NO3P
ER-AF-NO3P-3
12/07
Develop in containment a project of low risk genetically
modified organisms by rapid assessment
Application title:
The Formation of Spores in Biofilms of Thermophilic
Bacilli
Applicant organisation:
Fonterra Co-operative Group and Massey University
Considered by:
IBSC
ERMA
X
Please clearly identify any confidential information and attach as a separate appendix.
Please complete the following before submitting your application:
All sections completed
Appendices enclosed
Confidential information identified and enclosed separately
Copies of references attached
Application signed and dated
Electronic copy of application e-mailed to ERMA New
Zealand
Yes
NA
NA
Yes
Yes
Yes
Signed: ________________________________________
Fonterra Co-operative Group
Date: _______________
Signed: ________________________________________
Massey University
Date: _______________
20 Customhouse Quay
Cnr Waring Taylor and Customhouse Quay
PO Box 131, Wellington
Phone: 04 916 2426 Fax: 04 914 0433
Email: [email protected]
Website: www.ermanz.govt.nz
Develop in containment a project of low risk genetically modified organisms by rapid assessment
1.
An associated User Guide NO3P is available for this form and we strongly advise that you read this
User Guide before filling out this application form. If you need guidance in completing this form
please contact ERMA New Zealand or your IBSC.
This application form only covers the development of low-risk genetically modified organisms that
meet Category A and/or B experiments as defined in the HSNO (Low-Risk Genetic Modification)
Regulations 2003.
2.
If you are making an application that includes not low-risk genetic modification experiments, as
described in the HSNO (Low-Risk Genetic Modification) Regulations 2003, then you should complete
form NO3O instead.
3.
This form replaces all previous versions of Form NO3P.
4.
This application form may be used to seek approvals for more than one new organism where the
organisms are used in the same project, or have a similar risk profile.
5.
Any supporting material that does not fit in the application form must be clearly labelled, crossreferenced, and included as appendices to the application form.
6.
Commercially sensitive information must be collated in a separate appendix but referenced in the
application. You need to justify why you consider the material commercially sensitive, and make sure
it is clearly labelled as such. Confidentiality of material is subject to the provisions of the Official
Information Act 1982 and the basis of which is that information should be publicly available unless
there is good reason to protect it.
7.
Applicants must sign the form and enclose the correct application fee (plus GST) if it is submitted to
ERMA New Zealand. Details of the application fee can be found in our published Schedule of Fees
and Charges. Please check with ERMA New Zealand staff or the ERMA New Zealand website for the
latest schedule of fees.
8.
Unless otherwise indicated, all sections of this form must be completed for the application to be
progressed.
9.
Please provide an electronic version of the completed application form, as well as sending a signed
hard copy.
You can get more information by contacting your Institutional Biological Safety Committee or ERMA New
Zealand.
This version of the application form was approved by the Chief Executive of ERMA New Zealand on 12
November 2007.
Page 2 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Section One – Applicant details
refer to page 9 of the user guide
Name and details of the organisation making the application:
Name:
Fonterra Co-operative Group
Postal Address:
Private Bag 11029, Palmerston North
Physical Address:
Dairy Farm Road, Palmerston North 4442
Phone:
06 3504649
Fax:
06 356 1476
Name:
Massey University
Postal Address:
Private Bag 11222, Palmerston North
Physical Address:
Tennent Drive, Palmerston North
Phone:
06 3569099
Fax:
Name and details of the key contact person (if different from above):
Name:
Sara Burgess
Postal Address:
Private Bag 11029, Palmerston North
Physical Address:
Dairy Farm Road, Palmerston North 4442
Phone:
06 3504600
Fax:
06 356 1476
Email:
[email protected]
Name:
Professor Michael McManus
Postal Address:
Institute of Molecular Biosciences, Massey University,
Private Bag 11222, Palmerston North
Physical Address:
Turitea Campus, Tennent Drive, Palmerston North
Phone:
06 3505515, extn 2577
Fax:
06 350 5688
Email:
[email protected]
Name and details of a contact person in New Zealand, if the applicant is overseas:
Name:
Mrs Anna Beaven
Postal Address:
Office of the Pro Vice-Chancellor, College of Sciences,
Massey University, Private Bag 11222, Palmerston North
Physical Address:
Turitea Campus, Tennent Drive, Palmerston North
Phone:
06 3505237
Fax:
06 3505620
Email:
[email protected]
Note: The key contact person should have sufficient knowledge of the application to respond
to queries from ERMA New Zealand staff.
