ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 23 August 2007
28 August 2003
Application code
GMC03003
Application type
To import into containment organisms under section 40(1)(a) of the
Hazardous Substances and New Organisms (HSNO) Act.
Applicant
Institute of Environmental Science & Research (ESR)
Purpose
Importation of Acinetobacter calcoaceticus BD413 (chr::KGT) Rpr as a tool
for research on horizontal transfer of genes from genetically modified plants
to soil bacteria.
Date received
7 July 2003
Consideration date
28 August 2003
Considered by
A Committee of the Genetically Modified Organisms Standing
Committee of the Environmental Risk Management Authority (the
Authority).
1 Summary of Decision
The application to import into containment genetically modified Acinetobacter calcoaceticus
BD413 (chr::KGT) Rpr, is approved with controls, having been considered in accordance
with the relevant provisions of the Hazardous Substances and New Organisms (HSNO) Act
1996 and the HSNO (Methodology) Order 1998.
The organism has been given the following unique identifiers for the ERMA New Zealand
Organism Register:
Acinetobacter calcoaceticus BD413 (chr::KGT) Rpr.
The scope of the organism subject to the approval is limited to Acinetobacter calcoaceticus
BD413 (chr::KGT) Rpr where the bacterial chromosome was stably transformed with the
gene cassette KTG. This cassette contains the nptII gene (conferring kanamycin resistance),
the aadB gene (conferring gentamicin resistance at very low levels, if at all) and a partial, and
therefore non-expressed, cryIVB gene (a delta endotoxin from Bacillus thuringiensis var.
morrisoni).
Modified A. calcoaceticus will be imported as a pure culture into a ESR laboratory based at
Kenepuru and registered under MAF/ERMA New Zealand standard 154.03.02: Containment
facilities for micro-organisms at Physical Containment Level 2 (PC2) as defined in AS/NZS
2243.3.2002: Safety in Laboratories, Part 3: Microbiological aspects and containment
facilities.
2 Legislative Criteria for the application
The application was lodged pursuant to section 40(1)(a) of the HSNO Act. The decision was
determined in accordance with section 45, taking into account additional matters to be
considered under section 44, 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), with
particular regard to clauses 12 (dealing with assessment of risks) and clauses 13 (dealing with
assessment of costs and benefits). Unless otherwise stated, references to clause numbers in
this decision refer to clauses of the Methodology.
3 Application Process
3.1 Application receipt
The application was formally received by ERMA New Zealand on 7 July 2003 and verified as
containing sufficient information on 24 July 2003.
The organism to be imported is defined as low risk (Category A) in accordance with the
HSNO (Low-Risk Genetic Modification) Regulations 2003, and therefore the application was
not publicly notified according to ERMA New Zealand policy.
In accordance with clauses 2(2)(e) and 5 of the Methodology and section 58(c) of the HSNO
Act, the Department of Conservation (DoC) and Ministry of Agriculture and Forestry
BiosecurityAuthority (MAF) were invited to comment on this application.
In accordance with section 59(5) of the HSNO Act, two waivers were granted. The first was
to extend the consideration date, the second was to reduce the circulation time of the E&R
report.
3.2 Information available for consideration
The documents available to the Committee for consideration of this application included the
application and its appendices, a copy of the applicant’s containment manual, ESR
Containment Facility Registration by MAF, ESR Kenepuru Science Centre site map, contact
details of Kaare Nielsen, Travis Glare and Maureen O’Callaghan, copies of personal
communications between the applicant and these scientists, a poster of the FRST-funded
project entitled ‘HGT1 in New Zealand soils-application of a model system to aid
environmental impact analyses’, the IRL-IBSC-006 application and attached summary and
decision form, the IRL-IBSC-004 and application and decision form, and a number of
references.
MAF Biosecurity Authority had no specific comments on this application. A late response
from DoC, which was not included in the (Evaluation and Review) E&R Report, but emailed
to the Committee before the consideration date, noted “the department supports this research
1
Horizontal Gene Transfer
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as it will help provide an understanding of the risks associated with release of GMOs2 into the
environment from both field trials and release”.
3.3 Decision making Committee
The application was considered by the Genetically Modified Organism Standing Committee
of the Authority, appointed in accordance with section 19(2)(b) of the HSNO Act. The
Committee comprised the following members: Dr Max Suckling (Chair) and Mr Manuka
Henare.
4 Consideration
4.1 Purpose of the Application
The purpose of the application is the importation into containment of Acinetobacter
calcoaceticus BD413 (chr::KGT) Rpr as a tool for research on horizontal transfer of genes
from genetically modified plants to soil bacteria.
In accordance with section 45(1)(a)(i) of the HSNO Act, the Committee determined that the
purpose was appropriate under section 39(1)(h): “Such other purposes as the Authority thinks
fit”.
4.2 The Sequence of Steps in the Consideration
In accordance with clause 24 of the Methodology, the approach adopted by the Committee
was to look sequentially at identification, assessment and evaluation of risk, costs and
benefits. Interposed with this was the consideration of the adequacy of the proposed
containment regime, and the ability for the organisms to escape and to form self-sustaining
populations. Management techniques were considered in relation to the identified risks
(clause 24) 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 were evaluated in
accordance with clause 34, and the cost-effectiveness of the application of controls was
considered in accordance with clause 35.
