ERMA 0130/01
Institutional Biological Safety Committee Decision Form1 to Develop a
Low-Risk Genetically Modified Organism in Containment under section
42a of the Hazardous Substances and New Organisms (HSNO) Act
Amended under s67A of the HSNO Act on 19 May 2011
ERMA Office use only
Application Code:
GMD02064
Application Approval
Code(s):
GMD100988
BCH Number(s)2:
N/A
Institutional Biological Safety
Committee:
Massey University
IBSC Institution Code:
GMO02/MU007 s67A
Application type:
To develop a genetically modified organism into containment
under section 40(1) of the Hazardous Substances and New
Organisms (HSNO) Act.
Applicant:
Massey University
Date the application was
formally received:
14 June 2002
The application was considered
by:
Chairperson, Deputy BSO, Microbiologist/Molecular Biologist,
Plant Pathologist, Biochemist/Molecular Biologist, Lay Member,
Māori Advisor
The consideration date of the
application:
14 June 2002
First s67A amendment
Date application received:
Considered by:
6 May 2011
Consideration date:
6 May 2011
1
2
Chair, Deputy BSO, Biochemist/Molecular Biologist, Cell and
Molecular Biologist, Ecologist/Environmental Scientist, Lay
Member (2), Māori Representative, Māori Advisor
This decision form should be used in conjunction with the Matters to be considered section.
Biosafety Clearing House record identification number is used for the exportation of GMOs for contained use.
Page 1 of 15
ERMA 0130/01
1. Summary of the Decision
The application to develop the following organism(s) is approved with controls, having
been considered in accordance with the relevant provisions of the Hazardous Substances and
New Organisms (HSNO) Act 1996 (the Act), the Hazardous Substances and New Organisms
(Low-Risk Genetic Modification) Regulations 2003 (the Regulations), and the HSNO
(Methodology) Order 1998 (the Methodology).
The application was considered by the IBSC under delegation from the Authority as provided
for under section 19(2)(a) of the Act.
2. Sequence of the Consideration
In accordance with section 42A of the Act (rapid assessment), the approach adopted by the
IBSC was to identify the circumstances of the genetic modification(s), to evaluate these
against the criteria set out in the Regulations established under section 41 of the Act, and to
consider whether there are any residual risks of significance that require further consideration
(if so, see Annex A).
3. Decision
3.1.
Purpose of the approval is:
To isolate and characterise both plant and fungal genes involved in the establishment
and maintenance of symbiotic associations between temperate grasses and fungal
endophytes.
3.2.
The genetically modified organism(s) approved for development are:
Name of the host
organism (including
taxonomic authority):
Neotyphodium uncinatum (Gams, Petrini & Schmidt 1990)
Glenn, Bacon, Price & Hanlin 1996
Specify the category of
host organism
eg, Category 1 or 23
Category 1
What the organism is
modified with:
Integrative vectors containing gene regulatory elements from
Aspergillus epichloe and Neotyphodium spp, and insert DNA
from Epichloe and Neotyphodium spp, various reporter genes
including gusA and gfp, and various selectable markers such
as nptII, hph, nat1 and amdS.
Please specify vector and
source and function of
donor DNA
3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism, or its ability to escape containment.
According to the Regulations.
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Please specify the category
of genetic modification eg,
Category A or B3
Category A
Containment level
e.g. PC1/PC24
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Escherichia coli (non-pathogenic strains) (Migula 1895)
Castellani & Chalmers 1919
Specify the category of
host organism
eg, Category 1 or 25
Category 1
What the organism is
modified with:
Non-conjugative vectors (eg, pUC series, pBLUESCRIPT,
GATEWAY), selectable markers (blaA, nptII, cat, tet and
spc); DNA from yeast, Epichloë typhina, E. festucae,
Neotyphodium sp. LpTG-2, N. lolii, Penicillium paxilli,
Aspergillus spp, Lolium perenne, Festuca pratensis, F.
arundinaceae, jelly fish (GFP), E. coli (GUS), firefly (LUX).
Please specify vector and
source and function of
donor DNA
Non-conjugative vectors containing genomic and cDNA from
Epichloe brachyelytri, E. baconii, E. elymi, E. clarkii, E.
bromicola, E. glyceriae, all Neotyphodium spp, all Claviceps
spp, Aciculosporium take (bamboo endophyte), Periglandula
ipomoeae (epiphyte of morning glory, Ipomoea asarifolia)
and selectable markers such as Kan, Amp, Chl and Tet.
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC26
PC1
Approved/Declined
Approved
4
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
5
According to the Regulations.
6
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
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ERMA 0130/01
Name of the host
organism (including
taxonomic authority):
Lolium perenne protoplast (all cultivars) L. (Linnaeus 1753)
Specify the category of
host organism
eg, Category 1 or 27
Category 1
What the organism is
modified with:
Transient assays of characterised DNA from L. perenne, F.
arundinaceae, F. prantensis, jelly fish (GFP), E. coli (GUS),
firefly (LUX).
