ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 16 August 2007
Date signed: 06 June 2002
Application code
Application
category
Applicant
Purpose
Date received
Consideration date
Considered by
1
GMD02022
To develop in containment genetically modified organisms under
section 40(1)(b) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Ministry of Agriculture and Forestry (MAF) - National Plant Pest
Reference Laboratory (NPPRL)
To develop in containment PCR-amplified cDNA copies of two
thirds or less of viral or viroid genes from plants into commercial
vectors and to clone them into Escherichia coli prior to sequencing
02 May 2002
06 June 2002
The Chief Executive, ERMA New Zealand
Summary of decision
The application to develop in containment genetically modified Escherichia coli (Migula
1895) Castellani & Chalmers 1919 strain K12 or B derivatives (as described in Annex 2 of
this decision) is approved, with controls (as listed in Annex 1 of this decision), having been
considered in accordance with the relevant provisions of the:

Hazardous Substances and New Organisms (HSNO) Act 1996

HSNO (Low-Risk Genetic Modification) Regulations 1998 ("the Regulations"), and

HSNO (Methodology) Order 1988 ("the Methodology").
The development of genetically modified E. coli meets the following requirements of the
Regulations:

An approved Schedule 2 host/vector system;

Category B(b)(v)(B) experiments (since the foreign genetic material is derived from
pathogens and has yet to be fully characterised);

