ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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8 June 2005
GMD04096
 To develop in containment genetically modified organisms
under section 40(1)(b) of the Hazardous Substances and New
Organisms (HSNO) Act 1996.
 The New Zealand Institute for Crop and Food Research Limited
Applicant
 Cloning of synthetic DNA sequences in Escherichia coli and
Purpose
Pseudomonas fluorescens for use as DNA 'biomarker'
molecules, which will subsequently be applied to agrichemicals
to validate spray drift models
20 24 May 2005
Date received
Consideration date 22 8 June 2005
Chief Executive, ERMA New Zealand
Considered by
Application code
Application type
1 Summary of decision
1.1
The application to develop a new organism in containment is approved, with
controls, having been considered in accordance with the relevant provisions of
the Hazardous Substances and New Organisms (HSNO) Act 1996 (the Act), the
HSNO (Low-Risk Genetic Modification) Regulations 2003 (the Regulations),
and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The organisms approved for development are the genetically modified
microorganisms listed below in Table 1.
Table 1: Organisms as recorded on the ERMA New Zealand Register
Host Organism
Category
As modified by
of host
organism
Escherichia
1
Non-conjugative plasmid
coli
cloning vectors containing a
150-200bp non-protein coding
(Migula 1895)
synthetic DNA sequence
Castellani and
(DNA biomarker)1.
Chalmers 1919
Nonpathogenic
laboratory
strains
Pseudomonas
1
Non-conjugative plasmid
fluorescens
cloning vectors containing a
(Migula 1895)
150-200bp non-protein coding
Nonsynthetic DNA sequence
pathogenic,
(DNA biomarker).
rhizosphere
isolates
1.3
Category of
genetic
modification
A
A
The applicant has specified the following vector systems to be used:
1. Standard non-conjugative plasmid cloning vectors for transformation of
Escherichia coli and Pseudomonas fluorescens.
These vectors may contain standard and generally available regulatory elements
sourced from invertebrates, vertebrates, bacteria, viruses or bacteriophages including
the selectable markers kanamycin resistance, gentamicin resistance and
chloramphenicol resistance.
2. DNA biomarker sequences will be cloned into the non-conjugative
plasmid cloning vectors pBBR1MCS-2 and pME6041 for the
transformation of Pseudomonas fluorescens and subsequent treatment with
Iodine before the dead transformed cells are applied to agrichemicals as
biomarkers.
These plasmid vectors contain the kanamycin resistance gene (nptII) and a ColE1-like
origin of transfer, pME6041 contains the pVS1 origin of replication.
1.4
Category of low-risk genetic modification:
The genetic modification is a low-risk genetic modification as defined in clause
5 of the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 2003. Escherichia coli (non-pathogenic laboratory
strains) and Pseudomonas fluorescens (non-pathogenic rhizosphere isolates) are
category 1 host organisms as defined in clause 7(1) of the HSNO (Low- Risk
Genetic Modification) Regulations 2003. The transformation of these
1
Each DNA biomarker sequence must encode a stop codon in each reading frame as well as other
nonsense codons.
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microorganisms, as described in Table 1, constitutes a category A modification
as defined in clause 5 of those Regulations and therefore, must be performed
under a minimum of PC1 containment as described in the MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.02 Containment Facilities for
Microorganisms.
2 Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(b) of the Act and
determined according to the rapid assessment provisions of section 42A of the
Act.
2.2
The application has been approved by Dr Bas Walker, Chief Executive of
ERMA New Zealand, under delegation from the Authority, as provided for in
section 19 of the HSNO Act 1996.
2.3
In reaching this decision I have considered matters relevant to the purpose of
the HSNO Act 1996, as specified in Part II, and followed the relevant
provisions of the Hazardous Substances and New Organisms (Methodology)
Order 1998.
3 Consideration
Sequence of the consideration
3.1
The application was formally received and verified as containing sufficient
information on 24 May 2005. Although the application was on the form for a
fully assessed development rather than a rapid assessment, this was not
considered to be of material concern as all relevant information was
nevertheless provided.
