ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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Application code
Application type
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Applicant
Purpose
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20 12 December 2003
Date received
Consideration date 22 5 January 2004
Chief Executive, ERMA New Zealand
Considered by
5 January 2004
GMD03131
 To develop in containment genetically modified organisms
under section 40(1)(b) of the Hazardous Substances and New
Organisms (HSNO) Act 1996.
 AgResearch Limited
To clone cDNA encoding proteins expressed by sheep, cow, mouse,
rabbit, llama, alpaca, or nematodes that may play an important role in
sheep immunity to nematode infection in order to improve the health
of sheep.
1 Summary of decision
The application to develop a new organism 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 HSNO (Low-Risk
Genetic Modification) Regulations 2003, and the HSNO (Methodology) Order 1998.
The organisms approved are:
The organisms approved for development are the genetically modified
microorganisms and cell lines as listed below in table one:
Table 1: Organisms as recorded on ERMA New Zealand Register
Host Organism
1. Autographa californica
nuclear polyhedrovirus
(AcMNPV) laboratory nonpathogenic strains
(Chapman & Glaser 1915,
Allen 1921)
As modified by
modified with non-conjugative cloning and
expression plasmid vectors containing: DNA or
cDNA involved in regulating the induction,
maintenance and amplification of the immune
response sourced from sheep, cow, mouse, rabbit,
llama, or alpaca species and DNA or cDNA
encoding antigens from Caenorhabditis elegans,
Trichostrongylus colubriformis, Trichostrongylus
vitrinus, Trichostrongylus axei, Haemonchus
contortus, Teladorsagia circumcincta, Teladorsagia
ostertagii, Teladorsagia lyrata, Cooperia curticei,
Cooperia oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
Host Organism
As modified by
2. Cricetulus griseus cell lines modified with non-conjugative cloning and
(Milne-Edwards 1867)
expression plasmid vectors containing: DNA or
cDNA involved in regulating the induction,
maintenance and amplification of the immune
response sourced from sheep, cow, mouse, rabbit,
llama, or alpaca species and DNA or cDNA
encoding antigens from Caenorhabditis elegans,
Trichostrongylus colubriformis, Trichostrongylus
vitrinus, Trichostrongylus axei, Haemonchus
contortus, Teladorsagia circumcincta, Teladorsagia
ostertagii, Teladorsagia lyrata, Cooperia curticei,
Cooperia oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
3. Escherichia coli K12 or B
derivatives strains (Migula
1895) Castellani and
Chambers 1919
modified with non-conjugative cloning and
expression plasmid vectors containing: DNA or
cDNA involved in regulating the induction,
maintenance and amplification of the immune
response sourced from sheep, cow, mouse, rabbit,
llama, or alpaca species and DNA or cDNA
encoding antigens from Caenorhabditis elegans,
Trichostrongylus colubriformis, Trichostrongylus
vitrinus, Trichostrongylus axei, Haemonchus
contortus, Teladorsagia circumcincta, Teladorsagia
ostertagii, Teladorsagia lyrata, Cooperia curticei,
Cooperia oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
4. Pichia pastoris Phaff
(1956)
modified with non-conjugative cloning and
expression plasmid vectors containing: DNA or
cDNA involved in regulating the induction,
maintenance and amplification of the immune
response sourced from sheep, cow, mouse, rabbit,
llama, or alpaca species and DNA or cDNA
encoding antigens from Caenorhabditis elegans,
Trichostrongylus colubriformis, Trichostrongylus
vitrinus, Trichostrongylus axei, Haemonchus
contortus, Teladorsagia circumcincta, Teladorsagia
ostertagii, Teladorsagia lyrata, Cooperia curticei,
Cooperia oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
5. Spodoptera frugiperda cell
lines (JE Smith, 1797)
modified with baculoviral vectors (based on
AcMNPV) or non-conjugative plasmid cloning
vectors containing: DNA or cDNA involved in
regulating the induction, maintenance and
amplification of the immune response sourced from
sheep, cow, mouse, rabbit, llama, or alpaca species
and DNA or cDNA encoding antigens from
Caenorhabditis elegans, Trichostrongylus
colubriformis, Trichostrongylus vitrinus,
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Host Organism
6. Trichoplusia ni cell lines
(Hubner 1800-1803)
As modified by
Trichostrongylus axei, Haemonchus contortus,
Teladorsagia circumcincta, Teladorsagia ostertagii,
Teladorsagia lyrata, Cooperia curticei, Cooperia
oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
modified with baculoviral vectors (based on
AcMNPV) or non-conjugative plasmid cloning
vectors containing: DNA or cDNA involved in
regulating the induction, maintenance and
amplification of the immune response sourced from
sheep, cow, mouse, rabbit, llama, or alpaca species
and DNA or cDNA encoding antigens from
Caenorhabditis elegans, Trichostrongylus
colubriformis, Trichostrongylus vitrinus,
Trichostrongylus axei, Haemonchus contortus,
Teladorsagia circumcincta, Teladorsagia ostertagii,
Teladorsagia lyrata, Cooperia curticei, Cooperia
oncophora, Nematodirus spathiger or
Parastrongyloides trichosuri.
