decision - epa.govt.nz

DECISION

Amended under section 67A 20 October 2012

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Date 20 October 2011

Application Code APP201030, APP201031, APP201032 and APP201033

Application Type Develop in Containment any New Organism under section 40(1)

of the Hazardous Substances and New Organisms Act 1996.

Applicant University of Otago

Date Application Received 22 September 2011

Consideration Date 6 October 2011

Considered by Environmental Protection Authority (EPA)

Purpose of the Applications To develop and hold in containment organisms for laboratory

based research and educational purposes

1. Summary of Decision

1.1. The role of the Environmental Protection Authority (EPA) is to protect the environment, and the health

and safety of people and communities, by preventing or managing the adverse effects of hazardous

substances and new organisms.

1.2. The applications were considered in accordance with the Hazardous Substances and New Organisms

Act 1996 (the HSNO Act) and the Hazardous Substances and New Organisms (Methodology) Order

1998. Unless otherwise specified, references to sections in this decision refer to sections of the Act,

and references to clauses refer to clauses of the Methodology.

1.3. After considering all the evidence, the EPA has approved, with controls (set out in Appendix 1), the

four applications to develop in containment organisms for laboratory based research and educational

purposes.

1.4. To ensure that these organisms remain securely contained, the EPA has imposed physical and

procedural controls that must be followed. The list of these controls is provided in Appendix 1 of this

decision.

1.5. The approved organisms and modifications are described in Table 1 of this decision.

1.6. This approval is part of a trial to observe the effectiveness of a new compliance system, which

involves the production of a Containment Manual by the approval holder that addresses how they

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APP201030, APP201031, APP201032 and APP201033

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comply with the controls on this approval. Ongoing evaluation will be completed over the following 12

months to determine success. Hence this approval expires one calendar year after the decision has

been signed (Control 1).

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2. The Applications

Description of the organisms to be developed

2.1. The organisms approved for development are the genetically modified organisms described in Table

1.

Table 1: Organisms as recorded on EPA Register

Host organism Modified by:

Microorganisms:

Categorised as Risk Group 1

Prokaryotes (bacteria, archaea, and

cyanobacteria)

Bacteriophage lambda (ICTVapproved name is

Enterobacteria phage λ), non pathogenic

laboratory strains

Micro-eukaryotes (algae, fungi, phytoplankton,

zoo plankton, protozoa, and micro-invertebrates)

Human cell lines:

Homo sapiens Linnaeus, 1758 Insect cell lines:

Spodoptera frugiperda Smith & Abbot 1797

Drosophila melanogaster Meigen, 1830

Trichoplusia ni Hubner 1802

Bombyx mori Linnaeus, 1758

Aedes aegypti Linnaeus, 1762

Apis mellifera Linnaeus, 1758

Bombus sp. Latreille, 1802

Acyrthosiphon pisum Harris M, 1776

Mammalian cell lines:

Mus musculus Linnaeus, 1758

Mus spretus Lataste, 1883

Rattus rattus Linnaeus, 1758

Rattus norvegicus Berkenhout 1759

Chlorocebus aethiops Linnaeus 1758

Ovis aries Linnaeus 1758

Bos taurus Linnaeus 1758

Standard commercially available non-self transmissible

cloning and expression vectors.

Vectors will include standard and commercially available

promoters and other gene regulatory elements, reporter

and selectable marker genes, protein purification tags

and origins of replication.

Donor genetic material will be derived from the

Kingdoms Animalia, Planta, Fungi, Protista, Monera,

viruses and viroids and will consist of coding, non-coding

and regulatory regions of genes, and RNA interference-

inducing sequences for the purpose of understanding

gene function.

Libraries may also be created from native genomic or

complementary DNA from the Kingdoms Animalia,

Plantae, Fungi, Protista and Monera and viruses and

viroids.

The range of modifications and genetic material involved

are subject to the following exclusions;

(a) the modification will not—

(i) result in a genetically modified organism that is

more pathogenic, virulent, or infectious to

laboratory personnel, the community, or the

environment;

(ii) Intentionally produce infectious particles (except for bacteriophage).

(iii) result in the genetically modified organism having a greater ability to escape from containment than the unmodified host organism.

