To obtain approval for new organisms in containment

Send to Environmental Protection Authority preferably by email ([email protected]) or alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany final application; see our fees and charges schedule for details.

To obtain approval for new organisms in containment

APPLICATION FORM Containment

www.epa.govt.nz

Application Number

Date

mailto:[email protected]

2

Application Form Approval for new organism in containment

December 2013 EPA0324

Completing this application form 1. This form has been approved under section 40 of the Hazardous Substances and New Organisms

(HSNO) Act 1996. It only covers importing, development (production, fermentation or

regeneration) or field test of any new organism (including genetically modified organisms (GMOs))

in containment. If you wish to make an application for another type of approval or for another

use (such as an emergency, special emergency or release), a different form will have to be used.

All forms are available on our website.

2. If your application is for a project approval for low-risk GMOs, please use the Containment – GMO

Project application form. Low risk genetic modification is defined in the HSNO (Low Risk Genetic

Modification) Regulations:

http://www.legislation.govt.nz/regulation/public/2003/0152/latest/DLM195215.html.

3. It is recommended that you contact an Advisor at the Environmental Protection Authority (EPA)

as early in the application process as possible. An Advisor can assist you with any questions you

have during the preparation of your application including providing advice on any consultation

requirements.

4. Unless otherwise indicated, all sections of this form must be completed for the application to be

formally received and assessed. If a section is not relevant to your application, please provide a

comprehensive explanation why this does not apply. If you choose not to provide the specific

information, you will need to apply for a waiver under section 59(3)(a)(ii) of the HSNO Act. This

can be done by completing the section on the last page of this form.

5. Any extra material that does not fit in the application form must be clearly labelled, cross-

referenced, and included with the application form when it is submitted.

6. Please add extra rows/tables where needed.

7. You must sign the final form (the EPA will accept electronically signed forms) and pay the

application fee (including GST) unless you are already an approved EPA customer. To be

recognised by the EPA as an “approved customer”, you must have submitted more than one

application per month over the preceding six months, and have no history of delay in making

payments, at the time of presenting an application.

8. Information about application fees is available on the EPA website.

9. All application communications from the EPA will be provided electronically, unless you

specifically request otherwise.

http://www.legislation.govt.nz/regulation/public/2003/0152/latest/DLM195215.html

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Commercially sensitive information 1. Commercially sensitive information must be included in an appendix to this form and be identified

as confidential. If you consider any information to be commercially sensitive, please show this in

the relevant section of this form and cross reference to where that information is located in the

confidential appendix.

2. Any information you supply to the EPA prior to formal lodgement of your application will not be

publicly released. Following formal lodgement of your application any information in the body of

this application form and any non-confidential appendices will become publicly available.

3. Once you have formally lodged your application with the EPA, any information you have supplied

to the EPA about your application is subject to the Official Information Act 1982 (OIA). If a request

is made for the release of information that you consider to be confidential, your view will be

considered in a manner consistent with the OIA and with section 57 of the HSNO Act. You may be

required to provide further justification for your claim of confidentiality.

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Definitions

Containment

Restricting an organism or substance to a secure location or facility to prevent

escape. In respect to genetically modified organisms, this includes field testing

and large scale fermentation

Controls

Any obligation or restrictions imposed on any new organism, or any person in

relation to any new organism, by the HSNO Act or any other Act or any

regulations, rules, codes, or other documents made in accordance with the

provisions of the HSNO Act or any other Act for the purposes of controlling the

adverse effects of that organism on people or the environment

Genetically Modified

Organism (GMO)

Any organism in which any of the genes or other genetic material:

Have been modified by in vitro techniques, or

Are inherited or otherwise derived, through any number of replications, from

any genes or other genetic material which has been modified by in vitro

techniques

New Organism

A new organism is an organism that is any of the following:

An organism belonging to a species that was not present in New Zealand

immediately before 29 July 1998;

An organism belonging to a species, subspecies, infrasubspecies, 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;

An organism for which a containment approval has been given under the

HSNO Act;

An organism for which a conditional release approval has been given under

the HSNO Act;

A qualifying organism approved for release with controls under the HSNO Act;

A genetically modified organism;

An organism belonging to a species, subspecies, infrasubspecies, variety,

strain, or cultivar that has been eradicated from New Zealand;

An organism present in New Zealand before 29 July 1998 in contravention of

the Animals Act 1967 or the Plants Act 1970. This does not apply to the

organism known as rabbit haemorrhagic disease virus, or rabbit calicivirus

A new organism does not cease to be a new organism because:

It is subject to a conditional release approval; or

It is a qualifying organism approved for release with controls; or

It is an incidentally imported new organism

Project An individual or collaborative endeavour that is planned to achieve a particular

aim or research goal

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1. Applicant details

1.1. Applicant

Company Name AgResearch Limited

Contact Name Richard Scott

Job Title Science Team Leader - Plant Biotechnology

Physical Address Dairy Farm Road, Tennent Drive, Palmerston North 4442

Postal Address

(provide only if not the same as the physical)

