ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
27 April 2009
Application code:
GMD09017
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.
Applicant:
AgResearch
Purpose:
Plant improvement via the investigation of gene function
associated with plant development, metabolic processes,
symbiotic relationships and pathogen interactions for the
development of novel gene delivery systems and plantbased biotechnologies
Date application received:
27 April 2009
Consideration date:
27 April 2009
Considered by:
Chief Executive, ERMA New Zealand
1
1.1
Summary of Decision
Application GMD09017 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 to be recorded on ERMA New Zealand Register
Host organism
Category Modified by:
of host
organism
Bacterium
Escherichia coli
(Migula 1895)
Castellani and
Chalmers 1919, non
pathogenic laboratory
strains
1
Vectors for plant genetic transformation
may also be assembled entirely or in
part from DNA’s sourced from the
genome of the host species.
Agrobacterium
rhizogenes (Riker et al.
1930) Conn 1942,
disarmed laboratory
strains only
Genes may be isolated from plants that
encode peptides involved in plant
development or metabolism. Genes
may be sourced from model, pastoral
and crop species. Examples of genes
include those that encode peptides
involved in:
Agrobacterium
tumefaciens (Smith and
Townsend 1907) Conn
1942, disarmed
laboratory strains only
Synechocystis sp strain
PCC6803
Schizosaccharomyces
pombe Lindner 1893
A/PC1
Vectors will include standard and
commercially available promoters and
other gene regulatory elements, reporter
and selectable marker genes, protein
purification tags and origins of
replication.
Salmonella
typhimurium (Loeffler
1892) Castellani and
Chalmers 1919, non
pathogenic strains
Spirulina platensis
(Nordstedt) Geitler
Yeast –
Saccharomyces
cerevisiae Meyen ex
E.C. Hansen 1883
Standard non-conjugative cloning and
expression
plasmid
vectors,
bacteriophage vectors
and nontumourigenic binary plasmid vectors.
Category of
modification/
containment
level
1
 Cell wall synthesis and catabolism.
 Carbohydrate synthesis
(e.g. fructan:fructan 6Gfructosyltransferase
 Lipid synthesis (e.g. via DGAT1
[diacylglycerol
acyltransferase])
storage,
mobilisation
and
metabolism.
 Lignin biosynthesis
 Flowering regulation
 Chaperone proteins and proteins
Environmental Risk Management Authority Decision: Application GMD09017
A/ PC1
Page 2 of 16
Kluyveromyces lactis
(Boidin, Abadie, J.L.
Jacob & Pignal) Van
der Walt 1971, non
pathogenic strains
Pichia pastoris
(Guillierm.) Phaff 1956
Bacteriophage
Enterobacteria phage
lambda
non-pathogenic
AlgaeChlorella vulgaris M.
Beijerinck
involved
in
post-translational
processing and protein folding
(e.g. oleosins are proteins associated
with lipid bodies in plants, and also
may also have applications in the
food and drug industries).
 Signalling molecules.
1
1
Dunaliella salina
(Dunal) Teodoresco
Plants
Brachypodium
distachyon (L.) Beauv.
1Cultured
cells
Lolium perenne L.
2-Whole
plants
Lolium temulentum L.
Lolium arundinaceum
(Schreb.) S.J.
Darbyshire
Poa annua L.
Poa pratensis L.
Agrostis stolonifera L.
Paspalum vaginatum
Sw.
Triticum aestivum L.
Genes from bacterial species may be
used that encode peptides to express
novel plant traits.
Genes may be
sourced from other species.
For
example:
A/ PC1
 Natural and synthetic variants of
class II and class III EPSPS genes
which
confer
resistance
to
glyphosate herbicides. For example
the ATX21308 gene described by
Athenix
Corp
in
patent
US2007/0136840 A1.
Chlamydomonas
reinhardtii P.A.
Dangeard
Lolium perenne subsp.
multiflorum (Lam.)
Husnot
A/ PC1
A/ PC1
Genes from crustaceans involved in
antimicrobial activity.
B/ PC2
Genes from fungal endophytes involved
in the establishment and maintenance of
the
plant/endophyte
symbiotic
relationship. Examples of genes include
those that encode peptides involved in:
 Biosynthesis
of
metabolites
(e.g. indole diterpenes, ergopeptines,
lolines, amino acids, cyclic peptides,
non-ribosomal peptide synthetases,
polyketide
synthetases
and
cytochromes P450).
