ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A of the HSNO Act on 21 August 2008
Date Signed: 12 February 2007
Application code:
GMD06057
Application category:
Develop in Containment any New Organism under section
40(1)(b) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Applicant:
The Horticulture and Food Research Institute of New
Zealand Ltd (HortResearch)
University of Otago
Purpose:
Develop Epiphyas postvittana nucleopolyhedrovirus as a
disarmed vector to permit expression of reporter genes and
over-production of the encoded proteins in whole insects
and insect cell lines. It will be a non-pathogenic laboratoryonly organism.
Date application received:
11 December 2006
Consideration date:
2 February 2007
Considered by:
A Committee of the Environmental Risk Management
Authority (the Committee)
1
Summary of Decision
1.1
Application GMD06057 to develop in containment the genetically modified
organisms (as described in Table 1 of this decision) is approved, with controls
(as detailed in 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) and the HSNO (Methodology) Order
1998 (the Methodology):
Table 1: Organism description
Host organism
Category
of host
organism
Modified by
Wild-type
2
Homologous recombination to disarm the
baculovirus by replacing the polyhedrin
gene coding sequence with a reporter gene
such as Green Fluorescent Protein (GFP).
The disarming step may be performed in
E. coli or Epiphyas postvittana cell lines.
Disarmed
EppoNPV
1
Genomic DNA or complementary DNA
(cDNA) encoding genes involved in
enhancing protein expression and gene
regulatory elements such as promoters,
enhancers and terminator sequences.
Epiphyas
postvittana
nucleopolyhedrovir
us (EppoNPV).
Category of
modification/
containment
level
B/PC2
Until disarmed.
A/PC1 for
modification of
the disarmed
virus.
The genetic material will be sourced from
lepidopteran, coleopteran, hemipteran,
orthopteran, hymenopteran and dipteran
insects (a list of the insect families is
included below this table) and
baculoviruses, specifically Autographa
californica multinucleopolyhedrovirus
(AcMNPV).
Additional vector DNA as listed below this
table.
The genetic material may be modified by
insertion, deletion or alteration of
sequences or site-directed mutagenesis.
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Table 1 Organism description continued
Host organism
Category Modified by
of host
organism
Bacteriophage
lambda
(Enterobacteria
phage λ)1 Nonpathogenic
laboratory strains.
1
Escherichia coli
1
(Migula 1895)
Castellani &
Chalmers 1919
non-pathogenic
laboratory strains.
Epiphyas
postvittana
1
(Walker, 1863) cell
lines.
Epiphyas
postvittana
(Walker, 1863)
whole insects.
2
Standard Escherichia coli cloning and
expression plasmid vectors, bacteriophage
lambda vectors, bacmid vectors2 or insect
expression vectors (disarmed EppoNPV3).
The vectors may contain one or more of the
following:
 A reporter gene such as GFP.
 Genomic DNA or cDNA sequences
flanking the EppoNPV polyhedrin gene
or other EppoNPV genes.
 Genomic DNA or cDNA encoding
genes involved in enhancing protein
expression and gene regulatory elements
such as promoters, enhancers and
terminator sequences. The genetic
material will be sourced from
lepidopteran, coleopteran, hemipteran,
orthopteran, hymenopteran and dipteran
insects (a list of the insect families is
included below this table) and
baculoviruses, specifically AcMNPV and
EppoNPV.
 Additional vector genetic material as
listed below this table.
 The genetic material may be modified by
insertion, deletion or alteration of
sequences or site-directed mutagenesis.
Category of
modification
/
containment
level
A/PC1
A/PC1
A/PC1
B/PC2
Bacteriophage constructs will not be used for
homologous recombination for generating
disarmed EppoNPV.
Bacteriophage constructs will not be used for
the bacterial transposition system.
International Committee on Taxonomy of Viruses (ICTV) approved name.
In E. coli, the modified EppoNPV is a non-infectious bacmid vector consisting of disarmed genome of
the EppoNPV, a plasmid origin of replication and an antibiotic resistance gene under an E. coli active
promoter.