Phone (office and/or mobile) 06 351 8238 or 021 255 7062

Email [email protected]

1.2. New Zealand agent or consultant (if applicable)

N/A

2. Information about the application

2.1. Type of containment activity Tick the box(es) that best describe your application

Application type Type of new organism

Import into containment

GMO

Non-GMO

Develop in containment i.e. regeneration,

fermentation or genetic modification

GMO

Non-GMO

Field test in containment

GMO

Non-GMO

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2.2. Brief application description

Approximately 30 words about what you are applying to do

For the importation into containment of low risk genetically modified plant material to enable research and

development of new knowledge, practices and products relevant to primary production systems.

2.3. Summary of application

Provide a plain English, non-technical description of what you are applying to do and why you want to do it

AgResearch has strong industry linkages and supports New Zealand's pastoral industry to address

environmental impacts of pastoral farming, and provide solutions to combat pests, diseases and weeds,

and develop conventional forage cultivars and endophytes. Research programmes at AgResearch use

multiple technologies as tools to understand many aspects of how agricultural systems interact

(e.g. soil-plant and rumen microflora-livestock interactions). Studies in these areas are sometimes

supported through the use of transgenic plant systems containing genes and other nucleic acid sequences

in our species of interest, including model species.

The low risk plant material imported on this permit will be used to undertake research into:

plant development, plant architecture, plant metabolism, plant physiology, animal nutrition (in vitro

analyses only), floral regulation, plant-pathogen interactions, symbiotic relationships, gene regulation,

etc. This work will lead to the construction of novel tools and enable the development of new products

designed to deliver positive outcomes for NZ on the social, environmental and economic levels.

The list of potential host plant species and genetic elements for integration, and their subsequent

combinations, is broad but they all fall within the 'low risk' category of the HSNO Act. AgResearch has

previously filed a GM Development application (GMD09017) with a similar range of organisms and genes.

2.4. Background and aims of application

This section is intended to put the new organism(s) in perspective of the wider activities that they will be used in. You may use more technical language but all technical words must be included in a glossary.

The ability to import genetically modified organisms will help researchers to determine how very specific

individual components can influence highly complex systems. This research is designed to generate and

apply knowledge of processes involved in:

1. Growth, metabolism, differentiation and development;

2. Biological responses to environmental and chemical stress;

3. Host-pathogen and host-commensal interactions; and

4. The causation of disease.

The organisms to be imported will have been genetically modified prior to their importation. In many cases

the genetic manipulation of the organisms will have involved the complete sequence of a gene or group of

genes from one species being introduced into the same or a different host species, to enable changes in

the biology or biochemistry of the recipient host to be correlated with the function of the transferred gene.

In some cases nucleic acid sequences may have been introduced into a host to investigate function by

inactivating or activating genes within that host. In other cases the genetic modification may have involved

7



expression of proteins by modified organisms to determine their localisation within an organism and their

function, and to allow isolation and biochemical characterisation of the recombinant proteins. In other

cases, "reporter" genes may have been introduced into a host in order to allow the behaviour of the host

or expression of a gene within it to be monitored by various techniques that detect expression of the

reporter gene. The broad nature of studies to be undertaken using the imported organisms requires

approval to import a wide range of genetically modified organisms containing a variety of genes from the

same or different organisms, and/or with mutations in particular genes. However, in all cases the organisms

will have been defined at an appropriate taxonomic level and the organisms and modifications will have

been designated as low-risk.

Any further genetic modification of the organisms once imported would be carried out under a

development in containment approval (e.g. GMD09017, which is closely aligned to this application). The

imported genetically modified organisms will not have been modified in such a way that the organism will

have an increased ability to escape containment or survive in the natural environment outside of the

laboratory compared to the unmodified organism from which it was derived, and will not have increased

pathogenicity to humans, animals or plants.

3. Information about the new organism(s)

3.1. Name of organism

Non-GMOs - Provide a taxonomic description of the new organism(s). GMOs – Provide a taxonomic description of the host organism(s) and describe the genetic modification. Both -

Describe the biology and main features of the organism including if it has inseparable organisms.

Describe if the organism has affinities (e.g. close taxonomic relationships) with other organisms in New Zealand.

Could the organism form an undesirable self-sustaining population? If not, why not?

How easily could the new organism be recovered or eradicated if it established an undesirable self-sustaining population?

Taxonomic description of the host organism

Plants (most are also listed in GMD09017)

Unless stated otherwise, any strain/variety/cultivar of the plant listed may be imported.