Page 3 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Section Two: Lay summary and scientific project description
refer to page 9 of the user guide
Lay summary of the application (approximately 200 words)
Note: This summary should describe the genetically modified organism(s) being developed,
the purpose of the application or what you want to do with the organisms(s). Use simple nontechnical language.
This project aims to develop strains of Geobacillus and Anoxybacillus that have reporter
genes fused to the regulatory regions of genes with known or putative roles in
sporulation or biofilm formation. These organisms cannot cause disease or colonise
humans.
The work will be for research only, so that we can gain an understanding of how biofilms
and spore formation are linked in these organisms and where sporulation occurs within
the biofilm.
This research is a joint project between Fonterra and Massey University.
Page 4 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Scientific project description (describe the project, including the background, aims and
a description of the wider project)
refer to page 10 of the user guide
Note: This section is intended to put the genetically modified organism(s) being developed in
perspective of the wider project(s) that they will be used in. You may use more technical
language but make sure that any technical words are included in the Glossary.
Biofilms are the main source of bacterial contamination of final product in dairy
manufacturing plants. Preventing biofilm growth would result in extended manufacturing
time and hence more product, as well as improved product quality. One of the most
common groups of biofilm-forming organisms in the dairy processing context is the
thermophilic bacilli (Geobacillus and Anoxybacillus spp.). This group of bacteria is able
to grow in sections of manufacturing plants at elevated temperatures of 40 - 65 C.
At the end of a manufacturing run the plant is cleaned. However, thermophiles in the
biofilm form are able to survive these cleaning regimes as it is believed they are protected
by the biofilm and/or milk foulant. Many strategies have been tested to remove and/or
prevent the formation of biofilms, with limited success, using laboratory reactor systems,
which mimic dairy manufacturing conditions. This is, in part, because little is known
about the structure and composition of thermophilic biofilms in general, and more
specifically, in milk processing environments. Therefore, new cleaning regimes often do
not target the problem optimally.
The aim of this project is to understand the structure of thermophilic biofilms and how
these multicellular structures promote spore formation so that ultimately treatments can be
developed to prevent their formation.
As part of this project gene expression studies will be used to look at the effect of
different environmental conditions (e.g. nutrients and temperature) on biofilm formation
and spore development, as well as the link between these two characteristics. Gene
expression studies to understand sporulation and biofilm formation of a Geobacillus spp.
has not been previously described. However, a lot of work has been done on Bacillus
subtilis using reporter genes such as the gene encoding the green fluorescent protein from
jellyfish (gfp) or lac z. A reporter gene will allow tracking of when sporulation occurs
within biofilm cells.
Initially a Geobacillus isolate will be engineered with a reporter gene fused to the
promoter of a gene(s) involved in sporulation and/or biofilm formation. If the method is
successful Anoxybacillus isolates may also be engineered with a reporter gene.
To date the only gene involved with sporulation that has been well characterised within
the Geobacillus genus is Spo0A. However, as part of a separate project the full genome of
a Geobacillus milk powder isolate will be sequenced. This should be able to provide
information on other genes that could be incorporated into this study. Potential genes
could include those that have already been used in gene expression studies of B. subtilis
such as SpoOA, SpoIVFB, SpoOH, yqxM operon, eps operon.
The engineered Geobacillus strain will be used to determine what conditions such as
temperature and milk composition are critical for biofilm formation and spore production.
Page 5 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Short summary of purpose (please provide a short summary of the purpose of the
application) (255 characters or less, including spaces) refer to page 11 of the user guide.
This section will be transferred into the decision document.
To develop genetically modified thermophilic bacilli by adding reporter genes to
understand the link between biofilm formation and endospore production.
Section Three –Description of the organism(s) to be developed
refer to page 13 of the user guide
3.1
Identification of the host organism to be modified
Complete this section separately for each host organism to be modified.
Latin binomial, including full
taxonomic authority:
Geobacillus Nazina et al. 2001 (eg, Geobacillus
stearothermophilus DSM22)
Common name(s), if any:
Type of organism (eg bacterium,
virus, fungus, plant, animal, animal
cell):
bacteria
Taxonomic class, order and family:
Class: Bacilli Order: Bacillales Family:
Bacillaceae
Strain(s) if relevant:
Other information, including
presence of any inseparable or
associated organisms and any related
animals present in New Zealand:
We will predominantly be working with strains
isolated from milk powder. They have been
identified using genus specific PCR and partial
16S rDNA. However, the 16S rDNA is too
similar between species of this genus to identify
to the species level. However all members of this
genus have similar biological characteristics.
