ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
30 April 2009
Application code:
GMD08071
Application category:
To develop in containment genetically modified
organisms under sections 40(1)(b) and 42A of the
Hazardous Substances and New Organisms (HSNO) Act
1996.
AgResearch Limited
Applicant:
Date application received:
To develop genetically modified organisms for research
into characterizing the cellular and molecular function of
genes, gene products, and gene regulatory elements
involved in the microbial biocontrol of invertebrates.
30 April 2009
Consideration date:
30 April 2009
Considered by:
Chief Executive, ERMA New Zealand
Purpose:
1
1.1
Summary of Decision
Application GMD08071 to develop, as a project, genetically modified organisms (as
described in Table 1 of this decision) in containment is approved, with controls (see
Appendix 1 of this decision), having been considered in accordance with section 42A
of the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act), the
HSNO (Low-Risk Genetic Modification) Regulations 2003 (the Regulations), and the
HSNO (Methodology) Order 1998 (the Methodology).
The organisms approved are:
1.2
The organisms approved for development are the genetically modified organisms
described in Table 1:
Table 1: Organisms as recorded on ERMA New Zealand Register
Host organism
Category of
Modified by:
host
organism
Escherichia coli
(Migula 1895) Castellani and
Chalmers 1919
non pathogenic laboratory
strains
Bacteriophage lambda
(E. M. Lederberg 1951)
non pathogenic laboratory
strains
Caudovirales; Siphoviridae;
Lambda-like viruses
all strains are disarmed
Autographa californica
multiple nucleopolyhedrosis
virus (AcMNPV)
(Chapman and Glasier 1915,
Allen 1921)
non-pathogenic laboratory
strains (disarmed polyhedrinminus strains)
Insects:
1. Antheraea eucalypti
Scott, 1864
2. Bombyx mori
Linnaeus, 1758
3. Cydia pomonella
Linnaeus 1758
4. Drosophila melanogaster
Meigen, 1830
5. Galleria mellonella
Linnaeus, 1758
6. Epiphyas postvittana
Walker, 1863
7. Helicoverpa armigera
Hubner, 1805
8. Heliothis virescens
Fabricius, 1777
9. Helicoverpa zea
Boddie, 1850
10. Heteronychus arator
Fabricius, 1775
1
1
1
1
1 (Cell lines)
2 (Whole
invertebrates)
Category of
modification/
containment
level
A/PC1
“Donor” organisms will carry the
following recombinant vectors (either
exogenously or as sequences integrated
into the genome) which maybe
transferred into the “recipient”
organism’s genome.
A/PC1
Standard non-conjugative plasmid
cloning and expression vectors, bacmids,
transfer vectors, baculovirus,
bacteriophage and bacteriophage lambdaderived vectors.
The genetic material may be modified by
insertion, deletion, alteration of sequences
or site-directed mutagenesis, and by the
addition of regulatory elements or from
the list of donor DNA described below.
DNA carried by these plasmids may
direct transposon-mediated or
homologous recombination-mediated
insertion of DNA constructs into the
bacterial or invertebrate genomes for the
development of biocontrol agents.
