Download ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 16 August 2007
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Application code
Application type
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Applicant
Purpose
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Date received
Consideration date 
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Considered by
Date signed: 13 February 2006
GMD05124
To develop in containment genetically modified organisms
under sections 40(1)(b) and 42A of the Hazardous Substances
and New Organisms (HSNO) Act 1996.
Institute of Environmental Science Research Limited
To develop genetically modified Escherichia coli strains
containing cloned genetic material from bacteriophages that
infect foodborne bacteria
13 February 2006
13 February 2006
Chief Executive, ERMA New Zealand
1 Summary of decision
1.1
Application GMD05124 to develop, as a project, genetically modified
organisms (as described in Table 1 of this decision) in containment is
approved, with controls (see Appendix 1 of this decision), having been
considered in accordance with the relevant provisions of the Hazardous
Substances and New Organisms (HSNO) Act 1996 (the Act), the HSNO (LowRisk Genetic Modification) Regulations 2003 (the Low-Risk Regulations), and
the HSNO (Methodology) Order 1998 (the Methodology).
The organism approved is:
1.2
The organism approved for development is the genetically modified organism
described in Table 1:
Table 1: Organism as recorded on ERMA New Zealand Register
Host organism
Category of
Modified by:
host
organism
Escherichia coli (Migula
1895) Castellani and
Chalmers 1919 nonpathogenic laboratory
strains
1
Standard non-conjugative Escherichia coli
cloning and expression plasmid vectors
containing genomic DNA, cDNA or PCR
products derived from bacteriophage that
infect foodborne bacteria. Genetic material
selected for specific gene expression will
encode open reading frames of interest with
bactericidal activity.
The vectors may also contain any of a number
of other standard regulatory elements
including:
Promoter, operator, regulatory element
binding, enhancer and termination sequences;
Selectable marker genes that confer an ability
to be resistant against antibiotics, or
deactivate metabolic inhibitors, or deactivate
other selective bactericidal or bacteriostatic
agents; Origins of replication from bacterial
plasmids or single-stranded bacteriophage;
Multiple cloning sites; Primer recognition
sequences; Sequences enabling the detection,
purification and cleavage of expressed
proteins; Covalently bound Topoisomerase I;
and sequences encoding carbohydrate
synthesis and regulation genes.
Genetic material will not be sourced from
bacteriophage known to be lysogenic,
filamentous or contain vertebrate toxin genes.
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 40(1)(b) of the Act and
determined according to the rapid assessment provisions of section 42A of the
Act.
Environmental Risk Management Authority Decision: GMD05124
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Category of
modification/
containment
level
A/PC1
2.2
The application has been approved with controls (see Appendix 1 of this
decision) by Rob Forlong, Chief Executive of ERMA New Zealand, under
delegation from the Authority as provided for in section 19 of the Act.
3 Consideration
Sequence of the consideration
3.1
The application was formally received and verified as containing sufficient
information on 13 February 2006.
3.2
The decision was based on the information supplied by the applicant in their
application form: Develop in containment a project of low risk genetically
modified organisms by rapid assessment (NO3P).
3.3
The application was considered by the Chief Executive of ERMA New Zealand.
Relevant staff within ERMA New Zealand, including the Acting Manager,
Māori, were involved in providing advice on the consideration of the
application.
3.4
The development of the genetically modified organism described above
(Table 1) meets the criteria of a low-risk genetic modification specified in the
Regulations made under section 41 of the Act, being the HSNO (Low-Risk
Genetic Modification) Regulations 2003 (see sections 3.11 - 3.12 of this
decision).
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 Act, as
specified in Part II, and followed the relevant provisions of the Methodology.
3.6
In accordance with section 42A of the 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 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 Act);
 Assessment against the criteria for low-risk genetic modifications
(section 42A of the Act);
 Identification and assessment of the risks and other impacts of the organism;
 Precedents; and
 Proposed controls.
3.7
The Department of Conservation (DoC) was notified upon receipt of this
application.
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3.8
DoC responded with comments on the application by email on 4 February 2006,
and concluded with the following statement:
“The Department considers that the overall risk these organisms pose to the
Department's mission to be negligible…”
Purpose of the application
3.9
The purpose of the work covered by this application is to develop libraries of
genetic material from bacteriophages that are capable of killing foodborne
bacteria in Escherichia coli. The applicant is interested in developing new tools
to control foodborne bacteria. This project will enable the applicant to better
understand the biology of bacteriophages and to test if individual gene products
of these bacteriophages are lethal to selected bacteria.