Experiments that can be conducted in laboratory Physical Containment level 1 (PC1)
as specified in the Australian/New Zealand Standard AS/NZS 2243.3:2002 Safety in
Laboratories Part 3: Microbiological aspects and containment facilities and in
accordance with the controls imposed by this decision (refer to Annex 1).
2
Summary of consideration process & relevant legislative
criteria
Delegated authority for decision-making
Dr Bas Walker, Chief Executive (ERMA New Zealand) conducted a rapid assessment
consideration of this application under delegation from the Authority, as provided for under
section 19(2)(a) of the HSNO Act.
Application receipt
The application was formally received by ERMA New Zealand on 02 May 2002 pursuant to
section 40(1)(b) of the HSNO Act. ERMA New Zealand verified that the application
contained adequate information to be processed on 02 May 2002. A waiver was approved
regarding an extension of the statutory timeframe (until 12 June 2002) for processing a rapid
assessment application under the HSNO Act.
Purpose of the application
The purpose of the application is to develop in containment E. coli K12 and B strain
derivatives modified with copies of genetic material from plant viruses or viroids (as
specified in Annex 2), to provide material for DNA sequencing to permit identification of the
virus or viroid and enable the development of diagnostic tests. The Chief Executive considers
that this is an appropriate purpose as categorised under the HSNO Act sections 39(1)(a): The
development of any genetically modified organism; and 39(1)(g): Maintaining new organisms
in containment for diagnostic purposes.
Information available for consideration
The documents available for the consideration included the application, published references
as cited in the application, and the MAF NPPRL microorganism containment facility manual
for their Auckland site. In addition, staff advice was provided to the Chief Executive in the
form of: (i) a peer review checklist from the Manager, Science and Analysis, evaluating the
application in a format and sequence consistent with the decision-making requirements of the
HSNO Act, the Regulations and the Methodology; and (ii) a draft decision document.
Consideration approach and sequence
The decision was determined in accordance with section 42 (rapid assessment) and matters
relevant to the purpose of the HSNO Act (as specified under Part II of the Act).
Consideration of the application also followed the relevant provisions of the Methodology.
In accordance with section 42(1) of the HSNO Act and clauses 9, 10 and 12 of the
Methodology, the approach adopted by the Chief Executive was to identify, assess and
evaluate adverse effects of developing the genetically modified organisms in containment.
Adverse effects are defined as including risks and associated costs. Costs are defined as
values of negative effects (expressed in monetary or non-monetary terms).
In assessing adverse effects, it was considered whether or not the development met the
criteria for low-risk genetic modification as specified under the Regulations (as per sections
41 and 42(2) of the HSNO Act) and if there were any residual risks that required further
consideration. The Chief Executive then imposed controls to satisfactorily provide for the
Environmental Risk Management Authority Decision GMD02022
Page 2 of 8
matters specified in the Third Schedule (Part I) of the Act (in accordance with section 42(2)
of the HSNO Act and risk management under clauses 12(d) and 24 of the Methodology).
It is noted that rapid assessment of an application to develop a genetically modified organism
in containment (under section 42) does not provide for the consideration of benefits.
3
Identification and assessment of significant adverse effects
The Chief Executive conducted an identification and assessment of significant adverse effects
(ie risks and costs) related to the application (in accordance with section 42(1) of the HSNO
Act; clauses 9, 10 and 12 of the Methodology; and the Regulations).
In identifying adverse effects, the Chief Executive considered the characteristics of the
organism and the genetic modifications (including their categorisation against legislative
requirements for low-risk genetic modification in the Regulations). The Chief Executive is
satisfied that development of the genetically modified E. coli (as described in Annex 2 of this
decision), meets the criteria for low-risk genetic modification as specified in the Regulations.
E. coli strains K12 and B derivatives, and the non-conjugative plasmid vectors are approved
low risk host/vector systems as described in Schedule 2 of the Regulations and meet the
requirements of Category B(b)(v)(B) experiments.
