ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under Section 67A on 10 September 2002 and 6 July 2004 and 22
August 2007
21 Sept 2001
Application code
Application type
Applicant
Purpose
Date received
Consideration date
Considered by
GMD01164
To develop in containment genetically modified organisms under section
40(1)(b) of the Hazardous Substances and New Organisms (HSNO) Act
Trees and Technology Limited
To develop in containment Nicotiana species and Eucalyptus species and
hybrids modified with a construct containing a gene coding for avidin
which may confer resistance to herbivorous insects, to enable preliminary
assessment of the gene's effect.
7 June 2001
10 September 2001
GMO Standing Committee of the Authority
Summary of decision
The application to develop the following organisms is approved with controls having been
considered in accordance with the relevant provisions of the Hazardous Substances and New
Organisms (HSNO) Act 1996, the HSNO regulations, and the HSNO (Methodology) Order 1998:
The organisms approved are:
Bacteria
 Escherichia coli (Migula 1895) Castellani & Chalmers 1919 strains DH5α and HB101
 Agrobacterium tumefaciens (Smith & Townsend 1907) Conn 1942 non-pathogenic laboratory
strains
Plant species and hybrids
 Eucalyptus grandis W. Hill ex Maiden
 Eucalyptus camaldulensis Dehnh
 Eucalyptus urophylla S.T. Blake
 Eucalyptus nitens Maiden
 Eucalyptus occidentalis Endl.
 Eucalyptus saligna Smith
 Eucalyptus grandis x saligna
 Eucalyptus grandis x urophylla
 Eucalyptus grandis x camaldulensis
 Eucalyptus grandis x nitens
 Nicotiana tabacum L.
 Nicotiana glauca Graham
Each modified by insertion of a T-DNA vector (based on pART27) containing the npII gene and a
gene construct containing the chicken avidin gene which may confer resistance to insects.
Legislative criteria for application
The application was lodged pursuant to section 40(1)(b) of the HSNO Act. The decision was
determined in accordance with section 45, taking into account additional matters to be considered
under section 43, and matters relevant to the purpose of the Act, as specified under Part II of the
HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections
of the HSNO Act.
Consideration of the application followed the relevant provisions of the Hazardous Substances and
New Organisms (Methodology) Order 1998 (the Methodology). Unless otherwise stated, references to
clauses in this decision refer to clauses of the Methodology.
The experimental work proposed in this application falls within Category C(b)1 of the Hazardous
Substances and New Organisms (Low-Risk Genetic Modification Regulations) 1998. As such this
application cannot be considered by an Institutional Biological Safety Committee (IBSC) under
delegated authority, and is required to be considered by the Authority.
Application process
Introduction
Under section 53(2) of the Act, the Authority has the discretion as to whether or not applications to
develop a genetically modified organism are publicly notified. On 15 June 2001, it was decided by the
Chief Executive of ERMA New Zealand and the Chair of the GMO Standing Committee of the
Authority that the application did not require notification on the grounds that there was not likely to
be significant public interest in the application.
Agencies notified
In accordance with section 58(c) of the HSNO Act and clauses 2(e) & 5 of the Methodology, the
Department of Conservation (DoC) and the Ministry of Agriculture and Forestry (MAF) were
consulted with regard to this application.
Timeline
The application was formally received on 7 June 2001and stalled under section 52(1) of the HSNO
Act on 11 June 2001 pending further information from the applicant on possible adverse
environmental effects of the organisms. The revised application was re-submitted and verified on 2
August 2001.
The application was considered by the Genetically Modified Organisms (GMO) Standing Committee
of the Authority, appointed in accordance with section 19(2)(b) of the HSNO Act, on 10 September
2001. The committee comprised the following members: Helen Hughes (Chair); Prue Kapua; and
Jane Lancaster.
