ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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21 April 2006
GMD06008
 To develop in containment genetically modified organisms
under sections 40(1)(b) and 42A of the Hazardous Substances
and New Organisms (HSNO) Act 1996.
HortResearch, Palmerston North
Applicant
The aim of the research is to understand insect gene function
Purpose
and regulatory elements, such as promoters, terminators and
enhancers, involved in insect growth, development, behaviour,
digestion, olfaction and other traits.
20 21 March 2006
Date received
Consideration date 22 21 April 2006
Chief Executive, ERMA New Zealand
Considered by
Application code
Application type
1 Summary of decision
1.1
The application to develop, as a project, genetically modified organisms in
containment is approved, with controls, having been considered in
accordance with the relevant provisions of the Hazardous Substances and
New Organisms (HSNO) Act 1996 (the Act), the HSNO (Low-Risk
Genetic Modification) Regulations 2003 (the Low-Risk Regulations), and
the HSNO (Methodology) Order 1998 (the Methodology).
The organisms approved are:
1.2
The organisms approved for development are described in Table 1:
Table 1: Organisms as recorded on ERMA New Zealand Register
For the purposes of creating insect gene libraries:
Bacteriophage lambda (Enterobacteria phage λ)1 Non-pathogenic
Name of the host organism:
Category of the host
organism:
What the organism is
modified with:
commercially available laboratory strains of bacteriophage
lambda.
1
Genomic DNA or complementary DNA (cDNA) isolated from
lepidopteran, coleopteran, hemipteran, orthopteran, hymenopteran
and dipteran insects.
Category of the modification:
Donor DNA will be derived from the insect families listed below
the table but will exclude genetic material derived from species
listed by the Convention on International Trade in Endangered
Species (CITES).
A
Containment level:
PC1
Name of the host organism:
Escherichia coli (Migula 1895) Castellani & Chalmers 1919
non-pathogenic laboratory strains.
1
Category of the host
organism:
What the organism is
modified with:
Standard Escherichia coli bacteriophage lambda vectors
containing genomic DNA or complementary DNA (cDNA)
isolated from lepidopteran, coleopteran, hemipteran, orthopteran,
hymenopteran and dipteran insects.
Category of the modification:
Donor DNA will be derived from the insect families listed below
the table but will exclude genetic material derived from species
listed by the Convention on International Trade in Endangered
Species (CITES).
A
Containment level:
PC1
1
International Committee on Taxonomy of Viruses (ICTV) approved name.
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For the purposes of insect gene cloning and expression:
Names of the host organisms: Escherichia coli (Migula 1895) Castellani & Chalmers 1919
non-pathogenic laboratory strains.
Category of the host
organisms:
What the organisms are
modified with:
Autographa californica nucleopolyhedrovirus2
(Chapman and Glasier 1915, Allen 1921) AcMNPV nonpathogenic laboratory strains.
1
Standard Escherichia coli and insect cloning and expression
plasmid vectors containing genomic DNA or cDNA as sense or
antisense constructs. The genetic material will consist of genes
and regulatory elements involved in insect development, olfaction
such as pheromone receptors, gustation, insecticide resistance and
response such as esterase genes, host resistance, digestion and
gene regulation.
Donor DNA will be derived from the insect families listed below
the table.
The genetic material may be modified by insertion3, deletion,
alteration of sequences or site-directed mutagenesis, and by the
addition of regulatory elements such as promoter and terminator
sequences derived from baculoviruses, (Autographa californica
nucleopolyhedrovirus (AcMNPV) and Epiphyas postvittana
nucleopolyhedrovirus (EppoNPV)) or from the list of donor
insects described below.
Vectors will include promoters and other gene regulatory
elements, reporter and selectable marker genes, protein
purification tags and origins of replication, but the modifications
will exclude any of the following:

Material from species listed by the Convention on
International Trade in Endangered Species (CITES).

Genes encoding known or suspected vertebrate toxins
with an LD50 < 100 µg/kg.
Category of the modification: A
Containment level:
PC1
Names of the host organisms:
Spodoptera frugiperda (JE Smith, 1797) cell lines, such as Sf9
and Sf26.
Trichoplusia ni (Hübner 1803) cell lines, such as Tn5.
Epiphyas postvittana (Walker, 1863) cell lines.
1
Category of the host
organisms:
2
3
International Committee on Taxonomy of Viruses (ICTV) approved name.