A/PC1
A/PC1
A/PC1
B/PC2
The donor genetic material will be
sourced from non-native Kingdoms
Animalia, Plantae, Fungi, Protista and
Monera, viruses, viroids, and will include
coding, non-coding, antisense, and
regulatory regions of genes with known
or predicted functions in biocontrol such
as:
 signal transduction
 ligand-receptor interaction
 digestion
 detection of odours/tastes
 invertebrate development
 insecticidal resistance and associated
responses
Environmental Risk Management Authority Decision: Application GMD08071
Page 2 of 16
Insects:
11. Lymantria dispar
Linnaeus, 1758
12. Mamestra brassicae
Linnaeus, 1758
13. Manduca sexta
Linnaeus, 1763
14. Pieris brassicae
Linnaeus, 1758
15. Pieris rapae
Linnaeus, 1758
16. Plutella xylostella
Linnaeus, 1758
17. Spodoptera frugiperda
Smith 1797
18. Spodoptera litura
Fabricius, 1775
19. Tribolium castaneum
Herbst, 1797
20. Trichoplusia ni
Hübner 1803
Nematode:
21. Caenorhabditis elegans
Maupas, 1900
Mammalian Cell lines:
1. Chlorocebus aethiops
Linnaeus, 1758
2. Cricetulus griseus
Milne-Edwards, 1867
3. Homo sapiens1
Linnaeus, 1758
4. Mus musculus
Linnaeus, 1758
Bacteria:
1. Pseudomonas fluorescens
Migula 1895
2. Photorhabdus luminescens
(Thomas and Poinar 1979)
Boemare et al, 1993
3. Serratia entomophila
Grimont et al., 1988
4. Serratia proteamaculans
(Paine and Stansfield
1919) Grimont et al, 1978
5. Yersinia entomophaga
Hurst et al, 2009
6. Xenorhabdus nematophila
corrig. (Poinar and
Thomas 1965) Thomas
and Poinar 1979
1
1 (Cell lines)
2 (Whole
invertebrates)
1 (Cell lines)
2 (Whole
invertebrates)
1
2
The donor native genetic material will be
sourced from Canterbury and Westland,
New Zealand and includes the following
invertebrate and microbe species only:
 Costelytra
 Heterorhabditis
 Odontria
 Papuana
 Pericoptus
 Pyronota
 Wiseana
 Yersinia
Vectors will include standard and
commercially available promoters and
other gene regulatory elements, reporter
and selectable marker genes, restriction
enzyme sites, origins of replication,
recombination and transposition
sequences, protein targeting, localisation
and secretory signals, solubility
enhancement tags, protein purification
tags, and affinity tags including epitope
tags.
A/PC1
B/PC2
A/PC1
B/PC2
A/PC1
The genetic modifications will not:
 involve any human genetic material.
 involve any genetic material from
CITES listed species, unless the
appropriate approval has been
obtained.
 involve uncharacterised nucleic acid
sequences from pathogenic
microorganisms.
 produce infectious particles (except
for disarmed baculovirus,
bacteriophage and bacteriophage
lambda-derived viruses).
 result in the expression of genes
encoding known or suspected
vertebrate toxins with an
LD50 < 100µg/kg.
 increase the pathogenicity, virulence,
or infectivity of the host organism or
enhance its ability to escape
containment.
B/PC2
Excludes embryonic stem cells or cell lines derived from person of Māori descent.
Environmental Risk Management Authority Decision: Application GMD08071
Page 3 of 16
2
Consideration
Sequence of the consideration
2.1
The application was formally received and verified as containing sufficient
information on 30 April 2009.
2.2
The decision was based on the information supplied by the applicant in the application
form: Develop in containment a project of low risk genetically modified organisms by
rapid assessment (NO3P).
2.3
The application was considered by Rob Forlong, the Chief Executive of ERMA New
Zealand. Relevant staff within ERMA New Zealand, including the Acting Manager,
Māori, were involved in providing advice on the consideration of the application.
2.4
In reaching my decision I have considered matters relevant to the purpose of the Act,
as specified in Part II, and followed the relevant provisions of the Methodology.
2.5
In accordance with section 42A of the Act for rapid assessment, the approach adopted
was to identify the circumstances of the genetic modification, to evaluate these against
the criteria specified in the Regulations established under section 41 of the Act, and to
consider whether there are any residual risks that require further consideration. This
approach covered the following issues:

purpose of the application (section 39 of the Act);

assessment against the criteria of the Regulations;

identification and assessment of the risks and other impacts of the organism;

precedents; and

containment controls.
Purpose of the application
2.6
The purpose of the application is to develop genetically modified organisms for
research into characterizing the cellular and molecular function of genes, gene
products, and gene regulatory elements involved in the microbial biocontrol of
invertebrates. The genes of interest will be genes which have been identified via a
bioinformatics approach to ensure that the candidate genes are well characterised.
