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Environmental Protection Authority Te /VIana RauhT Taiao
DECISION
Date
Application code
Application type
Applicant
Date application received
Consideration date
Considered by
Purpose of the application
1. Summary of decision
23 July 2014
APP202127
To develop in containment genetically modified organisms under
sections 40(1) and 42A of the Hazardous Substances and New
Organisms Act 1996
The New Zealand Institute for Plant & Food Research (Plant and
Food)
10 July 2014
24 July 2014
The Chief Executive of the Environmental Protection Authority
(EPA)1
To develop genetically modified organisms (microorganisms and
plants) in containment to understand the secondary metabolite
pathways associated with abiotic stress response in plants, and
how these pathways have influenced the evolution of plants.
1.1 Application APP202127 to develop, as a project, genetically modified organisms (as described in
Table 1 of this decision) in containment is approved, with controls .
1.2 I had sufficient information to assess the application. The application was considered in accordance
with section 42A of the Hazardous Substances and New Organisms (HSNO) Act 1996 ("the Act"), the
Hazardous Substances and New Organisms (Low-Risk Genetic Modification) Regulations 2003 ("the
Regulations"}, and the Hazardous Substances and New Organisms (Methodology) Order 1998 ("the
Methodology").
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
New Zealand Government www.epa.govt.nz
2
------------------------------------------------------------------------------- ----------------------------- oeC:fsicin:-i>.F>-P'icii1-ii
2. The approved genetically modified organisms (GMOs) and the controls imposed
Purpose of the project
2.1 The purpose of this application is to develop genetically modified microorganisms and model plant
species to understand the cellular pathways that control the biosynthesis, regulation and accumulation
of secondary metabolites associated with abiotic stress response in plants (particularly UV-irradiation),
and how these pathways have influenced the evolution of land plants.
2.2 I determined that this application is for a valid purpose; the development of any new organism as
provided for in section 39(1 )(a) of the Act.
Description of the organisms to be developed
2.3 As per section 42A(2) of the Act, I was satisfied that the host organisms and the proposed genetic
modifications conform to the requirements of;
• Category 1 and 2 host organisms (as per clause 7 of the Regulations); and
• Category A and B genetic modifications (as per clause 5 of the Regulations) (as described in Table
1 ).
Table 1: Approved organism description
Category 1 Microorganisms
Host organism
Category of host organism
Escherichia coli (Migula 1895) Castenellani and Chalmers 1919 non conjugative, non
pathogenic laboratory strains
Agrobacterium tumefaciens (Smith and Townsend, 1907) Conn 1942 disarmed strains
Agrobacterium rhizogenes (Riker et al. 1930) Conn, 1942 disarmed strains
Saccharomyces cerevisiae Meyen ex EC Hansen (1883) non pathogenic, non-sporulating
laboratory adapted strains
Pichia pastoris Guillerm Phaff (1956) non pathogenic, non-sporulating laboratory adapted
strains
Ogataea angusta (Teun., H.H. Hall & Wick.) Suh & Zhou 2010 (syn. Pichia angusta) non
pathogenic, non-sporulating laboratory adapted strains
Schizosaccharomyces pombe Lindner 1893 non pathogenic, non-sporulating laboratory
adapted strains
Brevibacil/us choshinensis (Takagi et al. 1993) Shida et al. 1996 non pathogenic
laboratory strains
These organisms are Category 1 host organisms because;
• they are clearly identifiable and classifiable;
• they are characterised to the extent that their main biological characteristics
are known;
• they are not normally able to (or contain infectious agents normally able to)
cause disease in humans, animals, plants or fungi;
• they do not normally infect, colonise or establish in humans; and
• they do not produce desiccation-resistant structures such as spores or cysts
3
---- --------------- ----------- ------------ ------------ --------------- --- ----------------------------------- oe<:iSion:-.tiF>-P"ia21-2i
Modification
Category of modification
that can be normally disseminated in the air.
Standard non-conjugative cloning, binary or expression plasmid vectors will be used to
generate recombinant bacteria and yeast strains for protein expression, gene function
studies, and/or transformation of plants (either transient or stable transformation) . Vectors
such as pBin, pCambia, pArt, pMon, and pNov vectors may be used for expression
studies; pHANNIBAL, pKANNIBAL, pHELLSGATE Gateway™ may be used for RNAi
research ; and pPopoff series may be used for inducible expression.