The applicant has specified the following vector systems to be used:
Vector system(s):
The vectors used for this work shall only contain one or more of the following elements, and
involve genetic modifications that meet Category A experiments in the Hazardous Substances
and New Organisms (Low-Risk Genetic Modifications) Regulations 2003:
1. Promoters and terminators
Promoter, operator, and enhancer sequences and/or terminator sequences derived from
bacterial, vertebrate or invertebrate genes, or from mammalian or bacterial viruses.
2. Reporter genes
Fully characterised1 reporter genes whose products can be assayed by one or more of the
following techniques:
Visual colour or fluorescence
Spectrophotometrically
Histochemically
Enzyme-linked immunosorbent assays (ELISA)
Thin layer chromatography
Liquid scintillation counting
Affinity purification
Immunological detection
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And do not produce proteins that are pathogenic to vertebrates, or vertebrate toxins that have
an LD502 less than 100 μg/kg, or are involved in vertebrate cellular differentiation.
1
The sequence and function of the gene are known.
LD50 is defined as Lethal Dose, 50%. The basic idea (and practice) of the test is to take healthy animals
(usually mice or rats but sometimes dogs, monkeys or other animals) and force feed them enough toxin to
kill (usually slowly) 50% of them. (Variations include starving the individual before testing, injecting the
tested substance, or coating the animal's skin with the tested chemical.)
2
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3. Selectable marker genes
Fully characterised genes that confer the ability to:
 Tolerate or deactivate antibiotics
 Tolerate or deactivate metabolic inhibitors
 Synthesise amino acids
And do not produce proteins that are pathogenic to vertebrates, or vertebrate toxins that have
an LD50 less than 100 μg/kg, or are involved in vertebrate cellular differentiation.
4. Origins of replication3
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Origins of replication derived from E. coli plasmids.
Bacteriophage origins of replication.
5. Other features
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Multiple cloning site
Polyadenylation signals
Transcriptional activators, enhancers, responsive elements, receptor elements
Terminator sequences
Intron sequences to alter gene expression
Ribosomal binding sites and/or Kozak sequences
Viral packaging signals, e.g., Ψ+, cos sites
Viral genes required for replication that do not produce proteins that are pathogenic to
vertebrates, or vertebrate toxins that have an LD50 less than 100 μg/kg, or are involved in
vertebrate cellular differentiation. Viral sequences that are capable of producing more
than two thirds of a virus or produce a particle that is capable of infecting humans shall
not be included in the same organism.
6. Other Genetic Material
These vectors may contain regulatory elements sourced from bacteria, invertebrates,
vertebrates, viruses or bacteriophages but the genetic material shall not include:
 Genes encoding vertebrate toxins that have an LD50 of less than 100 μg/kg
 Genes encoding vertebrate toxins that have an LD50 of greater than 100 μg/kg if these
genes will be expressed at levels higher than found in the organism from which they were
derived
 More than two thirds of a complete viral genome
 Sequences that (with the exception of the ability of the laboratory-adapted AcNPV
vectors to infect insect cell lines) will produce particles able to infect humans, animals, or
plants.