Further restrictions to the range of modifications are outlined in Additional Control 25, Appendix 1

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Canis familiaris Linnaeus 1758

Oryctolagus cuniculus Linnaeus 1758

Sylvilagus sp Gray, 1867

Cricetulus griseus Milne-Edwards 1867

Cricetus cricetus Linnaeus, 1758

Cavia porcellus Linnaeus, 1758

Felis catus Schreber, 1775

Cervus elaphus Linnaeus, 1758

Pan troglodytes Blumenbach, 1776

Mustela lutreola Linnaeus, 1758

Mustela vison Linnaeus, 1761

Sus scrofa Linnaeus, 1758

Mesocricetus auratus Waterhouse, 1839

Amphibian cell lines:

Xenopus laevis Daudin, 1802 Fish cell lines:

Danio rerio Hamilton-Buchanan, 1822

Oncorhynchus sp. Suckley, 1861

Avian cell lines:

Gallus gallus Linnaeus, 1758

Plant cell cultures: including protoplasts,

cultured cells and tissue.

Allium cepa L.

Arabidopsis thaliana (L.) Heynh 1842

Asparagus officinalis L.

Capsicum annuum L.

Glycine max L. Merr.

Hordeum vulgare L.

Lolium perenne L.

Lotus corniculatus L. subsp. corniculatus (synonym Lotus japonicas)

Lupinus spp. L.

Lycopersicon esculentum L.

Medicago truncatula Gaertn

Nicotiana tabacum L.

Nicotiana benthamiana L.

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Oryza sativa L.

Physcomitrella patens (Hedw.) Bruch & Schimp.

Solanum tuberosum L.

Triticum aestivum L.

Zea mays L.

Host organism Modified by:

Microorganisms:

Categorised as Risk Group 2

Prokaryotes (bacteria, archaea, and

cyanobacteria),

Micro-eukaryotes (algae, fungi, phytoplankton,

zoo plankton, protozoa, and micro-invertebrates)

Terrestrial laboratory animals:

Mus musculus Linnaeus, 1758

Rattus norvegicus Berkenhout, 1759

Rattus rattus Linnaeus, 1758

Drosophila melanogaster Macquart, 1843

Aquatic laboratory animals:

Danio rerio Hamilton-Buchanan 1822

Xenopus laevis Daudin 1802

Whole Plants:

Arabidopsis thaliana (L.) Heynh 1842

Medicago sativa L.

Medicago truncatula Gaertn

Lotus corniculatus L.

Lotus corniculatus var. japonicus Regel

Nicotiana tabacum L.

Nicotiana benthamiana Domin

Standard commercially available non-self transmissible

cloning and expression vectors.

Vectors will include standard and commercially available

promoters and other gene regulatory elements, reporter

and selectable marker genes, protein purification tags

and origins of replication.

Donor genetic material will be derived from the Kingdoms Animalia, Planta, Fungi, Protista, Monera, viruses and viroids and will consist of coding, non-coding and regulatory regions of genes, and RNA interference-inducing sequences for the purpose of understanding gene function.

The range of modifications and genetic material involved

are subject to the following exclusions;

(a) nucleic acid must be characterised to the extent that—

(i) its sequence is known; or

(ii) its gene function is understood; or

....(iii) its potential gene products are understood; and

(b) the modification will not—

(i) result in a genetically modified organism that is more pathogenic, virulent, or infectious to laboratory personnel, the community, or the environment;

(ii) result in the genetically modified organism having a greater ability to escape from containment than the unmodified host organism.

Further restrictions to the range of modifications are

outlined in Additional Control 25, Appendix 1

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Applicant

2.2. The applicant is the University of Otago.

2.3. The EPA imposes Control 2 that this approval be used only at University of Otago’s campus in

Dunedin.

Purpose of the applications

2.4. The applicant has applied to develop and hold in containment new organisms for laboratory based

research and educational purposes.

2.5. These applications seek approval to genetically modify a range of host organisms to provide

researchers and students at the University of Otago with tools to explore the role and function of

genes. These developments will underpin research into distinct areas of biology.

2.6. The ability to genetically modify these organisms will help researchers determine gene function, and

more specifically how individual genes and groups of genes influence biological processes in vivo.

This research is designed to generate and apply new knowledge of processes involved in:

Cell growth, metabolism, differentiation and development;

Biological responses to environmental and chemical stress;

Host-pathogen and host-commensal interactions; and

The causation of disease.

2.7. In accordance with section 45(1)(a)(i) of the Act, the EPA determined that these applications were for

two valid purposes as specified in section 39 of the Act being:

section 39(1)(a): the development of any new organisms; and

section 39(1)(h): such other purposes as the Authority thinks fit, being for laboratory based

research and educational purposes.

2.8. The EPA considered that the proposed development of new organisms (identified in Table 1) for

laboratory-based contained research and education fits one or both of these purposes, and has

imposed a control to limit it as such (Control 3).

