ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
11 December 2001
Application code
Application type
Applicant
Purpose
Date received
Consideration date
Considered by
GMD01243
To develop in containment genetically modified organisms under section
40(1)(b) of the Hazardous Substances and New Organisms (HSNO) Act.
Landcare Research (Mt Albert, Auckland)
To develop in containment Escherichia coli modified with DNA from
Onychophora species and invertebrates (transfer of ACNGT approved
organisms to approved status under the HSNO Act)
4 December 2001
12 December 2001
Chief Executive, ERMA New Zealand
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
 Escherichia coli (Migula 1895) Castellani & Chalmers 1919 (GMD01243) derivatives of strain
K12 modified by pBluescript SK(+/-) phagemid containing DNA from Onychophora species
 Escherichia coli (Migula 1895) Castellani & Chalmers 1919 (GMD01243) derivatives of strain
K12 modified by pBluescript SK(+/-) phagemid pGEM containing DNA from Paryphantidae
(snails) and Athoracophoridae (slugs).
The genetic modifications meet the requirements of Category A experiments in the Hazardous
Substances and New Organisms (Low-Risk Genetic Modifications) Regulations 1998. The
development of genetically modified Escherichia coli involves an approved Schedule 2 host/vector
system, as described in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modification) Regulations 1998.
Experiments involving modification of the E. coli described above can be conducted in laboratory
Physical Containment level 1 (PC1) as in the Australian/New Zealand Standard AS/NZS 2243.3:1995
Safety in Laboratories Part 3: Microbiology and in accordance with the controls imposed by this
decision.
Relationships with previous approvals
The Chief Executive considers each application on its merits, and is therefore not bound by the stance
taken in previous decisions. However, the Chief Executive may wish to reflect on previous decisions
where these involve similar issues to those raised by this application.
The Chief Executive notes that he has previously considered and approved applications by Industrial
Research Limited (application GMD01242) and by AgResearch Ruakura (GMD01238) to develop in
containment low risk genetically modified organisms, which were previously approved by the
Advisory Committee on Novel Genetic Techniques (ACNGT).
Legislative criteria for application
The organisms described in this decision have pre-HSNO Act approval through the ACNGT. As such
these developments (and the resulting new organisms) were to be deemed approved under the HSNO
Act through the Order in Council (OIC) process as set out in section 257 of the Act. Before the OIC
process could be completed to include all the ACNGT approved developments, section 257 of the Act
expired, thereby removing this mechanism as a means of transferring previously approved
developments to the HSNO Act regime. Developments of this type and the existing organisms
therefore require a Part V application to ensure they have approved status under the HSNO Act.
Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO
Act.
As such, this application was lodged pursuant to section 40(1)(b) of the HSNO Act. The decision was
determined in accordance with section 42 (rapid assessment) and matters relevant to the purpose of
the Act, as specified in Part II of the HSNO Act.
Consideration of the application followed the relevant provisions of the HSNO (Methodology) Order
1998. Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
Application Process
The application was prepared by ERMA New Zealand on behalf of, and in consultation with, the
applicant. The applicant approved the content of the application on 24 October 2001. The application
was then referred to Ngā Kaihautū Tikanga Taiao for comment. The application was formally
received by ERMA New Zealand on 4 December 2001.
The documents available for the evaluation and review of the application by ERMA New Zealand
included the application and the accompanying Appendix outlining the ACNGT approval and the
need for the application to ERMA New Zealand.
The application was approved by Dr Bas Walker, Chief Executive, ERMA New Zealand, on 12
December 2001.
Consideration
Purpose of the application
The purpose of the application was to develop in containment Escherichia coli strain DH10B
modified with DNA from Onychophora, Paryphantodae and Athoracophoridae for the purpose of
studying gene expression in the host organisms. The Chief Executive considered that this was an
appropriate purpose under section 39(1)(a) of the Act.
Sequence of the consideration
In accordance with section 42 of the Act (rapid assessment), the approach adopted by the Chief
Executive was to identify the circumstances of the genetic modification(s), to evaluate these against
Environmental Risk Management Authority Decision: Application GMD01243
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the criteria specified in section 41, and to consider whether there are any residual risks that require
further consideration.