 Transport of molecules between the
two organisms (e.g. ABC [ATPbinding cassette] and MFS [Major
Facilitator
Superfamily]
transporters).
 Gene regulation (e.g. Velvet, protein
kinases, histone-modifying proteins,
transcription factors).
Environmental Risk Management Authority Decision: Application GMD09017
Page 3 of 16
Triticum durum Desf.
Hordeum vulgare L.
Trifolium repens L.
Trifolium arvense L.
Trifolium occidentale
Coombe
Trifolium pratense L.
Trifolium semipilosum
Fresen.
Expression of recombinant antigens
from E. coli as possible vaccine
candidates. Genes will be isolated from
non-toxigenic
strains
of
Shiga
Escherichia coli. Examples of genes
include those that encode peptides
involved in:
 Surface-expressed outer membrane
proteins (e.g. E. coli attaching and
effacing protein [EAE]).
 Secreted proteins (e.g. Translocated
intermin receptor [TIR]; E. coli
secreted protein [EspA]).
 Flagella protein subunits
Medicago sativa L.
Medicago truncatula
Gaertn.
Lupinus angustifolius
L.
Expression of genes from alpaca
(Vicugna pacos). Examples of genes
include those that encode peptides
involved in:
 Heavy
chain
antibodies
(Nanobodies™).
Lotus corniculatus L.
Lotus japonicas
(Regel) K.Larsen
Pisum sativum L.
Glycine max (L.)Merr.
Sesame indicum L.
Sesame orientale L.
Helianthus annuus L.
Carthamus tinctorius
L.
Solanum lycopersicum
L.
Solanum tuberosum L.
Petunia hybrida Vilm.
Genes from organisms associated with
digestive processes in ruminants. Also
genes from organisms capable of
producing methane. Examples of genes
include those that encode peptides
involved in:
 Production of methane as a
bi-product.
 Lytic enzyme genes.
 Fibre-degradation(e.g. cellulases,
hemicellulases).
 Nitrogen utilisation (e.g. proteases).
 Other rumen processes (e.g. lipases,
esterases).
 Key phage enzymes (e.g. metabolic
processes, lipid synthesis, cell wall
synthesis, lytic enzymes).
Genes from donor species may be
artificially synthesised for optimal
expression within the nominated host
species.
Nicotiana tabacum L.
Environmental Risk Management Authority Decision: Application GMD09017
Page 4 of 16
Nicotiana benthamiana
Domin.
Brassica oleracea L.
Brassica napus L.
Brassica nigra L.
Brassica rapa L.
Arabidopsis thaliana
(L.) Heynh.
Selaginella
moellendorffii Hieron.
Crypthecodinium
cohnii Seligo
2
The modifications will not include:
 Genetic material from New Zealand
indigenous fauna and flora.
 Genetic material from CITES
species.
 Genes encoding known or predicted
vertebrate toxins.
 Uncharacterised sequences from
pathogenic microorganisms.
 Genes encoding infectious particles,
except for bacteriophage.
 Genetic material that increases the
pathogenicity,
virulence,
or
infectivity of the host organism.
 Genetic material that results in the
modified organism having a greater
ability to escape from containment
than the unmodified host.
 Directly sourced human genetic
material (human genetic sequences
will be synthesised or obtained from
a reputable organisation).
Consideration
Sequence of the consideration
2.1
The application was formally received and verified as containing sufficient
information on 27 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, 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.
Environmental Risk Management Authority Decision: Application GMD09017
Page 5 of 16
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 this application is to understand plant gene function and assessment of
plant gene regulatory elements. This work will primarily be in the determination of
the function of genes involved in: plant development, floral regulation, stress
physiology, pathogen resistance and pathogen response, fungal symbiotic
relationships, secondary metabolite biosynthesis, lipid metabolism, carbohydrate
biosynthesis, and gene regulation. This work will lead to the construction of tools to
enable the development of new products from the applicant’s plant biotechnology
research. Also the applicant will development molecular tools for rapid protein
production, purification and characterisation using a Yeast based system. Moreover
the applicant will develop the technology to use algae as a source of omega-3 fatty
acids for processed foods and animal feed and as a new generation of low input, high
energy feedstock for biofuel production. These modified algae may form a viable
alternative to land plant-based production systems.