4.3 Organism description
The scope of the organism subject to this approval is limited to Acinetobacter calcoaceticus
BD413 (chr::KGT) Rpr where the bacterial chromosome was stably transformed with the
gene cassette KTG. This cassette contains the nptII gene (conferring kanamycin resistance),
the aadB gene (conferring gentamicin resistance at very low levels, if at all) and a partial, and
therefore non-expressed, cryIVB gene (a delta endotoxin from Bacillus thuringiensis var.
morrisoni). The kanamycin resistance gene (nptII) is fully expressed but the expression of the
gentamicin resistance gene (aadB) is at very low levels, if at all. The cryIVB gene contains a
2
Genetically Modified Organisms
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deletion that results in a non-functional gene that is incapable of producing the toxin protein
in an active form.
4.4 Identification of Adverse and Beneficial Effects
A number of significant adverse and beneficial effects were identified for assessment and
evaluation in terms of clauses 9(a), 9(b)(i), 9(c)(i), 9(c)(ii), 10(a), 10(b) and 10(d)-(f) of the
Methodology, which incorporates sections 5, 6, and 8 of the Act. In doing so, the Committee
gave particular regard to:
Adverse effects on the environment
The Committee noted no significant adverse effects on the environment associated with the
importation into containment of genetically modified A. calcoaceticus - other than through a
rather indirect route - the potential for the organism to have adverse effects on native and
valued flora and fauna, through pathogenicity and toxicity or other effects. Although there is
some uncertainty surrounding this potential, this is one of the questions that the intended
research proposes to study.
Adverse effects on human health and safety
The Committee noted that the organism is non-pathogenic to humans and considered the
potential for the organism to contribute to the spread of antibiotic resistance. Of the two
antibiotic genes inserted into this bacterium, only the kanamycin resistance gene (nptII) is
fully expressed, and this gene is already present in the environment.
Adverse effects on Māori and their culture
The Committee notes that the organism would not have any impact on specific native flora
and fauna or valued flora and fauna if it escaped, especially those of importance to Māori or
have any impact on Māori culture, or contains human genes. Comments included in the E&R
report and made by ERMA New Zealand’s Senior Māori Advisor were useful to the
committee.
Adverse effects on the economy
The committee noted that there could be some costs associated with the removal of this
organism from the environment if it escaped, but the committee also noted that it was
extremely unlikely that the organism would escape from containment.
Adverse effects on society and the community
The committee concluded that there were no likely adverse effects on society and the
community.
Costs and benefits (beneficial effects)
The Committee addressed potential costs and benefits associated with the application, in
accordance with the Methodology clauses 9, 10, 13, and 14, and section 6(e) of the HSNO
Act. The Committee considered that no significant costs were associated with the importation
of genetically modified A. calcoaceticus into containment, but that there were potential costs
associated with removal of this organism from the environment if it escaped.
The Committee identified the primary beneficial effects as those related to increased scientific
knowledge of HGT, and better management of GMOs in the environment.
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The committee concluded the following identified risks need not be assessed further as they
are considered to be insignificant:
 Adverse effects on Māori culture
 Adverse effects on society and the community
4.5 Adequacy of the proposed containment
In carrying out its consideration the Committee considered the adequacy of containment in
accordance with section 45(1)(a)(iii) of the Act, and the magnitude and probability of the
risks, costs and benefits at the same time 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(1)(a)(ii) of the Act.
The committee consider that the adequacy of containment is acceptable for A. calcoaceticus
for a number of reasons:
 The current containment facilities at ESR are operated, constructed and
maintained according to the MAF Regulatory Authority/ERMA New Zealand
Standard 154.03.02: Containment facilities for micro-organisms and the
AS/NZS 2243:3:2002: Safety in Laboratories, Part 3: Microbiological aspects
and containment facilities.
 The laboratories function at the higher PC2 level than the required PC1 level
for this bacterium.
 There are also extra precautions to guard against any malicious intent.
Ability to escape from containment
The committee considers that it would be extremely unlikely that A. calcoaceticus would
escape from containment, having regard for the adequacy of the containment facility, and the
fact that A. calcoaceticus does not produce spores, cysts or other desiccation resistant
structures normally able to be disseminated by air.
Ability of the organism to establish a self-sustaining population and the ease of
eradication
In accordance with sections 44 and 37 of the HSNO Act, the Authority considered the ability
of the organism to establish undesirable self-sustaining populations, should they escape from
containment, and the ease with which such populations could be eradicated. In evaluating
these matters the Committee took into account the nature of the organism.
The committee agreed that as A. calcoaceticus BD413 (chr::KGT) Rpr is derived from A.
calcoaceticus, a common organism found in New Zealand soil, it has a high chance of
establishing a self-sustaining population, however it is not likely to be present in sufficient
numbers to do so, although there is a small degree of uncertainty in its competitive advantage.