Vectors may conta in the following genetic elements derived from bacterial, animal, fungal ,
plant or viral sources: promoters, operators, regulatory elements, reporter and selectable
marker genes, secretory and targeting signals, flanking sequences, recombination sites,
sequences that facilitate recombination, protein purification tags, origins of replication and
conjugative transfer, binding sequences, enhancer and silencer sequences,
transcriptional terminators, transcriptional activators, transcriptional response elements,
secretory and targeting signals, ribosomal binding sites, multiple cloning sites,
polyadenylation signals, intron/exon spl ice sites, T-DNA and P-DNA border elements, and
T-DNA/P-DNA processing and transfer sequences (i.e. virD2 and T-DNA overdrive-like
elements).
Donor genetic material will be sourced from plant, animal, bacterial , fungal , viral, insect,
and synthetic sources (in sense and antisense orientation); and will be from genetic
regions involved in the biosynthesis, regulation or accumulation of secondary metabolites
associated with abiotic response.
The modifications will exclude:
• Genetic material from New Zealand native fauna and/or flora ;
• Sequences known to produce particles infectious to humans, animals or plants;
• RNAi technology that includes viral induced gene silencing ;
• Bacterial selectable marker genes that confer resistance to antibiotics that are
clinically significant in veterinary or human medicine;
• Uncharacterised nucleic acid sequences from pathogenic micro-organisms;
• Material from species covered under the relevant CITES agreements;
• Transgenes for proteins known to present a vertebrate disease or vertebrate
toxin with an LDso < 100 IJg/kg;
• Genetic material that increases the pathogenicity, virulence, or infectivity of the
host organism; and
• Those that result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Some of the molecular tools used in this project may contain human derived DNA
sequences, for example phage display libraries or inducible promoters. These molecular
tools will be sourced from overseas and will not contain DNA of Maori origin.
The modifications are Category A because these modifications are carried out under a
minimum of PC1 containment as defined in the Regulations. They do not increase the
pathogenicity, virulence or infectivity of the host organism to laboratory personnel , the
community or the environment and do not result in the GMO having a greater ability to
escape from containment than the unmodified host organism.
4
---------------------------------------------------------------- -- ------------------------------------ ------oecfsioii:-.A.F>-P"ioi1-ii
Minimum PC1
containment level required
Tissue culture plants, protoplasts and plant cell cultures (without reproductive structures and kept in closed containers)
Marchantia polymorpha (marchantia) L.
Nicotiana spp. L. and Graham Host organism Petunia spp. Juss.
Category of host organism
Modification
Antirrhinum spp. L.
Arabidopsis thaliana Heynh.
These organisms are Category 1 host organisms because;
• they are clearly identifiable and classifiable;
• they are characterised to the extent that their main biological characteristics
are known;
• they are not normally able to (or contain infectious agents normally able to)
cause disease in humans, animals, plants or fungi;
• they do not normally infect, colonise or establish in humans; and
• they do not produce desiccation-resistant structures such as spores or cysts
that can be normally disseminated in the air; and
• they will not have reproductive structures and will be kept in closed containers.
Standard non-conjugative cloning, binary or expression plasmid vectors will be used to
transiently express DNA sequences in plants and/or integrate DNA sequences into the
plant genome. Transformation and genetic modification will be by Agrobacterium
mediated transformation, biolistic transformation, or transformation via other direct
transfer methods. Vectors such as pBin, pCambia, pArt, pMon, and pNov vectors may be
used for expression studies; pHANNIBAL, pKANNIBAL, pHELLSGATE Gateway™ may
be used for RNAi research; and pPopoff series may be used for inducible expression.
Vectors may contain the following genetic elements derived from bacterial, animal, fungal,
plant or viral sources: promoters, operators, regulatory elements, reporter and selectable
marker genes, secretory and targeting signals, flanking sequences, recombination sites,
sequences that facilitate recombination, protein purification tags, origins of replication and
conjugative transfer, binding sequences, enhancer and silencer sequences,
transcriptional terminators, transcriptional activators, transcriptional response elements,
secretory and targeting signals, ribosomal binding sites, multiple cloning sites,
polyadenylation signals, intron/exon splice sites, T-DNA and P-DNA border elements, and
T-DNA/P-DNA processing and transfer sequences (i.e. virD2 and T-DNA overdrive-like
elements).