Latin binomial, including full
taxonomic authority:
Anoxybacillus Pikuta et al. 2000 (eg,
Anoxybacillus flavithermus DSM 2641)
Common name(s), if any:
Type of organism (eg bacterium,
virus, fungus, plant, animal, animal
cell):
bacteria
Taxonomic class, order and family:
Class: Bacilli Order: Bacillales Family:
Bacillaceae
Page 6 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Strain(s) if relevant:
Other information, including
presence of any inseparable or
associated organisms and any related
animals present in New Zealand:
We will predominantly be working with strains
isolated from milk powder. They have been
identified using genus specific PCR and partial
16S rDNA. However, the 16S rDNA is too
similar between species of this genus to identify
to the species level. All members of this genus
have similar biological characteristics.
Latin binomial, including full
taxonomic authority:
Escherichia coli (Migula, 1895) Castellani and
Chalmers 1919
Common name(s), if any:
E. coli
Type of organism (eg bacterium,
virus, fungus, plant, animal, animal
cell):
bacteria
Taxonomic class, order and family:
Class: Gammaproteobacteria, Order:
Enterobacteriales, Family: Enterobacteriaceae
Strain(s) if relevant:
Both commercially available and conventional
research laboratory strains.
Non-pathogenic laboratory strains only.
Other information, including
presence of any inseparable or
associated organisms and any related
animals present in New Zealand:
Page 7 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
3.2
Information on the host organism
Refer to pages 14-19 and pages 33-38 of the user guide for assistance in completing this
section
Complete this section separately for each host organism to be modified.
Geobacillus spp.
Yes
1
Is the organism normally capable of causing disease in humans,
animals, plants or fungi?
No
X
If yes, provide details here
2
Is the organism a human cell line?
X
If yes, provide details here of where the material has been obtained
from and whether approval has been obtained from an Ethics
Committee (if required)
3
Is the organism native to New Zealand?
X
Some of the strains have been isolated from New Zealand milk powder
4
Does the organism contain infectious agents normally able to cause
disease in humans, animals, plants or fungi?
X
If yes, provide details here.
5
Does the organism produce desiccation resistant structures (such as
spores or cysts) that can normally be disseminated in the air?
X
They produce endospores but these aren’t disseminated into the air
6
Is the organism characterised to the extent that its main biological
characteristics are known?
7
Does the organism normally infect, colonise or establish in humans?
X
X
If yes, provide details here.
If the organism is a whole plant or plant tissue, do you intend to:
a) Allow it to develop reproductive structures If yes, please
provide further information on containment in section 4
b) Keep it in a closed container?
N/A
9
Is the host a Category 1 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
X
10
Is the host a Category 2 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
8
Page 8 of 20
N/A
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Anoxybacillus spp.
Yes
1
Is the organism normally capable of causing disease in humans,
animals, plants or fungi?
No
X
If yes, provide details here
2
Is the organism a human cell line?
X
If yes, provide details here of where the material has been obtained
from and whether approval has been obtained from an Ethics
Committee (if required)
3
Is the organism native to New Zealand?
X
Some of the strains have been isolated from New Zealand milk powder
4
Does the organism contain infectious agents normally able to cause
disease in humans, animals, plants or fungi?
X
If yes, provide details here.
5
Does the organism produce desiccation resistant structures (such as
spores or cysts) that can normally be disseminated in the air?
X
They produce endospores but these aren’t disseminated into the air
6
Is the organism characterised to the extent that its main biological
characteristics are known?
7
Does the organism normally infect, colonise or establish in humans?
X
X
If yes, provide details here.
If the organism is a whole plant or plant tissue, do you intend to:
a) Allow it to develop reproductive structures If yes, please
provide further information on containment in section 4
b) Keep it in a closed container?
N/A
9
Is the host a Category 1 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
X
10
Is the host a Category 2 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
8
Page 9 of 20
N/A
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
E. coli (non-pathogenic laboratory strains)
Yes
1
Is the organism normally capable of causing disease in humans,
animals, plants or fungi?
No
X
If yes, provide details here
2
Is the organism a human cell line?
X
If yes, provide details here of where the material has been obtained
from and whether approval has been obtained from an Ethics
Committee (if required)
3
Is the organism native to New Zealand?