The committee noted that if the organism escaped into a waterway, containment and
eradication would be extremely difficult, if not impossible, and only slightly less difficult
from a soil environment.
Other precedents
The Committee noted an earlier successful application for the very similar soil bacterium A.
calcoaceticus BD413 (pFG4nptII) in October 2000.
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4.6 Assessment of Adverse and Beneficial Effects (risks, costs and benefits)
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.
Under clause 13(a), the Committee considered the primary benefits associated with this
application to be increased scientific knowledge (non-monetary) gained through using
Acinetobacter calcoaceticus BD413 (chr::KGT) Rpr as a tool to increase the scientific
knowledge of HGT. The Committee noted that while the magnitude and expected value of
this benefit (clause 13(b)) is uncertain, immediate benefits are likely to accrue directly to the
applicant and decision makers (clause 13(c)).
4.7 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.
The Committee is satisfied that the modified Acinetobacter calcoaceticus BD413 (chr::KGT)
Rpr bacteria can be adequately contained (sections 45(1)(a)(iii) and 44(b) of the HSNO Act)
under the controls required by this decision (refer to Appendix 1). In relation to the additional
matters to be considered under section 37 of the HSNO Act, the Committee considered that
the adverse effects on the economy and concluded it is very unlikely for genetically modified
A. calcoaceticus BD413 (chr::KGT) Rpr to escape or be removed inadvertently from
containment. If in the unlikely event escape did occur, the committee realises that the
organism is likely to form a self-sustaining, but small population. The committee also notes
that eradication, if required, would be extremely difficult, if not near impossible.
The Committee considered potential adverse effects on the environment, human health and
safety, and concluded the potential risks to be insignificant. The committee did not identify
any potential significant risks associated with this application to society and the community in
general or to Māori and their culture.
The Committee then considered this application in terms of clause 26 of the Methodology,
and thus considered that the benefits associated with the importation and use of the modified
A. calcoaceticus BD413 (chr::KGT) Rpr in containment outweighed the costs. In reaching this
conclusion, the Committee considered all the possible beneficial and adverse effects of the
organisms in accordance with sections 45(1) (a) (ii) and (iii) of the HSNO Act.
The Committee considered that it is inappropriate to impose a restricted time limit on this
approval because the approval is likely to be used over a period of time. The Committee also
noted that the controls imposed within this approval have been used in previous approvals,
and as such do not consider it necessary for the applicant to report to ERMA New Zealand on
the exercise of the controls imposed by this decision.
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In addition, the Committee considered that additional controls to measure or monitor adverse
effects are not necessary in this case since the work will be conducted within containment
facilities, and at a higher PC level than required for containment of this organism.
5 Decision
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)(h): “Such other
purposes the Authority sees fit.”
Having considered all the possible effects of the organisms 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 while 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 importation into containment
of the organism is outweighed by the benefits of conducting the research.
The Committee is satisfied that the proposed containment regime together with the control
imposed and detailed in Appendix 1 will adequately contain the organism as required by
section 45(1)(a)(iii) of the Act.
In accordance with clause 36(b) of the Methodology the Committee records that, in reaching
this conclusion, it has applied the balancing tests in section 45 of the Act and clause 26 of the
Methodology and has relied in particular on the following sections in the Act - section 5(a),
section 5(b), section 45(1)(iii), and the following clauses in the Methodology: clauses (9),
(10), (12), (13), (21), (22), (24), (25), (26), (34).
The application for importation into containment of genetically modified A. calcoaceticus
BD413 (chr::KGT) Rpr is thus approved, in accordance with section 45(a) of the HSNO Act.
As required under section 45(2) the approval is subject to controls (as listed in Appendix 1 of
this decision).
________________________
Date:
Dr Max Suckling
Genetically Modified Organisms
Standing Committee of the Authority
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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: 23 August 2007
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Appendix 1: Controls required by this approval
In order to satisfactorily address the matters detailed in the Third Schedule Part I:
Containment controls for importing, developing or field testing of genetically modified
organisms3 of the HSNO Act, and other matters in order to give effect to the purpose of the
HSNO Act (section 45(2)), the Authority’s approval of this application is subject to the
following controls:
1
To limit the likelihood of any accidental release of any organism or any
viable genetic material4:
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 registered by
the Ministry of Agriculture and Forestry (MAF) Biosecurity Authority in accordance
with the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.025:
Containment facilities for micro-organisms at Physical Containment Level: 2 (PC2) as
defined in AS/NZS Standard 2243.3.20025: Safety in Laboratories, Part 3:
Microbiological aspects and containment facilities.
1.3
The construction and operation of the containment facilities (‘the facility’) in which
the organisms are maintained, shall be in accordance with the relevant standards listed
in 1.2 above.
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 1.2 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 1.2 relating to the exclusion of other
organisms from the facility and the control of undesirable and unwanted organisms
within the facility.
Bold headings 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.
3
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 sublethally damaged by being frozen, dried, heated, or affected by chemical.
4
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand
5
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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 1.2 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 1.2 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 1.2.
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 1.2 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 MAF/ERMA New
Zealand Standards listed in control 1.2.
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 1.2.
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