3. Application Process

Application receipt

3.1. The applications APP201030, APP201031, APP201032 and APP201033 were formally received on 21

September 2011.

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Public notification

3.2. Under section 53(2) of the Act, the Authority has discretion as to whether to publicly notify an

application to import into containment any new organism. In this case, the applications were not

publicly notified (according to the EPA guidelines) because no exceptional circumstances warranting

public notification were identified, and significant public interest in these applications was not

anticipated.

Consultation with government departments

3.3. In accordance with section 58(1)(c) and clause 5 the Ministry of Agriculture and Forestry (MAF) were

invited to comment on these applications.

3.4. MAF supported these applications and considered that the containment regime proposed by the

applicant was suitable for containment of the organisms.

Consideration

3.5. The EPA considered the four applications on 6 October 2011. The consideration followed the process

described in the decision path for applications to develop new organisms into containment under

section 45 of the Act.

3.6. The information that the EPA took into consideration included:

The applications APP201030, APP201031, APP201032 and APP201033 (on Form 121/01)

prepared by the applicant;

Internal EPA advice; and

A Draft of University of Otago’s Containment Manual.

3.7. The applications were determined in accordance with section 45 of the Act, taking into account the

matters specified in section 43, and other matters relevant to the purpose of the Act, as specified in

Part 2 of the Act.

3.8. In accordance with clause 24, the EPA looked sequentially at identification, assessment and

evaluation of risks, costs and benefits. Interposed with this was the consideration of the adequacy of

the proposed University of Otago’s containment regime, and the ability of the organism to escape and

to form a self-sustaining population. Risk management techniques were considered in relation to the

identified risks (clause 24) and those risks identified as significant were assessed (clause 12). Costs

and benefits were assessed in accordance with clause 13.

3.9. Finally, taking account of the risk characteristics established in accordance with clause 33, the

combined impact of risks, costs and benefits was evaluated in accordance with clause 34.

Risk assessment methodology

3.10. The EPA evaluated the information provided in the applications and internal advice. The EPA took into

account all the potential adverse effects (risks and costs) and beneficial effects (benefits) of the

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organism and inseparable organisms on the environment, human health, Māori culture and traditions,

society and the community, and the market economy. The level of each effect was assessed

qualitatively, using the descriptors described in supporting documents.

4. Containment of the organism

4.1. The EPA considered the adequacy of the containment regime for the Organisms in Table 1 in

accordance with section 45(1)(a)(iii), including:

the biological characteristics of the organisms,

the proposed containment regime, and

the potential pathways for the escape of the organisms developed from the containment

facility.

the University of Otago’s Containment Manual

Biological characteristics of the organisms relating to containment

4.2. The EPA noted that the host organisms were well defined in the applications.

4.3. There are a large number of vectors, genetic elements and potential sources of donor genetic material

and therefore the range of potential modifications is broad. The EPA has imposed Control 25 in order

to limit the modifications possible.

4.4. The EPA note that all host organisms require specialised conditions to live (for example, specialised

media and temperatures are required) and either would not survive or not be competitive in the open

environment.

4.5. For the purposes of this approval the following definitions apply:

Risk Group 1 microorganisms are those organisms that require a microscope to observe, and are

unlikely to cause disease in humans, plants or animals.

Risk Group 2 microorganisms are those organisms that require a microscope to observe, and can

cause human, animal or plant disease but are unlikely to be a serious hazard to laboratory workers,

the community, livestock or the environment. Laboratory exposures may cause infection, but effective

treatment and preventive measures are available and the risk of spread is limited.

4.6. The EPA considered that it was possible to do a risk assessment of this range of organisms due to

their biological characteristics, and the limitations on the range of modifications possible to those

organisms. Both structural and procedural policies mean they can be safely used and held in purpose

built containment facilities. The EPA notes the organisational requirement that any user of this

University of Otago specific approval record the organism that is to be used, and that training relevant

to the risk of that organism has occurred before use.

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Containment regime

4.7. The EPA has imposed controls requiring that the organisms to be developed (described in Table 1) be

securely contained within the facility, and adequate provisions provided to ensure that containment is

maintained (see Appendix 1). These controls address the matters detailed in the Schedule 3 Part I of

the HSNO Act. These provisions cover access, staff training, contingency plans for

recovery/destruction should any escape from containment occur, waste disposal, record keeping and

packaging for organisms in transit.

4.8. The EPA noted the containment facility will be run in accordance with the University of Otago

Containment Manual which contains provisions relating to international best laboratory procedure.

4.9. The operator of the facility is responsible for ensuring compliance with the controls on this approval.

4.10. All containment facilities are initially inspected and approved, then regularly audited by MAF for

compliance to the controls of this approval.