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC28
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Festuca pratensis protoplast (all cultivars) (Hudson 1762)
Specify the category of
host organism
eg, Category 1 or 29
Category 1
What the organism is
modified with:
Transient assays of characterised DNA from L. perenne, F.
arundinaceae, F. prantensis, jelly fish (GFP), E. coli (GUS),
firefly (LUX).
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
7
According to the Regulations.
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
9
According to the Regulations.
8
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Containment level
e.g. PC1/PC210
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Festuca arundinaceae protoplast (all cultivars) (Schreber
1771)
Specify the category of
host organism
eg, Category 1 or 211
Category 1
What the organism is
modified with:
Transient assays of characterised DNA from L. perenne, F.
arundinaceae, F. prantensis, jelly fish (GFP), E. coli (GUS),
firefly (LUX).
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC212
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Epichloë typhina (strain E8) (Tul. & C. Tul. 1865) Sampson
1933
Specify the category of
host organism
eg, Category 1 or 213
Category 2
What the organism is
modified with:
Non-conjugative vectors, T-DNA; DNA from yeast, E.
typhina, E. festucae, Neotyphodium sp. LpTG-2, N. lolii,
Penicillium paxilli, Aspergillus spp, jelly fish (GFP), E. coli
(GUS), firefly (LUX), and selectable markers, blaA, hph and
nptII.
Please specify vector and
source and function of
donor DNA
10
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
11
According to the Regulations.
12
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
13
According to the Regulations.
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ERMA 0130/01
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category B
Containment level
e.g. PC1/PC214
PC2
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Epichloë festucae (all strains) (Leuchtmann et al 1994)
Specify the category of
host organism
eg, Category 1 or 215
Category 1
What the organism is
modified with:
Non-conjugative vectors, T-DNA; DNA from yeast, E.
typhina, E. festucae, Neotyphodium sp. LpTG-2, N. lolii,
Penicillium paxilli, Aspergillus spp, jelly fish (GFP), E. coli
(GUS), firefly (LUX), and selectable markers, blaA, hph and
nptII.
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC216
PC2
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Neotyphodium sp. LpTG-2 (all strains) (Christensen et al
1993)
14
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
15
According to the Regulations.
16
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
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ERMA 0130/01
Specify the category of
host organism
eg, Category 1 or 217
Category 1
What the organism is
modified with:
Non-conjugative vectors, T-DNA; DNA from yeast, E.
typhina, E. festucae, Neotyphodium sp. LpTG-2, N. lolii,
Penicillium paxilli, Aspergillus spp, jelly fish (GFP), E. coli
(GUS), firefly (LUX), and selectable markers, blaA, hph and
nptII
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC218
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Neotyphodium lolii (all strains) (Latch, Christensen &
Samuels 1984) Glenn, Bacon & Hanlin1996
Specify the category of
host organism
eg, Category 1 or 219
Category 1
What the organism is
modified with:
Non-conjugative vectors, T-DNA; DNA from yeast, E.
typhina, E. festucae, Neotyphodium sp. LpTG-2, N. lolii,
Penicillium paxilli, Aspergillus spp, jelly fish (GFP), E. coli
(GUS), firefly (LUX), and selectable markers, blaA, hph and
nptII.
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
17
According to the Regulations.
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
19
According to the Regulations.
18
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Containment level
e.g. PC1/PC220
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Penicillium paxilli (all strains) (Bainier 1907)
Specify the category of
host organism
eg, Category 1 or 221
Category 2
What the organism is
modified with:
Non-conjugative vectors, T-DNA; DNA from yeast, E.
typhina, E. festucae, Neotyphodium sp. LpTG-2, N. lolii,
Penicillium paxilli, Aspergillus spp, jelly fish (GFP), E. coli
(GUS), firefly (LUX), and selectable markers, blaA, hph and
nptII.
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category B
Containment level
e.g. PC1/PC222
PC2
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Saccharomyces cerevisiae (all strains) (Hawsworh et al 1991)
Specify the category of
host organism
eg, Category 1 or 223
Category 1
20
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
21
According to the Regulations.
22
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
23
According to the Regulations.
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ERMA 0130/01
What the organism is
modified with:
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Yeast/E. coli shuttle vectors, bacterial selectable markers,
blaA, nptII, cat and tet; DNA from yeast, Epichloë typhina, E.
festucae, Neotyphodium sp. LpTG-2, N. lolii, Penicillium
paxilli, Aspergillus spp, Lolium perenne, Festuca pratensis, F.
arundinaceae, jelly fish (GFP), E. coli (GUS), firefly (LUX).