The documents available for the evaluation and review of the application by ERMA New Zealand
included the application, appendices (confidential information in the form of a briefing paper, an
article for submission to an international journal, details of the gene construct and the vector used in
1
The rational for this categorisation is discussed on page 14 in an advisory to the decision
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the genetic modifications), comments from the Department of Conservation, and comments from
Ministry of Agriculture and Fisheries (MAF).
Consideration
Purpose of the application
The purpose of the application is to seek approval to develop in containment genetically modified
Eucalyptus species and hybrids and Nicotiana species (as a comparative control) using a single
plasmid construct. The outcome of the research will enable preliminary analysis of the efficacy (at
controlling insects) of a gene coding for avidin in Eucalyptus.
The Committee considered that this purpose was appropriate under section 39(1)(a) of the Act.
Sequence of the consideration
The approach adopted by the Committee was to look at identification, assessment and evaluation of
risks. This included consideration of the proposed management regime, and the ability of the
organism to escape and form self-sustaining populations. Management techniques were considered in
relation to the identified risks (clause 12) and those risks identified as significant were assessed
(clause 12). Costs and benefits were assessed in accordance with clause 13 of the Methodology.
Risk characteristics were then established, in accordance with clause 33 of the Methodology.
Finally, taking account of the risk characteristics established in accordance with clause 33 of the
Methodology, the combined impact of risks, costs and benefits was evaluated in accordance with
clause 34.
Identification of the significant risks, costs and benefits
Risks and associated costs
Under clauses 9 and 10 of the Methodology, which incorporates sections 5, 6, and 8 of the Act,
significant risks, costs and benefits identified for assessment and evaluation are detailed below. The
Committee considered that no significant risks existed if the modified bacteria and plants remained in
containment.
Under sections 5 and 6 of the HSNO Act and clause 9 of the Methodology Order, the Committee has
categorised the potential adverse effects of this application under the headings of environmental,
human health, Maori issues and concerns, and economic benefits.
Environmental
The Committee considered risks (and the associated costs arising) to native and other valued flora and
fauna (in accordance with clauses 9(a), 9(b), 9(c)(i), 9(c)(ii), 10(a), 10(b) and 10(d)), should the
escape of genetically modified bacterial cultures or plant material containing the avidin gene occur.
The principal risk identified was adverse effects on insects and other animals as a result of their
exposure to the avidin protein. This in turn could have consequential impacts on associated
ecosystems. Further effects on ecosystems could arise as plants and bacteria may have a selective
advantage (due to reduced predation of plants by insects and due to avidin possibly having antimicrobial action) over other flora.
Human Health
The Committee considered the risks (and associated costs arising) to human health from the
development of genetically modified bacteria and plants, including the potential harm to people
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working with the organisms, and any effects on public health, should the organisms escape, in
accordance with the Methodology clauses 9(b)(i) and (ii), 9(c)(iii) and (v) and 10(g). The Committee
considers there is potential for adverse health effects associated with allergenicity to modified pollen.
Māori issues and Concerns
The Committee considered the potential cultural effects associated with the development of
genetically modified bacteria and plants in accordance with the HSNO Methodology Order 1998
clauses 9(b)(i) and 9(c)(iv) and Sections 6(d) and 8 of the HSNO Act.
The Committee considers adverse effects on Māori culture are very unlikely, based on the fact that no
genetic material from humans or native flora and fauna are involved in the research and the research
will be carried out in containment. The genetically modified organism(s) are also not approved for
field trials or release. The Committee decided therefore, that no further consideration of adverse
effects on Māori culture was required.
However, the Committee notes that future field trials (if proposed) of these modified plants in the
future, could adversely affect Māori and advises that consultation with the local hapu/iwi will be
necessary.
Economic
The Committee considered risks (and associated costs arising) to the economy should the escape of
genetically modified bacterial cultures or plant material result in adverse impacts on valued plant
species (clauses 9 (b)(i) and 9(b)(ii)).