Potential escape from containment

4.11. The EPA considered the probability that the organism may escape from containment, in accordance

with section 45(4)(b).

4.12. The EPA considered the potential pathways of escape from containment of the organisms in Table 1

to be:

escape during transportation to and from the containment facility;

escape due to accidental or deliberate removal of cultures by staff or unauthorised persons;

escape by expelled air, discharge of water or liquid waste;

escape on unsterilised laboratory equipment or solid waste;

escape by improper handling of spills and waste;

escape resulting from uncontrolled organisms entering the facility;

escape following natural disaster (flood, earthquake)

4.13. Controls (see Appendix 1) have been imposed to ensure the containment facility is designed,

constructed and maintained to not allow the escape of any approved organism.

4.14. The University of Otago has produced a Containment Manual. This Manual describes in detail the

structural and procedural policies demonstrating how the University of Otago complies with the

controls on this approval.

4.15. The EPA considered that given the biology of the organisms and the specific environmental conditions

required for growth, and in many cases survival, escape from containment of these organisms would

require a deliberate human act. The EPA considered that compliance with the controls placed on this

approval would mean that escape from containment during transport is highly improbable.

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4.16. The EPA requires that everyone entering a containment facility be authorised. Specific to an

individual’s role, authorisation requires differing levels of training on the containment practises of the

containment facility.

4.17. The EPA considered that escape by deliberate or accidental removal by authorised or unauthorised

persons, is limited by the containment regime, particularly the security measures and audit

components. The EPA considered that compliance with the controls placed on this approval would

mean that escape from containment by these pathways is highly improbable.

4.18. The EPA notes that the University of Otago Containment Manual contains sufficient provisions to

ensure students receive appropriate training before entering a containment facility. Approved

organisms will be used in teaching laboratories which are in containment facilities. Teaching

laboratories being places where the primary purpose is to give instruction, training, or lessons. The

applicant noted that in teaching laboratories, students wear laboratory coats and handle organisms in

a controlled situation (for example agar petri dishes or small liquid volumes). The student’s exposure

to any organisms would be limited.

4.19. The EPA considered that escape by expelled air, discharge of water or liquid waste is limited by the

containment regime. The EPA considered that compliance with the controls placed on this approval

would mean that escape from containment by these pathways is highly improbable.

4.20. The EPA considered that escape on unsterilised laboratory equipment or solid waste is limited by the



4.21. The EPA considered that escape by improper handling of spills and waste is limited by the



4.22. The EPA considered that escape resulting from uncontrolled organisms entering the facility is limited

by the containment regime. Uncontrolled organisms refer to vermin, or other organisms that might

enter the containment facility unintentionally. The EPA considered that compliance with the controls

placed on this approval would mean that escape from containment by these pathways is highly

improbable.

4.23. The EPA considered that escape following a natural disaster is limited by the containment regime.

The EPA considered that compliance with the controls placed on this approval would mean that

escape from containment by these pathways is highly improbable.

4.24. The EPA concluded that escape from containment, by the organisms in Table 1, via the identified

pathways, is highly improbable.

Conclusion on adequacy of the containment regime

4.25. The EPA considered the ability of the organisms to escape containment given their biological

characteristics, the potential pathways of escape, and the proposed containment regime. Furthermore

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MAF will audit the facility and its procedures to assess the continuing compliance to the controls on

this approval. Taking all of these considerations into account the EPA concluded that it is highly

improbable that the organisms would be able to escape from containment by deliberate or accidental

means and that the proposed containment regime is adequate to contain these organisms.

5. Ability of the organism to establish an undesirable self-sustaining

population

5.1. In accordance with sections 43 and 37 and clause 10(e) the EPA considered the ability of the

organisms to establish undesirable self-sustaining populations should they escape containment, and

the ease of eradication of such populations.

5.2. The EPA noted that the organisms to be developed have the potential to form self-sustaining

populations within the environment. However, the potential for this to occur is limited by the

containment regime and good laboratory management practices.

5.3. The EPA also considered that it would be difficult to identify such a population if it were to establish, as

it could not be distinguished from the indigenous flora and fauna of the same species.

5.4. The EPA concluded that the establishment of a self-sustaining population is improbable, but such a

population would be difficult to distinguish and would be therefore difficult to eradicate.