Donor genetic material will be sourced from plant, animal, bacterial, fungal, viral, insect,
and synthetic sources (in sense and antisense orientation); and will be from genetic
regions involved in the biosynthesis, regulation or accumulation of secondary metabolites
associated with abiotic response.
The modifications will exclude:
• Genetic material from New Zealand native fauna and/or flora;
5
--- ------ · · · · --- ---- --- · -------- --------- -- --- --- ------- ------- ---- ------------------ ------ ---- ------ ------- oeC:isicin:-.ii.i:>P"ioi f ii
Category of modification
• Sequences known to produce particles infectious to humans, animals or plants;
• RNAi technology that includes viral induced gene silencing;
• Bacterial selectable marker genes that confer resistance to antibiotics that are
clinically significant in veterinary or human medicine;
• Uncharacterised nucleic acid sequences from pathogenic micro-organisms;
• Material from species covered under the relevant CITES agreements;
• Transgenes for proteins known to present a vertebrate disease or vertebrate
toxin with an LDso < 100 IJg/kg;
• Genetic material that increases the pathogenicity, virulence, or infectivity of the
host organism; and
• Those that result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Some of the molecular tools used in this project may contain human derived DNA
sequences, for example phage display libraries or inducible promoters. These molecular
tools will be sourced from overseas and will not contain DNA of Maori origin.
The modifications are Category A because these modifications are carried out under a
minimum of PC1 containment as defined in the Regulations. They are without
reproductive structures and will be kept in closed containers. They do not increase the
pathogenicity, virulence or infectivity of the host organism to laboratory personnel, the
community or the environment and do not result in the GMO having a greater ability to
I escape from containment than the unmodified host organism.
Minimum PC1
containment level required
Category 2 Microorganisms
Host organism
Category of host organism
Modification
Agrobacterium tumefaciens (Smith and Townsend, 1907) Conn 1942 armed strains
Agrobacterium rhizogenes (Riker et al. 1930) Conn, 1942 armed strains
These organisms are Category 2 host organisms because they are;
• clearly identifiable and classifiable according to genus, species, strain or other
subspecific category; and
• Risk Group 2 organisms as defined in the Regulations that are or contain an
infectious agent that is pathogenic to plants.
• Risk Group 2 organisms as defined in the Regulations that are characterised to
the extent that their main biological characteristics are known. ---
Standard non-conjugative cloning, binary or expression plasmid vectors will be used to
generate recombinant bacteria for protein expression, gene function studies, and/or
transformation of plants (either transient or stable transformation) . Vectors such as pBin,
pCambia, pArt, pMon, and pNov vectors may be used for expression studies;
pHANNIBAL, pKANNIBAL, pHELLSGATE Gateway™ may be used for RNAi research;
and pPopoff series may be used for inducible expression.
Vectors may contain the following genetic elements derived from bacterial, animal, fungal,
plant or viral sources: promoters, operators, regulatory elements, reporter and selectable
marker genes, secretory and targeting signals, flanking sequences, recombination sites,
sequences that facilitate recombination, protein purification tags, origins of replication and
6
----------------------------------------------------------------------------------------------------------- IDeciSion:AP-Pioi1ii
Category of modification
conjugative transfer, binding sequences, enhancer and silencer sequences,
transcriptional terminators, transcriptional activators, transcriptional response elements,
secretory and targeting signals, ribosomal binding sites, multiple cloning sites,
polyadenylation signals, intron/exon splice sites, T-DNA and P-DNA border elements, and
T-DNA/P-DNA processing and transfer sequences (i.e. virD2 and T-DNA overdrive-like
elements).
Donor genetic material will be sourced from plant, animal, bacterial, fungal, viral, insect,
and synthetic sources (in sense and antisense orientation); and will be from genetic
regions involved in the biosynthesis, regulation or accumulation of secondary metabolites
associated with abiotic response.