X
If yes, provide details here for example, from where will this material
be obtained? Be as specific as possible as this information may be
needed to determine whether Māori have been consulted appropriately
4
Does the organism contain infectious agents normally able to cause
disease in humans, animals, plants or fungi?
X
If yes, provide details here.
5
Does the organism produce desiccation resistant structures (such as
spores or cysts) that can normally be disseminated in the air?
X
If yes, provide details here.
6
Is the organism characterised to the extent that its main biological
characteristics are known?
7
Does the organism normally infect, colonise or establish in humans?
X
X
If yes, provide details here.
If the organism is a whole plant or plant tissue, do you intend to:
a) Allow it to develop reproductive structures If yes, please
provide further information on containment in section 4
b) Keep it in a closed container?
N/A
9
Is the host a Category 1 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
X
10
Is the host a Category 2 organism (as defined in the HSNO (Low-Risk
Genetic Modification) Regulations 2003)?
8
N/A
X
Note: If the genetic modification does not involve a Category 1 or 2 host organism then the
proposed project does not meet the criteria in section 42A(2)(a) of the HSNO Act for the
rapid assessment of projects for low-risk genetic modification.
Page 10 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
3.3
Nature and range of the proposed genetic modification(s)
Refer to pages 15-19 and pages 33-38 of the user guide for assistance in completing this
section
Provide details on the following
Complete this section separately for each host organism to be modified only if there are
significant differences in the modifications for each of the host organisms listed above.
Geobacillus spp.
Information on how the new organism(s) will be developed
Vector system used, eg cloning or
expression, plasmid, or viral
Standard non-conjugative E. coli cloning and
expression vectors. Vectors developed
specifically for gene expression in Geobacillus
spp. may also be used (Taylor et al. 2008).
Constructs will be integrated into the genome or
be carried as plasmid DNA.
Range of elements that the vectors
may contain
Vectors will consist of promoter sequences,
reporter genes, selectable markers, recombination
sites, sequences that facilitate recombination and
origins of replication.
Type, source and function of any
donor genetic material
DNA from Anoxybacillus and Geobacillus.
Reporter genes such as gfp from jellyfish
(Aequorea aequorea).
Use of special genetic material
Yes
Does the proposed modification use genetic material derived from
organisms capable of causing disease in humans, animals, plants or fungi?
No
X
If yes, provide details here including the sequences as well as the species
and strains they were derived from. If the genetic material to be introduced
is characterised so that its sequence and gene function are known, please
state this
Does the proposed modification use genetic material from native biota?
X
If yes, provide details here including where this material will be obtained
from. Be as specific as possible as this information may be needed to
determine whether Māori have been consulted appropriately
Does the proposed modification involve human genetic material? Answer
yes if human genetic material in any form is used, ie whether it is obtained
directly from humans, from a gene bank, synthesised, copied and so on.
Page 11 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
If yes, provide details here including where the material is obtained from,
and whether approval has been obtained from an Ethics Committee (if
required). Also complete section 5 of this form.
Other details of the modification, including any unusual manipulations, if the foreign
genetic material is to be expressed, where it is expected to be expressed and what techniques
will be used in the modification.
Standard techniques will be used.
Anoxybacillus spp.
Information on how the new organism(s) will be developed
Vector system used, eg cloning or
expression, plasmid, or viral
Standard non-conjugative E. coli cloning and
expression vectors. Vectors developed
specifically for gene expression in Geobacillus
spp. may also be used (Taylor et al. 2008).
Constructs will be integrated into the genome or
be carried as plasmid DNA.
Range of elements that the vectors
may contain
Vectors will consist of promoter sequences,
reporter genes, selectable markers, recombination
sites, sequences that facilitate recombination and
origins of replication.
Type, source and function of any
donor genetic material
DNA from Anoxybacillus and Geobacillus.
Reporter genes such as gfp from jellyfish
(Aequorea aequorea).
Use of special genetic material
Yes
Does the proposed modification use genetic material derived from
organisms capable of causing disease in humans, animals, plants or fungi?
No
X
If yes, provide details here including the sequences as well as the species
and strains they were derived from. If the genetic material to be introduced
is characterised so that its sequence and gene function are known, please
state this
Does the proposed modification use genetic material from native biota?