3.10 I have determined that this application is for a valid purpose being the
development of any [new] organism as provided for in section 39(1)(a) of the
Act.
Assessment against the criteria for low-risk genetic
modification
3.11 Category of host organism:
The non-pathogenic laboratory strains of Escherichia coli to be used by the
applicant are not capable of causing disease in humans, animals, plants or fungi
nor do they produce desiccation-resistant structures, such as spores or cysts. As
such, non-pathogenic laboratory strains of Escherichia coli are considered
Category 1 host organisms as defined in clause 7(1) of the HSNO (Low-Risk
Genetic Modification) Regulations 2003.
3.12 Category of genetic modification:
The genetic modifications to non-pathogenic laboratory strains of Escherichia
coli (described in Table 1) are not expected to increase the pathogenicity,
virulence or infectivity of the organism to laboratory personnel, the community,
or the environment. In addition, the developments will not result in the
organism having a greater ability to escape from containment than the
unmodified organism. Therefore, the genetic modifications as described in
Table 1 of this decision are Category A genetic modifications as defined in
clause 5(1) of the HSNO (Low-Risk Genetic Modification) Regulations 2003
and shall be contained at a minimum of Physical Containment Level 1 (PC1).
I am satisfied that the developments meet the criteria for low-risk genetic
modification specified in the Low-Risk Regulations, made under section 41 of
the Act. The experiments meet the requirements of Category A modifications as
defined in clause 5(1) of the Low-Risk Regulations in that the modifications
involve a Category 1 host organism and are to be carried out under a minimum
of PC1 containment.
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Identification and assessment of the risks, costs and other
impacts of the organism
3.13 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 (which incorporate
sections 5, 6, and 8 of the Act) the information supplied by the applicant has
been evaluated as follows:
3.14 I consider that, given the biological characteristics of the organism, the
containment system and the controls attached to this approval (see Appendix 1
of this decision), there is no evidence for, nor any reason to expect, any nonnegligible adverse effects of the proposed genetically modified organism on
humans, animals, plants, other organisms or the environment.
3.15 I have considered the potential Māori cultural effects in accordance with
sections 6(d) and 8 of the Act and clauses 9(b)(i) and 9(c)(iv) of the
Methodology, incorporating advice provided by the Acting Manager, Māori.
3.16 I note that bacteriophages to be used in this research will be isolated from food
and environmental samples from the Canterbury region. The Agency
considered it appropriate for the applicant to contact the local Iwi, Ngai Tahu, to
determine if they envisaged any cultural interests or concerns arising from the
proposed research, however no response was received.
3.17 I recognise that Māori maintain an ongoing interest and concern in the potential
long term cultural implications of genetic modification. However, taking into
account that this research will be conducted in containment under all relevant
associated regulations, conditions and controls, I consider that this application
poses negligible risk to the relationship of Māori culture and traditions with
their ancestral lands, water, sites, waahi tapu, valued flora and fauna, and other
taonga.
Precedents
3.18 I must consider each application on its merits, and am therefore not bound by
the stance taken in previous decisions. However, in reflecting on previous
decisions that involved similar genetic modifications to those proposed by this
application, I note that genetic developments of non-pathogenic laboratory
strains of Escherichia coli conforming to the HSNO (Low-Risk Genetic
Modification) Regulations 2003, have been considered and approved on several
occasions by both Institutional Biological Safety Committees (IBSCs) and the
Chief Executive of ERMA New Zealand, under delegated authority.
3.19 I consider that this current application does not raise any novel issues and there
are no residual risks that require further consideration.
Environmental Risk Management Authority Decision: GMD05124
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Controls
3.20 The experiments proposed in this application, to develop genetically modified
non-pathogenic laboratory strains of Escherichia coli meet the requirements of
Category A genetic modification as defined in clause 5(1) of the HSNO (LowRisk Genetic Modification) Regulations 2003. Category A experiments are
required to be contained within a Physical Containment level 1 facility (PC1).
The facility to be used shall be approved and registered as a containment facility
under section 39 of the Biosecurity Act, in accordance with MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.02: Containment Facilities for
Microorganisms. This containment regime contains clear guidelines for the safe
handling and disposal of cultures.
3.21 The facility in which the organisms will be maintained shall comply with the
requirements of the Australian/New Zealand Standard AS/NZS 2243.3:2002
Safety in laboratories: Part 3: Microbiological aspects and containment
facilities, except for the deviations specified in the MAF/ERMA New Zealand
Standard 154.03.02.
