ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under S67A on 16 November 2001 and 22 August 2007
Application Code
Consideration Date
Considered by
GMC99006
Original Decision
18 May 2000
28 April 2000 – 5 May 2000
Genetically Modified Organism (GMO) Standing Committee of the
Authority
Application Details
Applicant
Category
Purpose
Application Received
Massey University
Import into Containment any New Organism
To import into containment seed from the model plant Arabidopsis thaliana
which contains genetic modifications required to support research and
teaching efforts concerned with understanding basic mechanisms controlling
plant growth and development.
18 June 1999
Decision
The application is Approved with Controls.
The organisms approved are:
Arabidopsis thaliana modified by the introduction of recombinant DNA via Agrobacteriummediated transformation, comprising one or more of the following elements:
1.
Genes
Any cloned gene (including those modified by in vitro techniques) derived from Arabidopsis
thaliana. No plants shall be imported that contains any gene known to encode for proteins
that are known to cause disease, or are toxic to humans or animals.
2.
Promoters
i.
ii.
iii.
iv.
v.
vi.
vii.
3.
Cauliflower mosaic virus 35S promoter (CaMV 35S)
Nopaline synthase promoter (nos) from Agrobacterium tumefaciens
Mannopine synthase promoter (mas) from Agrobacterium tumefaciens
1' promoter from Agrobacterium tumefaciens
2' promoter from Agrobacterium tumefaciens
Heat shock inducible (hsp70) from Glycine max
Glutacorticoid inducible promoter system (GVG) from the rat
Termination Sequence
i.
ii.
iii.
All downstream termination sequences identified in the Arabidopsis genome
initiatives
nos termination sequence from Agrobacterium tumefaciens
ocs termination sequence from Agrobacterium tumefaciens
4.
T-DNA Sequences of Binary Vectors
Sequences that flank the left and right borders of Agrobacterium T-DNA as used in
Agrobacterium-plant binary vectors.
5.
Selectable Marker Genes
i.
ii.
iii.
iv.
v.
6.
Reporter Genes
i.
ii.
iii.
7.
APH4 gene. Confers resistance to the antibiotic hygromycin
ALS. The acetolactate synthase (ALS) gene provides resistance to the herbicide
chlorsulfuron (trade name Glean, Du Pont)
TMS2 gene from Agrobacterium tumefacians. A negative selectable marker using
indolacetamidehydrolase gene (IAAH)
NPTII gene. The bacterial neomycin phosphotransferase gene. This gene confers
resistance to the antibiotic kanamycin
BAR. The bacterial bar gene (that encodes PPT acetyltransferase). This gene
provides resistance to the herbicide glufosinate (trade name Basta, Agr Evo)
Glucuronidase (GUS). The bacterial gene -glucuronidase (GUS marker gene)
Green Fluorescent Protein (GFP) from the jelly fish (Aequorea victoria)
Luciferase (LUC) from the fire fly (Photinus pyralis)
Mobilisation Elements
i.
ii.
Ac/Ds; En/Spm transposable elements of maize
FLP site specific recombinase gene from Saccharomyces cerevisiae
Genetic modifications
Genetic modification of Arabidopsis plants is limited to:
i.
Insertional activation of endogenous genes (gene tagging) using combinations of the
genetic elements listed above.
ii.
Arabidopsis gene fusion using the heterologous promoters listed above.
iii.
Fusion of Arabidopsis promoters to the reporter genes listed above.
Application Process
The application was formally received on 18 June 1999. The application was stalled on 2 July
1999, whilst additional information was sought from the applicant. The application was verified
on 4 April 2000.
The application was not required under the Act to be publicly notified.
The documents available for the evaluation and review of the application by ERMA New
Zealand included the application, appendices (including copies of literature cited), and comments
from the Department of Conservation.
The application was determined by a Committee of the Genetically Modified Organisms
Standing Committee of the Authority appointed in accordance with section 19(2)(b) of the
Hazardous Substances and New Organisms (HSNO) Act 1996. The committee comprised
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members of the Authority: Mrs Helen Hughes (Chair), Dr Oliver Sutherland, and Professor
Colin Mantell.