A significant benefit was identified as being an increase in scientific knowledge through appraisal of
the benefits and possible risks of engineering insect resistance into a tree crop, and allowing for the
monitoring of the expressional behaviour of a novel gene in trees (in accordance with clauses 9(b)(i)
and 9(c)(v).
Adequacy of the proposed containment
In carrying out its consideration the Authority considered the adequacy of containment in accordance
with section 45(i)(a)(iii) of the Act, and the magnitude and probability of the risks, costs and benefits
at the same time and in an integrated fashion, This is because the former interact with the latter and
this is recognised in clause 12(d) of the Methodology and in section 45(i)(a)(ii) of the Act. For
convenience in setting out the decision the adequacy of containment is discussed first.
Ability of the organism to escape from containment
In accordance with section 44(b), the Committee considered the ability of the modified organisms to
escape containment.
The organisms are required to be contained in facilities that are approved containment facilities (under
the Biosecurity Act 1993) in compliance with the Ministry of Agriculture and Forestry (MAF)/ERMA
New Zealand Standard 154.03.02: Containment Facilities for Micro-organisms, at laboratory Physical
Containment Level 2 (PC2); and MAF/ERMA New Zealand Standard 155.04.09: Containment
facilities for new organisms (including genetically modified organisms) of plant species, at plant
house Physical Containment Level 2 (PC2).
These standards are the basis of the containment controls specified in this decision. Twelve additional
containment controls (numbers 5.4-5.15), ie controls above and beyond the standard requirements of
PC2, are discussed below under assessment of adverse environmental effects.
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The Committee is satisfied that it is very unlikely that bacterial cultures, plant tissue cultures, or plant
material could escape from containment, taking into account the laboratory procedures proposed by
the applicant (specified in section 5 of the E&R report) and the containment controls imposed in this
decision.
The Committee notes that the applicant is required in accordance with MAF/ERMA New Zealand
Standard 155.04.09: Containment facilities for new organisms (including genetically modified
organisms) of plant species, to implement procedures for the retrieval or destruction of any viable
material of any modified organism that has breached containment as part of the facility approval, and
as detailed in the Trees and Technology containment manual.
Ability of organisms to establish an undesirable self sustaining population and
ease of eradication
In accordance with sections 43 and 37 of the HSNO Act the Committee considered the ability of the
organisms to establish an undesirable self-sustaining population, should they escape from
containment, and the ease with which such a population could be eradicated. In evaluating these
matters the Committee took into account the nature of the organism.
Escherichia coli
The committee notes that the Escherichia coli intended for use in this work are laboratory strains
which are derivatives of E. coli K12. These are unable to survive outside of containment and therefore
cannot establish a self-sustaining population. As such the Committee does not consider there is any
evidence for nor any reason to expect any adverse effects of the proposed genetically modified
Escherichia coli strains on humans, animals, or the environment.
Agrobacterium tumefaciens
Should modified strains of Agrobacterium tumefaciens breach containment, they could possibly
survive and establish a self-sustaining population outside of containment (Matzk et al. 1996
[Localization of persisting agrobacteria in transgenic tobacco plants. Molecular Plant Microbe
Interactions 9, 373-381]). However, the Committee has imposed an additional control (5.5) requiring
that plant tissue cultures infected with A. tumefaciens be treated with timetin to kill Agrobacterium
before being transferred to the PC2 Plant House. With this additional control on the containment
regime the Committee considers that it is unlikely that bacterial cultures will escape from the PC2
plant house.
Modified Eucalyptus and Nicotiana species
Plant tissue cultures:
The Committee agrees with the ERMA New Zealand E&R Report which states that the ability of
plant tissue cultures to survive and form a self-sustaining population outside of containment is very
unlikely since in vitro plant tissue cultures lack an effective cuticle and normally lack a root system
required for plant survival. Consequently, the Committee considers that it is very unlikely that tissue
cultures would survive (or regenerate) outside of laboratory culture.