 Uncharacterised sequences from pathogenic microorganisms
 Sequences from New Zealand native flora and fauna
 Sequences from CITES species without specific approval
 Sequences derived from humans.
Background Information
This proposal received from AgResearch Limited examines the sheep’s ability to
develop immunity to nematode infections as part of a wider programme aimed at
discovering new methods such as vaccination to improve sheep health. Infection of
sheep by nematodes (gastrointestinal worms) causes economic loss due to reduced
3
Origins of replication are the nucleotide sequences at which DNA synthesis is initiated.
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productivity. Potentially, this work will lead to increased productivity of the sheep
and lessen the current reliance on widespread chemical treatments.
Proteins involved in the induction, maintenance and amplification of the immune
system of sheep, cow, or mouse will be cloned and expressed in bacteria yeast and
cell lines to develop immunologic reagents needed to investigate the role of these
proteins in the establishment of immunity to nematode infections.
Proteins from species other than sheep are required due to the discrepancy in the
knowledge of these proteins from the sheep compared to the mouse or cow. Also, the
use of mouse proteins will enable AgResearch to work in a small animal model
leading to higher throughput of work due to the greater availability of mouse reagents
and strains. In some instances, genes from other species, such as the mouse, rabbit,
llama, or alpaca encoding antibodies against immune proteins and nematode antigens,
will be cloned and expressed to generate diagnostic reagents for the detection of these
proteins. The mouse and rabbit species were chosen due to the wealth of knowledge in
the vaccination of these animals for antibody production. The alpaca and llama were
chosen due to their unique property of antibodies containing only heavy chains
(absence of light chain in functional antibody proteins). This property simplifies the
cloning of antibody proteins and as a consequence allows for fewer animals and
resources needed to generate these antibodies. In most cases, single chain antibodies
will be generated, these consist of only the binding domain of the heavy and light
chains without the constant domains of the various antibody isotypes. Single chain
antibodies will be cloned due to their ability to maintain binding activity as a single
protein domain. This allows for the expression either within organisms as a soluble
protein or incorporated within a bacteriophage amendable for in vitro binding assays.
In some instances the antibody constant domain may be re-engineered onto the single
chain antibody to investigate the role of this domain in the immunologic response.
Expression of these proteins will first be attempted in a bacterial system. In some
cases, other expression systems such as yeast, insect or mammalian cell lines will be
required in order to generate biologically functional molecules proteins because
sometimes bacteria cannot produce the correctly modified form (post-translational
modifications) of the proteins. In addition, nematode antigens, identified, sequenced,
and expressed under previously approved ERMA applications GMO-02/ARW022
(ERMA New Zealand application code GMD02108 and approval code GMF002314)
and GMO-00/ARW015 (ERMA New Zealand application code GMD00110 and
approval code GMD000820), will be expressed in expression systems other than
bacteria in order to generate biologically functional proteins. These will be used to
immunise animals for the production of antibodies or to investigate the role of these
antigens in the immune response.
2 Legislative Criteria for Application
The application was lodged pursuant to section 40(1)(b) of the HSNO Act 1996 and
determined according to the rapid assessment provisions of section 42 of the HSNO
Act 1996.
The application has been approved by Dr Bas Walker, Chief Executive of ERMA
New Zealand, under delegation from the Authority as provided for in section 19
HSNO Act 1996.
Category of low-risk genetic modification
I, the chief executive, am satisfied that the development of each of the genetically
modified organisms described above (Table 1) meets the criteria for a low-risk genetic
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modification specified in the regulations made under section 41, being the HSNO
(Low-Risk Genetic Modification) Regulations 2003.