Insertion of up to 250 bp of artificially created DNA
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What the organisms are
modified with:
Standard Escherichia coli and insect cloning and expression
plasmid vectors, and Autographa californica
nucleopolyhedrovirus vectors containing genomic DNA or cDNA
as sense or antisense constructs. The genetic material will consist
of genes and regulatory elements involved in insect development,
olfaction such as pheromone receptors, gustation, insecticide
resistance and response such as esterase genes, host resistance,
digestion and gene regulation.
Donor DNA will be derived from the insect families listed below
the table.
The genetic material may be modified by insertion4, deletion,
alteration of sequences or site-directed mutagenesis, and by the
addition of regulatory elements such as promoter and terminator
sequences derived from baculoviruses, (Autographa californica
nucleopolyhedrovirus (AcMNPV) and Epiphyas postvittana
nucleopolyhedrovirus (EppoNPV)) or from the list of donor
insects described below.
Vectors will include promoters and other gene regulatory
elements, reporter and selectable marker genes, protein
purification tags and origins of replication, but the modifications
will exclude any of the following:

Material from species listed by the Convention on
International Trade in Endangered Species (CITES).

Genes encoding known or suspected vertebrate toxins
with an LD50 < 100 µg/kg.
Category of the modification: A
Containment level:
PC1
Names of the host organisms:
Apis mellifera (Linnaeus, 1758), Cydia pomonella (Linnaeus,
1758), Drosophila melanogaster (Meigen, 1830), Epiphyas
postvittana (Walker, 1863), Helicoverpa armigera (Hübner,
1808), Hofmannophila pseudospretella (Stainton, 1849), Myzus
persicae (Sulzer, 1776), Phthorimaea operculella (Zeller, 1873),
Scolypopa australis (Walker, 1851), Spodoptera litura (Fabricius,
1775), Teleogryllus commodus (Walker), Tineola bisselliella
(Hummel, 1823) – whole insects
2
Category of the host
organisms:
What the organisms are
modified with:
4
Autographa californica nucleopolyhedrovirus vectors containing
genomic DNA or cDNA as sense or antisense constructs. The
genetic material will consist of genes and regulatory elements
involved in insect development, olfaction such as pheromone
receptors, gustation, insecticide resistance and response such as
esterase genes, host resistance, digestion and gene regulation.
Insertion of up to 250 bp of artificially created DNA.
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Donor DNA will be derived from the insect families listed below
the table.
The genetic material may be modified by insertion5, deletion,
alteration of sequences or site-directed mutagenesis, and by the
addition of regulatory elements such as promoter and terminator
sequences derived from baculoviruses, (Autographa californica
nucleopolyhedrovirus, AcMNPV and Epiphyas postvittana
nucleopolyhedrovirus, EppoNPV) or from the list of donor
insects.
Vectors will include promoters and other gene regulatory
elements, reporter and selectable marker genes, protein
purification tags and origins of replication, but the modifications
will exclude any of the following:

Material from species listed by the Convention on
International Trade in Endangered Species (CITES).

Genes encoding known or suspected vertebrate toxins
with an LD50 < 100 µg/kg.
Category of the modification: B
Containment level:
PC2
Donor DNA will be derived from the following insect families:
Lepidopteran insects:
 Tortricid family including Epiphyas postvittana and Cydia pomonella.
 Noctuid family including Helicoverpa armigera and Spodoptera litura.
 Oecophorid family including Hofmannophila pseudospretella.
 Teneid family including Tineola bisselliella.
 Gelechilid family including Phthorimaea operculella.
 Lymantrid family including Teia anartoides
 Bombyxicid family including Bombyx mori
 Orygid, Hyponomeutid, Pierid, Hepialid, Geometrid and Pyralid families
Coleopteran insects:
 Scarabaeid, Cerambycid, Chrysomelid, Bruchid, Tenebrionid and Curculonid
families
Hemipteran insects:
 Aphidid, Pentatomid, Ricaniid, Mirid, Eriococcid, Coccid and Diaspid families
including Scolypopa australis and Myzus persicae
Orthopteran insects:
 Gryllid and Acridid families including Telleogryllus commodus
Hymenopteran insects:
 Siricid, Formicid, Vespid and Apid families including Apis mellifera
Dipteran insects:
 Cecidomycid, Calliphorid, Muscid, Drosophilid and Culicid families including
Drosophila melanogaster
5
Insertion of up to 250 bp of artificially created DNA
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2 Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(b) of the Act and
determined according to the rapid assessment provisions of section 42A of
the Act.