Relevant Legislative Criteria
The matters considered in making this decision comprise those set out in sections 37, 44 and 45 of
the HSNO Act 1996, and those relevant matters in Part II of the Act.
Consideration of the application followed the relevant provisions of the Hazardous Substances
and New Organisms (Methodology) Order 1998, but with particular regard to clauses 8 (dealing
with the scale and significance of the risks, costs and benefits) and 26 (dealing with applications
where the risks are negligible).
Reasons for the Decision
Purpose
In accordance with section 45(1)(a)(i) of the Act, the Committee was satisfied that the application
was for one of the purposes specified in section 39(1) of the Act. The Committee concluded that
importation of genetically modified Arabidopsis thaliana into containment for research and
teaching constitutes an appropriate purpose under section 39(1)(h) of the Act, being Such other
purposes as the Authority sees fit.
Ability to Escape Containment
In accordance with section 44(b) the Committee considered the ability of genetically modified
Arabidopsis thaliana to escape from containment.
The applicant proposes to contain the organisms in a transgenic plant house that conforms to Plant
House Physical Containment Level 2 (PC2) as specified in section 12 of AS/NZS 2243.3: 1995
Safety in Laboratories. Part 3: Microbiology. In addition, the facility will be operated in accordance
with ERMA New Zealand/Ministry of Agriculture and Forestry (MAF) Biosecurity Authority
Standard 155.04.09 Containment Facilities for New Organisms (including genetically modified organisms) of
Plant Species (currently in final draft form).
Prior to the import into containment of genetically modified Arabidopsis thaliana seed under this
approval, the transgenic plant house will be registered by MAF as a containment facility under the
Biosecurity Act 1993, in accordance with the controls outlined in this decision, and, if available,
the ERMA New Zealand/MAF Biosecurity Authority Standard 155.04.09.
Containment of seed and pollen
The Committee noted that the requirements of a PC2 Plant House specify measures that will
prevent the entry and exit of insects, such as bees. However a PC2 Plant House will not prevent
the escape of pollen. The applicant has however proposed measures to prevent pollen or seed
loss from the containment facility.
Controls on this approval address the containment of the plants, and any heritable genetic
material, including pollen and seed. These controls require that, prior to inflorescence maturity,
the entire inflorescence be bagged to prevent pollen and seed escape. Bags shall remain on until
after all pollen and seeds from the plant are shed.
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The Committee also considered the possibility that genetically modified seed may inadvertently
be removed from the containment facility by being carried on researchers clothing.
Controls on this approval address the possibility of seed escape on clothing by requiring that
workers clothing and all laboratory coats used shall remain in the facility, except during cleaning,
and that pockets on laboratory coats shall be removed. In addition the controls require that slipon disposable over-shoes be worn at all times while in the plant house to prevent the loss of
genetically modified Arabidopsis seed by transportation on the soles of shoes.
The Committee concluded that the procedures undertaken in the laboratory, and the control
requirements of this approval, will minimise the likelihood of the loss of genetically modified
pollen and seed from the containment facility.
Taking into account the proposed containment regime, and subject to the controls imposed in
this decision the Committee was satisfied that Arabidopsis thaliana can be adequately contained in
this facility or an equivalent facility registered as a containment facility under the Biosecurity Act
1993 in accordance the Australian/New Zealand Standard AS/NZS 2243.3: 1995 Safety in
Laboratories. Part 3: Microbiology (Plant House Containment Level PC2).
Self-sustaining populations, eradication and adverse effects
In reaching its decision the Committee considered the ability of the organisms to establish
undesirable self-sustaining populations, which might cause adverse effects and the ease with
which any such populations could be eradicated [section 37(a) and (b)], in the event of any escape
from containment.
The Committee consider that should any seed or plants escape there is the potential for a selfsustaining population of genetically modified Arabidopsis thaliana to establish, but that the
genetically modified Arabidopsis thaliana lines pose little risk to the environment.