2.7
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
2.8
Non-pathogenic laboratory strains of Escherichia coli and Salmonella typhimurium,
disarmed strains of Agrobacterium rhizogenes and Agrobacterium tumefaciens,
Environmental Risk Management Authority Decision: Application GMD09017
Page 6 of 16
Synechocystis sp, Spirulina platensis; Enterobacteria phage λ; Saccharomyces
cerevisiae, Schizosaccharomyces pombe, Pichia pastoris, Kluyveromyces lactis;
Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella salina and all plants types
in cell culture listed in Table 1 to be used by the applicant are not capable of causing
disease in humans, animals, plants or fungi, normally do not 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 and
Salmonella typhimurium, disarmed strains of Agrobacterium rhizogenes and
Agrobacterium tumefaciens, Synechocystis sp, Spirulina platensis; Enterobacteria
phage λ; Saccharomyces cerevisiae, Schizosaccharomyces pombe, Pichia pastoris,
Kluyveromyces lactis; Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella
salina are considered Category 1 host organisms as defined in clause 7(1) of the
Regulations.
2.9
The plants in cell culture listed in Table 1 are considered Category 1 host organisms
as they will be kept in closed containers and will not produce reproductive structures
as defined in clause 8 of the Regulations.
2.10
All the whole plants listed in Table 1 to be used by the applicant are considered
Category 2 host organisms as they are whole plants with reproductive structures that
will not be kept in closed containers. As such, all the whole plants listed in Table 1 to
be used by the applicant are considered Category 2 host organisms as defined in
clause 7(2) of the Regulations.
Category of genetic modification
2.11
The genetic modifications to non-pathogenic laboratory strains of Escherichia coli
and Salmonella typhimurium, disarmed strains of Agrobacterium rhizogenes and
Agrobacterium tumefaciens, Synechocystis sp, Spirulina platensis; Enterobacteria
phage λ; Saccharomyces cerevisiae, Schizosaccharomyces pombe, Pichia pastoris,
Kluyveromyces lactis; Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella
salina and plants in cell culture 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 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).
2.12
The genetic modifications to whole plants (described in Table 1) are not expected to
increase the pathogenicity, virulence or infectivity of the organisms to laboratory
Environmental Risk Management Authority Decision: Application GMD09017
Page 7 of 16
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 whole plants
(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).
2.13
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 Salmonella typhimurium,
disarmed strains of Agrobacterium rhizogenes and Agrobacterium tumefaciens,
Synechocystis sp, Spirulina platensis; Enterobacteria phage λ; Yeast; Saccharomyces
cerevisiae, Schizosaccharomyces pombe, Pichia pastoris, Kluyveromyces lactis;
Algae; Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella salina and all
plants types in cell culture listed in Table 1 meet the requirements of Category A
modifications as defined in clause 5(1) of the Regulations. The developments
involving whole plants listed in Table 1 meet the requirements of Category B
modifications as defined in clause 5(2) of the Regulations.
Identification and assessment of the risks, costs and other impacts of the
organism
2.14
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:
2.15
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.
2.16
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. As this application
does not involve the use of genetic material from native or valued flora and fauna or
from Māori, and as this application is for a development in containment, there is no
requirement for the applicant to consult with Māori.
2.17
Although recognising that iwi/Māori maintain an ongoing interest and concern in the
potential long term cultural implications of genetic modification generally, I consider
Environmental Risk Management Authority Decision: Application GMD09017
Page 8 of 16
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.
2.18
This assessment is made with the understanding that all associated containment
regulations, controls and conditions are met by the applicant.
Precedents
2.19
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 Salmonella typhimurium, disarmed strains of Agrobacterium rhizogenes and
Agrobacterium tumefaciens, Synechocystis sp, Spirulina platensis; S. cerevisiae,
Schizosaccharomyces pombe, Enterobacteria phage λ, Pichia pastoris, Kluyveromyces
lactis; Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella salina and all
plants types in cell culture listed 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 GMO07/ARPN029, a proposal to
clone the DNA from specific plants, bacteria or fungi into non-pathogenic laboratory
strains of Escherichia coli and Salmonella typhimurium, disarmed strains of
Agrobacterium rhizogenes and Agrobacterium tumefaciens, and Enterobacteria phage
λ to produce proteins for biochemical analysis was approved. Furthermore, all plant
species have been previously considered and approved in multiple applications.
2.20
I consider that this current application does not raise any novel issues and there are no
residual issues that require further consideration.
Containment
2.21
The experiments proposed in this application, to develop genetically modified
bacteria, yeast, bacteriophage, algae and plants in cell culture specified in this
application (listed in Table 1) 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).