Simplified list of host organisms

Scientific name (Latin binomial) Common name

Agrostis stolonifera Creeping bent grass

Arabidopsis thaliana Arabidopsis, mouse-ear cress

Brachypodium distachyon Grasses

Brassica nigra

Brassica oleracea Cabbage

Brassica rapa

Camelina sativa Camelina, false flax

Carthamus tinctorius Safflower

Festuca arundinacea Tall fescue

Glycine max Soybean

Glycine soja Wild soybean (China)

Helianthus annuus Sunflower

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Hordeum vulgare Barley

Lolium multiflorum Italian ryegrass

Lolium perenne Perennial ryegrass

Lolium temulentum Darnel

Lotus corniculatus Bird's-foot trefoil

Lotus japonicus Japanese common name: Miyakogusa.

Lupinus angustifolius Narrowleaf lupine

Lycopersicon esculentum Tomato

Medicago sativa Alfalfa

Medicago truncatula Barrel medic, Barrel clover

Musa genus Banana

Nicotiana benthamiana

Nicotiana tabacum Tobacco

Oryza sativa Rice

Paspalum vaginatum Seashore paspalum

Petunia hybrida Petunia

Pisum sativum Pea

Poa annua Annual bluegrass

Poa pratensis Kentucky bluegrass

Sesame indicum Sesame

Sesame orientale Black sesame

Solanum tuberosum Potato

Trifolium arvense Rabbitsfoot clover

Trifolium occidentale Eastern clover

Trifolium pratense Red clover

Trifolium repens White clover

Trifolium semipilosum Kenya white clover

Triticum aestivum Wheat

Triticum durum Durum wheat

Zea mays Corn

Latin binomial Including full taxonomic authority

Brachypodium distachyon (L.) P. Beauv. Essai d'une nouvelle Agrostographie (1812)

Common name(s) If any Grasses

Taxonomic class, order and family

Kingdom Plantae Plants

Subkingdom Tracheobionta Vascular plants

Superdivision Spermatophyta Seed plants

Division Magnoliophyta Angiosperms

Class Liliopsida Monocots

Subclass Commelinidae

Order Cyperales

Family Poaceae Grass family

Genus Brachypodium False brome

Species distachyon Purple false brome

Latin binomial Lolium perenne L. Species Plantarum 2 (1753)

Common name(s) Perennial ryegrass

Taxonomy Kingdom Plantae Plants






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Order Cyperales


Genus Lolium Ryegrass

Species perenne Perennial ryegrass

Latin binomial Lolium multiflorum Lam. (Guss.) -- Fl. Sic. Syn. i. 58. (Lam.) -- Flore Francoise 1805

Common name(s) Italian ryegrass







Order Cyperales


Genus Lolium Ryegrass

Species multiflorum Italian ryegrass

Latin binomial Lolium temulentum L. Species Plantarum 2 (1753)

Common name(s) Darnel







Order Cyperales


Genus Lolium

Species temulentum Darnel

Latin binomial Festuca arundinacea Schreb. Spicilegium Florae Lipsicae (1771)

Common name(s) Tall fescue







Order Cyperales


Genus Festuca Fescue

Species arundinacea Tall fescue

Latin binomial Poa annua L. Species Plantarum 2 (1753)

Common name(s) Annual bluegrass







Order Cyperales


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Genus Poa

Species annua Annual bluegrass

Latin binomial Poa pratensis L. Species Plantarum 2 (1753)

Common name(s) Kentucky bluegrass







Order Cyperales


Genus Poa

Species pratensis Kentucky bluegrass

Latin binomial Agrostis stolonifera L. Species Plantarum 2 (1753)

Common name(s) Creeping bent grass







Order Cyperales


Genus Agrostis

Species stolonifera Creeping bent grass

Latin binomial Paspalum vaginatum Sw. Prodr. (Swartz) 21. (1788) Nova Genera & Species Plantarum seu Prodromus

Common name(s) Seashore paspalum







Order Cyperales


Genus Paspalum

Species vaginatum Seashore paspalum

Latin binomial Triticum aestivum L. Species Plantarum 2 (1753)

Common name(s) Wheat







Order Cyperales


Genus Triticum

Species aestivum Wheat

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Latin binomial Triticum durum Desf. Fl. Atlant. 1: 114. (1798)

Common name(s) Durum wheat







Order Cyperales


Genus Triticum

Species durum Durum wheat

Latin binomial Hordeum vulgare L. Species Plantarum 2 (1753)

Common name(s) Barley







Order Cyperales


Genus Hordeum

Species vulgare Barley

Latin binomial Trifolium repens L. Species Plantarum 2 (1753)

Common name(s) White clover





Class Magnoliopsida Dicots

Subclass Rosidae

Order Fabales

Family Fabaceae Pea family

Genus Trifolium

Species repens White clover

Latin binomial Trifolium arvense L. Species Plantarum 2 (1753)