Arabidopsis thaliana is self-fertilised although cross fertilisation is possible, is not wind pollinated
and seeds fall close to the parent plant. These characteristics reduce the dispersal ability of any
escaped plants that may establish. Also, Arabidopsis thaliana will not cross-pollinate with other
wild relatives, including native and valued flora, thereby minimising any potential effect on other
species. Arabidopsis thaliana colonises bare ground and does not survive well once other plant
species become established, nor does it appear to colonise in established ecosystems.
Based on the information available the Committee considered there is a low likelihood of any
selective advantage being gained by the plants due to modifications aimed at altering plant
growth and development.
Should genetically modified Arabidopsis thaliana populations establish, they would be susceptible
to common herbicides such as glyphosate (Roundup). It is understood that glyphosate is the
herbicide most widely used by Councils for weed control. However, such control methods would
be dependant on any populations being able to be identified.
The Committee also considered whether, in the event that any genetically modified Arabidopsis
thaliana pollen escaped, it could be picked up by bees and find its way into honey. The
Committee noted that most of the genetic material within the pollen grains is unlikely to be
expressed since pollen germination generally only occurs on receptive plant stigmas and that
protein products within the pollen grain are likely to be degraded when the honey is prepared or
consumed. As honey has antibacterial properties the Committee considers that transfer of the
genetically modified material to bacteria is unlikely. The quantity of Arabidopsis pollen grains
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collected or picked up by bees is likely to be very small in proportion to the pollen of other
species gathered by bees. The antibiotic resistance genes used in these experiments already occur
in the environment. Therefore, the Committee concluded that contamination of honey by
genetically modified Arabidopsis pollen would be unlikely and have a very small effect on human
health and the environment.
The Committee concluded that the probability of any adverse effects on the New Zealand
environment is very low, should any of the genetically modified Arabidopsis thaliana escape and
establish.
Inseparable Organisms
In accordance with section 45(a)(ii) the Committee considered the effects of any inseparable
organisms.
The Committee noted that the genetically modified Arabidopsis thaliana seeds have been collected
from plants grown in containment conditions and are unlikely to be imported containing any
inseparable organisms.
Negligible Risk
Based on the consideration and analysis of adverse effects to the environment, and public health,
and taking into account the containment regime, the Committee considered that the risks
associated with the importation into containment of genetically modified Arabidopsis thaliana seed
are negligible.
Benefits
The Committee identified the primary benefit associated with the importation into containment
of genetically modified Arabidopsis thaliana as the scientific knowledge to be gained from an
improved understanding of the basic mechanisms controlling plant growth and development. In
addition, the Committee noted benefits to New Zealand science to be gained by enabling
involvement of scientists in international research initiatives. Furthermore, there will benefits
derived from the use of the plants as a teaching tool.
Conclusion
The Committee concluded that, taking account of the ability of the organisms to escape from
containment as in section 44(b) of the Act, the beneficial effects of having the organisms in
containment outweighed the likely adverse effects of the organisms and any inseparable
organisms, should the organisms escape.
Having considered the possible effects of the organisms in accordance with sections 45(1)(a)(ii)
and (iii) of the Act, the Committee was satisfied that the proposed containment regime and
additional controls could adequately contain the organisms.
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Controls
1. To limit the likelihood of any accidental release of any organism or any
viable genetic material1:
1.1
The Plant House used to maintain genetically modified Arabidopsis thaliana as a part of this
approval shall be registered by the Ministry of Agriculture and Forestry (MAF) as a
containment facility under the Biosecurity Act 1993.
1.2
The operation, management and construction of the Plant House containment facility shall be
in accordance with the MAF/ERMA New Zealand Standard 155.04.092: Containment
Facilities for New Organisms (including GMO) of Plant Species, and Australian/New Zealand
Standard AS/NZS 2243.3:19952 Safety in Laboratories: Part 3: (Microbiology), Physical
Containment Level (PC2), and the controls of the Authority.
The requirements of AS/NZS 2243.3:19952 Plant House at PC2 and the controls imposed
in this decision constitute the standard applicable for the registration of this place as a
containment facility under section 39 of the Biosecurity Act 1993.
