ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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
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4 August 2006
GMC06011
 To import into containment genetically modified organisms
under sections 40(1)(a) and 42B of the Hazardous Substances
and New Organisms (HSNO) Act 1996.
 Sigma-Aldrich New Zealand Limited
Applicant
 Importation of Escherichia coli containing synthetic plasmids
Purpose
that code for shRNA hairpins for gene knockdown.
2031 July 2006
Date received
Consideration date Ju 4 August 2006
Chief Executive, ERMA New Zealand
Considered by
Application code
Application type
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1 Summary of decision
1.1
The application to import genetically modified organisms into containment is
approved, with controls, having been considered in accordance with the
relevant provisions of the Hazardous Substances and New Organisms Act
1996 (HSNO Act), the HSNO (Low-Risk Genetic Modification) Regulations
2003, and the HSNO (Methodology) Order 1998 (Methodology).
The organisms approved are:
1.2
The organisms approved for import into containment are the genetically
modified bacteria strains as listed below in Table 1:
Table 1: Organisms as recorded on ERMA New Zealand Register
Host organism
Category Modified by:
of host
organism
Escherichia coli
(Migula 1895)
Castellani &
Chalmers 1919
non-pathogenic
laboratory strains
1
1
Commercially available plasmid based
mammalian expression vectors, including
pLKO.1-Puro, containing sequences designed to
produce short hairpin loops1 to target Open
Reading Frames derived from the Human and
Mouse genomes.
Category of
modification/
containment
level
A / PC1
The target sequences are fully defined approximately 50 base pairs in length and of the following
structure: 20-21 base sense strand, 6 base loop, 20-21 base anti sense strand, 3 Thymidine base tag at
the 3’ end.
Background Information
1.3
The genetically modified Escherichia coli to be imported into containment
under this approval form part of the Sigma-Aldrich MISSION™ shRNA
library. The purpose of this application is to import into containment
genetically modified Escherichia coli for sale to New Zealand scientists and
laboratory researchers.
1.4
The MISSION™ shRNA Escherichia coli are ordered on line through the
Internet, with the researcher nominating the human or mouse gene(s) to be
targeted. The short hairpin loops (shRNA products) are designed specifically
to the human or mouse genome by bioinformatics examination of the open
reading frame, therefore, each shRNA molecule that is produced is specific
against the target gene of interest.
1.5
The MISSION™ shRNA Escherichia coli will be used in containment
laboratories by researchers to identify gene function by knocking out
(deletion) or knocking down (reduction) the function of the targeted gene and
then investigating the effects of these changes in cell function.
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(a) of the HSNO Act
and determined according to the rapid assessment provisions of section 42B
of the HSNO Act.
2.2
The application has been approved with controls by Mr Rob Forlong, Chief
Executive of ERMA New Zealand, under delegation from the Authority as
provided for in section 19 of the HSNO Act.
2.3
In reaching this decision I have considered matters relevant to the purpose of
the Act, as specified in Part II, and followed the relevant provisions of the
Methodology.
Environmental Risk Management Authority Decision: GMC06011
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3
Consideration
Sequence of the consideration
3.1
The application was formally received and verified as containing sufficient
information on 31 July 2006.
3.2
The decision was based on the information supplied by the applicant in their
application form Import into Containment low risk genetically modified
organisms by rapid assessment.
3.3
The application was considered by the Chief Executive of ERMA New
Zealand, in consultation with the Māori advisor and other relevant parties
within ERMA New Zealand.
3.4
The import of the genetically modified organisms described above (Table 1)
meet the criteria of a low-risk genetic modification specified in the
Regulations made under section 41 of the HSNO Act, being the HSNO
(Low-Risk Genetic Modification) Regulations 2003.
3.5
In reaching my 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 modifications and matters relevant to the purpose
of the HSNO Act 1996, as specified in Part II, and followed the relevant
provisions of the Methodology.
3.6
In accordance with section 42B of the HSNO Act for rapid assessment, the
approach adopted was to identify the circumstances of the genetic
modification, to evaluate these against the criteria specified in section 41 of
the HSNO Act, 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 of the HSNO Act)

Assessment against the criteria for low-risk genetic modifications
(section 42B of the HSNO Act)