Whole plants and plant material:
The Committee accepts the conclusion in the E&R Report that in the event that genetically modified
plants, pollen or seeds from modified plants escaped from containment, there is potential for some or
all of the species or hybrids to establish self-sustaining populations. However, the Committee notes
that there is uncertainty over which species or hybrids would be most likely to establish. The
Committee therefore considers that additional controls on disposing of and transporting modified
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materials be imposed (controls 5.4 – 5.15) to ensure the adequate containment of plants and plant
material at the site of the development, during transport, and at the HortResearch, Mt Albert site.
In the event that species of Nicotiana and Eucalyptus should survive and establish self-sustaining
populations outside of containment, the Committee notes that it may not be possible to find and
recover modified plants that grow outside of containment.
Assessment of the significant risks and costs
The risks and costs assessed were those identified as potentially significant, having regard for those
matters set out in clauses 9 and 10 of the Methodology. Risks were considered under clause 12 of the
Methodology, including especially the assessment of consequences and probabilities, the impact of
uncertainty and the impact of risk management. Costs were considered under clause 13 of the
Methodology.
The evidence available was largely scientific in nature and was considered in terms of evaluating risks
under clause 25 of the Methodology. This evidence comprised principally that provided by the
applicant and additional evidence set out in the Evaluation and Review Report prepared by the staff of
ERMA New Zealand.
Risks to the environment
Under clause 12(a) of the Methodology, the Committee considers that if A. tumefaciens (containing
the avidin gene), or plants or plant material (seeds, pollen) expressing avidin should escape from
containment, there is potential for adverse effects on insects or other animals or micro-organisms.
Avidin binds biotin which is required for normal growth and development of a range of organisms.
The presence of avidin in plants could therefore result in death of insects that feed primarily on these
plants. This could in turn result in modified plants having a selective advantage over other flora as a
result of reduced insect predation. In addition, prolonged biotin deficiency in mammals can cause
weight loss or poor weight gain (Green 1975, Baez-Saldana et al, 1998).
Under clause 12(b) the Committee notes that given the controls (standard controls and additional
controls 5.4 - 5.14) imposed within this decision (clause 12(d)), the escape of modified A. tumefaciens
and modified plant material from containment is very unlikely.
The Committee notes that there is uncertainty associated with the ability A. tumefaciens to survive and
establish self-sustaining populations outside of containment (clause 12(e) (see page 5 of this
decision). As previously discussed, the escape of A. tumefaciens from containment is very unlikely.
The magnitude of such an effect is considered to be minimal or minor (clause 12(b)) and the
associated overall risk is considered to be negligible (clause 12(c)).
The Committee notes that some species of modified plants and plant materials may be able to survive
and form self-sustaining populations should they escape from containment. The Committee agrees
with the conclusions in the E&R report that there is likely to be variability in the levels of avidin
expressed in modified plant tissues, so that it is difficult to predict the effects of avidin producing
plants on both insects and mammals consuming the plant tissue. The magnitude (under clause 12(b))
is considered by the Committee to be minimal or minor since for a large scale adverse effect to occur
large numbers of avidin producing plants would need to grow in the environment and/or large
quantities of avidin protein would need to be consumed. Given the additional controls imposed by this
decision (clause 12(d)), the overall risk associated with this effect is considered to be negligible
(clause 12(c)).
The Committee notes that there is potential for reduced predation of modified plants (expressing
avidin), to result in these plants having a selective advantage over other flora (clause 12(a)). The
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Committee considers that the magnitude (in accordance with clause 12(b) of such an effect would be
dependent on the number of plants expressing the protein, the level of expression, the invertebrate
species affected, and the extent to which a species is affected. As such the magnitude of such an
effect is difficult to ascertain.
While there is some uncertainty (clause 12(e)(a)) about the nature of the effects described above, the
Committee considers that given the additional controls imposed on the containment regime (controls
5.4-5.14), it is very unlikely that plants, pollen or seeds will escape from containment (Clause 12(d))
and therefore the risk (and associated costs) are considered to be negligible.