3
In Epiphyas postvittana, the disarmed EppoNPV is in the form of a non pathogenic modified infectious
virus.
1
2
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Vectors may contain:
Vectors may also contain one or more of the following sourced from commercial
baculovirus based vector systems, established plasmid clones or commercial vectors;
reporter genes, selectable markers, origins of replication, lacZ complementation, fusion
protein markers and peptide tags, bacterial transposition sites and those parts of the
transposition system that are transferred in a transposition event, promotors, enhancers,
terminators, DNA sequences containing rare restriction sites not present in EppoNPV,
additional restriction sites and multiple cloning sites. Vectors may also contain artificial
DNA sequence(s).
List of exclusions:
 Genes encoding known or suspected vertebrate toxins with an LD50 of less than
100 g/kg will not be used.
 The experiments will not increase expression of known or suspected vertebrate
toxin genes.
 The experiments will not increase the pathogenicity or infectivity of the virus.
 Genetic material from native insect species will not be used.
 Genetic material from CITES (Convention on International Trade in
Endangered Species of Wild Fauna and Flora) listed species will not be used.
Donor DNA will be derived from the following insect families:
Lepidopteran insects:
 Tortricid family including Epiphyas postvittana and Cydia pomonella.
 Noctuid family including Helicoverpa armigera and Spodoptera litura.
 Oecophorid family including Hofmannophila pseudospretella.
 Teneid family including Tineola bisselliella.
 Gelechilid family including Phthorimaea operculella.
 Lymantrid family including Teia anartoides
 Bombyxicid family including Bombyx mori
 Orygid, Hyponomeutid, Pierid, Hepialid, Geometrid and Pyralid families.
Coleopteran insects:
 Scarabaeid, Cerambycid, Chrysomelid, Bruchid, Tenebrionid and Curculonid
families.
Hemipteran insects:
 Aphidid, Pentatomid, Ricaniid, Mirid, Eriococcid, Coccid and Diaspid families
including Scolypopa australis and Myzus persicae.
Orthopteran insects:
 Gryllid and Acridid families including Telleogryllus commodus.
Hymenopteran insects:
 Siricid, Formicid, Vespid and Apid families including Apis mellifera.
Dipteran insects:
 Cecidomycid, Calliphorid, Muscid, Drosophilid and Culicid families including
Drosophila melanogaster.
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2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(b) of the Act and
determined in accordance with section 45, having regard to the matters specified
in section 43 and other matters relevant to the purpose of the Act, as specified in
Part II of the Act. Unless otherwise stated, references to section numbers in this
decision refer to sections of the Act.
2.2
The application does not qualify for rapid assessment under section 42A. The
proposed modifications are all low risk according to the HSNO (Low-Risk
Genetic Modification) Regulations 2003. However, the applicant cannot contain
the organisms, as prescribed by these Regulations, in a facility registered to the
MAF/ERMA standard 154.02.08 Transitional and Containment Facilities for
Invertebrates.
2.3
Consideration of the application followed the relevant provisions of the
Methodology, as specified in more detail below. Unless otherwise stated,
references to clause numbers in this decision refer to clauses of the Methodology.
3
Application Process
Application receipt
3.1
Application GMD06057 was determined to be in compliance with section 40(2)
of the Act and was formally received on 11 December 2006.
Notification
3.2
Under section 53(2) of the Act the Environmental Risk Management Authority
(the Authority) has discretion as to whether to publicly notify an application to
develop in containment any new organism. This application was not publicly
notified because it was considered unlikely that it would be of significant public
interest.
3.3
In accordance with section 58(1)(c) of the Act and clauses 2(2)(e) and 5 of the
Methodology, the Department of Conservation (DoC) and the Ministry of
Agriculture and Forestry (MAF) Biosecurity New Zealand were notified and
provided with an opportunity to comment on the application.