The modifications will exclude:
• Genetic material from New Zealand native fauna and/or flora ;
• Sequences known to produce particles infectious to humans, animals or plants;
• RNAi technology that includes viral induced gene silencing;
• Bacterial selectable marker genes that confer resistance to antibiotics that are
clinically significant in veterinary or human medicine;
• Uncharacterised nucleic acid sequences from pathogenic micro-organisms;
• Material from species covered under the relevant CITES agreements;
• Transgenes for proteins known to present a vertebrate disease or vertebrate
toxin with an LDso < 100 ~g/kg ;
• Genetic material that increases the pathogenicity, virulence, or infectivity of the
host organism; and
• Those that result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Some of the molecular tools used in this project may contain human derived DNA
sequences, for example phage display libraries or inducible promoters. These molecular
tools will be sourced from overseas and will not contain DNA of Maori origin.
The modifications are Category B because these modifications are carried out under a
minimum of PC2 containment as defined in the Regulations. They involve nucleic acid
that is characterised so that its sequence is known, its gene function and potential gene
products are understood and the modifications do not increase the pathogenicity,
virulence or infectivity of the host organism to laboratory personnel, the community or the
environment and do not result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Minimum PC2
containment level required
Whole plants or tissue cultures (either with or without reproductive structures and kept or not kept in closed containers)
Host organism
Nicotiana spp. L. and Graham
Petunia spp. Juss.
Antirrhinum spp. L.
Arabidopsis thaliana Heynh.
7
------------------------------- --- -.- •• --.-.------ .------------- ----- ••••••• ------------ -- ------ .•••.•••• --- DEicisioii:-A.F>-P"io212i
Category of host organism
Modification
These organisms are Category 2 host organisms because they are;
• clearly identifiable and classifiable according to genus, species, strain or other
subspecific category; and
• are with or without reproductive structures and will not be kept in closed
containers.
Standard non-conjugative cloning, binary or expression plasmid vectors will be used to
transiently express DNA sequences in plants and/or integrate DNA sequences into the
plant genome. Transformation and genetic modification will be by Agrobacterium
mediated transformation, biolistic transformation, or transformation via other direct
transfer methods. Vectors such as pBin, pCambia, pArt, pMon , and pNov vectors may be
used for expression studies; pHANNIBAL, pKANNIBAL, pHELLSGATE Gateway™ may
be used for RNAi research; and pPopoff series may be used for inducible expression.
Vectors may contain the following genetic elements derived from bacterial, animal, fungal,
plant or viral sources: promoters, operators, regulatory elements, reporter and selectable
marker genes, secretory and targeting signals, flanking sequences, recombination sites,
sequences that facilitate recombination, protein purification tags, origins of replication and
conjugative transfer, binding sequences, enhancer and silencer sequences,
transcriptional terminators, transcriptional activators, transcriptional response elements,
secretory and targeting signals, ribosomal binding sites, multiple cloning sites,
polyadenylation signals, intron/exon splice sites, T-DNA and P-DNA border elements, and
T-DNNP-DNA processing and transfer sequences (i.e. virD2 and T-DNA overdrive-like
elements).
Donor genetic material will be sourced from plant, animal, bacterial, fungal, viral , insect,
and synthetic sources (in sense and antisense orientation); and will be from genetic
regions involved in the biosynthesis, regulation or accumulation of secondary metabolites
associated with abiotic response.
The modifications will exclude:
• Genetic material from New Zealand native fauna and/or flora;
• Sequences known to produce particles infectious to humans, animals or plants;
• RNAi technology that includes viral induced gene silencing;
• Bacterial selectable marker genes that confer resistance to antibiotics that are
clinically significant in veterinary or human medicine;
• Uncharacterised nucleic acid sequences from pathogenic micro-organisms;
• Material from species covered under the relevant CITES agreements;
• Transgenes for proteins known to present a vertebrate disease or vertebrate
toxin with an LDso < 100 ~g/kg ;
• Genetic material that increases the pathogenicity, virulence, or infectivity of the
host organism; and
• Those that result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Some of the molecular tools used in this project may contain human derived DNA
sequences, for example phage display libraries or inducible promoters. These molecular
tools will be sourced from overseas and will not contain DNA of Maori origin.
8
--------- ------------------------------------------------------------------------------------- --------------DecTSiOri~A.F>f:iio2f2i
Category of modification
The modifications are Category B because these modifications are carried out under a
minimum of PC2 containment as defined in the Regulations. They do not increase the
pathogenicity, virulence or infectivity of the host organism to laboratory personnel, the
community or the environment and do not result in the GMO having a greater ability to
escape from containment than the unmodified host organism.