The Committee notes that it is the intention of the applicant to study the localisation of the avidin
protein in the plants. There is uncertainty over where in the plant the avidin will accumulate and the
Committee considers that it is important to investigate this issue to provide information that is likely
to be relevant in the event that future applications are made to field trial such plants. As such, an
additional control is imposed which requires that tests are undertaken to identify where avidin
accumulates in plant cells and tissues (including nectar), and that results of these tests be recorded and
made available for inspection by MAF inspectors upon request.
Risks to human health
The Committee considers that there may be an adverse effect to human health associated with
increased allergenicity to modified Eucalyptus pollen (clause 12(a)). The Committee agrees with the
information supplied in the E&R report that there is some uncertainty (clause 12(e)) over whether the
genetic modifications will result in increased allergenicity to modified Eucalypt pollen. Although
Eucalypt pollens have been reported as being allergenic, allergies appear to be primarily related to
proteins in the pollen grain. As such the Committee considers that the presence of avidin in vacuoles
within the pollen grain may not affect allergenicity. The Committee considers that because of an
absence of information, there is uncertainty as to the likelihood and magnitude of this effect (clauses
12(b) and 12(c)). Given the controls imposed by this decision (clause 12(d)), the Committee considers
these risks (and their associated costs) to be negligible.
Assessment of Costs
A “cost” is defined in clause 2 of the Methodology Order as “the value of a particular adverse effect
expressed in monetary or non-monetary terms”. The Committee determined that the potential adverse
effect which generates a greater than negligible risk is the risk to the environment associated with the
consumption of avidin-expressing plants by insects and other animals.
In terms of Clause 13(a), the cost or value to be ascribed to this effect may be monetary or nonmonetary, but in any event cannot be quantified in numeric terms. The Committee notes (in terms of
clause 32) that there is some uncertainty about the effects of the avidin-producing plants on insects
and animals. In a “worst case” scenario, the magnitude of the effects, and hence the costs would be
moderate to major (clause 13(b)). They would not persist or spread. However, as indicated above, the
Committee concluded that, given the controls imposed, the costs are negligible. As such, the
distributional effects, in terms of both groups in the community and space (clause 13(c)) do not
require further analysis.
Assessment of benefits (beneficial effects)
A “benefit” is defined in Clause 2 of the Methodology Order as “the value of a particular positive
effect expressed in monetary or non-monetary terms”. Benefits that may arise from any of the matters
set out in clauses 9 and 10 of the Methodology were considered in terms of clause 13.
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The evidence available to assess beneficial effects included scientific information and reference to
other values and matters relevant to Part II of the HSNO Act and was considered in terms of clause
25(2) of the Methodology. This evidence comprised that provided by the applicant and the
assessment of information in the E&R report prepared by staff.
The Committee considered the primary benefit associated with this application to be increased
scientific knowledge (non-monetary) gained by enabling an appraisal of the benefits and possible
risks of engineering insect resistance into a tree crop, and allowing for the monitoring of the
expressional behaviour of a novel gene in trees.
In considering the nature of benefits under clause 13 of the Methodology, the Committee concludes
that non-monetary benefits are possible. While the magnitude and expected value of benefits (clause
13(b)) is uncertain, immediate benefits related to increased scientific knowledge are likely to accrue
directly to the applicant (clause 13(c)). Longer term benefits to parties other than the applicant are
uncertain but may include increased knowledge to other research institutes.
Uncertainty
Under clauses 29-32 of the Methodology, the Authority is required to consider uncertainty associated
with potential adverse effects of an organism(s), and in relation to costs, benefits and risks. The
Committee considers that uncertainty of effects exists as a result of a limited number of studies having
been carried out on organisms containing the avidin gene. The Committee also notes that the work
proposed within this application, will help to address some of these uncertainties.