3.2
Because the purpose of the application entailed the use of non-viable bacteria as
a marker in agrichemicals, consideration was given to whether a parallel
application under the hazardous substances provisions should be made. It was
concluded that such an approval was not required because the non-viable
bacteria do not trigger any specific hazardous substance thresholds.
3.3
The decision is based on the information supplied by the applicant in the
application including copies of scientific literature referenced in the application.
3.4
In reaching this decision I have used information that is relevant and appropriate
to the scale and significance of the risks, costs, and benefits associated with the
genetic modification.
3.5
In accordance with section 42A of the Act (rapid assessment), the approach
adopted was to identify the circumstances of the genetic modification, to
evaluate these against the criteria specified in section 41, and to consider
whether there are any residual risks that require further consideration. This
approach covered the following issues:

Purpose of the application (section 39)
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3.6
3.7
Assessment against the criteria for low-risk genetic modifications (section
42A)
Identification and assessment of the risks and other impacts of the organism
Māori issues and concerns (sections 6(d) and 8)
Precedents
Proposed controls
In accordance with section 53(2)(b) of the Act this application was not publicly
notified. The Department of Conservation (DoC) and the Ministry of
Agriculture and Forestry (MAF) Biosecurity New Zealand were notified upon
receipt of this application.
DoC submitted comments on the application addressing the issues of
containment and potential risks to indigenous flora and fauna. These were
summed up in the following statement:
The Department considers that the likelihood of release of these genetically modified
bacterial lines and their biomarker molecule derivatives from the containment facilities (level
PC2), is minimal and that the risk to indigenous flora and fauna is not significant. Therefore
the Department would not oppose the approval of this application.
We do note, however, that the intended field trials using a treated non-viable form of these
bacteria and their biomarker derivatives may require a separate application for approval to
release.
3.8
As noted by DoC, the applicant intends to develop the organisms under Physical
Containment level 2 (PC2). However, as discussed in section 3.18 of this
decision, the level of containment required for these organisms, as described by
the HSNO (Low Risk Genetic Modification) Regulations 2003, is Physical
Containment level 1 (PC1). This level of containment is thus considered to be
sufficient. This does not prevent a higher level of containment (e.g. PC2) being
used if the applicant so chooses.
3.9
DoC’s comment regarding field trials is addressed in section 3.27 of this
decision.
3.10 MAF did not comment on the application.
Purpose of the application
3.11 The purpose of this project is to develop bacteria (non-pathogenic strains of
Escherichia coli and Pseudomonas fluorescens) genetically modified with
synthetic DNA sequences for use as DNA ‘biomarker’ molecules, which will
subsequently be applied to agrichemicals to validate agrichemical spray drift
models.
3.12 The applicant states that the research aims to develop a biomarker technology,
whereby a DNA-based molecule can act as a ‘barcode’, capable of identifying
the source of individual agrichemicals and the cumulative effects of routine
spray applications. In particular, it is predicted that the biomarker will facilitate
off-site spray drift detection and quantitation. The applicant intends to
investigate the potential of three different biomarker delivery systems for
application with agrichemicals to track deposition of agrichemical residues: (1)
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synthetic, non-coding DNA molecules; (2) plasmid vectors carrying a synthetic,
non-coding DNA molecule; (3) non-viable bacterial cells carrying the plasmid
construct described in 2.
3.13 To achieve this, the applicant states that they will construct unique synthetic
DNA ‘biomarker’ sequences with no known protein encoding capacity. The
constructs will either be added to agrichemicals directly as naked linear DNA or
as inserts in a bacterial plasmid vector. Carrying the biomarker sequence on a
bacterial plasmid vector will generate a circular biomarker molecule that may
be less susceptible to degradation in the environment and would therefore be
more detectable. Once the biomarker is cloned into the bacterial plasmid vector
the entire plasmid DNA will be applied to the agrichemical spray. In an
alternative approach, the plasmid will be transformed into non-pathogenic
strains of Escherichia coli and Pseudomonas fluorescens. Subsequent iodine
treatment of such bacterial cells will render them non-viable, but retain their
value as a protective capsule for the biomarker molecule that could reduce
biomarker degradation and improve its capture and detection.