Common name(s) Rabbitsfoot clover






Subclass Rosidae

Order Fabales


Genus Trifolium

Species arvense Rabbitsfoot clover

Latin binomial Trifolium occidentale Coombe Watsonia 5: 70. (1961)

Common name(s) Eastern clover

12








Subclass Rosidae

Order Fabales


Genus Trifolium

Species occidentale Eastern clover

Latin binomial Trifolium pratense L. Species Plantarum 2 (1753)

Common name(s) Red clover






Subclass Rosidae

Order Fabales


Genus Trifolium

Species pratense Red clover

Latin binomial Trifolium semipilosum Fresen. Flora 22(1): 52 (1839)

Common name(s) Kenya white clover






Subclass Rosidae

Order Fabales


Genus Trifolium

Species semipolosum Kenya white clover

Latin binomial Medicago sativa L. Species Plantarum 2 (1753)

Common name(s) Alfalfa






Subclass Rosidae

Order Fabales


Genus Medicago Alfalfa

Species sativa Alfalfa

Latin binomial Medicago truncatula Gaertn. De Fructibus et Seminibus Plantarum 2 (1791)

Common name(s) Barrel medic, Barrel clover




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Subclass Rosidae

Order Fabales


Genus Medicago Alfalfa

Species truncatula Barrel medic, Barrel clover

Latin binomial Lupinus angustifolius L. Species Plantarum 2 (1753)

Common name(s) Narrowleaf lupine






Subclass Rosidae

Order Fabales


Genus Lupinus

Species angustifolius Narrowleaf lupine

Latin binomial Lotus corniculatus L. Species Plantarum 2 (1753)

Common name(s) Bird's-foot trefoil






Subclass Rosidae

Order Fabales


Genus Lotus Trefoil

Species corniculatus Bird's-foot trefoil

Latin binomial Lotus japonicus (Regel) K.Larsen Bot. Tidsskr. lii. 13 (1955)

Common name(s) Japanese common name: Miyakogusa.






Subclass Rosidae

Order Fabales


Genus Lotus L. Trefoil

Species japonicus (

Latin binomial Pisum sativum L. Species Plantarum 2 (1753)

Common name(s) Pea






Subclass Rosidae

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Order Fabales


Genus Pisum

Species sativum Pea

Latin binomial Glycine max (L.) Merr. Interpr. Herb. Amboin. 274. (1917)

Common name(s) Soybean



Phylum Streptophyta




Subclass Rosidae

Order Fabales


Subfamily Papilionoideae

Tribe Phaseoleae

Genus Glycine Wild soybean

Species max Soybean

Latin binomial Glycine soja Siebold & Zucc. Abh. Akad. Muench. iv. II. (1843) 119.

Common name(s) Wild soybean (China)



Phylum Streptophyta




Subclass Rosidae

Order Fabales


Subfamily Papilionoideae

Tribe Phaseoleae

Genus Glycine Wild soybean

Species soja Wild soybean (China)

Latin binomial Sesame indicum Species Plantarum 2 (1753)

Common name(s) Sesame






Subclass Asteridae

Order Scrophulariales

Family Pedaliaceae Sesame family

Genus Sesamum Sesame

Species indicum Sesame

Latin binomial Sesame orientale Species Plantarum 2 (1753)

Common name(s) Black sesame




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Subclass Asteridae

Order Scrophulariales

Family Pedaliaceae Sesame family

Genus Sesamum Sesame

Species orientale Black sesame

Latin binomial Helianthus annuus L. Species Plantarum 2 (1753)

Common name(s) Sunflower






Subclass Asteridae

Order Asterales

Family Asteraceae Aster family

Genus Helianthus

Species annuus Common sunflower

Latin binomial Carthamus tinctorius L. Species Plantarum 2 (1753)

Common name(s) Safflower






Subclass Asteridae

Order Asterales

Family Asteraceae Aster family

Genus Carthamus Distaff thistle

Species tinctorius Safflower

Latin binomial Lycopersicon esculentum Mill. The Gardeners Dictionary, ed. 8. [820] (1768)

Common name(s) Tomato






Subclass Asteridae

Order Solanales

Family Solanaceae Nightshades

Genus Lycopersicon Tomato

Species esculentum Garden tomato

Latin binomial Solanum tuberosum L. Species Plantarum 2 (1753)

Common name(s) Potato






Subclass Asteridae

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Order Solanales


Genus Solanum

Species tuberosum Potato

Latin binomial Petunia hybrida hort. Ex E. Vilm. Ann. Mus. Natl. Hist. Nat. 2: 215. (1803)

Common name(s) Petunia






Subclass Asteridae

Order Solanales


Genus Petunia Petunia

Species hybrida

Latin binomial Nicotiana tabacum L. Species Plantarum 2 (1753)

Common name(s) Tobacco



Superdivision Magnoliophyta Seed plants

Division Magnoliopsida Angiosperms

Class Asteridae Dicots

Subclass Solanales

Order Solanaceae Nightshades

Family Nicotianoideae

Genus Nicotiana Tobacco

Species tabacum Cultivated tobacco

Latin binomial Nicotiana benthamiana Domin. Bibliotheca Botanica Heft 89, 591 (1929)

Common name(s)






Subclass Solanales

Order Solanaceae Nightshades

Family Nicotianoideae

Genus Nicotiana Tobacco

Species benthamiana Wild tobacco species endemic to Australia

Latin binomial Brassica oleracea L. Species Plantarum 2 (1753)

Common name(s) Cabbage






Subclass Solanales

Order Capparales

Family Brassicaceae Mustards

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Genus Brassica Annual mustard spp.