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category A
Containment level
e.g. PC1/PC224
PC1
Approved/Declined
Approved
Name of the host
organism (including
taxonomic authority):
Agrobacterium tumefaciens (all disarmed strains) (Smith &
Townsend 1907) Conn 1942
Specify the category of
host organism
eg, Category 1 or 225
Category 2
What the organism is
modified with:
Vectors with bacterial (blaA, nptII, cat, tet, spc) and fungal
(hph, nptIII, pyr4, prtA, tub2, trpC) selectable markers; DNA
from yeast, Epichloë typhina, E. festucae, Neotyphodium sp.
LpTG-2, N. lolii, Penicillium paxilli, Aspergillus spp, Lolium
perenne, Festuca pratensis, F. arundinaceae, jelly fish (GFP),
E. coli (GUS), firefly (LUX).
Please specify vector and
source and function of
donor DNA
Please specify the category
of genetic modification eg,
Category A or B3
Containment level
e.g. PC1/PC226
Genes derived from NZ native biota or from organisms
identified under the Convention on International Trade in
Endangered Species (CITES) will be excluded, as will genes
that may increase the pathogenicity, virulence or infectivity of
the host organism or its ability to escape containment.
Category B
PC2
24
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
25
According to the Regulations.
26
As in the Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories: Microbiological aspects and
containment facilities.
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Approved/Declined
Approved
3.3
Controls
In considering all the matters to be addressed detailed in the Third Schedule Part I
“Containment Controls for Importing, Developing or Field Testing of Genetically Modified
Organisms” of the Act, the organisms and any containment facility they are contained in are
subject to approval is subject to the following controls:
1. Requirements to meet the Standards
1.1. The approved organism must be developed and held within a containment facility
which complies with these controls.
1.2. The containment facility must be operated in accordance with the:
o
MAF/ERMA New Zealand Standard Facilities for Micro-organisms and Cell
Cultures: 2007a27
o
MAF/ERMA New Zealand Standard Containment Facilities for Plants: 200728
o
The Australian/New Zealand Standard 2243.3:2002 Safety in Laboratories:
Microbiological Aspects and Containment Facilities27, at Physical Containment
Levels 1 and 2 (PC1 and PC2).
2. Controls additional to the requirements of the Standards
2.1. If a breach of containment29 occurs, the approval holder must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the
breach within 24 hours.
Original Signature (details typed in)
Name:
Assoc Prof John Tweedie
(on behalf of the institution)
Position:
Chairperson, Massey University IBSC
Date: 18 October 2004
27
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
28
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
29
Breach of containment includes; escape of organism (s), unauthorised entry to facility, and/or structural
integrity of the facility compromised.
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ERMA 0130/01
First S67A amendment30
GMO02/MU007 s67A
(amendment under section 67A)

Updated May 2011 to add Neotyphodium uncinatum to the names of the host
organisms, and PCR products from selected Epichloë spp, all Neotyphodium spp, all
Claviceps spp, Aciculosporium take and Periglandula ipomoeae to the donor DNA for
the host, Escherichia coli.
Signed: ……………………………………….……………
(on behalf of the institution)
Name:
Prof Michael McManus
Position:
Chairperson, Massey University IBSC
30
Date ……………….........
Sections highlighted in blue are to be filled in for an s67A amendment, otherwise delete.
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ERMA 0130/01
Matters to be considered

Sections referenced in the text below indicate sections of the Hazardous Substances
and New Organisms Act 1996

Clauses referenced in the text below indicate clauses of the Hazardous Substances and
New Organisms (Methodology) Order 1998
Yes/No/
N/A
1
Legislative criteria for the application
1.1
The application was lodged pursuant to section 40(1) of the Act.
Yes
1.2
The application was considered in accordance with section 42A and
matters relevant to the purpose of the Act.
Consideration of the application
Yes
Does the IBSC hold delegated authority as provided under section
19(2)(a) of the Act?
Yes
2
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
3
3.1
If NO, the consideration cannot proceed.
Has the quorum for the Decision-making Committee (ie, the members
of the IBSC that will consider this application) been reached?
If NO, the consideration cannot proceed.
Does the Decision-making Committee have the appropriate expertise?
If NO, the consideration cannot proceed.
Does any member of the Decision-making Committee have a conflict
of interest?
If YES, the consideration cannot proceed until mitigated (eg, the
member steps out of the room). (This should be noted in minutes.)
Does the committee consider that there is sufficient information for the
formal receipt of the application using the acceptance checklist?
If NO, the application cannot be considered. Please return to the
applicant for further information.
Is the purpose provided for under section 39 of the Act?
Was any expert advice sought (clause 17 of the Methodology)?
If YES –
What is the name of the expert(s) and the nature of the advice sought?
Was the applicant informed (clause 18 of the Methodology)?
Is the consideration of this application within 10 working days of the
formal receipt of the application?