3.14 The constructed biomarkers will be added to widely used agrichemicals to
compare the feasibility of using each biomarker formulation to monitor
cumulative spray drift.
3.15 I have determined that this application may be approved for the purpose of the
development of a genetically modified organism as provided for in section
39(1)(a) of the HSNO Act 1996.
Assessment against the criteria for low-risk genetic
modifications
3.16 Category of host organisms:
Non-pathogenic laboratory strains of Escherichia coli and Pseudomonas
fluorescens are not capable of causing disease in humans, animals, plants or
fungi nor do they produce desiccation-resistant structures, such as spores or
cysts. As such, non-pathogenic laboratory strains of E. coli and P. fluorescens
are considered Category 1 host organisms as defined in clause 7(1) of the
HSNO (Low-Risk Genetic Modification) Regulations 2003.
3.17 Category of genetic modification:
The modifications as described in Table 1 are Category A modifications as
described in clause 5 (1) of the Regulations described above.
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3.18 In accordance with clause 5(1)(b) of the Regulations the modification must be
carried out under a minimum of PC1 containment. Clause 3 of the Regulations
defines PC1 by reference to the conditions for Physical Containment Level 1
specified in AS/NZS 2243.3:20022 and the modifications referred to in the MAF
Biosecurity Authority/ERMA New Zealand Standard 154.03.02 Containment
Facilities for Microorganisms. Therefore, the minimum level of containment for
the organisms specified in Table 1 is set at Physical Containment level 1 (PC1).
3.19 Provision 4.7.4(t) and 9.2 of AS/NZS 2243.3:2002 directs biological waste to be
treated and disposed of by inter alia pressure steam sterilisation (autoclave) or
treatment with chemical disinfectant. The purpose of this treatment is to render
any live organisms present non-viable. I note that autoclaving is the method
usually adopted for the disposal of genetically modified bacteria. However, in
this instance the applicant has indicated a preference for chemical treatment.
The applicant has proposed meeting these requirements in a manner that allows
for use of the products of the genetically modified bacteria following chemical
treatment. It is therefore prudent to enquire as to the sufficiency of the proposed
method. The chemical treatment is described as treatment of the bacterial cells
with 1% Lugol’s iodine for 4 hours. Evidence has been provided to support the
claim that this treatment will render the bacteria non-viable.
3.20 I find this evidence presented in the peer-reviewed publication Peng et al.
(2003)3, where this method was used to kill cell pellets from 100-ml broth
cultures of Pseudomonas fluorescens that had been resuspended in 10 ml of
water, and I am therefore satisfied that this treatment will render all of the
genetically modified bacteria non-viable and that this method is consistent with
the requirements for PC1 as stipulated in the relevant standards. This treatment
must be carried out within the containment facility and therefore no viable
organisms will be able to be removed from the facility. The requirement to
demonstrate this through a viability assay (see paragraph 3.23) provides an extra
level of assurance.
3.21 The applicant has indicated that, following this treatment, the killed organisms
will be removed from the facility and used in subsequent experiments as
described above in sections 3.11 - 3.14 of this decision. This raises the issue of
whether this proposal is consistent with the requirements specified for PC1 and
whether such subsequent activity with the non-viable products of genetically
modified organisms is regulated under the Hazardous Substances and New
Organisms Act.
3.22 AS/NZS 2243.3:2002 states that following chemical treatment, solid waste
should be disposed of by incineration or by landfill. I note that the language in
this provision refers to the chemical treatment as mandatory while the
subsequent waste disposal methods are not mandated. This suggests that the
containment standard allows for alternative waste disposal methods provided
that the organisms are first rendered non-viable.
2
Australian/New Zealand Standard AS/NZS 2243.3:2002: Safety in Laboratories Part 3:
Microbiological aspects and containment facilities. Fifth edition 2002.
3
Peng, R., Xiong, A., Li, X., Fuan, H. Yao, Q. 2003. A delta-endotoxin encoded in Pseudomonas
fluorescens displays a high degree of insecticidal activity. Applied Microbiology and Biotechnology.
