ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
17 September 2002
Application code
Application type
Applicant
Purpose
Date received
Consideration
date
Considered by
GMD01244
To develop in containment genetically modified organisms under
section 40(1)(b) of the Hazardous Substances and New Organisms
(HSNO) Act.
Victoria University of Wellington
To develop in containment genetically modified Escherichia coli
(transfer of ACNGT approved organisms to approved status under the
HSNO Act)
26 July 2002
17 September 2002
Chief Executive, ERMA New Zealand
SUMMARY OF DECISION
The application to develop non-pathogenic Escherichia coli (Migula 1895) Castellani &
Chalmers 1919 (Family Enterobacteriaceae) strain K-12 or B derivatives, eg K802, JM101,
HB101, C600 by the following vector and donor DNA:
Vector - Non-conjugative plasmids, eg pBR322, pBR325, pSP6. Bacteriophages M13
and Lambda.
Donor – DNA from invertebrates and vertebrates other than humans and other than from
invertebrate and vertebrate organisms which are native1 to New Zealand.
is approved with controls.
This approval does not cover the very broad nature of the work agreed to (in respect to donor
DNA) with the Advisory Committee on Novel Genetic Technique (ACNGT).
The application has been considered in accordance with the relevant provisions of the HSNO
Act, the HSNO regulations, and the HSNO (Methodology) Order 1998.
The genetic modification of bacterium Escherichia coli meet the requirements of Category A or
B experiments in the Hazardous Substances and New Organisms (Low-Risk Genetic
Modifications) Regulations 1998, as the modifications do not result in the production of
1
“Native” in this context means a species which has an established population and breeds in New Zealand. The term is
often used as synonym of both “endemic” and “indigenous”. It excludes “introduced” or “exotic” species that have been
brought into New Zealand by humans or self introduced in recent times.
infectious viruses, high level expression of toxins, or otherwise are likely to increase the risk of
the host organism.
Experiments involving modifications of bacteria are to be conducted in MAF registered
laboratories in accordance with MAF/ERMA New Zealand Standard 154.03.02: Containment
Facilities for Microorganisms at physical containment level 1 (PC1) and in accordance with the
controls imposed by this decision.
CONSIDERATION PROCESS
Background
Unless otherwise stated, references to section numbers in this decision refer to sections of the
HSNO Act. The organisms described in this decision had pre-HSNO Act approval through the
ACNGT. As such these developments (and the resulting new organisms) were eligible to be
deemed approved under the HSNO Act through the Order in Council (OIC) process as set out in
section 257 of the Act. They were not included in the OIC dated 30 July 1998, and 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 required a Part V application to ensure they have approved status under the
HSNO Act.
Relationships with previous approvals
I consider each application on its merits, and therefore not bound by the stance taken in previous
decisions. However, I note that I have previously considered and approved six applications
(GMD01238, GMD01239, GMD01240, GMD01241, GMD01242, and GMD01243) to develop
in containment low risk genetically modified organisms, which were previously approved by the
ACNGT.
Legislative criteria for application
The application on which this decision is based 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.
Sequence of the consideration
In accordance with section 42 of the Act (rapid assessment), the approach adopted by me was to
identify the circumstances of the genetic modification(s), to evaluate these against the criteria
specified in section 41, and to consider whether there are any residual risks that require further
consideration.
PROCESSING OF APPLICATION
The application was prepared by ERMA New Zealand on behalf of, and in consultation with, the
applicant. The application was signed on behalf of the applicant on 11 June 2002. The
Environmental Risk Management Authority Decision: Application GMD01244
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application was then referred to Ngā Kaihautū Tikanga Taiao for comment. The application was
formally received by ERMA New Zealand on 26 July 2002. A waiver was obtained from the
applicant on 19 August 2002 for the consideration to be completed by 6 September 2002. A
second waiver was obtained on 9 September 2002 for the consideration to be completed by 20
September 2002.
The documents available for my consideration of the application included the application, the
accompanying Appendix outlining the ACNGT approval and the need for the application to
ERMA New Zealand, and a report from Ngā Kaihautū Tikanga Taiao.
The application was approved on Tuesday 17 September 2002.
CONSIDERATION
Purpose of the application
The purpose of the application was to develop in containment Escherichia coli strains (eg K802,
LM101, HB101, C600) modified with DNA from non-native invertebrates, mouse, non-native
vertebrates (other than humans), humans, tuatara, blue duck and parakeets as well as non native
livestock and commercial fish species as part of a study to evaluate and add to the knowledge of gene
expression and to research and teaching activities.
I am satisfied that the purpose of the application falls under section 39(1)(a) of the Act.
Scope of organisms approved
The application included the development of Escherichia coli involving in some cases the use of
DNA from New Zealand native fauna. I also note that in obtaining ACNGT approval for these
modifications, no consultation with Māori took place. Comment was sought from Ngā Kaihautū
Tikanga Taiao regarding this application. Ngā Kaihautū Tikanga Taiao recommended that:
 the application be stalled pending receipt of requested information;
 the applicant be given a deadline to respond with the relevant information; and
 should the applicant not respond with the above requests the approval is declined.
With respect to human and fish DNA and on the basis of subsequent information provided by the
institution stating that as far as they are aware no human or fish sequences were used to create
GMOs in the past, I conclude that modifications of E. coli thus far has not involved donor DNA
from humans or native fish, although ACNGT approval included this.