Identification of the significant risks and costs of the organism
The Chief Executive considers that information provided by the applicant is relevant and appropriate
to the scale and significance of the risks, costs, and benefits associated with the application (as
required by clause 8 of the Methodology).
The Chief Executives notes that the Escherichia coli strains described in this application are
derivatives of E. coli strain K12. These strains are non-pathogenic and have been demonstrated to be
unable to establish a self-sustaining population outside of laboratory culture. They are also approved
host vector systems in Schedule 2 of the HSNO (Low-Risk Genetic Modification) Regulations. The
pBluescript vectors are non-conjugative and the DNA to be inserted is not derived from pathogenic
micro-organisms, poisonous or toxic invertebrates, and does not code for vertebrate toxins or
oncogenes. In accordance with clause 10 of the Methodology, the Chief Executive does not consider
there is any evidence or any reason to expect any adverse effects of the genetically modified E. coli to
humans, animals, or plants or on the environment, or that they could establish a self-sustaining
population should they escape containment. The Chief Executive considers that good microbiological
practice when handling the cultures will greatly reduce the risks of their escape from containment.
The proposed controls, which are designed to manage the risks associated with the maintenance of
these micro-organisms in containment, are outlined later in this application.
The Chief Executive notes that the development of these genetically modified organisms involves in
some cases the use of DNA from New Zealand native organisms. The Chief Executive also notes that
in obtaining ACNGT approval for these modifications, no consultation with Maori took place.
Comment was sought from Ngā Kaihautū Tikanga Taiao regarding this application. A sub-committee
of Ngā Kaihautū Tikanga Taiao reported that although some of the modifications involve native
species, the work is of low risk and the purpose of the research is good for science. The subcommittee did however express concern about the inadequacy of consultation with Maori in view of
the fact that the application involved native species, but believed it would be impractical to recall the
application as other applications that were approved under the ACNGT would also have to be
recalled. In addition the committee was not comfortable about approving applications retrospectively
and in some cases the research has already been completed. The sub-committee recognised the need
to improve the current process and steps have been implemented to achieve this. The Chief Executive
notes that the modifications described do not involve human genetic material, and advises that should
Landcare Research wish to carry out modifications involving the use of human genes or genes from
native flora or fauna in the future, they will need to consult with the appropriate iwi for the use of
native material prior to commencing work, and to obtain ethical approval from an appropriate ethics
committee for the use of human genetic material.
In light of this and taking into account the containment controls proposed, the view of the Chief
Executive (in accordance with clause 12 of the Methodology) is that to a high level of certainty, both
the magnitude and probability of occurrence of adverse effects arising from the genetically modified
organisms described above is negligible.
Assessment against the criteria for low-risk genetic modifications
The Chief Executive is satisfied that the development of the genetically modified organisms described
in this decision falls within low risk Category A of the HSNO (Low-Risk Genetic Modification)
Regulations 1998, as they include approved host vector systems and meet the requirements of low risk
experiments as set out in the Regulations.
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These modifications are therefore appropriately carried out under laboratory Physical Containment
Level 1 (PC1), as in the Australian/New Zealand Standard AS/NZS 2243.3:1995 Safety in
Laboratories Part 3: Microbiology and this decision as detailed below.
Decision
1.
Pursuant to section 42(1) of the HSNO Act, the Chief Executive 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.
Based on consideration and analysis of the information provided, and having considered the
characteristics of the organisms and the modifications and the criteria for low-risk genetic
modification detailed in the HSNO (Low-Risk Genetic Modification) Regulations 1998, the view
of the Chief Executive is that the organisms meet the criteria for rapid assessment (as per section
42(2) of the HSNO Act).
3.
The Chief Executive is satisfied that the proposed containment regime together with the
additional controls imposed will adequately contain the organism as required by section 42(2) of
the HSNO Act.
4.