The developments using Autographa californica nuclear polyhedrovirus (AcMNPV)
non-pathogenic strains, Cricetulus griseus cell lines, Escherichia coli K 12 or B
derivatives, Pichia pastoris, Spodoptera frugiperda and Trichoplusia ni cell lines as
host organisms meet the requirements of Category 1 host organisms with Category A
genetic modifications according to the HSNO (Low-Risk Genetic Modification)
Regulations 2003. The host organisms are considered Category one host organisms as
they are non-pathogenic, free of eukaryotic viruses or other infectious or pathogenic
agents; are not normally infectious or able to colonise humans and do not produce airborne desiccation-resistant spores or cysts; and the main biological characteristics are
known.
The host organism Autographa californica nuclear polyhedrovirus (AcMNPV) can be
infectious to insect cell lines. It is noted that the strains used in these experiments are
disabled and are not normally able to cause disease in insects and are wellcharacterised and do not normally infect, colonise or establish in humans and hence,
meet the requirements of a Category 1 host organism as described in the HSNO (LowRisk Genetic Modification) Regulations 2003.
All modifications are Category A as they are well characterised with respect to gene
sequence and function and the modification does not result in an organism with a
greater level of risk than a Category 2 host organism.
As Category 1 host organisms with Category A modifications they can be
appropriately carried out under Physical Containment level 1 (PC1), as defined in the
Australian/New Zealand Standard AS/NZS 2243.3 2002.
3 Consideration
Sequence of the consideration
The application was formally received and verified as containing sufficient
information on 12 December 2003.
The documents available for the evaluation and review of the application included the
application form and the two earlier applications and decisions made by the
AgResearch Walliceville Institutional Biological Safety Committee (IBSC) under
delegation from the Environmental Risk Management Authority (“the Authority”).
The AgResearch Walliceville IBSC elected to send this application to ERMA New
Zealand for processing as at the time they did not have the necessary Māori
membership on their IBSC. Therefore, in accordance with section of the HSNO Act,
as the development of each of the genetically modified organisms described above
(Table 1) meets the criteria for a low-risk genetic modification specified in the
regulations made under section 41, being the HSNO (Low-Risk Genetic Modification)
Regulations 2003, it was considered by Chief Executive of ERMA New Zealand, in
consultation with the Senior Advisor Māori.
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 HSNO Act 1996, as specified
in Part II, and followed the relevant provisions of the Hazardous Substances and New
Organisms (Methodology) Order 1998.
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In accordance with section 42 of the HSNO 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, and to consider whether there are any
residual risks that require further consideration. This approach covered the following
issues:
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Purpose of the application (section 39)
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Assessment against the criteria for low-risk genetic modifications (section 42)
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Identification and assessment of the risks and other impacts of the organism
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Precedents
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Proposed controls
The Department of Conservation (DoC) and Ministry of Agriculture and Forestry
Biosecurity Authority (MAFBA) were notified upon receipt of this application.
Leanne Perry-Meyers (DoC) stated by email on the 17 December 2003:
Thank you for the opportunity to comment on this application. The Department has
the following comments:
The Department notes that a long term goal of this research project is the
development of biological controls for gastrointestinal nematodes and the reduction
of reliance on chemical treatments. The reduction in chemical use and therefore
production is considered by the Department to have obvious positive consequences
for the environment as a whole.
The Departments primary concern with research of this nature is from the release of
genetically modified organisms into the environment (either inadvertently or not) and
the effects such an organism could have on the indigenous flora and fauna. Therefore
the Department aims to assess the application for the likelihood of this and the
potential impact that such an occurrence will have.
The Department notes that this application did not always address the details of these
issues as explicitly as it could. The applicant relied on the fact that some of the work
proposed in the application is an extension of work already approved under
GMD000820, GMD002314 and GMD000122. This factor does give confidence that
similar work is being carried out without any negative impact on the environment but
greater detail needs to be included for an accurate risk assessment can be carried out.
The Department has therefore identified two areas relevant to determining the
likelihood of escape and the impact of the pest. They are details of the containment
facilities proposed and the safety of the organism respectively.
On the issue of containment the Department notes the following factors;
All the work of cloning and the expression of genes are classified as Category
A. The application goes on to state at 3.4 that it can be carried out under a minimum
of PC1 containments. It is recommended that this should state that the work will be
carried out under a minimum of PC1 containment.