Species oleracea Cabbage

Latin binomial Brassica nigra (L.) W.D.J. Koch W.D.J. Koch. J.C. Röhlings Deutschlands Flora ed. 3, 4 (1833)

Common name(s) Black mustard






Subclass Dilleniidae

Order Capparales



Species nigra Black mustard, Shortpod mustard

Latin binomial Brassica rapa L. Species Plantarum 2 (1753)

Common name(s) Bird's rape, Birdsrape mustard, Field mustard, Rape, Rape mustard, Turnip rape, Wild mustard, Wild rutabaga, Wild turnip







Order Capparales



Species rapa

Latin binomial Arabidopsis thaliana (L.) Heynh. Flora von Sachsen 2 (1842)

Common name(s) Arabidopsis, mouse-ear cress







Order Capparales


Genus Arabidopsis Rockcress

Species thaliana Mouse-ear cress

Latin binomial Zea mays

Common name(s) Corn

Kingdom Plantae Plants

Subkingdom Viridiplantae Green plants

Division Tracheophyta Vascular plants

Class Magnoliopsida

Order Poales

Family Poaceae Grasses

Genus Zea Corn

Species mays L.

Latin binomial Oryza sativa

Common name(s) Rice

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Subkingdom Viridiplantae Green plants

Division Tracheophyta Vascular plants

Class Magnoliopsida

Order Poales

Family Poaceae Grasses

Genus Oryza Rice

Species sativa L.

Latin binomial Camelina sativa

Common name(s) Camelina, false flax







Order Capparales Angiosperms


Genus Camelina

Species sativa (L.)

Latin binomial Musa genus (gm only)

Common name(s) Banana





Class Liliopsida Monocotyledons

Subclass Zingiberidae

Order Zingiberales

Family Musaceae Banana family

Genus Musa L. Banana

Genetic modification

Plants will have been modified by, or be the parents or descendant of plants modified by, the introduction

or targeted modification of nucleic acid sequences (DNA or RNA). The introduction, deletion or

modification may have been achieved using plasmid or bacteriophage-based cloning, genome-editing

technologies, in vitro synthesis of DNA, or by using purified nucleic acids with or without an origin of

replication that functions in the host organism, or by using viral or transposon-based vectors, including

replication-defective viral vectors such as lentiviral vectors, adenoviral vectors, and adeno-associated viral

(AAV) vectors; and replicative viral vectors (including baculovirus-based vectors).

The donor genetic material will be modified or non-modified non-coding nucleic acid and/or nucleic acid

sequences that may be genes, parts of genes, gene regulatory elements, transposons,

transposable elements, and code for reporters, selectable markers, epitopes, synthetic peptides,

polypeptides, proteins, etc; and may have been sourced from plant, animal (including protozoa,

zooplankton and phytoplankton), human, insect, bacterial, archael, fungal (including yeasts), viral

or synthetic sources.

Genetic material that may have been introduced may have included wild-type genes and mutants thereof

(e.g. deletion, substitution and chimeric mutant genes). The genetic modifications may have included

insertions, deletions and point mutations and may have included short sequences derived from

microorganisms capable of causing disease in plants. Such sequences include promoters from Cauliflower

19



Mosaic Virus and borders and regulatory sequences from Agrobacterium tumefaciens or Agrobacterium

rhizogenes (i.e. left and right border sequences required for the transfer of DNA into plant cells; promoters

and three-prime non-coding sequences derived from Ti or Ri plasmid genes). In each case the genetic

material will have been well characterized and was not expected to increase the pathogenicity of the

modified organism.