Environmental Risk Management Authority Decision: Application GMD09017
Page 9 of 16
2.22
The facility to be used shall be approved as a containment facility under section 39 of
the Biosecurity Act, in accordance with the MAF/ERMA New Zealand Standard
Facilities for Microorganisms and Cell Cultures:2007. This containment regime
contains clear guidelines for the safe handling and disposal of cultures.
2.23
The experiments proposed in this application, to develop genetically modified whole
plants, specified in this application (listed in Table 1) meet the requirements of
Category B genetic modifications as defined in clause 5(2) of the Regulations.
Category B experiments are required to be contained within a Physical Containment
level 2 facility (PC2).
2.24
The facility to be used shall be approved as a containment facility under section 39 of
the Biosecurity Act, in accordance with the MAF/ERMA New Zealand Standard:
Containment Facilities for Plants: 2007. This containment regime contains clear
guidelines for the safe handling and disposal of plants.
2.25
I note that Sections 8.2.6 and 8.2.7 of the MAF/ERMA New Zealand Standard:
Containment Facilities for Plants: 2007 describes the regulations for transfer of plants
or viable plant material to another Containment Facility and the transport and packing
requirements for plants. I note that the Operator shall make a written application to
the MAF Inspector for transfer of plants to another containment facility on another
site and comply with the requirements of the standards listed in Appendix 1 Control
1.5.
2.26
I note that the applicant states that reproductive structures of the whole plants will be
bagged during crossing and seed production to restrict pollen movement and prevent
seed dispersal.
2.27
Therefore I consider that compliance to PC2 containment and the operational
procedures proposed by the applicant will be adequate to ensure that the experimental
organisms approved by this decision are fully contained and no additional controls are
required.
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
Environmental Risk Management Authority Decision: Application GMD09017
Page 10 of 16
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.
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 Salmonella typhimurium, disarmed strains of Agrobacterium rhizogenes and
Agrobacterium tumefaciens, Synechocystis sp, Spirulina platensis; Enterobacteria
phage λ; Saccharomyces cerevisiae, Schizosaccharomyces pombe, Pichia pastoris,
Kluyveromyces lactis; Chlorella vulgaris, Chlamydomonas reinhardtii, Dunaliella
salina and all plants (cell culture and whole) described in Table 1 of this decision,
subject to the controls specified in Appendix 1 of this decision.
_________________________
27 April 2009
Mr Rob Forlong
Date
Chief Executive, ERMA New Zealand
Approval codes (BCH numbers): GMD005378 – 431 (48594 – 48647)
Environmental Risk Management Authority Decision: Application GMD09017
Page 11 of 16
Approval numbers and BCH numbers for Organisms in Application
GMD09017
Approval
number
GMD005378
GMD005379
GMD005380
GMD005381
GMD005382
GMD005383
GMD005384
GMD005385
GMD005386
GMD005387
GMD005388
GMD005389
GMD005390
GMD005391
GMD005392
GMD005393
GMD005394
GMD005395
GMD005396
GMD005397
GMD005398
GMD005399
GMD005400
GMD005401
GMD005402
GMD005403
GMD005404
GMD005405
GMD005406
Organism
Agrobacterium rhizogenes (Riker et al. 1930)
Conn 1942 (GMD09017)
Agrobacterium tumefaciens (Smith & Townsend
1907) Conn 1942 (GMD09017)
Agrostis stolonifera L. (GMD09017)
Arabidopsis thaliana (L.) Heynh (1842)
(GMD09017)
Brachypodium distachyon (L.) Beauv.
(GMD09017)
Brassica napus L. (GMD09017)
Brassica nigra L. (GMD09017)
Brassica oleracea L. (GMD09017)
Brassica rapa L. (GMD09017)
Carthamus tinctorius L. (GMD09017)
Chlamydomonas reinhardtii P.A. Dangeard
(GMD09017)
Chlorella vulgaris M. Beijerinck (GMD09017)
Crypthecodinium cohnii Seligo (GMD09017)
Dunaliella salina (Dunal) Teodoresco
(GMD09017)
Enterobacteria phage lambda (GMD09017)
Escherichia coli (Migula 1895) Castellani &
Chalmers 1919 (GMD09017)
Glycine max (L.)Merr. (GMD09017)
Helianthus annuus L. (GMD09017)
Hordeum vulgare L. (GMD09017)
Kluyveromyces lactis (Boidin, Abadie, J.L. Jacob
& Pignal) Van der Walt 1971 (GMD09017)
Lolium arundinaceum (Schreb.) S.J. Darbyshire
(GMD09017)
Lolium perenne L. (GMD09017)
Lolium perenne subsp. multiflorum (Lam.)