The Chief Executive notes that the E. coli strains subject to the application are debilitated and
very unlikely to survive outside containment due to genetic defects. These non-pathogenic
laboratory strains include genetic mutations making them dependent upon laboratory culture
for survival. The genetic material to be cloned represents less than two thirds of the viral or
viroid genome. Hence, while the genetic material to be introduced into the vector is derived
from pathogenic organisms, the modifications are very unlikely to result in the production of
infectious particles or introduce pathogenic or toxic traits into the host.
The diagnostic procedures do not involve human genes or DNA from native flora and fauna.
The Chief Executive considers that the application poses no risk to the relationship between
Māori culture and their traditions with their ancestral lands, water, sites, waahi tapu, valued
flora and fauna and other taonga.
Taking into account the containment regime (as discussed in section 4 below), the Chief
Executive does not consider there is any evidence or reason to expect that the genetically
modified E. coli strains subject to this application would have significant adverse effects on
humans, animals, plants or the general environment; or that the organisms could establish a
self-sustaining population should they escape containment.
4
Assessment of containment regime adequacy
In assessing adverse effects, the Chief Executive considered the adequacy of containment (in
accordance with section 42(2) of the HSNO Act). The controls imposed by this approval (as
specified in Annex 1) reflect the containment requirements specified by the Regulations and
address the matters detailed in the Third Schedule Part I: Matters to be addressed by
containment controls for importing, developing or field testing of genetically modified
organisms of the HSNO Act. These controls incorporate requirements for management of
risks (under clauses 12(d) and 24 of the Methodology) posed by the development of the
genetically modified organisms subject to this approval. The controls have been imposed to
Environmental Risk Management Authority Decision GMD02022
Page 3 of 8
ensure that exposure of laboratory workers and other persons, and the outside environment, to
risks posed by the organisms are negligible.
The basis of the containment regime is that the organisms shall be maintained in a
containment facility that is registered by the MAF Biosecurity Authority in accordance with
the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02 (Containment
Facilities for Microorganisms). General containment requirements for safe management of
microorganisms in the laboratory environment are addressed in this standard. These crossreference to detailed Physical Containment (PC) requirements in the Australian New Zealand
Standard AS/NZS 2243.3:2002 Safety in Laboratories Part 3: Microbiological aspects and
containment facilities. The physical containment level has been set at PC1, as per the AS/NZ
standard (refer to Control 1.2, Annex 1). The other controls specified in Annex 1 emphasize
and/or clarify how the above containment standards address the matters required under the
Third Schedule (Part I) of the HSNO Act.
5
Relationship with previous approvals
In considering application GMD02022, the Chief Executive has reflected on previous
decisions that involve similar issues to those raised by this application. However, the Chief
Executive notes that each application is considered on its merits, and therefore the outcome
of the current application is not bound by the stance taken in previous decisions.
It is noted that both the Chief Executive of ERMA New Zealand and Institutional Biological
Safety Committees (IBSCs) have considered and approved (under delegated authority) many
applications to develop in containment genetically modified E. coli under the rapid
assessment provisions of the HSNO Act. Examples include the University of Auckland IBSC
application GM0099/UA028 (ERMA approval code GMD000353, application code
GMD00042) and amendment GM2001/UA020A (ERMA approval code GMD01677,
application code GMD01187). These developments involved cloning of the same or similar
material to this application (GMD02022) into E. coli for viral plant disease diagnostic
purposes. Both of the above IBSC applications were approved and required PC1 containment
with no additional controls.
6
Overall evaluation of adverse effects
In the overall evaluation of adverse effects associated with application GMD02022, the Chief
Executive records that the following criteria in the HSNO Act and Methodology have been
particularly relied on (in accordance with clauses 21 and 36(2)(b) of the Methodology):