Decision Making Committee
3.4
The application was considered by a Committee of the Environmental Risk
Management Authority (the Committee), appointed in accordance with section
19(2)(b) of the Act and clause 43 of the First Schedule to the Act. For the
purposes of determining this application the Committee comprised the following
members: Neil Walter (Chair), Val Orchard and Manuka Henare
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Information Available for Consideration
3.5
The information available for the consideration of the application was:

The application GMD06057(Form NO3) submitted by HortResearch (the
applicant);

References as listed in the application;

A memo dated 16 January 2007 from the Agency to the Committee to assist
and support the Committee's decision-making.
3.6
DoC raised no issues with this application.
3.7
MAF raised no issues with this application.
3.8
The Committee determined that the information available for the consideration
was relevant and appropriate considering the scale and significance of the risks,
costs and benefits associated with these organisms.
4
Sequence of the Consideration
4.1
In accordance with clause 24 of the Methodology, the approach to the
consideration adopted by the Committee was to look sequentially at the
identification, assessment and evaluation of risks, costs and benefits. Techniques
for identifying and preparing information on risks, costs and benefits were based
on internal procedures as specified in the ERMA New Zealand Technical Guide
publications. Those risks identified as significant were assessed in accordance
with clause 12 of the Methodology. Management techniques were considered in
relation to the identified risks. Costs and benefits were assessed in accordance
with clause 13 of the Methodology. Qualitative scales used by the Committee to
measure likelihood and magnitude of risks, costs and benefits are provided in
Appendix 2 of this decision.
4.2
In carrying out its consideration the Committee considered the adequacy of
containment in accordance with section 45(1)(a)(iii) of the Act, and the
magnitude and probability of the risks, costs and benefits alongside each other
and in an integrated fashion. This is because the former interact with the latter
and this is recognised in clause 12(d) and in section 45(1)(a)(ii).
4.3
The Committee set controls to satisfactorily provide for the matters in the Third
Schedule (Part I) of the Act.
4.4
Benefits associated with this application were considered in accordance with
clauses 9, 10, 13 and 14 and section 6(e).
4.5
Finally, taking account of the risk characteristics established in accordance with
clause 33, the combined impact of risks, costs and benefits was evaluated in
accordance with clause 34. The approach to the consideration followed the
decision path outlined in Appendix 3 of this decision.
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5
Purpose of the Application
5.1
The purpose of application GMD06057 is to seek approval to develop in
containment a disarmed strain of the baculovirus, Epiphyas postvittana
nucleopolyhedrovirus (EppoNPV), and to test this as a vector for protein
expression in whole insects, and insect cell lines. The long term goal of
developing recombinant baculoviruses as insect expression vectors is to provide a
simpler and more-cost effective way of producing proteins for medical and
research purposes.
5.2
In accordance with section 45(1)(a)(i) of the Act, the Committee determined that
this purpose falls within the scope of section 39(1)(a) of the Act: “the development
of any [new] organism.”
6
Adequacy of the Containment Regime
6.1
In considering the adequacy of the containment regime and the ability of the
organisms to escape from containment, the Committee considered the following:

biological characteristics of the organisms;

the containment regime; and

the potential pathways for escape of the organisms from the containment
facility.
(i)
Biological characteristics of the organisms
6.2
As non pathogenic laboratory strains of Escherichia coli (E. coli) and
bacteriophage lambda are category 1 host organisms, they are unlikely to cause
disease in humans, animals, plants or fungi. The E. coli and bacteriophage
strains to be used in this study have nutritional requirements, making survival
outside laboratory culture highly improbable. The proposed genetic
modifications of these organisms will not increase the pathogenicity of the hosts
or increase their ability to escape from containment.
6.3
The wild-type baculovirus, Epiphyas postvittana nucleopolyhedrovirus
(EppoNPV), is a category 2 host organism. EppoNPV is found in New Zealand
and infects the lightbrown apple moth, Epiphyas postvittana (E. postvittana), a
non-native pest insect. EppoNPV also infects some closely-related endemic New
Zealand leafrollers that, together with the lightbrown apple moth, form a pest
complex attacking apples, summer-fruit, grapes and kiwifruit (Markwick et al,
2002). All known baculoviruses are restricted to arthropods, almost exclusively
to insects, and their host range is limited to the taxonomic order from which they
were isolated. EppoNPV is safe to work with in the laboratory as it is not
infectious to vertebrates and does not pose a risk to public health (OECD 2002;
Gröner, 1986).