Minimum PC2
containment level required
Marchantia polymorpha whole plants or tissue cultures (either with or without reproductive structures and kept or not kept in closed containers)
Host organism
Category of host organism
Modification
Marchantia polymorpha (marchantia) L.
This organism is a Category 2 host organism because it is;
• clearly identifiable and classifiable according to genus, species, strain or other
subspecific category; and
• a Risk Group 2 organism as defined in the Regulations that produces
desiccation-resistant structures such as spores or cysts that can be normally
disseminated in the air.
• are with or without reproductive structures and will not be kept in closed
containers.
Standard non-conjugative cloning, binary or expression plasmid vectors will be used to
transiently express DNA sequences in plants and/or integrate DNA sequences into the
plant genome. Transformation and genetic modification will be by Agrobacterium
mediated transformation, biolistic transformation, or transformation via other direct
transfer methods. Vectors such as pBin, pCambia, pArt, pMon, and pNov vectors may be
used for expression studies; pHANNIBAL, pKANNIBAL, pHELLSGATE Gateway™ may
be used for RNAi research; and pPopoff series may be used for inducible expression.
Vectors may contain the following genetic elements derived from bacterial, animal, fungal,
plant or viral sources: promoters, operators, regulatory elements, reporter and selectable
marker genes, secretory and targeting signals, flanking sequences, recombination sites,
sequences that facilitate recombination, protein purification tags, origins of replication and
conjugative transfer, binding sequences, enhancer and silencer sequences,
transcriptional terminators, transcriptional activators, transcriptional response elements,
secretory and targeting signals, ribosomal binding sites, multiple cloning sites,
polyadenylation signals, intron/exon splice sites, T-DNA and P-DNA border elements, and
T-DNA/P-DNA processing and transfer sequences (i.e. virD2 and T-DNA overdrive-like
elements).
Donor genetic material will be sourced from plant, animal, bacterial, fungal, viral, insect,
and synthetic sources (in sense and antisense orientation); and will be from genetic
regions involved in the biosynthesis, regulation or accumulation of secondary metabolites
associated with abiotic response.
The modifications will exclude:
• Genetic material from New Zealand native fauna and/or flora;
• Sequences known to produce particles infectious to humans, animals or plants;
9
----- ---.----... --------------------- ------------ ------.----------- ---. --- ----- --------------------- ----- -- -becision: i>.'P-Pi 6i 1-i i
Category of modification
• RNAi technology that includes viral induced gene silencing;
• Bacterial selectable marker genes that confer resistance to antibiotics that are
clinically significant in veterinary or human medicine;
• Uncharacterised nucleic acid sequences from pathogenic micro-organisms;
• Material from species covered under the relevant CITES agreements;
• Transgenes for proteins known to present a vertebrate disease or vertebrate
toxin with an LDso < 100 IJg/kg;
• Genetic material that increases the pathogenicity, virulence, or infectivity of the
host organism; and
• Those that result in the GMO having a greater ability to escape from
containment than the unmodified host organism.
Some of the molecular tools used in this project may contain human derived DNA
sequences, for example phage display libraries or inducible promoters. These molecular
tools will be sourced from overseas and will not contain DNA of Maori origin .
The modifications are Category B because these modifications are carried out under a
minimum of PC2 containment as defined in the Regulations. They do not increase the
pathogenicity, virulence or infectivity of the host organism to laboratory personnel, the
community or the environment and do not result in the GMO having a greater ability to
escape from containment than the unmodified host organism.
Minimum PC2
containment level required
2.4 I considered that this project represents a particular line of scientific inquiry and has clearly defined
objectives to develop microorganisms and plants, specified in Table 1, within a containment structure.
This will allow the research described above. I determined that the organism description in this
application falls within the bounds of a project for the development of GMOs. This is because it
complies with the requirements of the Regulations as described above.
3. Rapid assessment of adverse effects of the project
3.1 As I am satisfied that the host organisms and genetic modifications meet the criteria of low risk genetic
modification (as per the Regulations), as per section 42A(2) of the Act, I have made a rapid
assessment of the adverse effects of carrying out the project as follows.