63(3):300 –306.
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3.23 Provision 9.2(i) of AS/NZS 2243.3:2002 mandates that all waste involving
genetically manipulated organisms shall be disposed of in accordance with the
requirements of the relevant regulatory authority. Therefore I consider, acting
under delegation from the Environmental Risk Management Authority, that
given the purpose of the application, the only disposal requirement for the
organisms that are the subject of this approval is that they are rendered nonviable prior to removal from the containment facility and demonstrated as such
by a viability assay before subsequent use in experiments. I have therefore
imposed an additional control to this effect (additional control 8.2, section 5).
3.24 By prescribing the PC1 requirements the Regulation can be read as implying
that these measures are satisfactory for managing the risks associated with
organisms that conform to the criteria for low-risk genetic modification i.e.
rendering such an organism non-viable is sufficient to manage any risks. As the
organisms in this application do meet the criteria for a category A genetic
modification (as defined in clause 5(1) of the Regulations) it follows that all
mandatory disposal requirements are met once the organisms are made nonviable.
3.25 I conclude that the proposed method of disposal of the genetically modified
organisms conforms to the requirements of PC1 as specified in the HSNO (Low
Risk Genetic Modification) Regulations (2003), AS/NZS 2243.3:2002 and the
MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02.
3.26 This leaves the question of whether the subsequent activity with the non-viable
products of the genetically modified organisms following disposal by chemical
treatment is regulated under the HSNO Act (1996). I note that section 42A(2)
instructs the Authority (or in this case myself, acting under delegation from the
Authority) to make an assessment of the adverse effects of carrying out the
project. Additionally, there are the matters in Part II of the Act which must be
considered for all applications. Thus my consideration of this application does
not end with the satisfaction of the criteria for a low-risk genetic modification
but goes on to include an identification and assessment of the risks, costs and
other impacts of the organism. Refer to sections 3.29 - 3.41 below for this
assessment.
3.27 In their comments on the application DoC suggested that a further approval
under the Act may be required prior to use of the non-viable modified
organisms in field trials. I note however, that once the organisms are rendered
non-viable, they no longer meet the definition of a new organism according to
section 2 of the Act. Therefore an approval for their release is not required, as
long as the disposal requirements of this approval are met (as discussed in
section 3.23 above).
3.28 I am satisfied that the development meets the criteria for low-risk genetic
modification specified in the Regulations, made under section 41 of the Act.
The experiments meet the requirements of Category A modification as defined
in clause 5 of the Regulations in that the modification involves category 1 host
organisms and is to be carried out under a minimum of PC1 containment. The
developments, described in Table 1, will not increase the pathogenicity,
virulence, or infectivity of the host organism to laboratory personnel, the
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community or the environment. In addition, the developments will not result in
organisms that have a greater ability to escape from containment than the
unmodified organism.
Identification and assessment of the risks and costs (adverse
effects) and other impacts of the organism
3.29 I consider that pursuant to clause 8 of the HSNO (Methodology) Order 1998
that the information provided by the applicant is relevant and appropriate to the
scale and significance of risks, costs and benefits associated with this
application. Further, I have identified the risks, costs and other impacts related
to the application in accordance with clauses 9 and 10 of the Methodology,
which incorporate sections 5, 6, 8 and 43 of the HSNO Act.
3.30 I note the genetic modification of Pseudomonas fluorescens and Escherichia
coli with non-coding DNA biomarker sequences will not generate more
ecologically fit organisms or increase the pathogenicity or infectivity of the
host.
3.31 I consider, given the containment system and the controls attached (see section
5 of this decision), that there is no evidence for any significant adverse effects
on humans, animals, plants, other organisms, the environment or the economy.
3.32 I have considered the potential for the genetic material released from
containment, including the nptII gene for resistance to the antibiotic kanamycin
and the non-coding DNA biomarker sequence, to have adverse impacts on New
Zealand’s microbial biodiversity or the spread of kanamycin resistance among
bacteria.