Environmental Risk Management Authority Decision: Application GMD08071
Page 4 of 16
2.7
Transient, stable and viral expression studies will be carried out in insect and
mammalian cell lines, and expression of genes or parts of genes may also be
performed in whole insects by injecting these insects with genetically modified
plasmid DNA, RNAi constructs or genetically modified organisms such as modified
baculoviruses.
2.8
I have determined that this application is for a valid purpose being the development of
any new organism as provided for in section 39(1)(a) of the Act.
Assessment against the criteria for low-risk genetic modification
Category of host organism
2.9
Non-pathogenic laboratory strains of Escherichia coli and Bacteriophage lambda,
disarmed strains of Caudovirales and Siphoviridae, disarmed polyhedrin-minus strains
of Autographa californica multiple nucleopolyhedrosis virus (AcMNPV), insect and
mammalian cell lines as listed in Table 1 to be used by the applicant are not capable
of causing disease in humans, animals, plants or fungi, normally infect, colonise, or
establish in humans, nor do they produce desiccation-resistant structures, such as
spores or cysts. As such, non-pathogenic laboratory strains of Escherichia coli,
Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae, disarmed
polyhedrin-minus strains of AcMNPV, insect and mammalian cell lines as described
in Table 1 are considered Category 1 host organisms as defined in clause 7(1) of the
Regulations.
2.10
The applicant intends to use the following Gram-negative bacteria: Photorhabdus
luminescens, Pseudomonas fluorescens, Serratia entomophila,
Serratia proteamaculans, Yersinia entomophaga, and Xenorhabdus nematophila.
2.11
Photorhabdus luminescens is a symbiotic bacterial pathogen of insects. It lives in the
gut of an entomopathogenic nematode of the family Heterorhabditidae. When the
nematode infects an insect, Photorhabdus luminescens is released into the blood
stream and rapidly kills the insect host by producing toxins.
2.12
Pseudomonas fluorescens is known to cause disease to some phytophagous
nematodes eg, root-knot nematode, Meloidogyne incognita and New Zealand grass
grub, Costelytra zealandica. Pseudomonas fluorescens can also infect hospital
patients with compromised immune systems.
2.13
Serratia entomophila and Serratia proteamaculans are non-spore forming bacteria
which cause amber disease in the native grass grub beetle, Costelytra zealandica, an
important pasture pest in New Zealand. Amber disease is highly host specific,
affecting only grass grub larvae and the disease is characterised by cessation of
Environmental Risk Management Authority Decision: Application GMD08071
Page 5 of 16
feeding and gut clearance. Serratia entomophila was subsequently developed into a
commercial biopesticide for Costelytra zealandica in New Zealand.
2.14
Yersinia entomophaga is a non-spore forming bacterium which is pathogeic to some
Coleoptera and Lepidoptera species of invertebrates in New Zealand eg.
Costelytra zealandica. The applicant stated that the “Host range testing for
Y. entomophaga found no activity towards earthworms (Eisenia fetida; Aporrectodea
caliginosa), honey bees (Apis mellifera), American cockroach (Periplaneta
americana), black field cricket (Teleogryllus commodus), or the sour paste nematode
(Panagrellus redivivus), and toxicology tests in mice (Mus musculus) showed no
adverse effects. Furthermore, Y. entomophaga has a poor ability to survive in the
soil.”
2.15
Xenorhabdus nematophila is a non-spore forming bacterium and is a nematode
(Steinernema carpocapsae) vectored insect pathogen.
2.16
Photorhabdus luminescens, Pseudomonas fluorescens, Serratia entomophila,
Serratia proteamaculans, Yersinia entomophaga, and Xenorhabdus nematophila are
risk group 22 micro-organisms that are pathogenic to invertebrates, and normally
infects, colonises or establishes in invertebrates, and therefore, these microorganisms
are Category 2 host organisms as defined in clause 7(2) of the Regulations.