1.3
Genetically modified Arabidopsis thaliana seed shall be imported and transported in
accordance with the Packaging Instruction No. 650 of the International Air Transport
Association (IATA) Dangerous Goods Regulations. All containers must be clearly labelled
with the name, address, and phone number of both the sender and the recipient.
1.4
All imported genetically modified Arabidopsis thaliana seed shall be maintained at all times
within the containment facility. During storage in the containment facility, genetically
modified Arabidopsis thaliana seed must be kept separate from all other seed stock at all
times.
1.5
All genetically modified Arabidopsis thaliana material shall be properly and adequately
identified at all times.
1.6
All solid waste material, including plant material and growing medium shall be autoclaved
or incinerated.
1.7
A register of plants held in the Plant House containment facility shall be maintained. The
following records shall be made for each plant:
i.
ii.
iii.
iv.
v.
the identity of plant(s) and details of genetic modification
unique identification number allocated to the accession or modification
date of import into the facility
place of storage
date and method of final disposal of plants.
Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can be defined to
mean biological material capable of growth even though resuscitation procedures may be required, eg when organisms or parts
thereof are sublethally damaged by being frozen, dried, heated, or affected by chemical.
1
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand
2
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2. To exclude unauthorised people from the facility:
2.1
At all times only persons authorised by the Operator/Manager (of the containment
facility) shall have access to the Plant House.
2.2
A log of all persons accessing the Plant House shall be maintained and be available for
inspection by the facility Supervisor3.
3. To exclude other organisms from the facility and to control undesirable
and unwanted organisms within the facility:
3.1
The applicant shall comply with the requirements of the standards listed in control 1.2
relating to exclusion of other organisms from the facility and the control of undesirable
and unwanted organisms within the facility.
4. To prevent unintended release of the organism by experimenters working
with the organism:
4.1
The applicant shall comply with the requirements contained in the standard listed in
control 1.2 relating to the prevention of unintended release of genetically modified
Arabidopsis thaliana by experimenters working with the Arabidopsis thaliana within the Plant
House.
4.2
Prior to inflorescence maturity the entire inflorescence shall be enclosed in a bag, secured
at the base, with the inflorescence bent over to collect the pollen and seed in the bottom
of the bag so as to prevent release of pollen or spillage of seed and transfer out of
containment. Bags shall remain on until after all pollen and seeds from the plant are shed.
4.3
The applicant shall ensure that seeds are not transported out of the containment facility on
workers clothing and that all laboratory coats used shall remain in the facility, except
during cleaning. Pockets on laboratory coats shall be removed.
4.4
All people working within the containment facility shall at all times wear slip-on disposable
over-shoes to prevent the loss of genetically modified Arabidopsis seed from the
containment facility.
5. To control the effects of any accidental release or escape of an organism:
5.1
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the breach
within 24 hours.
6. Inspection and monitoring requirements for containment facilities:
6.1
The Plant House containment facility shall be inspected by the Supervisor at least annually,
and at any report of a breach of containment.
6.2
The applicant shall prepare and use a containment manual to implement the controls
imposed by this approval. The manual shall specify the containment system within the
Plant House.
3
An inspector appointed under the Biosecurity Act
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The containment manual shall also describe contingency plans in place to take account of:
i.
ii.
the accidental release of plants outside the facility
fire or any other emergency.
7. Qualifications required of the persons responsible for implementing those
controls:
7.1
The applicant shall comply with the requirements of the standards listed in control 1.2
relating to the training of personnel working in the facility.
Signed on behalf of the Authority
Mrs Helen Hughes, Chair
Date: 18 May 2000
Amendment: November 2001
Controls amended
Mrs Helen Hughes, Chair
Date: 18 May 2000
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the Australian/New
Zealand containment facility references to “future proof” the decision
 Standardise the wording of the breach of containment control
 Removal of the control regarding inspection of facilities by the Authority, its agent or
enforcement officers
____________________________
Dr Kieran Elborough
Chair, GMO Standing Committee
Date: 22 August 2007
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