3.2 I note that the GMOs would first need to escape from the containment facility into the environment to
cause non-negligible adverse effects on the environment, public health or the market economy.
However, as the GMOs will be developed within approved containment facilities which have structural
requirements and operational procedures to prevent the escape of the GMOs, I consider that it would
be highly improbable that the GMOs will escape from containment. Therefore I did not identify non
negligible adverse effects on the environment, public health or the market economy.
10
------ ---------------------------- --------------------- ---------------------------------------------------- -oeC:iSiori:P.F>'P:iai1-ii
3.3 In some cases, for this project, Plant and Food will utilise "armed" A. tumefaciens and A. rhizogenes
strains that have the tumour-causing genes of the resident Ti-plasmid intact. However, given
Agrobacteria are widespread in the New Zealand environment, the bacteria will be held in
containment, and the proposed genetic modifications do not increase virulence or confer a competitive
advantage to the bacteria , I did not identify any non-negligible environmental adverse effects
associated with using armed A. tumefaciens and A. rhizogenes strains during this project.
3.4 I did not identify non-negligible adverse effects on personnel handling the GMOs as exposure to the
GMOs is voluntary and those personnel are trained to safety handle the GMOs.
3.5 I did not identify non-negligible adverse effects on society and community as;
• the GMOs will be developed within approved containment facilities which have structural
requirements and operational procedures to prevent the escape of the GMOs; and
• the GMOs do not involve host organisms or genetic modifications that I consider will adversely
affect society and community.
3.6 I did not identify non-negligible adverse effects on Maori and their culture and traditions with their
ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other taonga as;
• the GMOs will be developed within approved containment facilities which have structural
requirements and operational procedures to prevent the escape of the GMOs; and
• the host organism or genetic modifications do not involve native or valued flora and fauna.
3.7 I note that the applicant respectfully submitted the proposed application to Tanenuiarangi Manawatu
lncoroprated, the mandated iwi authority for Rangitane o Manawatu, for comment. No concerns were
raised.
4. The decision-making
4.1 I had sufficient information to assess the application as submitted by the applicant.
4.2 As per section 42A(3) of the Act, after completing a rapid assessment of adverse effects, I have
decided to approve the application and impose controls providing for each of the matters specified in
Schedule 3 as I think fit.
4.3 The matters to be addressed by containment controls for developing GMOs are listed in Part 1 of
Schedule 3 of the Act. To address these, controls must be imposed to;
• limit the likelihood of any accidental release of any organism or any viable material;
• exclude unauthorised people from the facility;
• exclude other organisms from the facility and control undesirable and unwanted organisms within
the facility;
11 • · · · · · · · · · · · · · · · · -- · · · · · · ·- • • • • ·--- ·-- ·- • ·---- ---- --- · · ·-- ------- · ··- --- ----------------- ·---- · ·- · ·- ·-- ·- · · • f>'ix:TSioii: • .APP2o21-ii
• prevent the unintended release of the organisms by experimenters working with the organisms;
• control the effects of any accidental release or escape of the organisms; and
• specify inspection and monitoring requirements for the containment facilities.
4.4 I imposed the controls detailed in Table 2 to provide for the matters above and any other matters I
considered necessary to give effect to the purpose of the Act. Further, given Marchantia polymorpha
liverworts produce spores and reproduce both asexually and sexually, I imposed controls 6 and 7 to
manage the potential risk of haploid and diploid spores escaping containment.
4.5 I note that the applicant has detailed their containment regime in section 4.2 of the application (see
Appendix). I consider that the regime for the containment of the GMOs outlined in Table 1 is adequate
taking into account the controls imposed in Table 2 and the proposed containment regime in the
Appendix.
Table 2: Controls
The approval holder (The New Zealand Institute for Plant & Food Research) must ensure compliance with the following controls.
1) This approval is limited to the development of the GMOs described in Table 1 ("approved organisms") to understand the cellular pathways that control the biosynthesis, regulation and accumulation of secondary metabolites associated with abiotic stress response in plants, and how these pathways have influenced the evolution of land plants.
2) The approved organism must not escape containment.