The application has been considered in the context of the purpose and principles of
the HSNO Act (sections 4 – 8 inclusive).

Pursuant to section 42(1) of the HSNO Act, the Chief Executive is satisfied that this
application meets the purposes specified in sections 39(1)(a) and (g) of the Act.

The information provided by the applicant is relevant and appropriate to the scale and
significance of the risks and costs associated with the application (clause 8 of the
Methodology).

The Chief Executive is satisfied that the development of genetically modified E. coli
(as described in Annex 2 of this decision) meets the criteria for rapid assessment (as
per section 42(2) of the HSNO Act). This conclusion is based on consideration and
analysis of the information provided, and having considered the characteristics of the
Environmental Risk Management Authority Decision GMD02022
Page 4 of 8


7
host organism and the genetic modifications (including the criteria for low-risk
genetic modification detailed in the HSNO (Low-Risk Genetic Modification)
Regulations 1998).
The Chief Executive is satisfied that the containment controls imposed (refer to
Annex 1 of this decision) will adequately contain the genetically modified E. coli, as
required by section 42(2) of the HSNO Act.
In accordance with section 41 of the HSNO Act and clauses 9, 10 and 12 of the
Methodology, the Chief Executive considers that to a high level of certainty, both the
magnitude and probability of occurrence of adverse effects arising from the
development of the genetically modified E. coli subject to application GMD02022 is
negligible.
Decision
The application to develop in containment genetically modified Escherichia coli (as
described in Annex 2 of this decision) is approved in accordance with section 45 of the
HSNO Act. As required under section 42(2) the approval is subject to controls (as listed in
Annex 1 of this decision).
6 June 2002
Dr Bas Walker
Chief Executive, ERMA New Zealand
Date
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
Environmental Risk Management Authority Decision GMD02022
16 August 2007
Date:
Page 5 of 8
Annex 1: Controls required by approval of Application GMD02022
In order to satisfactorily address the matters detailed in the Third Schedule Part I: Matters to
be addressed by containment controls for importing, developing or field testing of genetically
modified organisms1 of the HSNO Act, the 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 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 containment facility shall be registered by the Ministry of Agriculture and Forestry
(MAF) in accordance with the MAF/ERMA New Zealand Standard 154.03.023:
Containment Facilities for Microorganisms at laboratory physical containment level 1
(PC1) (as specified in the Australian New Zealand Standard AS/NZS 2243.3:20023
Safety in Laboratories Part 3: Microbiological aspects and containment facilities and
other controls of the Authority. The construction, operation and management of the
containment facilities shall be in accordance with these standards.
1.3 The scope of organisms covered by this approval is limited to those specified in Annex 2
of this decision.
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 1.2.
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 1.2.
1
Bold headings refer to matters to be specifically addressed by containment controls under the Third
Schedule (Part I) of the HSNO Act.
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 sub-lethally 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 GMD02022
Page 6 of 8
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 1.2.
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 1.2.
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 MAF/ERMA New Zealand Microorganism Standard
154.03.023.
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 applicant shall comply with the requirements of the standards listed in control 1.2
relating to compliance and the maintenance of records, as required by the quality
assurance programme.
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 1.2.
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 Microorganism 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 1.2.
7.2 The facility Operator, in consultation with the Institutional Biological Safety Committee
(IBSC), 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.
Environmental Risk Management Authority Decision GMD02022
Page 7 of 8
Annex 2: Organisms approved under this decision for Application
GMD02022 (subject to controls specified in Annex 1, above)
The organism approved is Escherichia coli (Migula 1895) Castellani & Chalmers 1919 strain
K12 or B derivatives as modified by non-conjugative plasmid vectors containing plant virus
or plant viroid sequences (GMD02022).
The Escherichia coli strains shall be non-pathogenic and shall not contain conjugative
plasmids or generalized transducing phages.
Genes inserted:
The cloned viral and viroid sequences shall represent less than two thirds of the viral or viroid
genome and shall not result in the production of infectious particles.
Genetic material derived from plant viruses shall be derived from the following types of
viruses: Bromoviridae, Bunyaviridae, Caulimoviridae, Closteroviridae, Comoviridae,
Geminiviridae, Luteoviridae, Partitiviridae, Potyviridae, Reoviridae, Rhabdoviridae,
Sequiviridae and Tombusviridae families, those genera which have been unassigned to a
family (specifically the genera Allexivirus, Benyvirus, Capillovirus, Carlavirus, Foveavirus,
Furovirus, Hordeivirus, Idaeovirus, Marafivirus, Nanovirus, Ophiovirus, Ourmiavirus,
Pecluvirus, Pomovirus, Potexvirus, Sobemovirus, Tenuivirus, Tobamovirus, Tobravirus,
Trichovirus, Tymovirus, Umbravirus, Varicosavirus and Vitivirus) and those species which
are currently unassigned to a genus (specifically Black raspberry necrosis virus,
Brachypodium yellow streak virus, Cassava Ivorian bacilliform virus, Chara australis virus,
Flame chlorosis virus, Grapevine fleck virus, Hart's tongue fern mottle virus, Maize white
line mosaic virus, Nicotiana velutina mosaic virus, Orchid fleck virus, Parsley latent virus,
Pelargonium zonate spot virus, Vicia faba 447 cytolasmic male sterility-associated virus,
Watercress yellow spot virus and White clover virus L), as described by van Regenmortel et
al., 2000.
Genetic material derived from plant viroids shall be derived from the following types of
viroids: plant viroids belonging to the Pospiviroidae and Avsunviroidae families, and those
species currently unassigned to a genus (Apple fruit crinkle viroid, Blueberry mosaic viroidlike RNA, Burdock stunt viroid, Eggplant latent viroid, Nicotiana glutinosa stunt viroid,
Pigeon pea mosaic mottle viroid and Tomato bunchy top viroid) as described by van
Regenmortel et al., 2000.
Cloned viral and viroid sequences shall not represent more than two thirds of the genome of
the virus or viroid, and the cloned sequences shall not result in the production of infectious
particles pathogenic to plants.
Reference
van Regenmortel MHV, Fauquet CM, Bishop DHL, Carstens EB, Estes MK, Lennon SM,
Maniloff J, Mayo MA, McGeoch DJ, Pringle CR and Wickner RB. 2000. Virus Taxonomy:
Seventh Report of the International Committee on Taxonomy of Viruses. Academic Press, San
Diego.
Environmental Risk Management Authority Decision GMD02022
Page 8 of 8