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6.4
The strain of EppoNPV to be developed will be “disarmed” by replacing the
polyhedrin gene coding sequence with a reporter gene such as green fluorescent
protein (GFP). Polyhedron, produced when the polyhedrin gene is present,
envelops the viral particles and is essential for establishing a natural infection in
an insect and for viral transmission between insects. The absence of polyhedron
also renders the virus extremely sensitive to UV radiation (sunlight) (Bishop et al,
1989). The genetic modification of the EppoNPV host organism, to create the
disarmed virus, will not increase the pathogenicity of these hosts or increase their
ability to escape from containment or establish a self-sustaining population in the
environment.
6.5
The disarmed EppoNPV can be infectious to insect cells lines. However, it is
disabled and is not normally able to cause disease in insects, nor infect, colonise
or establish in humans, animals, plants or fungi. Hence, the disarmed EppoNPV
meets the requirement of a category 1 host organism, as described in the HSNO
(Low-Risk Genetic Modification) Regulations, 2003.
6.6
Disarmed EppoNPV will be further modified as described in Table 1 to enhance
protein expression in insects and insect cell lines. The further genetic
modifications of disarmed EppoNPV will not increase the pathogenicity of the
host or increase its ability to escape from containment.
6.7
Both E. coli and the E. postvittana insect cell line, established from neonate
larvae of E. postvittana, will be used as host organisms in the process of
disarming the wild-type EppoNPV. The E. postvittana insect cell line will also
be used as a host to propagate the disarmed EppoNPV allowing for protein
expression. The modification/infection of E. coli or insect cell line, with wildtype EppoNPV will not increase the infectivity of these organisms to laboratory
personnel, the community or the environment and will not increase their ability
to escape from containment. The modification/infection of the host insect cell
lines with disarmed EppoNPV will not increase the infectivity of this cell line or
increase its ability to escape from containment.
6.8
The host insect species to be used, the light brown apple moth, E. postvittana, is
a non-native pest insect. The E. postvittana used in these experiments will be
derived from a laboratory colony, established from field moths collected and
reared under laboratory conditions
6.9
Larvae of E. postvittana will be microinjected with the disarmed virus. The
larvae will either die from the viral infection, or if the larvae survive the viral
infection they will be killed by freezing at -20°C, before reaching pupation.
Frozen larvae will be used for protein analysis. The host insects will only be
infected with the disarmed virus not the wild-type strain. Therefore, the
modification/infection of E. postvittana larvae will not increase the
pathogenicity of these insects or increase their ability to escape from containment
or establish a self-sustaining population in the environment.
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(ii)
Containment regime
6.10
The controls imposed by this approval (as specified in Appendix 1) establish a
containment regime that addresses the matters detailed in the Third Schedule
Part I of the Act.
6.11
Insect cell lines of E. postvittana and E. coli are category 1 host organsisms.
However, the development of disarmed EppoNPV is a category B modification
as the wild-type EppoNPV virus is infectious. Therefore, the development of
the disarmed EppoNPV in E. postvittana insect cell lines and in E. coli, is
subject to containment within a containment facility registered under the
Biosecurity Act 1993 in accordance with the MAF Biosecurity Authority/ ERMA
New Zealand Standard 154.03.02: Containment Facilities for Microorganisms
(Standard 154.03.02) and operated to Physical Containment level 2 (PC2) (see
controls 1.1, 1.2 and 1.4 in Appendix 1 of this decision). The minimum
requirements for PC2 containment are those identified in the Australian/New
Zealand Standard 2243.3:2002: Safety in Laboratories Part 3: Microbiological
aspects and containment facilities, fifth edition (AS/NZS 2243.3:2002) except for
the deviations specified in Standard 154.03.02.