Identification and assessment of the risks and other impacts of the
organism

Precedents

Proposed controls
3.7
The Department of Conservation (DoC) was notified upon receipt of this
application.
3.8
DoC raised no issues with the application.
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Purpose of the application
3.9
The importation into containment of modified Escherichia coli containing
synthetic plasmids that code for shRNA hairpins for gene knockdown.
3.10
I have determined that this application may be approved for the purpose of
the import of any new organism as provided for in section 39(1)(a) of the
HSNO Act 1996.
Category of low-risk genetic modification
3.11
I am satisfied that the genetically modified Escherichia coli described above
in Table 1, meets the criteria for a low-risk genetic modification specified in
clause 5 of the Regulations made under section 41 of the HSNO Act, being
the HSNO (Low-Risk Genetic Modification) Regulations 2003.
3.12
Non-pathogenic laboratory strains of Escherichia coli are considered
Category 1 host organisms2 that are unlikely to cause disease in humans,
animals, plants or fungi. The development of these genetically modified
Escherichia coli constitute a Category A genetic modification, as defined in
clause 5(1) under the HSNO (Low-Risk Genetic Modification) Regulations
2003, as it involved a Category 1 host organism and hence, containment is
set at a minimum of Physical Containment 1 (PC1). The modifications are
not expected to increase the pathogenicity, virulence or infectivity of the
bacteria and will not result in these strains having a greater ability to escape
from containment.
4
Identification and assessment of the risks, costs
and other impacts of the organism
4.1
I consider that the 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).
In accordance with clauses 9 and 10 of the Methodology the information
supplied by the applicant has been evaluated as follows:
4.2
I consider that, taking into account the biological characteristics of the
organisms and 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, other organisms
or the environment.
2
HSNO (Low-Risk Genetic Modification) Regulations 2003
Environmental Risk Management Authority Decision: GMC06011
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4.3
I have considered the potential Māori cultural effects in accordance with
sections 6(d) and 8 of the HSNO Act and clauses 9(b)(i), 9(c)(iv) of the
HSNO Methodology Order 1998: Information Used by the Authority, in
consultation with the Māori advisor.
4.4
In accordance with ERMA New Zealand policy, the applicant was not
required to consult with Māori as the application is for the import into
containment of genetic material that is not human in origin nor is it sourced
from native or valued taonga flora and fauna. Taking this into account I
consider that this genetic material 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.
Precedents
4.5
I must consider each application on its merits, and am therefore not bound by
the stance taken in previous decisions. I note that there are several approvals
to import genetically modified Escherichia coli strains into containment,
such approvals have been considered and approved on many occasions by
Institutional Biological Safety Committees (IBSCs) under delegated
authority and by the Chief Executive of ERMA New Zealand.
4.6
I consider that this current application does not raise any novel issues that
would warrant it being considered other than via section 42A of the Act.
Containment
4.7
The genetically modified Escherichia coli do not contain infectious agents
pathogenic to humans, animals, plants or fungi and are Category 1 host
organisms that have undergone a Category A genetic modification and shall
be contained under a minimum of PC1 containment.
4.8
The Environmental Risk Management Authority holds the current version of
the certificate of approval as a containment facility for Logical Freight
Solutions NZ Ltd and details of the agreement between Sigma-Aldrich NZ
Ltd and the Logical Freight Solutions NZ Ltd containment facility.
4.9
The imported Escherichia coli strains will be housed and grown under a
minimum of physical containment level 1 (PC1) as described in the standard
AS/NZS 2243.3.2002. The construction, operation and management of the
containment facility 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.
3
Or any updated Standard endorsed by ERMA New Zealand and MAF Biosecurity New Zealand.
Environmental Risk Management Authority Decision: GMC06011
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b. Australian New Zealand Standard AS/NZS 2243:3 2002 Safety in
Laboratories: Part 3: (Microbiological aspects and containment facilities)4,
excluding those deviations specified in section 4.2 of Standard 154.03.02.
5
Decision
5.1
I am satisfied that this application is for one of the purposes specified in
section 39(1) of the Hazardous Substances and New Organisms Act 1996,
being section 39(1)(a): the import of any new organism.
5.2
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organisms, 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 42B of the Hazardous
Substances and New Organisms Act 1996.
5.3
I am satisfied that the proposed containment regime and the controls imposed
in accordance with section 42B(2) of the Hazardous Substances and New
Organisms Act 1996, as set out below, will adequately contain the
organisms.
5.4
Pursuant to section 42B(2) of the HSNO Act 1996, and acting under
delegation from the Authority provided for in section 19 of the HSNO Act
1996, I have approved this application subject to the controls specified
herein.
5.5
In reaching this decision I have relied upon the following criteria in the
HSNO Act and the Methodology:
4

Criteria for assessing the purpose of the application (section 39 of the
HSNO Act 1996).

Criteria for rapid assessment of adverse effects for the import of a
genetically modified organism in containment (section 42B of the HSNO
Act 1996).

Criteria for a low-risk genetic modification specified in the HSNO (LowRisk Genetic Modification) Regulations 2003, made under section 41 of
the HSNO Act 1996.

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 import of
genetically modified organisms specified in Part 1 of the Third Schedule
to the Hazardous Substances and New Organisms Act 1996.
Or any updated version
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6
Controls
6.1
In order to provide for the matters detailed in Part 1 of the Third Schedule of
the HSNO Act5, Containment Controls for Importation, Development and
Field Testing of Genetically Modified Organisms, the approved organisms
are subject to the following controls:
1 To limit the likelihood of any accidental release of any organism or
any viable genetic material6.
1.1
The approved organisms shall be imported 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 facilities (‘the facility’) shall
inform all personnel involved in the handling of the organisms of the
Authority’s controls.
1.3
The containment facility shall be approved by the Ministry of Agriculture and
Forestry (MAF), in accordance with section 39 of the Biosecurity Act and the
MAF/ERMA New Zealand Standard 154.03.027: Containment Facilities for
Microorganisms.
1.4
The construction, operation, and management of the microorganism
containment facility shall be in accordance with the:
a) Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand
Standard 154.03.027: Containment Facilities for Microorganisms.
b) Australian New Zealand Standard AS/NZS 2243:3 20027 Safety in
Laboratories: Part 3: (Microbiological aspects and containment facilities),
excluding those deviations specified in section 4.2 of Standard 154.03.027.
c) A minimum of Physical Containment Level 1 (PC1) requirements of the
above Standards.
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 and 1.4 of this document.
5
Bold headings in the following text refer to Matters to be Addressed by Containment Controls for
Import 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 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 1.4.
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 1.4.
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 1.4 as stated above.
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.
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.
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 and 1.4 as stated above.
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 1.4.
Mr Rob Forlong
Chief Executive ERMA New Zealand
Date: 4 August 2006
Approval code (BCH code): GMC001306 (15649)
Environmental Risk Management Authority Decision: GMC06011
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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
____________________________
Mr Rob Forlong
Chief Executive, ERMA New Zealand
Environmental Risk Management Authority Decision: GMC06011
16 August 2007
Date:
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