4 Decision
4.1
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 development of any [new] organism.
4.2
Based on consideration and analysis of the information provided, and having
considered the characteristics of the organism that is the subject of this
approval, 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 organism meets the criteria for rapid assessment under
section 42A of the Hazardous Substances and New Organisms Act 1996.
4.3
I am satisfied that the proposed containment regime and the controls imposed in
accordance with section 42A(3)(b) of the Hazardous Substances and New
Organisms Act 1996, as set out in Appendix 1 of this decision, will adequately
contain the organism.
4.4
Pursuant to section 42A(3)(a) of the Hazardous Substances and New Organisms
Act 1996, and acting under delegation from the Authority provided for in
section 19 of the Act, I have approved this project application for genetically
modified Escherichia coli described in Table 1 of this decision, subject to the
controls specified in Appendix 1 of this decision.
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4.5
In reaching this decision I have relied upon the following criteria in the Act and
the Methodology:
 Criteria for assessing the purpose of the application (section 39 of the Act);
 Criteria for rapid assessment of adverse effects for the development of a
genetically modified organism in containment (section 42A of the Act);
 Criteria for a low-risk genetic modification specified in the HSNO (LowRisk Genetic Modification) Regulations 2003, made under section 41 of the
Act;
 The information provided by the applicant was assessed against the criteria
in clauses 9, 10 and 12 of the HSNO (Methodology) Order 1998; and
 Matters to be addressed by containment controls for developing genetically
modified organisms specified in Part 1 of the Third Schedule to the Act.
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Appendix 1: Controls required by this approval
In order to provide for the matters detailed in Part 1 of the Third Schedule of the Act1,
Containment Controls for Importation, Development and Field Testing of Genetically
Modified Organisms, and other matters in order to give effect to the purpose of the
Act, the approved organism 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 approved organism shall be developed 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 facility shall inform all
personnel involved in the handling of the organism of the Authority’s controls.
1.3
The facility shall be approved and registered by MAF as a containment facility
under section 39 of the Biosecurity Act, in accordance with the MAF/ERMA
New Zealand Standard (below), and controls imposed by the Authority (as
follows):
1.4
The construction, operation and management of the containment facility shall be
in accordance with the:
a) MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.023:
Containment Facilities for Microorganisms.
b) Australian/New Zealand Standard AS/NZS 2243.3:20023: Safety in
laboratories: Part 3: Microbiological aspects and containment facilities;
and
c)
Physical Containment level 1 (PC1) requirements of the above Standards.
1
Bold headings in the following text refer to Matters to be Addressed by Containment Controls for
Import, Development and Field Testing of Genetically Modified Organisms, specified in the Third
Schedule of the 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, e.g. 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
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2 To exclude unauthorised people from the facility.
2.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 relating to the identification
of entrances, numbers of and access to entrances and security requirements for
the entrances and the facility.
3 To exclude other organisms from the facility and to control
undesirable and unwanted organisms within the facility.
3.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 relating to the exclusion of
other organisms from the facility and the control of undesirable and unwanted
organisms within the facility.
4 To prevent unintended release of the organism by experimenters
working with the organism.
4.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 relating to the prevention of
unintended release of the organism by experimenters working with the
organism.
5 To control the effects of any accidental release or escape of an
organism.
5.1
Construction and operation of the containment facility shall comply with the
requirements of the standards listed in control 1.4 relating to controlling the
effects of any accidental release or escape of an organism.
5.2
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.
5.3
In the event of any breach of containment of the organism, the contingency plan
for the attempted retrieval or destruction of any viable material of the organism
that has escaped shall be implemented immediately. The contingency plan shall
be included in the containment manual in accordance with the requirements of
standards listed in control 1.4.
6 Inspection and monitoring requirements for containment facilities.
6.1
The operation of the containment facilities shall comply with the requirements
contained in the standards listed in control 1.4 relating to the inspection and
monitoring requirements for containment facilities.
6.2
The containment manual shall be updated, as necessary, to address the
implementation of the controls imposed by this approval, in accordance with the
standards listed in control 1.4.
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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.
_____________________
_______________
Rob Forlong
Date 13 February 2006
Chief Executive, ERMA New Zealand
Approval code (BCH code): GMD004158 (11681)
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: GMD05124
16 August 2007
Date:
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