6. Risk assessment

6.1. In accordance with clause 9(c), the EPA has categorised potential adverse effects into environmental,

human health, Māori culture, market economy and social categories. These adverse effects have

been considered in terms of the requirements of clauses 12, 13, and 14 including the probability of

occurrence and the magnitude of adverse effects, whether or not they are monetary, and the

distribution of costs and benefits over time, space and groups in the community. Risk characteristics

are considered in terms of clause 33. The degree of uncertainty attached to evidence is taken into

account, as required under clauses 25, 29 and 30.

Potential adverse effects on human health and safety

6.2. The EPA noted that any adverse effects on human health and safety would be dependent on the

highly improbable event of the organisms escaping containment. The EPA also noted that some of

the host organisms are classified as Risk Group 2. Therefore, while they may be able to cause

disease, they are unlikely to be a serious hazard to laboratory personnel or the community and can be

treated and present a limited risk of spread. Control 25 has been imposed to limit the range of

modifications possible, which mitigates any modified organism being an increased risk than the host

organism. The magnitude of any potential adverse effects would therefore be minimal. The EPA

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concluded that the potential adverse effects on human health and safety resulting from exposure to

these organisms are negligible.

Potential adverse effects on the environment

6.3. The EPA noted that any adverse effects on the environment were dependent on escape from

containment, and pathogenic infection of a suitable host. The EPA considered that the likelihood of

escape from containment was highly improbable.

6.4. The EPA noted there are host organisms in Table 1 that may inhabit the intestinal tract of animals, or

the vascular system of plants. The EPA also noted that as with humans, the organisms could

potentially cause disease in animals or plants. All Risk group 1 or 2 organisms by definition are

effectively treatable, and exposure would be limited to individuals rather than whole populations of

animals or plants. Control 25 has been imposed to limit the range of modifications possible, which

mitigates any modified organism being an increased risk than the host organism. The EPA therefore,

considered the magnitude of any potentially adverse effects on plants or animals to be minimal.

6.5. The EPA considered the likelihood of these potential adverse effects occurring to be

highly improbable as they are dependent on escape from containment and infection of a suitable

host.

6.6. The EPA concluded that the potential adverse effects on the environment are negligible.

Potential adverse effects on Māori and their culture and traditions

6.7. The EPA considered the potential Māori cultural effects of these applications in accordance with

clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8.

6.8. The EPA noted that the University of Otago has consulted with the Ngai Tahu representative

concerning the research currently taking place at the University. Furthermore the University of Otago

has strict policies in place concerning the procedures for research that may use native fauna and flora.

6.9. The EPA considered it highly improbable that staff at the University of Otago would not adhere to

such polices. Any effect would be minimal to minor. The EPA concluded that the potential adverse

effects on Māori and their culture and traditions are negligible.

Potential adverse effects on the market economy

6.10. The EPA considered the information available and did not identify any potentially significant adverse

effects on the market economy.

Potential adverse effects on society and communities

6.11. The EPA considered the information available and did not identify any potentially significant adverse

effects on society and communities.

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7. Identification and assessment of potentially significant beneficial effects

7.1. The EPA considered the potential beneficial effects associated with the applications, in accordance

with sections 5 and 6(e) and clauses 9(c), 10, 13, and 14.

7.2. The EPA considered that there are benefits to the increased scientific knowledge through maintaining

New Zealand’s standing in the international science community, the applicant’s ability to attract

research funding and students, and their publications in top-tier peer-reviewed scientific journals to be

likely.

7.3. The EPA noted that the research may lead to the development of new innovative products and

services. However, there is a high degree of uncertainty surrounding the expected benefits, as it

depends on how successful the research is. Therefore, the EPA determined that the magnitude of

any benefits would be minor to moderate.

7.4. The EPA concluded that the potential beneficial effects are low to medium.

8. Associated approvals

8.1. The EPA noted that any approval user would need to meet the requirements of the Biosecurity Act

1993, which includes the approval of University of Otago’s Containment Manual.

9. Overall evaluation of risks, costs and benefits

9.1. The applications have been considered in the context of the purpose and principles of the HSNO Act.

9.2. Pursuant to section 45(1)(a)(i) of the HSNO Act, the EPA is satisfied that the purpose of the

applications fall under section 39(1).

9.3. The EPA considered all of the adverse and beneficial effects, and also the additional matters set out in

sections 43 and 45. The EPA assessed each of the potential adverse effects (risks and costs). In

making this assessment, the EPA considered both the impact of containment and the controls, and the

effects of the genetically modified organisms if they were to escape from containment. Overall, the

EPA concluded taking into account the controls imposed that the adverse effects are negligible.

9.4. As assessed in section 7 of the decision the benefits are for increased scientific knowledge. While

these benefits are likely to occur, their magnitude may range from minimal to minor depending on the

success of the research and the scientific value of the research results, thus the EPA concluded that

the beneficial effects to be low to medium.