Vectors may have contained regulatory elements including promoters, regulatory element binding sites,

transcriptional activators, enhancers, terminators, multiple cloning sites, site directed recombination

sequences, T-DNA border sequences; silencing elements; and origins of replication. The vectors may also

have contained selectable marker genes; reporter genes; antibiotic resistance genes; transposons,

recombination sequences and recombinases; retrotransposons or other transposable elements, protein

targeting, localisation and secretory signals; internal ribosomal entry sites; solubility enhancement tags;

protein purification tags, and affinity tags including epitope tags. Modifications may include the expression

of multiple transgenes

Modifications of plants to be imported will not involve:

o The production of infectious particles normally able to cause disease in humans, animals, plants, or

fungi;

o Genes that encode for vertebrate toxins with an LD50 < 100 pg/kg;

o Genetic material derived from Māori;

o Genetic material derived from New Zealand native or taonga flora and fauna;

o Genetic material from species listed by the Convention on Intonational Trade in Endangered Species

(CITES) unless appropriate permission has been gained;

o Uncharacterised sequences from pathogenic microorganisms;

o Modifications that increase the pathogenicity, virulence, or infectivity of the host organism to

laboratory personnel, the community, or the environment;

o Modifications that result in the GMO having a greater ability to escape from containment than the

unmodified host organism;

Summary

Each of the genetically modified organisms to be imported will meet the criteria for a low-risk genetic

modification specified under section 41 of the Act, being the Hazardous Substances and New Organisms

(Low-Risk Genetic Modification) Regulations 1998, in that the organisms will not be more pathogenic,

virulent or infectious than the host organism and will not have a greater ability to escape from containment

than the host organism. All organisms imported will be received into, and maintained within, an MPI-

registered containment facility.

Describe the biology and main features of the organism including if it has inseparable organisms.

While there is no simple way to describe all of the biology and main features of the listed organisms, all of

the organisms listed are plants. These plants are not known to contain inseparable organisms.

20



Describe if the organism has affinities (e.g. close taxonomic relationships) with other organisms in New

Zealand.

Some of the plants listed will have close taxonomic relationships with other plants in New Zealand.

However as the plants will be held in containment, no exposure of the imported plants to related plants in

New Zealand will occur.

Could the organism form an undesirable self-sustaining population? If not, why not?

The GM lines will not possess a phenotype that enhances their ability to establish any more than a wild-

type form of the species.

How easily could the new organism be recovered or eradicated if it established an undesirable self-

sustaining population?

Should a population become established within the vicinity of the containment facility, then a customised

eradication programme can be expected to be effective.

3.2. Regulatory status of the organism

Is the organism that is the subject of this application also the subject of:

An innovative medicine application as defined in section 23A of the Medicines Act 1981?

Yes No

An innovative agricultural compound application as defined in Part 6 of the Agricultural Compounds and

Veterinary Medicines Act 1997?

Yes No

4. Information about the containment

4.1. For field tests: The nature and method of the field test

Describe the nature and method of the field test and the experimental procedures to be used

N/A

21



4.2. Proposed containment of the new organism(s) (physical and operational)

Describe how you propose to contain the new organism(s) after taking into account its ability to escape from containment (i.e. the possible pathways for escape).

Material will be imported into the appropriate registered Containment Facilities and will be used for

research under appropriate Approvals.

Plant cell/tissue cultures (Laboratories)

All experiments will be conducted using PC2 or higher conditions. All staff that will work on the project

will be qualified to work under PC2 or higher conditions.

Whole plants (Planthouses)

All planthouse experiments will be conducted using PC2 conditions. All staff that will work on the

project will be qualified to work with whole plants under PC2 conditions. All seed material will be

securely stored; and any plants (or plant materials) that have been in the Planthouses will be destroyed

by a MPI-approved method when the experiment(s) are completed.

Plants that have not flowered and therefore are not producing pollen or seed, and that have not been

growing in the presence of plants that have flowered, may be transferred to a microbiological

laboratory (under double containment) that is part of the containment facility for experimental work.

Following such work, they will either be destroyed or returned to the Planthouse. Such plants will

therefore pose no risk of escape.

Access to the Planthouses is restricted to authorised persons trained in the particular protocols

required for working with the specific type of genetically modified plants in the relevant containment

facilities.

Procedures to manage plants within the facility are detailed in the relevant facility manuals. These

include procedures to prevent pollen or seed escaping from the plant house and to prevent

unauthorized removal of the plants.

Plant material will not be imported under this Approval if it is known or suspected to have improved

survival characteristics outside of the laboratory compared to the unmodified host material.

Therefore the modifications will not make the modified host plants any more likely to escape

containment or to survive outside of containment than the unmodified host organism.

Details and protocols for handling imported material, when it is received into the facility, can be found

in AgResearch's Plant Molecular Genetics Facility's Transitional And Containment Facility Manual,

which is audited by MPI and required to operate the Facility.

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5. Māori engagement

Discuss any engagement or consultation with Māori undertaken and summarise the outcomes.

Please refer to the EPA policy ‘Engaging with Māori for applications to the EPA’ on our website (www.epa.govt.nz) or contact

the EPA for advice.

The scope of any research for which imported material will be used, falls within the relevant Approvals and

is for research only in containment. It is expected that, where appropriate, engagement and consultation

with Māori was undertaken in order to obtain those Approvals. As these importations will not involve

native or taonga flora or fauna, as providers of genetic material or hosts, and the material will be maintained

in containment, it is considered that Māori engagement is not required for this Application.