2.2
The application has been approved with controls by Mr Rob Forlong, Chief
Executive of ERMA New Zealand, under delegation from the Authority as
provided for in section 19 of the Act.
3 Consideration
Sequence of the consideration
3.1
The application was formally received and verified as containing sufficient
information on 21 March 2006.
3.2
The decision was based on the information supplied by the applicant in their
application form: Develop in containment a project of low risk genetically
modified organisms by rapid assessment (ER-AF-NO3P-1).
3.3
It was determined that further information was required to complete the
assessment of this application. The Authority authorised the obtaining of
this information under section 58(1)(b) of the HSNO Act 1996, and the
applicant was notified accordingly. The consideration of this application was
postponed under section 58(3) of the HSNO Act 1996, until the information
was obtained.
3.4
The application was considered by 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.
3.5
The development of the genetically modified organism described above
(Table 1) meets the criteria of a low-risk genetic modification specified in
the Regulations made under section 41 of the Act, being the HSNO (LowRisk Genetic Modification) Regulations 2003.
3.6
In reaching my decision I have used information that is relevant and
appropriate to the scale and significance of the risks, costs, and benefits
associated with the genetic modifications and matters relevant to the purpose
of the Act, as specified in Part II, and followed the relevant provisions of the
Methodology.
3.7
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 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)
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 Assessment against the criteria for low-risk genetic modification
(section 42A of the Act)
 Identification and assessment of the risks and other impacts of the
organism
 Precedents
 Proposed controls
3.8
The Department of Conservation (DoC) was notified upon receipt of this
application.
3.9
DoC responded with comments on the application by email on 27 March
2006 , and concluded with the following statement:
“The Department considers that the containment system is adequate to
contain the host organisms and the modifications are not expected to change
the ability of the host organisms to escape containment. Therefore, based on
the low likelihood of escape from containment, the Department considers
that the overall risk to its mission from the developed microorganisms to be
negligible”.
Purpose of the application
3.10 The purpose of this project is to analyse insect genes, and DNA elements
regulating expression such as promoters, transcriptional and translational
enhancers, to determine their function in insect development and
biochemical processes. The genes of interest will be genes which have been
identified via a bioinformatics approach as being likely to be involved in:
insect development, olfaction such as pheromone receptors, gustation,
insecticide resistance and response such as esterase genes, host resistance
and gene regulation.
3.11 Transient, stable and viral expression studies will be carried out in insect
cell lines, and transient expression of genes or parts of genes may also be
performed in whole insects by injecting these insects with modified
baculoviruses. The host insects for these experiments have been specifically
chosen as ones in which the virus (AcMNPV baculovirus) cannot replicate,
with the exceptions of Helicoverpa armigera and Spodoptera litura, in which
the AcMNPV baculovirus can establish an infection. Understanding the
function of insect genes and regulatory elements will offer the potential to
develop new methods of influencing insect development, behaviour,
physiology and other traits and thus allow the control of pest species.
3.12 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.
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Assessment against the criteria for low-risk genetic
modification
3.13 Category of host organisms:
Laboratory strains of Escherichia coli (non-pathogenic), bacteriophage
lambda, Autographa californica nucleopolyhedrovirus (AcMNPV) (nonpathogenic strains) and insect cell lines from Spodoptera frugiperda,
Trichoplusia ni, and Epiphyas postvittana, are Category 1 host organisms as
defined in clause 7(1) of the HSNO (Low-Risk Genetic Modification)
Regulations 2003. These organisms are not capable of causing disease in
humans, animals, plants or fungi nor do they produce desiccation-resistant
structures, such as spores or cysts.
Non-pathogenic laboratory strains of bacteriophage lambda are viral hosts,
frequently used for the establishment of genomic DNA and cDNA libraries
as these vectors can contain large fragments of genetic material. The host
organism Autographa californica nucleopolyhedrovirus (AcMNPV) can be
infectious to insect cell lines. It is noted that the laboratory strains have been
disarmed, by having the polyhedrin gene deleted. These strains are unable to
infect moths or survive outside the laboratory.
The insects, Epiphyas postvittana, Spodoptera litura, Helicoverpa armigera,
Drosophila melanogaster, Cydia pomonella, Hofmannophila
pseudospretella, Tineola bisselliella, Phthorimaea operculella, Scolypopa
australis, Myzus persicae, Teleogryllus commodus, and Apis mellifera, are
category 2 host organisms as defined by clause 7(2)(iii) of the HSNO (LowRisk Genetic Modification) Regulations 2003, as these are whole insects.