4.1 the application states that the laboratories where the work is to be done
conform to PC2 requirements. The Department suggests that to have all the work
carried out in a PC2 containment facility would greatly reduce the risk of inadvertent
exposure of the organisms to the environment.
With regards to the safety of the organisms themselves the application included that;
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Because of the containment regime in place, these organisms are unlikely to
escape and should they do so they have a limited ability to form self sustaining
populations. The E. Coli used is standard laboratory strains which have been
disabled and therefore are only able to survive transiently outside the laboratory.
Further the expression of the construct requires the presence of an inducer
substance and the expression vector will not likely persist in the absence of the
antibiotic drug selection. This is due to the negative pressure imposed by increased
metabolic requirements of carrying a plasmid.
The application states in section 5.1 that the host organisms are all widely
used, non-pathogenic and that the genetic modifications will not affect this status. The
applicant states that these laboratory strains do not pose a health risk either inside or
outside of the laboratory.
The vector systems used includes reporter genes, selectable marker genes and
viral genes that don not produce proteins that are pathogenic to vertebrates, or have
vertebrate toxins that have an LD50 less than 100μg/kg, or are involved in cellar
differentiation.
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They do not pose any health risk to humans or native flora and fauna.
Further the Department notes that there is no cloning of cDNA encoding proteins
expressed by indigenous fauna.
Conclusion
Taking into account the information supplied by the applicant on details of
containment, the Department has assessed the likelihood of escape of the organism to
be highly unlikely. With regards to the potential impact of the organism, the
Department considers that any negative impacts on the indigenous flora and fauna
would be minimal. Overall the Departments finds that the risks from approving this
application to be insignificant.
No comment was received from MAFBA.
Purpose of the application
To clone cDNA encoding proteins expressed by sheep, cow, mouse, rabbit, llama,
alpaca, or nematodes that may potentially play an important roles in sheep immunity
to nematode infection, in order to improve the health of sheep.
The applicant states that infection of sheep by gastrointestinal worms (nematodes)
causes economic loss due to reduced productivity. This proposal received from
AgResearch Limited examines the sheep’s ability to develop immunity to these
infections as part of a wider programme aimed at discovering new methods such as
vaccination to improve sheep health. Potentially, this work will lead to increased
productivity of the sheep and lessen the current reliance on widespread chemical
treatments.
I have determined that this application may be approved for the purpose of the
development of a genetically modified organism as provided for in section 39(1)(a) of
the HSNO Act 1996.
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Identification and assessment of the risks, costs and
other impacts of the organism
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:
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 organisms on humans, animals, plants, other organisms or the
environment.
I note that the host organisms Autographa californica nuclear
polyhedrovirus(AcMNPV) can be infectious to insect cell lines. However, I note that
the strains used in these experiments are disabled and are not normally able to cause
disease in insects and are well-characterised and do not normally infect, colonise or
establish in humans and hence, meet the requirements of a Category 1 host organism
as described in the HSNO (Low-Risk Genetic Modification) Regulations 2003.
I have considered the potential Māori cultural effects in accordance with the HSNO
Methodology Order 1998: Information Used by the Authority, Methodology clauses
9(b)(i) and 9(c)(iv) and Sections 6(d) and 8 of the HSNO Act 1996 and in consultation
with the Senior Advisor Māori. As this application does not involve the use of genetic
material from native flora and fauna or humans, there was no requirement for the
applicant to consult with Māori.
I do note however that some Māori groups have previously indicated concern over the
genetic modification of potential food products, and that the genetic modification of
sheep to increase immunity to nematode infection may raise cultural concern. As this
is an application for development in containment only, there is negligible risk of the
genetic modification entering the food chain.
Based on this advice, I consider that this application poses negligible risk of adverse
effects to the relationship between Māori culture and their traditions with their
ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga.
