ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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20 July 2006
GMC06007
 To import into containment genetically modified organisms
under sections 40(1)(a) and 42B of the Hazardous Substances
and New Organisms (HSNO) Act 1996.
 Victoria University of Wellington
Applicant
 To import into containment genetically modified strains of
Purpose
bakers yeast (Saccharomyces cerevisiae) to study regulation of
gene expression through genetic networks.
20 7 July 2006
Date received
Consideration date Ju 20 July 2006
Chief Executive, ERMA New Zealand
Considered by
Application code
Application type
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 yeast strains as listed below in Table 1:
Table 1: Organisms as recorded on ERMA New Zealand Register
Host organism
Category Modified by one or more of the following :
of host
organism
Saccharomyces
cerevisiae Meyen ex
EC Hansen (1883)
non-pathogenic
laboratory strains
1
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Site-directed mutagenesis;
Disruption of genes (random and targeted);
Deletion of any gene;
Insertion of Saccharomyces DNA, and/or
regulatory elements as listed below the table,
stably integrated into the yeast genome;
 Plasmids or Escherichia coli/yeast shuttle
vectors with altered expression of yeast genes,
by use of conditional promoters or modified
regulatory sequences;
 Addition of protein purification and affinity
tags;
 Incorporation of short non-coding nucleotide
sequences serving as unique bar-code
identifiers.
Category of
modification/
containment
level
A / PC1
Genetic material shall not include sequences
derived from humans.
The yeast strains may contain the following vectors:
Plasmid vectors, Escherichia coli/yeast cloning and expression shuttle vectors
and 2-micron circle plasmid vectors.
Additional genetic material will include some or all of the classes of gene
regulatory elements sourced from invertebrates, vertebrates, bacteria, viruses or
bacteriophages as listed below:
1. Promoters;
2. Enhancers;
3. Transcription termination signals;
4. Operator sequences;
5. Polyadenylation signals;
6. Untranslated regions such as introns/spacers, insulators, 5’- & 3’-UTRs.;
7. Multiple cloning sites;
8. Protein purification and identification tags;
9. Affinity tags;
10. tTransactivator sequence;
11. Reporter genes;
Environmental Risk Management Authority Decision: GMC06007
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12. Selectable markers;
13. Origins of replication;
14. Secretory, targeting and localisation signals;
The genetic material may also contain standard and generally available regulatory
elements sourced from invertebrates, vertebrates, bacteria, viruses or
bacteriophages including selectable markers for geneticin resistance, kanamycin
resistance, and nourseothricin resistance, and nutritional markers.
Background Information
1.3
The purpose of this application is to import into containment collections of
genetically modified yeast strains (Saccharomyces cerevisiae) to study
through network analysis the interactions of genes and their products and
how these affect or contribute to the organism’s phenotype.
1.4
Network analysis requires analysing the contributions of all the organism’s
genes. Yeast strains in which genes and the expression of gene products have
been altered by a range of modifications including mutations, deletions, and
insertions of regulatory elements, plasmids and/or affinity purification tags,
will be used as a suite of tools for network analysis of the yeast genome.
1.5
The modified strains will be used to manipulate how yeast genes and their
products are expressed and localised. Through pairwise interactions of the
different strains, the applicant is able to determine the network combinations
of genes effecting and affecting the organism’s phenotype. Information from
the use of these strains can be collated to provide an understanding on the
network processes underpinning yeast gene expression.
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.
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3
Consideration
Sequence of the consideration
3.1
The application was formally received and verified as containing sufficient
information on 7 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 Acting Manager, Māori 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:
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Purpose of the application (section 39 of the HSNO Act)
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Assessment against the criteria for low-risk genetic modifications
(section 42B of the HSNO Act)
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Identification and assessment of the risks and other impacts of the
organism
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Precedents
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Proposed controls
3.7
The Department of Conservation (DoC) was notified upon receipt of this
application.
3.8
DoC did not comment on this application.
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Purpose of the application
3.9
To import into containment genetically modified strains of bakers yeast
(Saccharomyces cerevisiae) to study regulation of gene expression through
genetic networks.
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 organism 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 Saccharomyces cerevisiae are
considered Category 1 host organisms1 that are unlikely to cause disease in
humans, animals, plants or fungi. The development of these genetically
modified yeast strains 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 yeast strains 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.
1
HSNO (Low-Risk Genetic Modification) Regulations 2003
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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 Manager, Māori.
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 laboratory yeast strains into containment, such
developments 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 Saccharomyces cerevisiae strains 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
Victoria University of Wellington’s containment manual.
4.9
The imported S. cerevisiae 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 154.03.022: Containment Facilities for
Microorganisms.
b. Australian New Zealand Standard AS/NZS 2243:3 2002 Safety in
Laboratories: Part 3: (Microbiological aspects and containment facilities)3,
excluding those deviations specified in section 4.2 of Standard 154.03.02.
2
3
Or any updated Standard endorsed by ERMA New Zealand and MAF Biosecurity New Zealand.
Or any updated version
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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:

Criteria for assessing the purpose of the application (section 39 of the
HSNO Act 1996).
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Criteria for rapid assessment of adverse effects for the import of a
genetically modified organism in containment (section 42B of the HSNO
Act 1996).
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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.
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The information provided by the applicant was assessed against the
criteria in clauses 9, 10 and 12 of the HSNO (Methodology) Order 1998.
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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.
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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 Act4, 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 material5.
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 154.03.026: 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 154.03.026: Containment Facilities for Microorganisms.
b) Australian New Zealand Standard AS/NZS 2243:3 20026 Safety in
Laboratories: Part 3: (Microbiological aspects and containment facilities),
excluding those deviations specified in section 4.2 of Standard 154.03.026.
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.
4
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.
5
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.
6
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: 20 July 2006
Approval code (BCH code): GMC001305 (15465)
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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: GMC06007
16 August 2007
Date:
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