9.5. The EPA then considered whether, given the organism description, the containment and controls

proposed, the benefits outweigh the non-negligible risks and costs. The EPA concluded that the

benefits do outweigh the risks and costs.

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9.6. The EPA was satisfied that the organisms described in Table 1 for laboratory based research and

education can be adequately contained (sections 45(1)(a)(iii) and 44(b) of the HSNO Act), by the

controls required in this decision Appendix 1.

9.7. In accordance with clause 36(2)(b) of the Methodology, the EPA records that in reaching this

conclusion, it has applied the balancing tests in section 45 of the Act.

10. Decision

10.1. Pursuant to section 45(1)(a)(i), the EPA is satisfied that these applications are for purposes specified

in section 39(1)(a) and (h).

10.2. Having considered all the possible effects in accordance with sections 43, 45(1)(a)(ii) and 45(4), and

pursuant to clause 26, and based on consideration and analysis of the information provided and taking

into account the application of risk management controls specified in this decision, the EPA is satisfied

the beneficial effects of having the organism(s) in containment outweigh the adverse effects of the

organism(s).

10.3. The EPA is satisfied that the containment regime detailed in the controls set out in Appendix 1 will

adequately contain the organism as required by section 45(1)(a)(iii).

10.4. The applications to develop in containment organisms in Table 1 for the purpose of laboratory based

research and educational purposes is approved in accordance with section 45(1)(a). As required

under section 45(2), the approval is subject to the controls listed in the Appendix 1 of this decision.

Manuka Henare

Chair, Decision Making Committee

Environmental Protection Authority

Date

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October 2012 1st Amendment

To amend Control 1 to extend trial finish date by six months

Shaun Ogilvie Date 20 October 2012

Chair, Decision Making Committee

Environmental Protection Authority

Approval Codes:GMD101061 – GMD101123

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Appendix 1: Controls Required by the Approval

The University of Otago must ensure compliance with the controls set out in this Appendix

in respect of any work carried out under this approval.

1. This approval expires 20 April 2013.

2. Development conducted under this approval must be conducted within the containment facilities at

University of Otago’s campus in Dunedin.

3. This approval is limited to the development in containment of the approved organisms (listed in Table 1)

for the purposes of laboratory-based contained research and education.

Requirements for containment facility

4. The containment facility must be designed and constructed to contain the approved organisms held

within it under any reasonably foreseeable circumstances.

5. The containment facility must be maintained in order to contain all approved organisms held within it

(i.e., preventing escape) under reasonably foreseeable circumstances.

Requirement for entering/exiting containment facility

6. All reasonably practical measures must be taken to ensure that persons entering containment facility

enter and exit the containment facility in a way that does not compromise the containment of the new

organisms.

Requirements for moving new organisms

7. All reasonably practicable measures must be taken to prevent the escape of new organisms during any

transfers within the containment facility or outside the containment facility.

8. New organisms may only be removed from a containment facility for a reasonably necessary purpose

(e.g. transfer to another containment facility).

9. Containment measures for approved organisms being transferred must clearly identify the contents,

containment requirements, and the sender’s and receivers’ details.

Requirements to limit access to the containment facility

10. All entrances must clearly identify the facility as being a containment facility.

11. All personnel entrances into the containment facilities are specified.

12. All reasonably practicable measures must be taken to prevent unauthorised persons gaining access to

the containment facility.

13. All reasonably practicable measures must be taken to prevent the accidental or deliberate release of

new organisms from the containment facility.

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Requirements for removing equipment and waste from the containment facility

14. Any waste (including biological material) that may contain a new organism, or heritable material from a

new organism, must be killed prior to its removal from containment.

Requirement for training of staff

15. All authorised persons who enter the containment facility must be trained on the containment practices

of the containment facility relevant to the responsibility of the individual.

Requirements for contingency plans

16. The containment facility must have a documented contingency plan detailing processes on the event of

a breach of containment, including recapture or eradication protocols, for each type of new organism

held within the containment facility under this approval. The contingency plan must cover any reasonably

foreseeable event that could compromise containment of any new organism within the containment

facility.

17. The contingency plan must be implemented if there is reason to believe that a new organism has

escaped or been released from the containment facility.

18. The containment facility must maintain the capability to eradicate any new organisms held within the

containment facility in the event of escape.

Requirements for internal audits, inspections and monitoring

19. To ensure containment is being achieved and to identify any remedial maintenance requirements each

containment facility must be inspected at reasonable intervals given the nature of the approved

organism(s) being contained.