The use of human DNA and DNA from native fauna can be expected to have particular
significance to Māori. However, I cannot, on the basis of information provided, form a view on
the manner by which the relationship of Māori and their culture and traditions with the taonga
referred to in section 6(d) of the Hazardous Substances and New Organisms (HSNO) Act 1996
might be affected by the developments proposed in this application. I have therefore excluded
these components. If the University wishes to proceed with these developments, then they
should be the subject of a separate application, which will need to be supported with information
on risks, costs and benefits to Māori that will need to be obtained through consultation.
The scope of organisms approved under this decision is therefore less than was applied for, in
that the use of human DNA and native DNA has been excluded. In case of tuatara and yellowEnvironmental Risk Management Authority Decision: Application GMD01244
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crowned parakeet the developments are already authorised by virtue of item 48 of the
Supplement to New Zealand Gazette of Thursday 30 July 1998 [Hazardous Substances and New
Organisms (Genetically Modified Organisms Approvals) Order 1998]. In the case of blue duck,
other parakeets, native invertebrates, and the use of human DNA there is no current approval.
However, given that these particular developments have not yet taken place, they fall outside of
the purpose for this application, being to authorise current and historical GM developments.
Assessment against the criteria for low-risk genetic modifications
I am satisfied that the development of the genetically modified organisms described in this
decision falls within low risk Category A and B 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.
These modifications are therefore appropriately carried out under laboratory Physical
Containment Level 1 (PC1) as in the Australian/New Zealand Standard AS/NZS 2243.3:2002.
Safety in Laboratories Part 3: Microbiological aspects and containment facilities, as
supplemented by additional controls and this decision as detailed below.
Identification and assessment of the significant risks and costs of the organism
I have considered the scale and significance of the risks, costs, and benefits associated with the
application (as required by clause 8 of the Methodology), in particular to the relationship of
Māori and their culture and traditions as required by section 6(d) of the Hazardous Substances
and New Organisms Act 1996. This aspect is reflected in this decision.
I note that the Escherichia coli strains subject to this approval are for example derivatives of E.
coli strain K-12 or B. These strains are non-pathogenic and have been demonstrated to be unable
to establish a self-sustaining population outside of laboratory culture. The DNA to be inserted
does not code for vertebrate toxins or oncogenes. In accordance with clause 10 of the
Methodology, I do 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.
DECISION
1. Pursuant to section 42(1) of the HSNO Act, I am 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, I
consider that the organisms meet the criteria for rapid assessment (as per section 42(2) of
the HSNO Act).
3.
The approval is for a more restrictive range of developments than was applied for, for the
reasons described above. It does not cover the very broad nature of approval granted for the
use of human DNA and DNA from native fauna by the ACNGT. Should Victoria University
of Wellington wish to carry out in the future modifications involving the use of human
Environmental Risk Management Authority Decision: Application GMD01244
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DNA, or DNA from native fauna the institution will make a new application after
consultation with the appropriate iwi for the use of human DNA or DNA from native fauna,
and to obtain ethical approval from an appropriate ethics committee for the use of human
DNA.
4.
I am satisfied that the proposed containment regime together with the additional controls
imposed will adequately contain the organisms as required by section 42(2) of the HSNO
Act.
5.
In accordance with clause 36(b) of the Methodology, in reaching this conclusion, I have
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



6.
The application to develop non-pathogenic Escherichia coli (Migula 1895) Castellani &
Chalmers 1919 (Family Enterobacteriaceae) strain K-12 or B derivatives, eg K802, JM101,
HB101, C600 by the following vector and donor DNA:
Vector - Non-conjugative plasmids, eg pBR322, pBR325, pSP6. Bacteriophages M13
and Lambda.
Donor – DNA from invertebrates and vertebrates other than humans and other than from
invertebrate and vertebrate organisms which are native to New Zealand.
is thus approved with controls, detailed below:
7.
I note that there may be changes to staff originally responsible for the development of the
genetically modified organisms, and therefore this approval is to Victoria University of
Wellington as an institution.
Environmental Risk Management Authority Decision: Application GMD01244
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CONTROLS
In considering all the matters to be addressed as detailed in Part I of the Third Schedule of the
HSNO Act: Matters to be addressed by containment controls for importation, development and
field testing of genetically modified organisms, this approval (on behalf of the Authority) of the
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 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 154.03.023: Containment Facilities for
Microorganisms at laboratory physical containment levels 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 154.03.023: Containment Facilities for Microorganisms at laboratory
physical containment levels 1 (PC1).
b) Australian New Zealand Standard AS/NZS 2243.3:20023 Safety in Laboratories: Part 3:
Microbiological aspects and containment facilities, at the Physical Containment Levels
1 (PC1).
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
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
Environmental Risk Management Authority Decision: Application GMD01244
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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 Standards 154.03.023 listed in control 1.3(a).
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 Standards
154.03.023, 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 154.03.023.
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 the 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.
_____________________
17 September 2002
Dr Bas Walker, Chief Executive
Date
ERMA New Zealand
Environmental Risk Management Authority Decision: Application GMD01244
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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
____________________________
Mr Rob Forlong
Chief Executive, ERMA New Zealand
16 August 2007
Date:
Environmental Risk Management Authority Decision: Application GMD01244
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