2.17
The insects as described in Table 1 are Category 2 host organisms as defined by
clause 7(2)(iii) of the HSNO (Low-Risk Genetic Modification) Regulations 2003, as
these are whole insects.
Category of genetic modification
2.18
The genetic modifications to non-pathogenic laboratory strains of Escherichia coli
and Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae,
disarmed polyhedrin-minus strains of AcMNPV, insect and mammalian cell lines
(described in Table 1) are not expected to increase the pathogenicity, virulence or
infectivity of the organisms to laboratory personnel, the community, or the
environment. In addition, the developments will not result in the organisms having a
greater ability to escape from containment than the unmodified organisms. Therefore,
the genetic modifications to non-pathogenic laboratory strains of Escherichia coli and
Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae, disarmed
polyhedrin-minus strains of AcMNPV, insect and mammalian cell lines as described
in Table 1 of this decision are Category A genetic modifications as defined in clause
5(1) of the Regulations and shall be contained at a minimum of Physical Containment
level 1 (PC1).
2
Risk group 2 means micro-organisms that may cause disease in humans, animals, plants, or fungi but are
unlikely to be a serious hazard to laboratory personnel, the community, animals, or the environment; and have
effective treatment and preventative measures with respect to any infections that they may cause; and present a
limited risk of the spread of infection.
Environmental Risk Management Authority Decision: Application GMD08071
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2.19
The genetic modifications to Photorhabdus luminescens, Pseudomonas fluorescens,
Serratia entomophila, Serratia proteamaculans, Yersinia entomophaga, and
Xenorhabdus nematophila (described in Table 1) involve the introduction of nucleic
acid sequence which is characterised so that the sequence is known and gene function
and potential gene products are understood. The modifications are not expected to
increase the pathogenicity, virulence or infectivity of the organisms to laboratory
personnel, the community, or the environment. In addition, the developments will not
result in the organism having a greater ability to escape from containment than the
unmodified organism. Therefore, the genetic modifications to
Photorhabdus luminescens, Pseudomonas fluorescens, Serratia entomophila,
Serratia proteamaculans, Yersinia entomophaga, and Xenorhabdus nematophila as
described in Table 1 of this decision are Category B genetic modifications as defined
in clause 5(2) of the Regulations and shall be contained at a minimum of Physical
Containment Level 2 (PC2).
2.20
The applicant has stated that “only gene disruption modification such as mutagenesis
of gene deletion will be undertaken in Photorhabdus luminescens, Serratia
entomophila, Pseudomonas fluorescens, Serratia proteamaculans, Yersinia
entomophaga, and Xenorhabdus nematophilus. These gene disruptions will result in a
loss of function of that gene and therefore attenuating that organism for that trait.”
2.21
The proposed injection of a genetically modified organism, RNAi construct, modified
plasmid DNA into whole insects will not increase the pathogenicity, virulence,
infectivity or the ability of the insects to escape from containment. Therefore, the
genetic modifications as described in Table 1 of this decision are Category B genetic
modifications as defined in clause 5(4)(b) of the HSNO (Low-Risk Genetic
Modification) Regulations 2003 and require a minimum of Physical Containment
Level 2 (PC2).
2.22
I am satisfied that the developments meet the criteria for low-risk genetic
modification specified in the Regulations. The developments involving nonpathogenic laboratory strains of Escherichia coli and Bacteriophage lambda, disarmed
strains of Caudovirales and Siphoviridae, disarmed polyhedrin-minus strains of
AcMNPV, insect and mammalian cell lines described in Table 1 meet the
requirements of Category A modifications as defined in clause 5(1) of the
Regulations. The developments involving Photorhabdus luminescens,
Pseudomonas fluorescens, Serratia entomophila, Serratia proteamaculans,
Yersinia entomophaga, and Xenorhabdus nematophila meet the requirements of
Category B modifications as defined in clause 5(2) of the Regulations.