6. Risks, costs and benefits

Provide information of the risks, costs and benefits of the new organism(s).

These are the positive and adverse effects referred to in the HSNO Act. It is easier to regard risks and costs as being adverse

(or negative) and benefits as being positive. In considering risks, cost and benefits, it is important to look at both the likelihood

of occurrence (probability) and the potential magnitude of the consequences, and to look at distribution effects (who bears

the costs, benefits and risks).

Consider the adverse or positive effects in the context of this application on the environment (e.g. could the organism cause

any significant displacement of any native species within its natural habitat, cause any significant deterioration of natural

habitats or cause significant adverse effect to New Zealand’s inherent genetic diversity, or is the organism likely to cause

disease, be parasitic, or become a vector for animal or plant disease?), human health and safety, the relationship of Māori to

the environment, the principles of the Treaty of Waitangi, society and the community, the market economy and New Zealand’s

international obligations.

You must fully complete this section referencing supporting material. You will need to provide a description of where the

information in the application has been sourced from (e.g. from in-house research, independent research, technical literature,

community or other consultation), and provide that information with this application.

Risks

Employees

Risks.

o Working with these organisms in containment may lead to issues with:

Human health and safety.

Mitigation.

o Access to the containment facility where these plants will be maintained is restricted to authorised

persons trained in the particular protocols required for working with the specific type of plants in

containment in the relevant facility.

o In the unlikely event of an incident or accident, directly related to the modified plant, that may

affect the health and safety of those people working with the plants, then this type of effect should

be identified as part of the operational guidelines of the facility and the associated institute. It is

expected that EPA and MPI will be notified should this occur.

o The specific combination of the host and the nature of the genetic changes, as listed above in

Section 3, is not expected to result in plants or material that will result in increased risk to human

health and safety above those that would typically be raised by the non-modified parent plant.

o Therefore, we consider that MITIGATION IS STRONG.

http://www.epa.govt.nz/

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The likelihood that the mitigated risk will occur is HIGHLY UNLIKELY.

If the mitigated risk occurs we predicted that it will have a MINOR impact on the health and safety of

those working with the material.

Overall - MODERATE RISK.

Public

Risks

o Release from containment may lead to issues with:

Human health and safety. Relationship of Māori to the environment. Principles of the Treaty of Waitangi. Society and the community. Market economy. New Zealand’s international obligations.

Mitigation.

o The genetically modified plants described in this application will be maintained in approved

containment facilities. The containment procedures adopted will ensure that there is negligible risk

of exposure of these groups to the organisms.

o Access to the containment facility where these plants will be maintained is restricted to authorised

persons trained in the particular protocols required for working with the specific type of plants in

containment in the relevant Facility.

o In the unlikely event of an incident or accident that may lead to the inadvertent release of a

modified plant or restricted plant material, then specific contingency plans are described in the

relevant Facility Manual.

o Due to the combination of the normal host range and the nature of the genetic changes, we see

these modified plants as being unlikely to be capable of negatively impacting on human health and

wellbeing.

o No adverse effects of specific importance to Māori have been identified.

o The host:modification combinations are not predicted to be capable of forming large self-sustaining

population that would threaten any commercial, domestic or native species; nor would it form a

population that could not be eliminated using current control methods.

o Therefore, we consider that MITIGATION IS STRONG.


If the mitigated risk occurs we predicted that it will have a MINOR impact on health, te ao Māori,

society, commercial activity - including domestic and international markets, or New Zealand’s

international obligations.

Overall - LOW RISK.

Environment

Risks.

o Release from containment may lead to:

Significant displacement of any native species within its natural habitat. Any significant deterioration of natural habitats.

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Significant adverse effect to New Zealand’s inherent genetic diversity. Likely to cause disease, be parasitic, or become a vector for animal or plant disease.

Mitigation.

o The genetically modified plants described in this application will be maintained in approved

containment facilities for plants in accordance with the relevant Facility manual. Access to the

Facility is restricted to authorised persons trained in the particular protocols required for working

with the specific type of plants in containment in the relevant Facility.

o In the unlikely event of an incident or accident that may lead to the inadvertent release of a

modified plant or restricted plant material, then specific contingency plans are described in the

relevant Facility Manual.

o Due to the combination of the normal host range and the nature of the genetic changes, we see

these modified plants as being unlikely to be capable of forming large self-sustaining population

that would threaten any commercial, domestic or native species; nor would it form a population

that could not be eliminated using current control methods. Establishment from tissue culture is

impossible without human intervention.

o There will be no risk to the environment while the organisms are held in containment.

o Therefore we consider that MITIGATION IS STRONG.


If the mitigated risk occurs we predicted that it will have a MINOR impact on New Zealand ecosystems.

Overall - LOW RISK.