If yes, provide details here including where this material will be obtained
from. Be as specific as possible as this information may be needed to
determine whether Māori have been consulted appropriately
Page 12 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Does the proposed modification involve human genetic material? Answer
yes if human genetic material in any form is used, ie whether it is obtained
directly from humans, from a gene bank, synthesised, copied and so on.
X
If yes, provide details here including where the material is obtained from,
and whether approval has been obtained from an Ethics Committee (if
required). Also complete section 5 of this form.
Other details of the modification, including any unusual manipulations, if the foreign
genetic material is to be expressed, where it is expected to be expressed and what techniques
will be used in the modification.
Standard techniques will be used.
E. coli (non-pathogenic laboratory strains)
Information on how the new organism(s) will be developed
Vector system used, eg cloning or
expression, plasmid, or viral
Standard non-conjugative E. coli cloning and
expression vectors. Vectors developed
specifically for gene expression in Geobacillus
spp. may also be used (Taylor et al. 2008).
Constructs will be integrated into the genome or
be carried as plasmid DNA.
Range of elements that the vectors
may contain
Vectors will consist of promoter sequences,
reporter genes, selectable markers, recombination
sites, sequences that facilitate recombination and
origins of replication.
Type, source and function of any
donor genetic material
DNA from Anoxybacillus and Geobacillus.
Reporter genes such as gfp from jellyfish
(Aequorea aequorea).
Use of special genetic material
Yes
Does the proposed modification use genetic material derived from
organisms capable of causing disease in humans, animals, plants or fungi?
No
X
If yes, provide details here including the sequences as well as the species
and strains they were derived from. If the genetic material to be introduced
is characterised so that its sequence and gene function are known, please
state this
Does the proposed modification use genetic material from native biota?
Page 13 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
If yes, provide details here including where this material will be obtained
from. Be as specific as possible as this information may be needed to
determine whether Māori have been consulted appropriately
Does the proposed modification involve human genetic material? Answer
yes if human genetic material in any form is used, ie whether it is obtained
directly from humans, from a gene bank, synthesised, copied and so on.
X
If yes, provide details here including where the material is obtained from,
and whether approval has been obtained from an Ethics Committee (if
required). Also complete section 5 of this form.
Other details of the modification, including any unusual manipulations, if the foreign
genetic material is to be expressed, where it is expected to be expressed and what techniques
will be used in the modification.
Standard techniques will be used.
Page 14 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
3.4
Identify the category of experiments as described in the HSNO (Low-Risk
Genetic Modification) Regulations, 2003.
Refer to pages 17-19 and pages 33-38 of the user guide for assistance in completing this
section.
Geobacillus spp.
Yes
1
2
3
4
Is the proposed modification to a Category 1 host organism?
No
X
Is the proposed modification to a Category 2 host organism?
X
Will the proposed modification increase the pathogenicity, virulence,
or infectivity of the host organism to laboratory personnel, the
community, or the environment? If you answer yes to this question,
please confirm with an ERMA advisor that the modification is low risk.
X
Will the proposed modification result in a genetically modified
organism with a greater ability to escape from containment than the
unmodified host? If you answer yes to this questions, please confirm
with an ERMA advisor that the modification is low risk.
X
5
Is the proposed modification to be carried out under a minimum of
PC1 containment?
6
Is the proposed modification to be carried out under a minimum of
PC2 containment?
7
Does the proposed modification conform to the requirements of a
Category A genetic modification?
8
Does the proposed modification conform to the requirements of a
Category B genetic modification?
X
X
X
Explanation of categorisation, if necessary. This is particularly important for work
involving pathogenic microorganisms and viral vectors
N/A
Page 15 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Anoxybacillus spp.
Yes
1
2
3
4
Is the proposed modification to a Category 1 host organism?
No
X
Is the proposed modification to a Category 2 host organism?
X
Will the proposed modification increase the pathogenicity, virulence,
or infectivity of the host organism to laboratory personnel, the
community, or the environment? If you answer yes to this question,
please confirm with an ERMA advisor that the modification is low risk.
X
Will the proposed modification result in a genetically modified
organism with a greater ability to escape from containment than the
unmodified host? If you answer yes to this questions, please confirm
with an ERMA advisor that the modification is low risk.
X
5
Is the proposed modification to be carried out under a minimum of
PC1 containment?
6
Is the proposed modification to be carried out under a minimum of
PC2 containment?
7
Does the proposed modification conform to the requirements of a
Category A genetic modification?
8
Does the proposed modification conform to the requirements of a
Category B genetic modification?