3.33 There is potential for the kanamycin resistance gene nptII to be transferred to
environmental micro-organisms as soil is a reservoir of micro-organisms with
the capacity to produce antibiotics. I note that the applicant has stated “the
kanamycin resistance gene nptII (aph), has been shown to be widely distributed
in a variety of environments including soils, waste water, and plant-associated
habitats and will therefore have little effect on the environment (Smalla et al.,
1993). Indeed, a European Union advisory committee has recently determined
that the use of the nptII gene will impact little on the already existing bulk
spread of this antibiotic resistance gene or impact significantly on human and
animal health (EU scientific panel, 2004)”.
3.34 The evolution and spread of antibiotic resistance depends on the selective
pressure exerted in the bacterial environment. According to the applicant
“acquiring the nptII gene would only be advantageous when selection is taking
place (i.e. in a hospital) and this does not happen in the natural environment.
Standard antibiotic resistance genes carried on vectors proposed in this study
are unlikely to contribute to the burden of resistance in clinically relevant
pathogens because they do not confer resistance to currently available drugs
(Salyers 1996) or to environmental bacteria because the vectors used for
modification will be non-conjugative”.
3.35 I consider there is a lack of information about the extent of selective pressure of
different antibiotics in the soil and the soil conditions that promote such
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selective pressure. I also note there is a lack of information on the prevalence of
naturally competent bacteria in the environment, the frequency of
transformation and environmental factors triggering transformation. I consider
that the vectors containing the kanamycin resistance gene nptII for use in these
experiments as prescribed in additional control 8.3 are highly unlikely to be
spread in this manner as they are non-conjugative.
3.36 I note that the use of antibiotic resistance marker genes in the environment has
been extensively considered by ERMA New Zealand in the December 2000
report “Use of Antibiotic Resistance Marker Genes in Genetically Modified
Organisms”. The report concludes “Each genetically modified organism (GMO)
containing antibiotic resistance marker genes should be evaluated on a case-bycase basis.” I note that this case-by-case evaluation of the use of antibiotic
resistance genes is also in accordance with the “Policy on the Use of Antibiotic
Resistance Genes in Genetically Modified Organisms (GMOs)” published
February 2005. However, this policy specifically relates to release or
conditional release applications for GMOs containing antibiotic resistance
marker genes and since this application is not for release or conditional release
of a GMO the Policy is not directly relevant.
3.37 I agree with the applicant that the use of the kanamycin resistance gene nptII in
these experiments at the Scion facilities in Rotorua, as prescribed in additional
controls 8.1 and 8.3, will not impact on the already existing bulk spread of this
antibiotic resistance gene.
3.38 I have considered the potential Māori cultural effects in accordance with
sections 6(d) and 8 of the Act and clauses 9(b)(i), 9(c)(iv) of the Methodology,
in consultation with the Manager, Māori. The applicant was required to consult
with iwi/hapū groups in the region from which the Pseudomonas fluorescens
were isolated (Te Taumutu Rūnanga, Lincoln), and from the area proposed for
trial of the spray (Ngāti Whakaue, Rotorua). The iwi in both regions responded
positively to the purpose of the research though expressed some concern about
the use of synthetic DNA in the environment and the potential risks posed by an
increase in the prevalence of antibiotic resistance. However, the parties were
generally comfortable with the contained nature of the trial and did not consider
that the research posed significant risk.
3.39 However, given that consultation only occurred in two areas of New Zealand
and the spraying was only proposed for Forest Research Institute (or Scion4)
facilities in Rotorua, it is possible that unidentified adverse effects to Māori
culture could result from spraying in other areas of New Zealand. Therefore I
consider it appropriate to mitigate this risk by imposing an additional control on
this approval to limit the subsequent use of the non-viable organisms in
agrichemical sprays to Scion research facilities in Rotorua (see additional
control 8.1 in section 5 of this decision).
3.40 Although recognising that iwi/Māori maintain an ongoing interest and concern
in the potential long term cultural implications of genetic modification
generally, I consider that, given the additional control discussed above, this
4
Since the application was submitted the Forest Research Institute has changed its name to Scion.