2.23
Injection of a genetically modified organism into the whole insects meet the
requirement of Category B genetic modifications as defined in clause 5(4)(b) of the
HSNO (Low-Risk Genetic Modification) Regulations 2003 and require a minimum of
PC2 containment under the MAF/ERMA New Zealand Standard: Transitional and
Containment Facilities for Invertebrates 2008.
Environmental Risk Management Authority Decision: Application GMD08071
Page 7 of 16
Identification and assessment of the risks, costs and other impacts of the
organism
2.24
I consider that the information provided by the applicant is relevant and appropriate to
the scale and significance of the risks, costs, and benefits associated with the
application (as required by clause 8 of the Methodology). In accordance with clauses
9, 10 and 12 of the Methodology (which incorporate sections 5, 6, and 8 of the Act)
the information supplied by the applicant has been evaluated as follows:
2.25
I consider that, given the biological characteristics of the organisms, the containment
system and the controls attached to this approval (see Appendix 1 of this decision),
there is no evidence for, nor any reason to expect, any non-negligible adverse effects
of the proposed genetically modified organisms on humans, animals, plants, other
organisms or the environment.
2.26
I have considered the potential Māori cultural effects in accordance with sections 6(d)
and 8 of the Act and clauses 9(b)(i), 9(c)(iv) of the Methodology, in consultation with
the Acting Manager, Māori. This application involves the use of genetic material
from native or valued flora and fauna. The applicant consulted with Frania Zygadlo
(on behalf of the Te Rūnanga o Ngāi Tahu Hazardous Substances and New Organism
Committee) and no concerns were raised.
2.27
The applicant stated that “native invertebrates are not generally considered targets
for microbial control. However, there are cases where native invertebrates are
recognized as pests while on agricultural lands.”
2.28
Although recognising that iwi/Māori maintain an ongoing interest and concern in the
potential long term cultural implications of genetic modification generally, I consider
that this application poses negligible risk of adverse effects to the relationship of
Māori culture and traditions with their ancestral lands, water, sites, waahi tapu, valued
flora and fauna, and other taonga. Te Rūnanga o Ngāi Tahu supports research which
aims to reduce the use of insecticides on pastoral farming.
2.29
This assessment is made with the understanding that all associated containment
regulations, controls and conditions are met by the applicant.
Environmental Risk Management Authority Decision: Application GMD08071
Page 8 of 16
Precedents
2.30
I must consider each application on its merits, and am therefore not bound by the
stance taken in previous decisions. However, in reflecting on previous decisions that
involved similar genetic modifications to those proposed by this application, I note
that genetic modifications of non-pathogenic laboratory strains of Escherichia coli
and Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae,
disarmed polyhedrin-minus strains of AcMNPV, insect and mammalian cell lines
(described in Table 1), conforming to the Regulations, have been considered and
approved on several occasions by both Institutional Biological Safety Committees
(IBSCs) and the Chief Executive of ERMA New Zealand, under delegated authority.
For example, in application GMD06033, a proposal to clone the DNA from specific
plants to develop DNA markers, including microsatellites, to be used for studies in
genetic variation in native and non-native plants for the purpose of addressing
taxonomic and evolutionary questions was approved.
2.31
I also note that genetic modifications of pathogenic bacteria have been considered and
approved on several occasions by both IBSCs and the Chief Executive of ERMA New
Zealand, under delegated authority. For example, in application GMD05033, a
proposal to modify Serratia entomophila to investigate genes involved in stress
tolerance was approved.
2.32
I consider that this current application does not raise any novel issues that would
warrant it not to be considered via section 42A of the Act. However, several issues
have been raised as to whether in the process of infection of whole insects with a
genetically modified virus or plasmid DNA, the insect becomes genetically modified
for the purposes of the HSNO Act. Different conclusions can be reached depending
on how section 2 of the HSNO Act which defines a genetically modified organism is
interpreted and also on how the HSNO (Organisms Not Genetically Modified)
Regulations 1998, is interpreted. I note though, that the classification of the insects as
being either genetically modified or non genetically modified makes no difference to
the ability to contain the insects or the containment standards and controls imposed.