3.14 Category of genetic modification:
The proposed genetic modifications to established laboratory strains of
Escherichia coli, bacteriophage lambda, Autographa californica
nucleopolyhedrovirus and insect cell lines from Spodoptera frugiperda,
Trichoplusia ni, and Epiphyas postivittana, 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 as described in Table 1 of this decision are Category A
genetic modifications as defined in clause 5(1) of the HSNO (Low-Risk
Genetic Modification) Regulations 2003 and require a minimum of Physical
Containment Level 1 (PC1).
The proposed injection of genetically modifed baculoviruses 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
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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).
3.15 I am satisfied that the development meets the criteria for low-risk genetic
modification specified in the Regulations, made under section 41 of the Act.
The experiments on Escherichia coli, bacteriophage lambda, Autographa
californica nucleopolyhedrovirus and the insect cell lines, meet the
requirements of Category A modifications as defined in clause 5 of the
Regulations in that the modification involves a category 1 host organism and
is to be carried out under a minimum of PC1 containment.
3.16 Injection of Autographa californica nucleopolyhedrovirus 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 154.02.08 ‘Transitional and
Containment Facilities for Invertebrates’.
Identification and assessment of the risks, costs and other
impacts of the organisms
3.17 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 and 10 of the Methodology the
information supplied by the applicant has been evaluated as follows:
3.18 I consider that, given the controls attached to this approval, there is no
evidence for, nor any reason to expect, any non-negligible adverse effects of
the proposed genetically modified organism on humans, animals, plants,
other organisms or the environment.
3.19 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.
3.20 As this application does not involve the use of genetic material from native
or valued flora and fauna from New Zealand or DNA sourced from Māori,
and as this application is for a development in containment, there is no
requirement for the applicant to consult with Māori.
3.21 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.
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Precedents
3.22 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 low-risk genetic developments of
non-pathogenic Escherichia coli, bacteriophage lambda, Autographa
californica nucleopolyhedrovirus, and insect cell lines, have been
considered and approved on many occasions by Institutional Biological
Safety Committees (IBSCs) under delegated authority and by the Chief
Executive of ERMA New Zealand.
3.23 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, 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.
3.24 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
which are genetically modified by infection with the modified
baculoviruses. This decision however, does not set a precedent as to how the
Authority will consider future decisions with regard to this issue.
Containment
3.25 The proposed genetic modifications on category 1 hosts, Esherichia coli,
bacteriophage lambda, Autographa californica nucleopolyhedrovirus and
the insect cell lines, meet the requirements of Category A genetic
modifications as defined in clause 5 of the HSNO (Low-Risk Genetic
Modification) Regulations 2003. Category A experiments are required to be
contained within a Physical Containment level 1 facility (PC1) registered
under MAF/ERMA New Zealand Standard 154.03.02 ‘Containment
Facilities for Microorganisms’. The containment regime contains clear
guidelines for the safe handling and disposal of bacterial cultures and
biological wastes.
3.26 The facility in which the organisms will be maintained shall comply with
the requirements of the Australian New Zealand Standard AS/NZS
2243.3:2002 Safety in Laboratories: Part 3: Microbiological aspects of
containment and facilities, except for the deviations specified in the
MAF/ERMA New Zealand Standard 154.03.02. The laboratory proposed to
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be used by the applicant is currently approved and registered as a
containment facility under section 39 of the Biosecurity Act, in accordance
with the MAF/ERMA New Zealand Standard 154.03.02.
3.27 Transient expression of insect genes will be studied by injecting genetically
modified baculoviruses 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 154.02.08 ‘Transitional and
Containment Facilities for Invertebrates’, 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.
4 Decision
4.1
I am satisfied that this application is for one of the purposes specified in
section 39(1) of the Hazardous Substances and New Organisms Act 1996,
being section 39(1)(a): the development of any [new] organism.
4.2
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organism that is the subject of this
approval, the modification and the criteria for low-risk genetic modification
detailed in the HSNO (Low-Risk Genetic Modification) Regulations 2003, I
am of the view that these organisms meet the criteria for rapid assessment
under section 42A of the Hazardous Substances and New Organisms Act
1996.