Environmental Risk Management Authority Decision: Application GMD03131
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Precedents
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
where these involve similar issues to those raised by this application I consider that a
number of previous applications considered by the AgResearch Wallaceville IBSC are
particularly relevant to the consideration of this application. In particular,
Table 2: Relevant precedents
IBSC application
code
ERMA New
Zealand
application
code
purpose
GMO99ARW013
GMD00023
To identify genes in Caenorhabditis elegans
that are critical for normal function of the
worms and that may serve as model targets
for development of biological control
methods for parasitic worms
GMO00ARW015
GMD00110
The purpose is to identify genes in parasitic
nematodes that are critical for normal
function of the worms and that may serve as
model targets for development of biological
control methods
GMO00ARW021
GMD01053
To identify and characterise potential gene
targets for future biological control strategies
of tapeworms through identification of genes
that are critical for worm viability and
development.
I note that a large number of applications to develop in containment genetically
modified Escherichia coli have been previously approved.
Proposed Controls
As all host organisms meet the requirements of Category 1 host organisms with
Category A genetic modifications according to the HSNO (Low-Risk Genetic
Modification) Regulations 2003 and are therefore, carried out under Physical
Containment level 1 (PC1), as defined in the Australian/New Zealand Standard
AS/NZS 2243.3 2002.
ERMA New Zealand holds the current version of the Transition/Containment Facility
of the Parasitology group which is the group which will be carrying out this work.
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4 Decision
I am satisfied that this application is for one of the purposes specified in section 39(1)
of the HSNO Act, being section 39(1)(a): the development of any genetically modified
organism.
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organisms, 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 the organisms meet the criteria for rapid
assessment under section 42 of the HSNO Act.
I am satisfied that the proposed containment regime in accordance with section 42(2)
HSNO Act 1996 will adequately contain the organisms.
Pursuant to section 42(2) of the HSNO Act 1996, and acting under delegation from
the Authority provided for in section 19, I have approved this application subject to
the controls specified herein.
In reaching this decision I have relied upon the following criteria in the HSNO Act
and the Methodology:
 Criteria for assessing the purpose of the application (section 39 HSNO
Act).
 Criteria for rapid assessment of adverse effects for the development of a
genetically modified organism in containment (section 42 HSNO Act).
 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 development of
genetically modified organisms specified in Part 1 of the Third Schedule
to the HSNO Act.
5
Controls
In order to provide for the matters detailed in Part 1 of the Third Schedule of the
HSNO Act, Containment Controls for Importation, Development and Field Testing of
Genetically Modified Organisms, the approved organisms are subject to the following
controls:
1
1.1
1.2
To limit the likelihood of any accidental release of any organism
or any viable genetic material.
The approved organism shall be developed and maintained within a
containment facility which complies with these controls.
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 organisms of the Authority’s
controls.
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1.3
The construction and operation of the containment facility in which the
organisms are maintained, shall be in accordance with the:
a) MAF/ERMA New Zealand Standard 154.03.024: Containment Facilities for
Micro-organisms, at laboratory Physical Containment Level 1 (PC1) for
organisms with Category A genetic modifications.
b) Australian New Zealand Standard AS/NZS 2243.3:20024 Safety in
Laboratories: Part 3: Microbiological aspects of containment and facilities.
1.4
2
2.1
3
3.1
4
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 154.03.024, and controls imposed by the Authority.
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 1.3 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 1.3 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.
4.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.3 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 1.3 relating to controlling the
effects of any accidental release or escape of an organism.
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.
4
Any reference to this standard in these controls refers to any subsequent version approved or
endorsed by ERMA New Zealand
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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
organisms that have 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 1.3.
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 1.3 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 1.3.
7
Qualifications required of
implementing those controls.
7.1
The training of personnel working in the facility shall be in compliance with
the standards listed in control 1.3.
the
persons
responsible
for
_____________________
Date: 5 January 2004
Dr Bas Walker,
Chief Executive ERMA New Zealand
Approval codes: GMD002898-GMD002903
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
____________________________
16 August 2007
Date:
Mr Rob Forlong
Chief Executive, ERMA New Zealand
Environmental Risk Management Authority Decision: Application GMD03131
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