2.33
Previous applications have taken the approach that organisms involved in transient
transfections of recombinant DNA molecules meet the definition of genetically
modified organisms for the purposes of the HSNO Act. I consider that this issue
would benefit from further policy work. For this application, these insects will be
considered as category 2 host organisms. This decision however, does not set a
precedent as to how the Authority will consider future decisions with regard to this
issue.
2.34
I consider that this current application does not raise any novel issues and there are no
residual issues that require further consideration.
Environmental Risk Management Authority Decision: Application GMD08071
Page 9 of 16
Containment
2.35
The experiments proposed in this application, to develop genetically modified nonpathogenic laboratory strains of Escherichia coli and Bacteriophage lambda, disarmed
strains of Caudovirales and Siphoviridae, disarmed polyhedrin-minus strains of meet
the requirements of Category A genetic modifications as defined in clause 5(1) of the
Regulations. Category A experiments are required to be contained within a Physical
Containment level 1 facility (PC1).
2.36
The facility to be used shall be approved and registered as a containment facility
under section 39 of the Biosecurity Act, in accordance with the MAF Biosecurity
Authority/ERMA New Zealand Standard: Facilities for Microorgansisms and Cell
Cultures: 2007. This containment regime contains clear guidelines for the safe
handling and disposal of cultures. The cell lines, bacteria, and baculovirus as
described in Table 1 can also be destroyed with 10% Bleach, or other common
laboratory cleaners such as Vircon, Tri-Clean.
2.37
Transient and stable expression of insect genes will be studied by injecting genetically
modified organisms into whole insects. This procedure meets the requirements of
Category B genetic modification as defined in clause 5(2) of the HSNO (Low-Risk
Genetic Modification) Regulations 2003. Category B experiments are required to be
contained within a Physical Containment level 2 facility (PC2). The facility to be used
shall be registered to the MAF/ERMA New Zealand Standard: Transitional and
Containment Facilities for Invertebrates: 2008, and comply with the requirements
within the relevant sections of the Australian New Zealand Standard AS/NZS
2243.3:2002. I consider the provisions within that Standard requiring all insect and
biological waste to be made non-viable prior to disposal, to be adequate to ensure that
the experimental organisms approved by this decision, are fully contained.
3
Decision
3.1
I am satisfied that this application is for one of the purposes specified in section 39(1)
of the Act, being section 39(1)(a): the development of any new organism.
3.2
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organisms that are the subject of this approval,
the modifications and the criteria for low-risk genetic modification detailed in the
Regulations, I am of the view that the organisms meet the criteria for rapid assessment
under section 42A of the Act.
3.3
I have considered all the matters to be addressed by the containment controls for
Importing, Developing or Field testing of Genetically Modified Organisms detailed in
the Third Schedule Part I, of the Act, and in accordance with section 42A(3)(b) of the
Act, this approval is subject to the controls specified in Appendix 1.
Environmental Risk Management Authority Decision: Application GMD08071
Page 10 of 16
3.4
I consider that this current application does not raise any novel issues and there are no
residual issues that require further consideration.
3.5
Pursuant to section 42A(3)(a) of the Act, and acting under delegation from the
Authority provided for in section 19 of the Act, I have approved this project
application for genetically modified non-pathogenic laboratory strains of Escherichia
coli and Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae,
disarmed polyhedrin-minus strains of AcMNPV, insect and mammalian cell lines,
Photorhabdus luminescens, Pseudomonas fluorescens, Serratia entomophila,
Serratia proteamaculans, Yersinia entomophaga, and Xenorhabdus nematophila as
described in Table 1 of this decision, subject to the controls specified in Appendix 1
of this decision.