Husnot (GMD09017)
Lolium temulentum L. (GMD09017)
Lotus corniculatus L. (GMD09017)
Lotus japonicas (Regel) K.Larsen (GMD09017)
Lupinus angustifolius L. (GMD09017)
Medicago sativa L. (GMD09017)
Medicago truncatula Gaertn. (GMD09017)
Environmental Risk Management Authority Decision: Application GMD09017
BCH number
48594
48595
48596
48597
48598
48599
48600
48601
48602
48603
48604
48605
48606
48607
48608
48609
48610
48611
48612
48613
48614
48615
48616
48617
48618
48619
48620
48621
48622
Page 12 of 16
GMD005407
GMD005408
GMD005409
GMD005410
GMD005411
GMD005412
GMD005413
GMD005414
GMD005415
GMD005416
GMD005417
GMD005418
GMD005419
GMD005420
GMD005421
GMD005422
GMD005423
GMD005424
GMD005425
GMD005426
GMD005427
GMD005428
GMD005429
GMD005430
GMD005431
Nicotiana benthamiana Domin. (GMD09017)
Nicotiana tabacum L. (GMD09017)
Paspalum vaginatum Sw. (GMD09017)
Petunia hybrida Vilm. (GMD09017)
Pichia pastoris Guillerm Phaff (1956)
(GMD09017)
Pisum sativum L. (GMD09017)
Poa annua L. (GMD09017)
Poa pratensis L. (GMD09017)
Saccharomyces cerevisiae (Meyen ex E. C.
Hansen, 1883) (GMD09017)
Salmonella typhimurium (Loeffler 1892)
Castellani and Chalmers 1919 (GMD09017)
Schizosaccharomyces pombe Lindner 1893
(GMD09017)
Selaginella moellendorffii Hieron. (GMD09017)
Sesame indicum L. (GMD09017)
Sesame orientale L. (GMD09017)
Solanum lycopersicum L. (GMD09017)
Solanum tuberosum L. (GMD09017)
Spirulina platensis (Nordstedt) Geitler
(GMD09017)
Synechocystis sp (GMD09017)
Trifolium arvense L. (GMD09017)
Trifolium occidentale Coombe (GMD09017)
Trifolium pratense L. (GMD09017)
Trifolium repens L. (GMD09017)
Trifolium semipilosum Fresen.(GMD09017)
Triticum aestivum L. (GMD09017)
Triticum durum Desf. (GMD09017)
Environmental Risk Management Authority Decision: Application GMD09017
48623
48624
48625
48626
48627
48628
48629
48630
48631
48632
48633
48634
48635
48636
48637
48638
48639
48640
48641
48642
48643
48644
48645
48646
48647
Page 13 of 16
Appendix 1: Controls required by this approval
In order to provide for the matters detailed in Part I of the Third Schedule of the Act1,
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 material2.
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 personal 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: 20073;
1.4.2 Australian/New Zealand Standard AS/NZS 2243.3:20023 Safety in
laboratories: Part 3: Microbiological aspects and containment facilities; 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 Salmonella typhimurium, disarmed strains of Agrobacterium rhizogenes
and Agrobacterium tumefaciens, Synechocystis sp, Spirulina platensis;
Enterobacteria phage λ; Saccharomyces cerevisiae, Schizosaccharomyces
pombe, Pichia pastoris, Kluyveromyces lactis; Chlorella vulgaris,
Chlamydomonas reinhardtii, Dunaliella salina and all plants types in cell
culture.
1
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.
2
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.
3
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
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1.5 The construction, operation and management of the containment facility shall be in
accordance with the:
1.5.1 MAF/ERMA New Zealand Standard: Containment Facilities for Plants:
20074;
1.5.2 Australian/New Zealand Standard AS/NZS 2243.3:20024 Safety in
laboratories: Part 3: Microbiological aspects and containment facilities; and
1.5.3 Physical Containment level 2 (PC2) requirements of the above Standards for
developments involving whole plants.
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.
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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5.2 If a breach of containment occurs5 the 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.
5
Breach of containment includes: escape of organism(s), unauthorised entry to facility, and/or structural
integrity of facility compromised.
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