Assessment against the criteria for low risk genetic modifications
Is the IBSC satisfied that each of the genetically modified organisms
described in the application meets the criteria for a low-risk genetic
Yes
Yes
No
Yes
Yes
No
Yes
Yes
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Yes/No/
N/A
modification specified in the criteria made under section 41 of the Act,
being the Regulations?
If NO, give details.
Applications involving native flora and fauna
4
4.1
Does the application involve native or valued introduced flora and/or
fauna as host organisms or as a source of genetic material?
No
If “YES”, please clearly record below the evidence that appropriate
Māori consultation has occurred with local iwi regarding this approval
(i.e. who was consulted, their status and the results of the consultation).
Applications involving human genetic material or human cells
5
5.1
5.2
Does the application involve the use any genetic material or cells
obtained directly from human beings?
If YES, has approval from a Human Ethics Committee been obtained?
Does the application involve the use of human cells or human genetic
material sourced directly from individuals of Māori whakapapa or
origin?
No
No
If “YES”, please clearly record below the evidence that appropriate
Māori consultation has occurred with local iwi regarding this approval
(i.e. who was consulted, their status, and the results of the
consultation).
Applications involving animal experimentation
6
6.1
Does the application involve animal experimentation (either in the
genetic modification or subsequent use of the GMO)?
No
If YES, has approval from an Animal Ethics Committee been obtained?
Identification of significant risks31
7
7.1
Are there any significant risks or costs to the environment, including
the sustainability of all native and valued introduced flora and fauna?
Are there any significant risks to the intrinsic value of ecosystems?
No
No
7.4
Are there any significant risks or costs to human health, including
public health?
Are there any significant risks to Māori and their taonga?
7.5
Are there any significant economic risks or costs?
No
7.6
Are there any risks to New Zealand’s international obligations,
including DNA derived from CITES species or use of CITES species
as host organisms?
No
7.2
7.3
31
No
No
See Annex A
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7.7
8
8.1
8.2
If YES is checked in 7.1-7.6, please list the significant risks identified
below and discuss how they were assessed in terms of likelihood and
consequence, and what controls were imposed to manage them32.
Justify below any additional controls (in addition to the requirements in
the appropriate MAF/ ERMA New Zealand Standard) applied to
manage the risks.
Containment of the organisms
Has the IBSC considered the adequacy of containment in accordance
with section 42A of the Act?
Please ensure the containment controls have been specified. Note that
controls relevant to the physical containment level set in the
Regulations cannot be removed.
Are any additional measures proposed because of the particular nature
of the organism(s)?
Yes/No/
N/A
N/A
Yes
No
8.3
If YES, please ensure additional controls are listed on the decision
form. Discuss the reasons for imposing the additional controls below.
Are there any other matters that may affect the adequacy of
containment, such as the expected time-frame for the project, and
external matters such as the potential for sabotage?
No
8.4
If YES, please explain.
Is this decision restricted to a specific site (in the case of multi-site
applicant organisations)?
No
9
9.1
9.2
9.3
9.4
32
IF YES, which site and why?
Decision
If any of the answers to 9.1-9.4 are NO, then the application must be
declined.
The IBSC is satisfied that the application is for one of the purposes
specified in section 39 of the Act.
Based on analysis of the information provided, and having considered
the characteristics of the organisms and the modifications and the
criteria for low-risk genetic modification detailed in the HSNO (LowRisk Genetic Modification) Regulations 2003, it is the view of the
IBSC that the organism(s) meet the criteria for rapid assessment (as per
section 42A(2) of the Act).
The IBSC is satisfied that the proposed containment regime, together
with any additional controls imposed, will adequately contain the
organism(s) as required by section 42A(2) of the Act.
In accordance with clause 36(2)(b) of the Methodology, the IBSC
records that, in reaching this conclusion, it has applied the relevant
criteria from the Methodology.
Yes
Yes
Yes
Yes
Clauses 12 and 13 of the Methodology.
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9.5
9.6
The application for development of genetically modified organism(s) is
thus approved, with controls as detailed on the decision document.
Is the Committee’s decision made by consensus?
Yes
Yes
Original details typed in
Signed: ……………………………………….……………
(on behalf of the institution)
Name:
Prof Michael McManus
Position:
Chairperson, Massey University IBSC
Date ……………….........
Administrative requirements
Confirm that the minutes record the decision-making process including the
discussion of adequacy of containment and the reasons for imposing or not
imposing additional controls.
Confirm that hard copies of the application and decision, the consideration
documentation (such as the minutes) and any other correspondence related to
this application will be maintained by the IBSC.
Yes/No
Yes
Yes
Approval numbers for organisms on Application GMD02064 (GM002/MU007)
Approval number Organism
Neotyphodium uncinatum (Gams, Petrini &
GMD100988
Schmidt 1990) Glenn, Bacon, Price & Hanlin
1996
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