20. MAF must be allowed access to the containment facility and relevant documentation for the purpose of

auditing.

21. Each containment facility must be 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.

22. Faults in containment must be remedied as soon as possible, including taking such interim measures as

are necessary to mitigate the risk of breach of containment.

23. Any structural modifications to a containment facility must be approved by a MAF Inspector prior to being

used to contain the approved organisms.

24. A record of host organisms must be kept at the facility.

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Additional Controls

25. The following developments are excluded:

(a) developments involving host organisms that are microorganisms categorized as risk group 3 or risk

group 41;

(b) developments involving the expression of genes encoding known toxins;

(c) developments involving production of pharmacologically active forms of other biologically active

molecules that have an oral or dermal vertebrate LD50 of less than 100 μg/kg;

(d) developments involving the expression of genes that encode a substance toxic to vertebrates at

levels higher than the level occurring in the organism from which they are derived—

(i) including, despite paragraph (b), genes that encode a substance toxic to vertebrates that

have an oral or dermal LD50 greater than 100 μg/kg; but

(ii) excluding developments involving the expression of genes that are—

(A) from a toxin-producing organism as donor; and

(B) shown not to encode a substance toxic to vertebrates:

(e) developments involving viral vectors whose host range includes human cells and that contain 1 or

more inserted nucleic acid sequences coding for a product that can lead to uncontrolled

mammalian cellular proliferation or be toxic to mammalian cells, or both;

(f) developments involving or resulting in viral genomes, viroids, or fragments of a genome capable, in

the host/vector system used, of giving rise to particles naturally infectious and normally able to

cause disease in humans, animals, plants, or fungi other than those that satisfy the requirements of

genetic modifications excluded from Table 1.

(g) developments using micro-organisms as a host or vector that are normally able to cause disease in

humans, animals, plants, or fungi and that use defective vector/helper virus combinations with the

potential to regenerate a non-defective recombinant virus other than those that satisfy the

requirements of genetic modification excluded from Table 1.

(h) developments involving recombinations between whole viral genomes, viroids, or complementary

fragments of these genomes, where 1 or more fragments contain 1 or more virulence determinants

or pathogenic determinants, including developments that can alter the host range of a pathogen or

that increase the virulence or infectivity of the virus;

1 A Risk group 3 microorganism is one that can cause severe human disease and present a serious hazard to workers; it

may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available; A Risk Group 4 microorganism means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

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(i) developments involving the introduction of genes determining pathogenicity into microorganisms

other than Risk Group 1 host organisms;

(j) developments involving microorganisms that are capable of causing disease in humans, animals,

plants, or fungi unless the developments only involve cloning genetic material that is well

characterised and is known not to increase the virulence or infectivity of the host; and

(k) developments involving modifications to pathogenic microorganisms that result in resistance to

antibiotics used for clinical or veterinary treatment of infections caused by that microorganism.

Interpretation

1. In these controls, unless otherwise specified below, a word has the same meaning as it is defined in the

HSNO Act (if any).

2. Unless the context otherwise requires:

audit means a systematic documented review or examination and evaluation of evidence to determine

the extent to which specific criteria are fulfilled.

authorised person is someone who has completed training relevant to the responsibility of that

individual on the containment practises at the containment facility. Authorisation is given by the Operator

(or delegated person) of the containment facility.

breach means the escape of organism(s), unauthorised entry to the containment facility, and/or the

structural integrity of the facility being compromised.

contingency plan means a plan devised for a specific situation where things could go wrong. 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.

documentation means written or electronic records.

EPA means the Environmental Protection Authority, established under section 7 of the Environmental

Protection Authority Act 2011.

MAF means Ministry of Agriculture and Forestry.

maintenance means the process of maintaining (preserving or providing for the preservation of) or

continuing a state of good repair.

operator the person who has overall responsibility for a containment facility, its maintenance and

operation, in terms of section 40 of the Biosecurity Act 1993.

reasonable intervals means a period of time that MAF considers appropriate for that organisation

depending on its history of compliance.

trained means individuals that undergo training or instruction in preparation for a particular role, in this

case containment practices of the containment facility.

waste unusable or unwanted substances or materials (including water or liquids, and solids).