Establishment of the approach to risk in the light of risk
characteristics
Clause 33 of the Methodology requires the Authority to have regard to the extent to which a specified
set of risk characteristics exist when considering applications. The intention of this provision is to
provide a route for determining how cautious or risk averse the Authority should be in weighing up
risks and costs against benefits. In this case of the present application the relevance of clause 33 is
much reduced because the application is “in containment” and it has already been concluded that the
containment provisions and other controls will reduce most biological and physical risks to a low
level. For these biological and physical risks the extent of the need for caution, over and above the
exercise of caution in setting conditions and controls, is not considered to be material to the overall
weighing of risks costs and benefits.
Overall evaluation of risks, costs and benefits
The overall evaluation of risks, costs and benefits set out below was carried out having regard to
Clauses 22 and 34 of the Methodology and in accordance with the tests in clause 26 of the
Methodology and section 45 of the Act.
Clause 34 of the Methodology sets out the approaches available to the Authority in evaluating the
combined impact of risks costs and benefits i.e. weighing up risks, costs and benefits.
In making its decision under clause 26 of the Methodology, the Committee is satisfied that the risks
and associated costs are cumulatively negligible, that costs are unlikely to accrue to parties other than
the applicant and that the benefits outweigh the costs.
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Decision
1.
Pursuant to section 45(1)(a)(i) of the Act, the Committee is satisfied that this application is for
one of the purposes specified in section 39(1) of the Act, being section 39(1)(a): The
development of any genetically modified organism.
2.
Having considered all the possible effects of the organisms (E. coli, A. tumefaciens, species and
hybrids of Eucalyptus, species of Nicotiana) in accordance with sections 45(1)(a)(ii) and (iii) of
the Act and pursuant to clause 26 of the Methodology, and based on consideration and analysis
of the information provided and taking into account the application of risk management controls
specified in this decision, the view of the Committee is that the risks (or costs) of adverse effects
associated with the development in containment of the organism(s) are outweighed by the
benefits of conducting the research.
3.
The Committee is satisfied that the proposed containment regime together with the additional
controls imposed will adequately contain the organism as required by section 45(1)(a)(iii) of the
Act.
4.
In accordance with clause 36(b) of the Methodology the Committee records that, in reaching this
conclusion, it has applied the balancing tests in s.45 of the Act and clause 26 of the Methodology
and has relied in particular on the following criteria in the Act:



Sections 6(a) and (b) – Taking into account sustainability of all native and introduced
flora and fauna, and the intrinsic value of ecosystems
Section 5(a) – The safeguarding of the life-supporting capacity of air, water, soil and
ecosystems
Section 45(1)(iii) – That the organism can be adequately contained.
5.
It has also applied the following criteria in the Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 10 - equivalent of sections 36 and 37;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques;
 clause 25 – the evaluation of risks;
 clause 26 - risks are negligible and costs are outweighed by benefits;
 clause 34 – the aggregation and comparison of risks, costs and benefits.
6.
The application for development in containment of the organisms (detailed on pages 1 and 2 of
this document) is thus approved, with controls, as follows.
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Containment Controls
In order to provide for the matters detailed in Part I of the Third Schedule to the Act, Containment
Controls for Development and Field Testing of Genetically Modified Organisms, the approved
organisms are subject to the following controls:
1
To limit the likelihood of any accidental release of any organism or any
viable genetic material2:
1.1
The person responsible for a particular research area and/or the person responsible for the
operation of the containment facility shall inform all personnel involved in the handling of the
organisms of the Authority’s controls.
1.2
The containment facility in which the organisms are maintained shall be approved by the
Ministry of Agriculture and Forestry (MAF) in accordance with the MAF/ERMA New
Zealand Standard 154.03.023 Containment Facilities for Micro-organisms, at laboratory
Physical Containment Level 2 (PC2); and MAF/ERMA New Zealand Standard 155.04.093:
Containment Facilities for New organisms (including genetically modified organisms) of
plant species, at plant house Physical Containment Level 2 (PC2), and the controls of the
Authority.