In accordance with clause 36(b) of the Methodology, the Chief Executive records that, in
reaching this conclusion, he has applied the following criteria from the Methodology:
clause 10 – evaluation of information on risks, costs, and benefits (equivalent of sections 36 and
37)
clause 12 – evaluation of assessment of risks (to meet requirements of section 41)
clause 21 – the decision accords with the requirements of the Act and regulations
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5.
The application for development of genetically modified organisms (detailed in Table 1) is thus
approved with controls, as follows:
6.
The Chief Executive notes there are likely to be changes to staff that were originally responsible
for the development of the genetically modified organisms, and therefore this approval is to
Landcare as an institution. As such, the modified organisms shall be maintained at Landcare
Research’s Mt Albert site in laboratory physical containment level 1.
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Controls
In considering all the matters to be addressed as detailed in Part I of the Third Schedule: Matters to be
addressed by containment controls for development and field testing of genetically modified
organisms of the HSNO Act, the Chief Executive’s (on behalf of the Authority) approval of the
organisms requiring PC1 containment are subject to the following controls:
1.
To limit the likelihood of any accidental release of any organism or any viable
genetic material1:
1.1
The person responsible for a particular research area and/or the person responsible for the
operation of the containment facilities (‘the facility’) shall inform all personnel involved in the
handling of the organisms of the Authority’s controls.
1.2
The Ministry of Agriculture and Forestry (MAF) shall approve the facility in accordance with
the MAF/ERMA New Zealand Standard 154.03.022: Containment Facilities for
Microorganisms at laboratory physical containment level 1 (PC1) and the controls of the
Authority.
1.3
The operation and management of the containment facilities shall be in accordance with the:
a) Ministry of Agriculture and Forestry (MAF) Regulatory Authority/ERMA New Zealand
Standard 154.03.022: Containment Facilities for Microorganisms at PC1 laboratory physical
containment.
b) Australian New Zealand Standard AS/NZS 2243.3:19952 Safety in Laboratories: Part 3:
(Microbiology), at Physical Containment Level 1.
2.
To exclude unauthorised people from the facility:
2.1
The identification of entrances, numbers of and access to entrances, and security requirements
for the entrances and the facility shall be in compliance with the requirements of the standards
listed in control 1.3.
3.
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
3.1
The exclusion of other organisms from the facility and the control of undesirable and unwanted
organisms within the facility shall be in compliance with the standards listed in control 1.3
1
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.
2
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
The prevention of unintended release of the organisms by experimenters working with the
organisms shall be in compliance with the standards listed in control 1.3.
5.
To control the effects of any accidental release or escape of an organism:
5.1
Control of the effects of any accidental release or escape of the organisms shall be in
compliance with the standards listed in control 1.3.
5.2
In the event of any breach of containment 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 Standard (154.03.022).
5.3
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.
5.4
The applicants shall comply with the requirements of the standards listed in control 1.3 relating
to the maintenance of records demonstrating compliance with the Standard (154.03.022), as
required by the quality assurance programme, and documented in the containment manual.
6.
Inspection and monitoring requirements for containment facilities:
6.1
The inspection and monitoring requirements for containment facilities shall be in compliance
with the standards listed in control 1.3
6.2
The containment manuals shall be updated, as necessary, to address the implementation of the
controls imposed by this approval, in accordance with the MAF/ERMA New Zealand Standard
154.03.022.
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.
7.2
The facility Operator, in consultation with the institution shall ensure that only suitably trained
individuals will handle infectious material covered under this approval.
7.3
The facility Operator shall record the qualifications and training undertaken of all personnel
working with organisms under this approval, and make these records available for examination
by the Inspector.
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Additional control
The applicant shall obtain approval from the Department of Conservation for the use of genetic
material from organisms subject to the requirements of the Convention on International Trade
in Endangered Species (CITES).
______________________
Dr Bas Walker, Chief Executive
11 December 2001
Date
ERMA New Zealand
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
____________________________
Mr Rob Forlong
Chief Executive, ERMA New Zealand
16 August 2007
Date:
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