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application poses negligible risk of adverse effects to the relationship of Māori
culture and traditions with their ancestral lands, water, sites, waahi tapu, valued
flora and fauna, and other taonga.
3.41 I consider that, given the controls attached to this approval, there is no evidence
for, nor any reason to expect, any non-negligible adverse effects of the proposed
genetically modified organisms on humans, animals, plants, or other organisms
or the environment.
Precedents
3.42 I must consider each application on its merits, and am therefore not bound by
the stance taken in previous decisions. However, in reflecting on previous
decisions that involved similar issues to those raised by this application, I note
that low-risk genetic developments of Escherichia coli and Pseudomonas
fluorescens have been considered and approved on several occasions both by
the Authority and by Institutional Biological Safety Committees (IBSCs) under
delegated authority.
3.43 These previous applications met the criteria for low-risk genetic modification,
specified in the HSNO (Low-Risk Genetic Modification) Regulations 1998 and
2003, and were approved with controls. The controls specified that the
developments be contained within a facility registered under MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.02 Containment Facilities for
Microorganisms at physical containment level 1 (PC1). These controls have
been adopted and applied to the current application (see section 5 of this
decision). Under the HSNO (Low-Risk Genetic Modification) Regulations
2003, Escherichia coli and Pseudomonas fluorescens are considered Category 1
hosts and may therefore, be contained at PC1.
3.44 I consider that the current application does not raise any novel issues that would
warrant it not to be considered via section 42A of the HSNO Act.
Proposed controls
3.45 The experiments proposed in this application, to develop a genetically modified
Escherichia coli and Pseudomonas fluorescens, meet the requirements of
Category A genetic modification as defined in clause 5 of the Hazardous
Substances and New Organisms (Low-Risk Genetic Modification) Regulations
2003. Category A experiments are required to be contained within a Physical
Containment level 1 facility (PC1) registered under MAF/ERMA New Zealand
Standard 154.03.02 ‘Containment Facilities for Microorganisms’. This
containment regime contains clear guidelines for the safe handling and disposal
of bacterial cultures.
3.46 The facility in which the organisms will be maintained shall comply with the
requirements of the Australian New Zealand Standard AS/NZS 2243.3:2002
Safety in Laboratories: Part 3: Microbiological aspects of containment and
facilities, except for the deviations specified in the MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.02. The laboratory proposed to
be used by the applicant is currently approved and registered as a containment
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facility under section 39 of the Biosecurity Act, in accordance with the MAF
Biosecurity Authority/ERMA New Zealand Standard 154.03.02.
4 Decision
4.1
I am satisfied that this application is for one of the purposes specified in section
39(1) of the HSNO Act, being section 39(1)(a): the development of any
genetically modified organism.
4.2
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organisms and the modification and the
criteria for low-risk genetic modification detailed in the HSNO (Low-Risk
Genetic Modification) Regulations 2003, I am of the view that the organisms
meet the criteria for rapid assessment under section 42A(2) of the HSNO Act.
4.3
I am satisfied that the proposed containment regime together with the controls
imposed in accordance with section 42A(3)(b) of the HSNO Act 1996 will
adequately contain the organisms.
4.4
In accordance with section 42(A)(3)(c) of the HSNO Act 1996 I have
considered the provision of progress reports on this development to the
Authority and do not consider that it is necessary for this approval.
4.5
Pursuant to section 42A(3)(a) of the HSNO Act 1996, and acting under
delegation from the Authority provided for in section 19, I have approved this
application subject to the controls specified herein.
4.6
In reaching this decision I have relied upon the following criteria in the HSNO
Act and the Methodology:

Criteria for assessing the purpose of the application (section 39).

Criteria for rapid assessment of adverse effects for the development of a
genetically modified organism in containment (section 42A).

Criteria for a low-risk genetic modification specified in the HSNO (Low-Risk
Genetic Modification) Regulations 2003, made under section 41 of the Act.

The information provided by the applicant was assessed against the criteria in
clauses 9, 10 and 12 of the HSNO (Methodology) Order 1998.