6.12
After the disarming step has been performed, the success of the disarming step
will be confirmed using PCR and DNA sequencing. Furthermore, in insect cell
lines the disarmed virus will be distinguishable by the expression of the reporter
gene and by the absence of polyhedra. In E. coli, the disarmed virus will be
distinguishable by the expression of selectable marker genes such as those
encoding antibiotic resistance.
6.13
Once the baculovirus is demonstrated to be disarmed, the genetically modified
baculovirus (disarmed EppoNPV) is subject to containment in accordance with
Standard 154.03.02 at Physical Containment level 1 (PC1) (AS/NZS
2243.3:2002) (see controls 1.1, 1.2 and 1.4 in Appendix 1 of this decision).
6.14
The Committee considers that disarmed EppoNPV is a category 1 host
organism. The Committee considers that the appropriate level of containment
for the disarmed EppoNPV is PC1, as the genetic modifications will reduce the
ability of the organism to escape from containment and establish a self-sustaining
population.
6.15
The genetic modification of E. coli (with the exception of the modifications
involving wild type EppoNPV, discussed in 6.11), bacteriophage lambda and
disarmed EppoNPV, as well as the infection of E. coli and E. postvittana cell
lines with modified disarmed EppoNPV, are subject to containment in
accordance with Standard 154.03.02 at PC1 (AS/NZS 2243.3:2002) (see controls
1.1, 1.2 and 1.4 in Appendix 1 of this decision).
6.16
The Committee considers that the appropriate level of containment for these
organisms is PC1 as the genetic modifications are not anticipated to affect the
ability of the organisms to escape from containment.
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6.17
The infection of E. postvittana larvae with disarmed EppoNPV, is subject to
containment in accordance with Standard 154.03.02 at PC2 (AS/NZS
2243.3:2002) (see controls 1.1, 1.2 and 1.4 in Appendix 1 of this decision) as well
as additional controls (see controls 8.1, 8.2 and 8.3 in Appendix 1 of this
decision).
6.18
The Committee notes that the E. postvittana larvae are a category 2 host
organism, and the modification/infection of these larvae with genetically
modified viruses is a category B modification. Based on this information, the
Committee notes that the HSNO (Low-Risk Genetic Modification) Regulations
2003 prescribe that the appropriate containment for modified/infected insect
larvae would be a containment facility registered under the Biosecurity Act 1993
in accordance with the MAF Biosecurity Authority/ ERMA New Zealand
Standard 154.02.08 Transitional and Containment Facilities for Invertebrates and
operated to PC2. The Committee notes that the applicant does not have a facility
registered to this standard in the location where this work is to be carried out.
6.19
However, the Committee consider that, with three additional controls (see
additional controls 8.1, 8.2 and 8.3 in Appendix 1 of this decision), the
modified/infected insect larvae can be adequately contained in accordance with
Standard 154.03.02 operated to PC2 (see controls 1.1, 1.2 and 1.4 in Appendix 1
of this decision).
6.20
To ensure the adequate containment of the infected insect larvae, the following
additional controls are imposed. Firstly, a control is imposed that stipulates that
microinjection of insect (E. postvittana) larvae, with the recombinant virus, is
undertaken in a Class II biological safety cabinet, within a PC2 laboratory
registered to MAF/ERMA Standard 154.03.02 Containment Facilities for
Microorganisms (see additional control 8.1). Secondly, all larvae injected with
the recombinant baculovirus will be maintained individually in sealed containers,
on trays, inside clear plastic bags, within an incubator within a PC2 facility (see
additional control 8.2). Thirdly, a control is imposed that no larvae injected with
the recombinant baculovirus will be allowed to survive to adulthood. Larvae will
be killed before pupation using a scientifically validated method (those that have
not died from the viral infection) (see additional control 8.3).
6.21
The Committee consider that, based on the biological characteristics of the
infected insect larvae, containment within a PC2 laboratory registered to
MAF/ERMA Standard 154.03.02 Containment Facilities for Microorganisms,
combined with the additional controls outlined in Appendix 1 of this decision,
would make it highly improbable that the infected insect larvae would escape.