___________________________
Mr Rob Forlong
30 April 2009
Date
Chief Executive, ERMA New Zealand
Approval codes (BCH numbers): GMD005432 – 66 (48650 – 84)
Environmental Risk Management Authority Decision: Application GMD08071
Page 11 of 16
Approval numbers and BCH numbers for Organisms in Application
GMD08071
Approval code
GMD005432
GMD005433
GMD005434
GMD005435
GMD005436
GMD005437
GMD005438
GMD005439
GMD005440
GMD005441
GMD005442
GMD005443
GMD005444
GMD005445
GMD005446
GMD005447
GMD005448
GMD005449
GMD005450
GMD005451
GMD005452
Organism
Antheraea eucalypti Scott, 1864
(GMD08071)
Autographa californica multiple
nucleopolyhedrosis virus (AcMNPV)
(Chapman and Glasier 1915,
Allen 1921) (GMD08071)
Bacteriophage lambda
(E. M. Lederberg 1951) (GMD08071)
Bombyx mori Linnaeus, 1758
(GMD08071)
Caenorhabditis elegans Maupas, 1900
(GMD08071)
Caudovirales; Siphoviridae (GMD08071)
Chlorocebus aethiops (Linnaeus,1758)
(GMD08071)
Cricetulus griseus (Milne Edwards,1857)
(GMD08071)
Cydia pomonella Linnaeus 1758
(GMD08071)
Drosophila melanogaster (Meigen, 1830)
(GMD08071)
Epiphyas postvittana Walker, 1863
(GMD08071)
Escherichia coli (Migula 1895) Castellani
& Chalmers 1919 (GMD08071)
Galleria mellonella Linnaeus, 1758
(GMD08071)
Helicoverpa armigera Hubner, 1805
(GMD08071)
Helicoverpa zea Boddie, 1850
(GMD08071)
Heliothis virescens Fabricius, 1777
(GMD08071)
Heteronychus arator Fabricius, 1775
(GMD08071)
Homo sapiens (Linnaeus, 1758)
(GMD08071)
Lymantria dispar Linnaeus, 1758
(GMD08071)
Mamestra brassicae Linnaeus, 1758
(GMD08071)
Manduca sexta Linnaeus, 1763
(GMD08071)
Environmental Risk Management Authority Decision: Application GMD08071
BCH number
48650
48651
48652
48653
48654
48655
48656
48657
48658
48659
48660
48661
48662
48663
48664
48665
48666
48667
48668
48669
48670
Page 12 of 16
GMD005453
GMD005454
GMD005455
GMD005456
GMD005457
GMD005458
GMD005459
GMD005460
GMD005461
GMD005462
GMD005463
GMD005464
GMD005465
GMD005466
Mus musculus Linnaeus, 1758
(GMD08071)
Photorhabdus luminescens (Thomas and
Poinar 1979) Boemare et al, 1993
(GMD08071)
Pieris brassicae Linnaeus, 1758
(GMD08071)
Pieris rapae Linnaeus, 1758 (GMD08071)
Plutella xylostella Linnaeus, 1758
(GMD08071)
Pseudomonas fluorescens Migula 1895
(GMD08071)
Serratia entomophila Grimont et al., 1988
(GMD08071)
Serratia proteamaculans (Paine and
Stansfield 1919) Grimont et al, 1978
(GMD08071)
Spodoptera frugiperda (Smith, 1797)
(GMD08071)
Spodoptera litura Fabricius, 1775
(GMD08071)
Tribolium castaneum Herbst, 1797
(GMD08071)
Trichoplusia ni (Huebner, 1803)
(GMD08071)
Xenorhabdus nematophila corrig. (Poinar
and Thomas 1965) Thomas and Poinar
1979 (GMD08071)
Yersinia entomophaga Hurst et al, 2009
(GMD08071)
Environmental Risk Management Authority Decision: Application GMD08071
48671
48672
48673
48674
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Appendix 1: Controls required by this approval
In order to provide for the matters detailed in Part I of the Third Schedule of the Act3,
Containment Controls for Importation, Development and Field Testing of Genetically
Modified Organisms, and other matters in order to give effect to the purpose of the Act, the
approved organisms are subject to the following controls:
1
To limit the likelihood of any accidental release of any organism or any viable
genetic material4.
