persons are those identified in the containment facility person documentation as being allowed to be in the containment facility or any part thereof.

breach Escape of organism(s), unauthorised entry to the facility and/or the structural integrity of the facility being compromised.

containment Restricting an organism to a secure location or facility to prevent escape (section 2 of the HSNO Act).

containment A place approved by MPI in accordance with section 39 of the Biosecurity Act facility 1993, for holding approved organisms.

contingency A plan devised for a specific situation where things could go wrong, for plan example escape of an approved organism. It contains information, tasks and procedures that are necessary for timely decision-making and response to an unexpected event, or situation where the preferred plan fails.

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Term Definition controls Any obligations or restrictions imposed on any approved organism, or on any person in relation to any approved organism, by the HSNO Act, or any regulations, rules, codes, or other documents made in accordance with the provisions of this or any other Act for the purposes of controlling the adverse effects of that organism on people or the environment (section 2 of the HSNO Act). disposal The action or process of discarding or getting rid of something, including but not limited to burial, incineration, or placing in the general waste.

[Excludes the act of transferring to another containment facility under section 29 of the Biosecurity Act]. decontaminate Kill or remove all approved organisms and heritable material. documentation Written or electronic records (including manuals, lists, diagrams, maps, policies, procedures, plans and protocols, records of training, access).

EPA The Environmental Protection Authority. heritable (In relation to an approved organism) viable biological material, including material gametes and spores, arising from that organism that can, without human intervention, regenerate the organism or reproduce a new generation of the same species of the organism (section 2, HSNO Act).

HSNO Act Hazardous Substances and New Organisms Act 1996.

MPI Ministry for Primary Industries.

MPI Inspector A person appointed under the Biosecurity Act to undertake administering and enforcing the provisions of the Biosecurity Act. maintenance The process of maintaining (preserving or providing for the preservation of) or continuing a state of good repair. new organism Defined by section 2A of the HSNO Act

(a) an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998 (b) an organism belonging to a species, subspecies, infra-subspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation (c) an organism for which a containment approval has been given (ca) an organism for which a conditional release approval has been given under the HSNO Act (cb) a qualifying organism approved for release with controls (d) a genetically modified organism Term Definition

(e) an organism that belongs to a species, subspecies, infra-subspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

organism Defined in section 2 of the HSNO Act:

(a) Does not include a human being

(ab) Includes a human cell

(b) Includes a microorganism

(c) Includes a genetic structure, other than a human cell, that is capable of replicating itself, whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity

(d) Includes an entity (other than a human being) declare to be an organism for the purposes of the Biosecurity Act 1993

(e) Includes a reproductive cell or developmental stage of an organism. treat (with Kill all approved organisms and make heritable material non-viable. reference to waste) undesirable Organisms such as rodents, insects, and birds within the containment facility organism that could compromise containment (dependent on what organism is being contained). waste Unusable or unwanted substances or materials (including water, liquids, solids or air).

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