1.3
The construction and operation of the containment facilities (‘the facility’) in which the
organisms are maintained, shall be in accordance with the:
a) MAF/ERMA New Zealand Standard 154.03.023: Containment Facilities for Microorganisms, at laboratory Physical Containment Level 2 (PC2)
b) MAF/ERMA New Zealand Standard 155.04.093: Containment Facilities for New
organisms (including genetically modified organisms) of plant species, at plant house
Physical Containment Level 2 (PC2)
c) Australian New Zealand Standard AS/NZS 2243.3:19953 Safety in Laboratories: Part 3:
(Microbiology)
2
To exclude unauthorised people from the facility:
2.1
Construction and operation of the containment facility shall comply with the requirements of
the standards listed in control 1.3 relating to the identification of entrances, numbers of and
access to entrances and security requirements for the entrances and the facility.
3
To exclude other organisms from the facility and to control undesirable
and unwanted organisms within the facility:
3.1
Construction and operation of the containment facility shall comply with the requirements of
the standards listed in control 1.3 relating to the exclusion of other organisms from the facility
and the control of undesirable and unwanted organisms within the facility.
2
Viable Genetic Material is biological material that can be resuscitated to grow into tissues or organisms. It can
be defined to mean biological material capable of growth even though resuscitation procedures may be required,
eg when organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by
chemical.
3
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand
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4
To prevent unintended release of the organism by experimenters
working with the organism:
4.1
Construction and operation of the containment facility shall comply with the requirements of
the standards listed in control 1.3 relating to the prevention of unintended release of the
organisms by experimenters working with the organisms.
5
To control the effects of any accidental release or escape of an
organism:
5.1
Construction and operation of the containment facility shall comply with the requirements of
the standards listed in control 1.3 relating to controlling the effects of any accidental release
or escape of an organism.
5.2
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.
5.3
In the event of any breach of containment of the organisms, the contingency plan for the
attempted retrieval or destruction of any viable material of the organism that has escaped shall
be implemented immediately. The contingency plan shall be included in the containment
manual in accordance with the requirements of standards listed in control 1.3.
Additional Controls
5.4
Plants infected with A. tumefaciens shall be treated in the laboratory with timetin before being
transferred to the PC2 plant house containment facility.
5.5
On establishment of root or shoot growth in tissue culture the transformed plants shall be
transferred in sterile plastic sealed containers to PC2 plant house containment
5.6
Before or following transfer of plant tissue cultures to the PC2 plant house, tests shall be
undertaken to identify where avidin accumulates in plant cells and tissues, and in nectar.
Results of these tests shall be recorded within researchers laboratory books and made
available for inspection upon request.
5.7
All modified plants shall be monitored weekly to check for development of reproductive
structures.
5.8
Prior to flower maturation all of the reproductive structures shall be removed or securely
enclosed by a bag so as to ensure that no pollen or seeds shall escape.
5.9
All genetically modified plant material (including roots) and used soil not required for
reference purposes or further analysis shall be autoclaved prior to disposal.
5.10
Seeds, other plant material, and soil or litter samples retained for reference purposes or further
analysis shall be collected and securely stored in sealed containers within PC2 laboratory or
plant house containment as appropriate. The containers shall clearly identify the contents.
5.11
Whole plants (including seeds), soil samples or leaf litter derived from the genetically
modified plants shall be transported in secure containers and in accordance with the
packaging requirements: Packaging Instructions No. 602 of the IATA Dangerous Goods
Regulations as referred to in AS/NZS 2243.3:20023 Safety in Laboratories: Part 3
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"Microbiological aspects and containment facilities" section 13.4(g). Laboratory cultures of
genetically modified plant material in tubes and dishes shall be transported in secure
containers and in accordance with the packaging requirements: Packaging Instructions No.