3) The approved organisms must be developed within a containment facility that complies with; • The MAF/ERMA New Zealand Standard : Facilities for Microorganisms and Cell
Cultures2: 2007a;
• The Australian/New Zealand Standard AS/NZS 2243.3:2002 Safety in laboratories: Part 3: Microbiological aspects and containment facilities3
;
• Physical Containment level1 (PC1) requirements of the above Standards (at minimum) for developments involving E. coli, yeast strains, B. choshinensis and disarmed Agrobacteria; and
• Physical Containment level 2 (PC2) requirements of the above Standards (at minimum) for developments involving armed Agrobacteria.
4) The approved organisms must be developed within a containment facility that complies with; • MAF/ERMA New Zealand Standard Containment Facilities for Plants: 200J4;
• The Australian/New Zealand Standard AS/NZS 2243.3:2002 Safety in laboratories: Part 3: Microbiological aspects and containment facilities5
;
2 Any reference to MAF/ERMA New Zealand or AS/NZS Standards in these controls also refers to any subsequent version approved or endorsed by the EPA. 3 Any reference to MAF/ERMA New Zealand or AS/NZS Standards in these controls also refers to any subsequent version approved or endorsed by the EPA. 4 Any reference to MAF/ERMA New Zealand or AS/NZS Standards in these controls also refers to any subsequent version approved or endorsed by the EPA.
12
------ ---.-. -· .. --- .......................... ...... ---· -· ..... -- ---------.---- ......... --- ..... -- ..... -... ··oeciiion:· .A.F>"P2ci21.2i
• Physical Containment level 1 (PC1) requirements of the above Standards (at minimum) for developments involving tissue culture plants, protoplasts or plant cell cultures kept in closed containers and without reproductive structures;
• Physical Containment level 2 (PC2) requirements of the above Standards (at minimum) for developments involving whole plants and tissue cultures kept in a closed container and with or without reproductive structures.
• Physical Containment level 2 (PC2) requirements of the above Standards (at minimum) for developments involving whole plants and tissue cultures not kept in a closed container and with or without reproductive structures.
5) The approval holder must ensure that within 24 hours of the discovery of any breach of containment (includes the escape of an organism(s) or a failure in the structural integrity of physical containment), the Ministry for Primary Industries biosecurity inspector responsible for supervision of the facility, has received notification (written or verbal)6 of the breach and the details of any remedial action taken.
6) Given asexual reproduction of Marchantia polymorpha liverworts is via gemma that form in splash cups on the thallus surface, water must not be directly applied to Marchantia polymorpha thalli.
7) Male and female Marchantia polymorpha thalli must be kept separated.
4.6 The applicant is not, in this instance, required to provide progress reports as this application does not
raise any novel issues.
4.7 I have not imposed an expiry date on this approval.
5. Summary of the decision
5.1 Application APP202127, to develop in containment GMOs (as described in Table 1 of this decision}, is
approved, with controls under section 42A(3) (as described in Table 2 of this decision). This
decision was based on the information supplied by the applicant and was considered in accordance
with section 42A of the Act, the Regulations, and the Methodology.
'~~--~=-=---------Rob Forlong -;.;--- Date :;)3 I 9-( J-f;-Chief Executive, under delegated authority from the EPA
Approval code(s): G MD \0 \s--)~- C-M 1) \o \ ~oq ) ~rv'\~ \ol ~10- ~M~ lol s---71 5 Any reference to MAF/ERMA New Zealand or AS/NZS Standards in these controls also refers to any subsequent version approved or endorsed by the EPA. 6 The biosecurity inspector's contact details can be found in the facility containment manual.
13
· · · · · · · · ·-----· · ---· · ·- ·-- ·---- ·-· · · · ·· ·-· · · · · · · · · · · · · · · · · · ·- · · · · · · · · · · · · · · · ·--· · · ·-- ·--· · · · · · · · ·---· · · · · ·--oe<:islon: AF'fiioi fii
Appendix: Description of the proposed containment regime from the application
"• All research will be performed within Plant and Food Research's MPI-registered PC1 and PC2
containment facilities approved for micro-organism and/or plant containment.
• Modifications involving E. coli, Agrobacterium or yeast species will be carried out in facilities
approved to the MAF/ERMA Standard Facilities for Micro-organisms and Cell Cultures 2007a, and
minimum Physical Containment level 1 (for Category A modifcations), or minimum Physical
Containment level2 (for Category 8 modifications).