(iii) Potential pathway for escape of the organisms from containment
6.22
In accordance with section 37, the Committee considered the ability of the
organisms to escape from containment. The pathways identified and the
associated mitigating factors prescribed under the Standard 154.03.02 are
discussed below.
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6.23
The Committee has identified the following potential routes by which the
organism may escape from containment:
a) Accidental or deliberate release of the organisms by staff or unauthorized
persons.
b) Escape of organisms while in transit between facilities.
c) Escape of organisms from containment via animals
d) Escape from containment following natural disaster
6.24
The Committee concluded that escape of the organisms via pathways a)-d) is
highly improbable.
6.25
This conclusion was formed on the basis of the biological characteristics of the
organisms as well as the provisions of the Standard 154.03.02 and the AS/NZ
containment standard 2243.3:2002 imposed by control 1.2 that relate to operating
procedures, packaging of the organisms for transport, waste disposal,
management of the facility (including access to the facility and staff training)
contingency plans and vermin control. To enhance staff training, the Committee
imposed additional control 1.3 that requires the person responsible for the
operation of the facility to ensure that all staff are aware of the containment
controls for this approval.
6.26
Standard 154.03.02 requires contingency plans to be in place in the event of
accidental release of new organisms outside the facility and for fire and other
emergencies. To enhance this measure, the Committee requires that contingency
plans be implemented immediately following any breach of containment (control
5.3) and notification to the MAF Inspector of that facility following such an
occurrence (control 5.2) Taking this into account, the Committee considers that
it is highly improbable that organisms would be able to escape from containment
following a natural disaster.
6.27
The Committee noted that the proposed modifications are all low risk according
to the HSNO (Low-Risk Genetic Modification) Regulations 2003. However, the
Committee notes that the insect larvae infected with genetically modified
EppoNPV will not be contained as prescribed by these regulations. Rather than
containment in accordance with Standard 154.02.08, Transitional and
Containment Facilities for Invertebrates, the insects will be contained in
accordance with Standard 154.03.02.
6.28
The Committee has imposed additional controls (see additional controls 8.1 – 8.3
in Appendix 1 of this decision), to ensure that the infected insect larvae can be
adequately contained in accordance with Standard 154.03.02 at PC2 (see controls
1.2 in Appendix 1 of this decision).
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6.29
The Committee considers that these additional containment controls together
with the requirements of Standard 154.03.02 will reduce the likelihood of
genetically modified viruses, or insect larvae infected with the genetically
modified viruses escaping from containment.
(iv) Conclusion on adequacy of containment
6.30
Taking all of the above considerations into account, the Committee considers
that it is highly improbable that the organisms would be able to escape from
containment via pathways a-d. The Committee concludes that the genetically
modified organisms as described in Table 1 of this decision can be adequately
contained under the proposed containment regime and controls described in
Appendix 1.
7 Ability of the Organism to Establish a Self-Sustaining Population
and Ease of Eradication
7.1
In accordance with sections 43 and 37 and clause 10(e) the Committee
considered the ability of the organisms to form self-sustaining populations should
they escape from containment, and the ease of eradication of such populations.
7.2
The Committee considered that it is highly improbable that the genetically
modified E. coli and bacteriophage strains would establish self-sustaining
populations outside containment due to their nutritional requirements for
survival.
7.3
The Committee considered that it is highly improbable that disarmed EppoNPV
would establish a self-sustaining population outside containment due to the
absence of the polyhedrin gene coding sequence. Disarmed EppoNPV is highly
sensitive to UV radiation and is unable to transmit infection naturally in the
environment.
7.4
The Committee considered that it is highly improbable that the E. postvittana
cell lines infected with disarmed EppoNPV would establish a self-sustaining
population outside containment. Cell lines are unlikely to survive outside of
culture vessels due to their need for nutritional supplementation and sterile
conditions.
7.5
The Committee considered that it is highly improbable that the E. postvittana
insect larvae infected with disarmed EppoNPV would establish a self-sustaining
population outside containment. If infected larvae were to escape from
containment they would be unlikely to survive to adulthood as the baculovirus
infection is fatal.