4.3
I am satisfied that the proposed containment regime and the controls
imposed in accordance with section 42A(3)(b) of the Hazardous Substances
and New Organisms Act 1996, as set out below, will adequately contain the
organism.
4.4
Pursuant to section 42A(3)(a) of the Hazardous Substances and New
Organisms Act 1996, and acting under delegation from the Authority
provided for in section 19 of the Act, I have approved this project
application for the genetically modified organisms described in Table 1 of
this decision, subject to the controls specified herein.
4.5
In reaching this decision I have relied upon the following criteria in the Act
and the Methodology:
 Criteria for assessing the purpose of the application (section 39 of the
Act)
 Criteria for rapid assessment of adverse effects for the development of a
genetically modified organism in containment (section 42A of the Act).
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 Criteria for a low-risk genetic modification specified in the HSNO
(Low-Risk Genetic Modification) Regulations 2003, made under section
41 of the Act.
 The information provided by the applicant was assessed against the
criteria in clauses 9, 10 and 12 of the HSNO (Methodology) Order 1998.
 Matters to be addressed by containment controls for developing
genetically modified organisms specified in Part 1 of the Third Schedule
to the Act.
5 Controls
In order to provide for the matters detailed in Part 1 of the Third Schedule of the Act6,
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 organism is subject to the following controls:
1 To limit the likelihood of any accidental release of any organism or
any viable genetic material7.
1.1
The approved organisms shall be developed and maintained within a
containment facility which complies with these controls.
1.2
The person responsible for a particular research area and/or the person
responsible for the operation of the containment facility shall inform all
personnel involved in the handling of the organism of the Authority’s controls.
1.3
The facility shall be approved and registered 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 and operation of the containment facility shall be in
accordance with:
a) MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.028:
Containment Facilities for Microorganisms.
b) Australian New Zealand Standard AS/NZS 2243.3:20028: Safety in
Laboratories: Part 3: Microbiological Aspects and Containment
Facilities.
6
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.
7
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.
8
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand
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c) Physical Containment Level 1 (PC1) requirements of the above
standards for Escherichia coli, bacteriophage lambda, Autographa
californica nucleopolyhedrovirus (AcMNPV), and insect cell lines from
Spodoptera frugiperda, Trichoplusia ni, and Epiphyas postvittana.
1.5
The construction and operation of the containment facility shall be in
accordance with:
d) MAF Biosecurity Authority/ERMA New Zealand Standard 154.02.088:
Transitional and Containment Facilities for Invertebrates.
e) Australian New Zealand Standard AS/NZS 2243.3:20028: Safety in
Laboratories: Part 3: Microbiological Aspects and Containment
Facilities.
f) Physical Containment Level 2 (PC2) requirements of the above
standards for Epiphyas postvittana, Spodoptera litura, Helicoverpa
armigera, Drosophila melanogaster, Cydia pomonella, Hofmannophila
pseudospretella, Tineola bisselliella, Phthorimaea operculella,
Scolypopa australis, Myzus persicae, Teleogryllus commodus, and Apis
mellifera
2 To exclude unauthorised people from the facility.
2.1
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.
3 To exclude other organisms from the facility and to control
undesirable and unwanted organisms within the facility.
3.1
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.
4 To prevent unintended release of the organism by experimenters
working with the organism.
4.1
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.
5 To control the effects of any accidental release or escape of an
organism.
5.1
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
If a breach of containment occurs, the facility operator must ensure that the
MAF Inspector responsible for supervision of the facility has received
notification of the breach within 24 hours.
5.3
In the event of any breach of containment of the organism, the contingency plan
for the attempted retrieval or destruction of any viable material of the organism
that has escaped shall be implemented immediately. The contingency plan shall
be included in the containment manual in accordance with the requirements of
standards listed in control 1.4 and 1.5.
6 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 Qualifications required of the persons responsible for implementing
those controls.
7.1
The training of personnel working in the facility shall be in compliance with the
standards listed in control 1.4 and 1.5.
_____________________
_____________
Rob Forlong
Date
Chief Executive, ERMA New Zealand
Approval code (BCH code): GMD004226 – GMD004242 (12181 – 12197)
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the
Australian/New Zealand containment facility references to “future proof” the
decision
 Standardise the wording of the breach of containment control
 Removal of the control regarding inspection of facilities by the Authority, its
agent or enforcement officers
____________________________
Mr Rob Forlong
Chief Executive, ERMA New Zealand
Environmental Risk Management Authority Decision: GMD06008
16 August 2007
Date:
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