913 of the IATA Dangerous Goods Regulations as referred to in AS/NZS 2243.3:20023
Safety in Laboratories: Part 3 "Microbiological aspects and containment facilities" section
13.4(f). Each transfer shall be recorded in the containment facility register. The applicant shall
ensure that no escape of material occurs during this transfer and examination. Prior to the
transfer from the containment facility the applicant shall request approval in writing from the
Supervisor in accordance with the requirements of the MAF/ERMA New Zealand Standard
154.04.093: Containment Facilities for New Organisms (including genetically modified
organisms) of Plant Species.
5.12
Plants that are in flower, or are developing reproductive structures, shall not be transported.
5.13
If feeding studies are undertaken, these shall be conducted in MAF-registered facilities in
accordance with MAF/ERMA New Zealand Standard 154.02.083: Transitional and
containment facilities for invertebrates; and/or MAF/ERMA New Zealand Standard
154.03.033: Containment facilities for vertebrate laboratory animals at Physical containment
level 2. At all times escape of plant material from containment shall be prevented and all plant
reproductive structures securely bagged.
5.14
Trials involving soil derived from containers holding genetically modified plants, or
genetically modified plant material in soil or other microcosms, shall be conducted in MAFregistered PC2-level microbiology laboratories (in accordance with Australia/New Zealand
Standard AS/NZ 2243.3:19953 Safety in Laboratories: part 3 (Microbiology).
5.15
Plant material, soil, or leaf litter derived from the genetically modified plants that is used in
feeding or microcosm studies and is no longer required for analysis shall be autoclaved and
disposed of.
6
Inspection and monitoring requirements for containment facilities:
6.1
The operation of the containment facilities shall comply with the requirements contained in
the standards listed in control 1.3 relating to the inspection and monitoring requirements for
containment facilities.
The containment manual shall be updated, as necessary, to address the implementation of the
controls imposed by this approval, in accordance with the Standards listed in control 1.3.
6.2
7
Qualifications required of the persons responsible for implementing
those controls:
7.1
The training of personnel working in the facility shall be in compliance with the standards
listed in control 1.3.
Signed on behalf of the Authority:
_______________________________
Mrs Helen Hughes, Chair
Genetically Modified Organisms
Standing Committee of the Authority
Date: 21 September 2001
Environmental Risk Management Authority: Application GMD01164
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Amendment: September 2002
Amendment involves change to control 5.11 to specify the correct IATA Packaging
Instructions for whole plants and laboratory tissue cultures
_____________________________
Mrs Jane Lancaster, Chair
Genetically Modified Organisms
Standing Committee of the Authority
Date: 10 September 2002
Amendment: July 2004
Amendment involves changing applicant from Trees and Technology Limited to Horizon2
Partnership Limited
_____________________________
Associate Professor Marie Dziadek
Date: 6 July 2004
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
Environmental Risk Management Authority: Application GMD01164
Date: 22 August 2007
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ADVISORY TO DECISION GMD01164
This decision was made by the Authority under Category C(b) of Schedule 1 to the HSNO (Low-Risk
Genetic Modification) Regulations 1998 (the Regulations). This category is assigned to “experiments
involving toxin genes at levels higher than that occurring in the parent organism even if the LD50 is
greater than 100μg/kg”.
Additional information received after this decision was made suggests that, in a range of plants
modified using the same genetic construct, avidin is expressed at levels less than or equal to the levels
present in the parent organism (chicken egg). Under such circumstances the experiments could be
classified as Category B under the Regulations (if the other Category B criteria also apply). No such
evidence is available for Eucalyptus species and hybrids, and there is evidence to suggest that in some
situations, the level of protein expression from similar types of constructs and transformation
techniques can be higher than that occurring in the parent organism.
Modification of plants where there is appropriate evidence that levels of expression of avidin from
this construct are less than occurs in eggs may be able to be decided as Category B experiments.
Category B developments can be decided by Institutional Biological Safety Committees, under
delegation from the Authority.
Environmental Risk Management Authority: Application GMD01164
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