1.1
The approved organism shall be developed and maintained within a containment
facility which complies with these controls.
1.2
The Operator must ensure all personnel involved in the handling of the organism are
made aware of and understand the Authority’s controls.
1.3
The facility shall be approved by MAF as a containment facility under section 39 of
the Biosecurity Act, in accordance with the MAF/ERMA New Zealand Standard
(below), and controls imposed by the Authority (as follows):
1.4
The construction, operation and management of the containment facility shall be in
accordance with the:
1.4.1 MAF/ERMA New Zealand Standard: Facilities for Microorganisms and Cell
Cultures: 20075;
1.4.2 Australian/New Zealand Standard AS/NZS 2243.3:2002. Safety in
laboratories: Part 3: Microbiological aspects and containment facilities5; and
1.4.3 Physical Containment level 1 (PC1) requirements of the above standards for
developments involving non-pathogenic laboratory strains of Escherichia coli
and Bacteriophage lambda, disarmed strains of Caudovirales and Siphoviridae,
disarmed polyhedrin-minus strains of AcMNPV, insect and mammalian cell
lines described in Table 1; or
3
Bold headings in the following text refer to Matters to be Addressed by Containment Controls for Import,
Development and Field Testing of Genetically Modified Organisms, specified in the Third Schedule of the Act.
4
Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can
be defined to mean biological material capable of growth even though resuscitation procedures may be required,
e.g. when organisms or parts thereof are sub-lethally damaged by being frozen, dried, heated, or affected by
chemical.
5
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
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1.4.4 Physical Containment level 2 (PC2) requirements of the above standards for
developments involving Photorhabdus luminescens,
Pseudomonas fluorescens, Serratia entomophila, Serratia proteamaculans,
Yersinia entomophaga, and Xenorhabdus nematophila bacteria.
1.5
The construction, operation and management of the containment facility shall be in
accordance with the:
1.4.5 MAF/ERMA New Zealand Standard: Transitional and Containment Facilities
for Invertebrates5;
1.4.6 Australian/New Zealand Standard AS/NZS 2243.3:2002. Safety in
laboratories: Part 3: Microbiological aspects and containment facilities5; and
1.4.7 Physical Containment level 2 (PC2) requirements of the above standards for
developments involving whole insects.
2
2.1
3
3.1
4
4.1
5
5.1
To exclude unauthorised people from the facility.
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 and 1.5 relating to the identification
of entrances, numbers of and access to entrances and security requirements for the
entrances and the facility.
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility.
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 and 1.5 relating to the exclusion of
other organisms from the facility and the control of undesirable and unwanted
organisms within the facility.
To prevent unintended release of the organism by experimenters working with the
organism.
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 and 1.5 relating to the prevention of
unintended release of the organism by experimenters working with the organism.
To control the effects of any accidental release or escape of an organism.
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 and 1.5 relating to controlling the
effects of any accidental release or escape of an organism.
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5.2
6
If a breach of containment occurs6 the Operator must ensure that the MAF Inspector
responsible for supervision of the facility has received notification of the breach
within 24 hours.
Inspection and monitoring requirements for containment facilities.
6.1
The operation of the containment facilities shall comply with the requirements
contained in the standards listed in control 1.4 and 1.5 relating to the inspection and
monitoring requirements for containment facilities.
6.2
The containment manual shall be updated, as necessary, to address the
implementation of the controls imposed by this approval, in accordance with the
standards listed in control 1.4 and 1.5.
7
7.1
Qualifications required of the persons responsible for implementing those controls.
The training of personnel working in the facility shall be in compliance with the
standards listed in control 1.4 and 1.5.
6
Breach of containment includes: escape of organism(s), unauthorised entry to facility, and/or structural
integrity of facility compromised.
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