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Approval numbers for organisms on applications APP201030, APP201031, APP201032 and

APP201033

Approval number Organism

GMD101061 Prokaryotes (bacteria, archaea, and cyanobacteria) Risk Group 1

GMD101062 Bacteriophage lambda

GMD101063 Micro-eukaryotes Rick Group 1

GMD101064 Prokaryotes (bacteria, archaea, and cyanobacteria) Risk Group 2

GMD101065 Micro-eukaryotes Risk Group 2

GMD101066 Mus musculus Linnaeus, 1758 (whole animals)

GMD101067 Rattus norvegicus Berkenhout 1759 (whole animals)

GMD101068 Rattus rattus Linnaeus, 1758 (whole animals)

GMD101069 Drosophila melanogaster (Meigen, 1830) (whole animals)

GMD101070 Danio rerio Hamilton-Buchanan, 1822 (whole animals)

GMD101071 Xenopus laevis Daudin, 1802 (whole animals)

GMD101075 Homo sapiens (Linnaeus, 1758) (cell lines)

GMD101074 Spodoptera frugiperda Smith & Abbot 1797 (cell lines)

GMD101073 Drosophila melanogaster (Meigen, 1830) (cell lines)

GMD101072 Trichoplusia ni Hubner 1802 (cell lines)

GMD101076 Bombyx mori Linnaeus, 1758 (cell lines)

GMD101078 Aedes aegypti Linnaeus, 1762 (cell lines)

GMD101077 Apis mellifera Linnaeus, 1758 (cell lines)

GMD101081 Bombus sp. Latreille, 1802 (cell lines)

GMD101080 Acyrthosiphon pisum Harris M, 1776 (cell lines)

GMD101079 Mus musculus Linnaeus, 1758 (cell lines)

GMD101084 Mus spretus Lataste, 1883 (cell lines)

GMD101085 Rattus rattus Linnaeus, 1758 (cell lines)

GMD101086 Rattus norvegicus Berkenhout 1759 (cell lines)

GMD101082 Chlorocebus aethiops Linnaeus 1758 (cell lines)

GMD101083 Ovis aries Linnaeus 1758 (cell lines)

GMD101091 Bos taurus Linnaeus 1758 (cell lines)

GMD101087 Canis familiaris Linnaeus 1758 (cell lines)

GMD101088 Oryctolagus cuniculus Linnaeus 1758 (cell lines)

GMD101089 Sylvilagus sp Gray, 1867 (cell lines)

GMD101090 Cricetulus griseus Milne-Edwards 1867 (cell lines)

GMD101093 Cricetus cricetus Linnaeus, 1758 (cell lines)

GMD101092 Cavia porcellus Linnaeus, 1758 (cell lines)

GMD101094 Felis catus Schreber, 1775 (cell lines)

GMD101095 Cervus elaphus Linnaeus, 1758 (cell lines)

GMD101098 Pan troglodytes Blumenbach, 1776 (cell lines)

GMD101096 Mustela lutreola Linnaeus, 1758 (cell lines)

GMD101097 Mustela vison Linnaeus, 1761 (cell lines)

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GMD101100 Sus scrofa Linnaeus, 1758 (cell lines)

GMD101099 Mesocricetus auratus Waterhouse, 1839 (cell lines)

GMD101101 Xenopus laevis Daudin, 1802 (cell lines)

GMD101103 Danio rerio Hamilton-Buchanan, 1822 (cell lines)

GMD101102 Oncorhynchus sp. Suckley, 1861 (cell lines)

GMD101104 Gallus gallus Linnaeus, 1758 (cell lines)

GMD101105 Allium cepa L (cell cultures)

GMD101106 Arabidopsis thaliana (L.) Heynh (1842) (cell cultures and whole plants)

GMD101107 Asparagus officinalis L (cell cultures)

GMD101109 Capsicum annuum L. (cell cultures)

GMD101108 Glycine max L. Merr. (cell cultures)

GMD101112 Hordeum vulgare L. (cell cultures)

GMD101110 Lolium perenne L. (cell cultures)

GMD101111 Lotus corniculatus L.subsp. corniculatus (cell cultures and whole plants)

GMD101116 Lupinus spp. L. (cell cultures)

GMD101113 Lycopersicon esculentum L. (cell cultures)

GMD101117 Medicago truncatula Gaertn (cell cultures and whole plants)

GMD101114 Nicotiana tabacum (Linnaeus 1753) (cell cultures and whole plants)

GMD101115 Nicotiana benthamiana L. (cell cultures and whole plants)

GMD101118 Oryza sativa L (cell cultures)

GMD101120 Physcomitrella patens (Hedw.) Bruch & Schimp. (cell cultures)

GMD101119 Solanum tuberosum L. (cell cultures)

GMD101121 Triticum aestivum L. (cell cultures)

GMD101122 Zea mays (Linnaeus 1753) (cell cultures)

GMD101123 Medicago sativa L. (whole plants)

decision - epa.govt.nz

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