X
X
X
Explanation of categorisation, if necessary. This is particularly important for work
involving pathogenic microorganisms and viral vectors
N/A
Page 16 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
E. coli (non-pathogenic laboratory strains)
Yes
1
2
3
4
Is the proposed modification to a Category 1 host organism?
No
X
Is the proposed modification to a Category 2 host organism?
X
Will the proposed modification increase the pathogenicity, virulence,
or infectivity of the host organism to laboratory personnel, the
community, or the environment? If you answer yes to this question,
please confirm with an ERMA advisor that the modification is low risk.
X
Will the proposed modification result in a genetically modified
organism with a greater ability to escape from containment than the
unmodified host? If you answer yes to this questions, please confirm
with an ERMA advisor that the modification is low risk.
X
5
Is the proposed modification to be carried out under a minimum of
PC1 containment?
6
Is the proposed modification to be carried out under a minimum of
PC2 containment?
7
Does the proposed modification conform to the requirements of a
Category A genetic modification?
8
Does the proposed modification conform to the requirements of a
Category B genetic modification?
X
X
X
Explanation of categorisation, if necessary. This is particularly important for work
involving pathogenic microorganisms and viral vectors
N/A
Page 17 of 20
X
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Section Four – The proposed containment system
Refer to page 20 of the user guide for assistance in completing this section
Describe the containment facility and the proposed containment system (physical and
operational)
Question
Answer
Which MAF/ERMA Standard is this
containment facility approved under?
MAF/ERMA New Zealand Standards: Facilities
for Microorganisms and Cell Cultures: 2007a
and Transitional Facilities for Biological Products
What physical containment level
(AS/NZS 2243.3:2002) is this
containment facility approved to
operate at (where relevant)?
The facilities at Fonterra and Massey University
to be used for this research will be approved to a
minimum of PC1.
What other physical measures do you
propose to use to contain this
organism?
No other physical measures (eg, the use of
biosafety cabinets) are required when handling
these organisms as even though some of the
organisms can produce spores, they are not
disseminated in the air.
What procedural or operational
measures do you propose to use to
contain this organism?
Standard PC1 or PC2 procedures as appropriate.
Any other information relevant to the
containment of the organism.
No
Page 18 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Section Five – Identification and assessment of adverse effects
Refer to page 21 of the user guide for assistance in completing this section
This section should only be completed in detail if pathogenic microorganisms, human cells,
native or valued flora and fauna were identified as host or sources of donor genetic material
in section 3. It is expected that organisms meeting the low-risk regulations will not normally
have any significant biological risks associated with them. However, there may still be some
adverse effects that need to be identified and assessed. This might include economic, social
and cultural adverse effects and other risks not addressed by the HSNO (Low-Risk Genetic
Modification Regulations) 2003
What adverse effects could this organism have on the environment? For all stages of
the life cycle
No adverse effects on the environment are anticipated. All genetically modified organisms
will be handled in containment and will be autoclaved before disposal.
What adverse effects could this organism have on human health and safety?
None identified. These organisms cannot cause disease or colonise humans.
What adverse economic effects could this organism have?
None identified.
What adverse effects could this organism have on the relationship of Māori and their
culture and traditions with their ancestral lands, water, sites, waahi tapu, valued
flora and fauna and other taonga (taking into account the principles of the Treaty of
Waitangi)?
Consultation was undertaken with Rangitaane iwi through Massey University and no
adverse effects have been identified.
Are there any other potential adverse effects?
None identified.
Page 19 of 20
Develop in containment a project of low risk genetically modified organisms by rapid assessment
Section Six – Additional information
Refer to page 31 of the user guide for assistance in completing this section
Additional Information
Y/N
Do any of the organism(s) need
approvals under any other New
Zealand legislation?
N
Does New Zealand have any
international obligations relating to
(any of) the organism(s)?
N
Have any of the new organism(s) in
this application previously been
considered in New Zealand or
elsewhere?
N
Is there any additional information
that you consider relevant to this
application that has not already been
included?
N
Following the development of this
organism what will the genetically
modified organism be used for? eg
will experimental animals or plants
be exposed to this organism?
If yes, explain
It will be used in the laboratory to study
biofilm formation and endospore
production.
Provide a glossary of scientific and technical terms used in the application:
PCR – polymerase chain reaction
List of appendices attached:
Not applicable
List of references attached:
Taylor et al (2008) Plasmid 60: 45-52
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