Distribution of effects (What/Who bears the risks, costs and benefits?).

The primary risk is in maintaining containment and lies with the institutes operating the containment

facilities.

The initial cost will be borne by the institutes maintaining and operating the containment facilities. In

the highly unlikely event that the modified plants are inadvertently released from containment then

monitoring and control would be expected to be met by the institutes operating the containment

facilities. Should subsequent extensive monitoring and control be required then costs may begin to

affect society and industries.

The benefits will be:

o The importation of these genetically modified organisms will assist research programmes to either

provide fundamental information or lead to economic, health and well-being benefits for New

Zealanders through the development of new knowledge, practices and products that can be applied

to agricultural systems.

o This approval will allow ongoing gains in world-class scientific research across the wider New

Zealand research community, which will bring a variety of long-term benefits to New Zealand. New

Zealand scientists will also be able to continue to participate in international research programmes,

and further develop international research collaborations.

o Research undertaken using the modified organisms is likely to generate knowledge that will have

significant direct and/or indirect beneficial effects on people's health, wellbeing, and society.

o Research undertaken using the modified organisms may generate benefits for the environment in

the longer term.

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7. Alternative methods and potential effects from the transfer of genetic elements

This section is for developments of GMOs that take place outdoors and field tests of GMOs only

Discuss if there are alternative methods of achieving the research objective. Discuss whether there could be effects resulting from the transfer of genetic elements to other organisms in or around the site of the development or field test.

N/A

8. Pathway determination and rapid assessment This section is for the imports of GMOs only

Under section 42B of the HSNO Act your application may be eligible for a rapid assessment. The pathway for your application will be determined after its formal receipt, based on the data provided in this application form. If you would like your application to be considered for rapid assessment (as per the criteria below), we require you to complete this section.

8.1. Discuss whether the GMO(s) to be imported fulfil the criteria

The criteria are:

The host organism(s) are Category 1 or 2 host organisms as per the HSNO (Low Risk Genetic Modification) Regulations.

The genetic modifications are Category A or B modifications as per the HSNO (Low Risk Genetic Modification) Regulations and the modifications are not listed in the Schedule of these Regulations.

The minimum containment of the GMO(s) will be as per the HSNO (Low Risk Genetic Modification) Regulations (PC1 or PC2 as per AS/NZS2243.3:2002).

The host organism(s) are Category 1 or 2 host organisms as per the HSNO (Low Risk Genetic Modification)

Regulations.

The hosts listed in this application are considered to be Category 1 or Category 2 host organisms under

Section 7 of Hazardous Substances and New Organisms (Low-Risk Genetic Modification)

Regulations (2003).

The genetic modifications are Category A or B modifications as per the HSNO (Low Risk Genetic

Modification) Regulations and the modifications are not listed in the Schedule of these Regulations.

The genetic modifications listed in this application are considered to be Category A modifications under

Section 5 of Hazardous Substances and New Organisms (Low-Risk Genetic Modification)

Regulations (2003).

The minimum containment of the GMO(s) will be as per the HSNO (Low Risk Genetic Modification)

Regulations (PC1 or PC2 as per AS/NZS2243.3:2002).

The modified plants covered by this application will be maintained in a PC1 or PC2 facility operating to

Safety in Laboratories - Microbiological aspects and containment facilities, AS/NZS 2243.3 2002 (Standards

New Zealand).

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9. Other information

Add here any further information you wish to include in this application including if there are any ethical considerations that you are aware of in relation to your application.

10. Checklist This checklist is to be completed by the applicant

Application Comments/justifications

All sections of the application form completed

or you have requested an information waiver

under section 59 of the HSNO Act

Yes No

(If No, please discuss with an

Advisor to enable your

application to be further

processed)

Confidential data as part of a separate,

identified appendix

Yes No

Supplementary optional information attached:

Copies of additional references Yes No

Relevant correspondence Yes No

Administration

Are you an approved EPA customer? Yes No

If Yes are you an:

Applicant:

Agent:

If you are not an approved customer,

payment of fee will be by:

Direct credit made to the EPA bank

account (preferred method of payment)

Date of direct credit:

Cheque for application fee enclosed

Yes No

Payment to follow

Yes No

Payment to follow

Electronic, signed copy of application e-

mailed to the EPA

Yes

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Signature of applicant or person authorised to sign on behalf of applicant

I am making this application, or am authorised to sign on behalf of the applicant or applicant

organisation.

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.

04 October 2019

Signature Date

Request for information waiver under section 59 of the HSNO Act

I request for the Authority to waive any legislative information requirements (i.e. concerning the

information that has been supplied in my application) that my application does not meet (tick if

applicable).

Please list below which section(s) of this form are relevant to the information waiver request:

Appendices and referenced material (if any) and glossary (if required)

Glossary

To obtain approval for new organisms in containment

Documents

Transcript of To obtain approval for new organisms in containment