• Modifications involving tissue culture plants, protoplasts or plant cell cultures (kept in closed
containers and with no reproductive structures present) will be carried out in facilities approved to
the MAF/ERMA
• Standard Facilities for Plants 2007/Micro-organisms and Cell Cultures 2007a, and minimum
Physical Containment level1 (for Category A modifcations), or minimum Physical Containment
level 2 (for Category 8 modifications).
• Modifications involving tissue culture plants, protoplasts or plant cell cultures (kept in closed
containers and where reproductive structures may be present) will be carried out in facilities
approved to the MAF/ERMA Standard Facilities for Plants 2007/Micro-organisms and Cell Cultures
2007a, and minimum Physical Containment level 2.
• Developments and experiments involving whole plants or tissue cultures (either with reproductive
structures, or without reproductive structures and will not be kept in closed containers) will be
contained in facilities approved under MAF/ERMA Standard Containment Facilities for Plants 2007,
at Physical Containment level 2.Standard operating procedures are detailed in the Operating
Manual of each containment facility. These Operating Manuals have been approved by MPI, and
meet the requirements of the MAF/ERMA Standard Facilities for Micro-organisms and Cell Cultures
2007a and MAF/ERMA Standard Containment Facilities for Plants 2007).
Marchantia is a liverwort and they have characteristics that are different to seed plants that mean specific
containment measures may be required. They are present already in the New Zealand environment and
rapidly colonise bare moist ground. They reproduce both sexually and asexually. Sexual reproduction in
liverworts leads to the formation of diploid spores. Fertilisation requires male and female thalli to be in close
proximity. Asexual reproduction in liverworts is via gemma, that form in splash cups on the thallus surface.
Dispersion of gemmae out of the cups is via water drops splashing the gemmae into the immediate
surroundings.
A management plan will be developed to contain spores based on international best practice. This will
include the separation of male and female thalli , the propagation of Marchantia in closed tubs except where
14
----------------- ----- ---------------- --- -- -- - ---- ----- --- ----------------------- --- ---- ------- ---- -- -----·· oecisioii:-P.F>iiicii1-ii
specific experimental treatments are to be applied, controlled fertilisations of transgenic plants to be carried
out in vitro in the laboratory, and management of growth in the greenhouse so that no direct application of
water occurs to thalli or sporophytes_"
15
•.••.•••.•....•..............••...................... .... --...... --- - .. - ....... ... ....... . .................. Decfsioii:· .A.F>-F'26i1-2i
Organism Approval
Ogataea angusta (Teun., H. H. Hall & Wick.) Suh & Zhou 2010 GMD101558
(syn. Pichia angusta) non pathogenic, non-sporulating laboratory adapted strains
Saccharomyces cerevisiae Meyen exEC Hansen (1883) non pathogenic, GMD101559
non-sporulating laboratory adapted strains
Brevibacillus choshinensis (Takagi et al. 1993) Shida et al. 1996 non pathogenic GMD101560
laboratory strains
Agrobacterium rhizogenes (Riker et al. 1930) Conn, 1942 disarmed strains GMD101561
Agrobacterium tumefaciens (Smith and Townsend, 1907) Conn 1942 disarmed GMD101562
strains
Escherichia coli (Migula 1895) Castenellani and Chalmers 1919 non conjugative, non GMD101563
pathogenic laboratory strains
Pichia pastoris Guillerm Phaff (1956) non pathogenic, GMD101564
non-sporulating laboratory adapted strains
Schizosaccharomyces pombe Lindner 1893 non pathogenic, GMD101565
non-sporulating laboratory adapted strains
Marchantia polymorpha (marchantia) L. GMD101566
Nicotiana spp. L. and Graham GMD101567
Petunia spp. Juss. GMD101568
Antirrhinum spp. L. GMD101570
Arabidopsis tha/iana Heynh. GMD101571
Agrobacterium tumefaciens (Smith and Townsend, 1907) Conn 1942 armed strains GMD101572
Agrobacterium rhizogenes (Riker et al. 1930) Conn, 1942 armed strains GMD101573
Nicotiana spp. L. and Graham GMD101574
Petunia spp. Juss. GMD101575
Antirrhinum spp. L. GMD101576
Arabidopsis thaliana Heynh. GMD101577
Marchantia polymorpha (marchantia) L. GMD101578