Matters to be addressed by containment controls for development of
genetically modified organisms specified in Part 1 of the Third Schedule to the
HSNO Act.

Notification under section 53(4) was given to DoC and MAF. DoC indicated
that they would not oppose the approval of this application.
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5
Controls
In order to provide for the matters detailed in Part 1 of the Third Schedule of the
HSNO Act, Containment Controls for Importation, Development and Field
Testing of Genetically Modified Organisms, the approved organisms are subject to
the following controls:5
1
To limit the likelihood of any accidental release of any organism
or any viable genetic material.6
1.1
The approved organism shall be developed and maintained within a
containment facility which complies with these controls.
1.2
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.
1.3
The construction and operation of the containment facility in which the
organisms are maintained, shall be in accordance with the:
a) MAF/ERMA New Zealand Standard 154.03.027: Containment Facilities for
Microorganisms, at laboratory Physical Containment Level 1 (PC1).
b) Australian New Zealand Standard AS/NZS 2243.3:20027 Safety in
Laboratories: Part 3: Microbiological aspects of containment and facilities,
except for the deviations specified in the Standard referred to in (a).
1.4
2
2.1
The facility shall be approved and registered by MAF as a containment facility
under section 39 of the Biosecurity Act, in accordance with the MAF/ERMA
New Zealand Standard 154.03.027, and controls imposed by the Authority.
To exclude unauthorised people from the facility.
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.
5
Bold headings in the following text refer to Matters to be Addressed by Containment Controls for
Development and Field Testing of Genetically Modified Organisms, specified in the Third Schedule of
the HSNO Act 1996.
6
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, e.g. when organisms or parts thereof are sub lethally damaged by being
frozen, dried, heated, or affected by chemical.
7
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand.
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3
3.1
4
To exclude other organisms from the facility and to control
undesirable and unwanted organisms within the facility.
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.
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 organism by experimenters working with the
organism.
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 organism, the contingency
plan for the attempted retrieval or destruction of any viable material of the
organisms that have 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.
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.
6.2
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.
Environmental Risk Management Authority Decision: GMD04096
Page 13 of 15
7
Qualifications required of
implementing those controls.
the
persons
responsible
for
7.1 The training of personnel working in the facility shall be in compliance with the
standards listed in control 1.3.
8 Controls additional to the requirements of the MAF/ ERMA New
Zealand
Standard
154.03.027:
Containment
Facilities
for
Microorganisms at PC1.
8.1 All agrichemical spraying containing non-viable organisms that have been
developed in accordance with this approval or genetic material derived from these
organisms is limited to the validation of spray drift models and shall only be
undertaken at the Scion8 facilities in Rotorua.
8.2 Organisms that have been developed in accordance with this approval shall be
rendered non-viable by chemical treatment prior to their removal from the
containment facility. Non-viability of the organisms shall be demonstrated by a
viability assay prior to their removal from the containment facility. Records shall
be kept of the outcome of all viability assays undertaken in accordance with this
approval.
8.3 Only the following material is approved for use in agrichemical sprays in order to
validate agrichemical spray drift models:
1) non-coding DNA biomarker sequences9
2) non-coding DNA biomarker sequences cloned into the non-conjugative plasmid
cloning vectors pBBR1MCS-2 and/or pME6041, containing the kanamycin
resistance gene (nptII)
3) Non-viable Pseudomonas fluorescens as modified by non-coding DNA
biomarker sequences cloned into the non-conjugative plasmid cloning vectors
pBBR1MCS-2 and/or pME6041, containing the kanamycin resistance gene
(nptII).
_____________________
_______________
Dr Bas Walker,
Date 8 June 2005
Chief Executive ERMA New Zealand
Approval codes:
8
9
GMD003828
GMD003829
Formerly known as Forest Research Institute.
as described in Table 1 of this decision.
Environmental Risk Management Authority Decision: GMD04096
Page 14 of 15
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
`
____________________________
16 August 2007
Date:
Mr Rob Forlong
Chief Executive, ERMA New Zealand
Environmental Risk Management Authority Decision: GMD04096
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