7.6
The Committee notes that, even in the highly improbable event that infected
insects escaped containment and were able to survive to adulthood in the
environment, it is highly improbable that the disarmed recombinant virus they
carried would establish a self-sustaining population. The disarmed baculovirus
could not naturally infect other insects. Furthermore, the genome of the insects
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themselves is not modified compared with the naturally occurring population of
these insects.
7.7
The Committee considered that should an escape from containment occur, it is
highly improbable that a self-sustaining population could establish, given the
information supplied relating to the fitness of the modified organisms. The
Committee considered that in the event that a population did establish, it would
be difficult to detect and eradicate.
8 Identification and assessment of potentially significant adverse
and beneficial effects (risks, costs and benefits)
8.1
The Committee considered the potential risks, costs and benefits relating to the
application. In accordance with sections 5 and 6, and clause 9, the potential
adverse effects of this application were categorised and considered in terms of
their area of impact on the environment, on human health and safety, the culture
and traditions of Māori, the market economy and society and the community.
8.2
The risks and costs assessed here are those identified as potentially significant,
having regard for those matters set out in clauses 9 and 10, which reflect sections
5, 6, 8 and 43. Risks were considered in terms of the requirements of section
45(4) and clause 12, including the assessment of consequences and probabilities,
the impact of uncertainty and the impact of risk management. Costs were
considered in terms of clause 13. A “cost” is defined as “the value of a particular
adverse effect expressed in monetary or non-monetary terms”. Therefore, these
have been assessed in an integrated fashion together with the risks of those
adverse effects in the following assessment.
Adverse effects
The Environment
8.3
The Committee considered the potential for the modified organisms described in
table 1 to escape from containment, establish in the environment, and then to
cause disruption of New Zealand’s flora and fauna through competition with and
displacement of endemic species.
8.4
Based on the biological characteristics of the organisms, the Committee considers
that the magnitude of the adverse effect that these organisms may have on New
Zealand’s flora and fauna would be minimal. The Committee considers it to be
highly improbable that the organisms would escape and form a self-sustaining
population (section 6.30 and 7.7 of this decision). Therefore, the level of adverse
effect is A. The Committee considers this risk is negligible if the described
containment and controls imposed in Appendix 1 of this decision are adhered to.
Human health and safety
8.5
The Committee considered that no potential adverse effects on human health
and safety will arise from the development of EppoNPV as a disarmed vector to
permit expression of reporter genes and over-production of the encoded proteins
in whole insects and insect cell lines.
Environmental Risk Management Authority Decision: Application GMD06057
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Māori culture and traditions
8.6
The Committee considered the potential Māori cultural effects of these
applications in accordance with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and
8. In addition, the Committee used the assessment framework contained in the
ERMA New Zealand User Guide “Working with Māori under the HSNO Act
1996”, and the ERMA New Zealand revised protocol “Incorporating Māori
perspectives in Part V Decision-making”, as guides in assessing the information
contained in these applications.
8.7
Taking into account the assessment of the potential adverse environmental
effects associated with these applications, the Committee considers that these
applications present negligible risk to Māori culture or traditional relationships
with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other
taonga. This assessment is made on the condition that the specimens are,
transported, handled, stored, and used in accordance with the explicitly stated
controls (in Appendix 1 of this decision).
Market economy
8.8
The Committee considered that no potential adverse effects on the market
economy will arise from the development of EppoNPV as a disarmed vector to
permit expression of reporter genes and over-production of the encoded proteins
in whole insects and insect cell lines.
Society and community
8.9
The Committee considered that no potential adverse effects on society or
community will arise from the development of EppoNPV as a disarmed vector
to permit expression of reporter genes and over-production of the encoded
proteins in whole insects and insect cell lines.
Potential beneficial effects associated with the development of the
organisms
8.10
The Committee considered the potential beneficial effects associated with the
application, in accordance with sections 5 and 6(e) and clauses 9, 10, 13, and 14.
8.11
The Committee identified the potential short term beneficial effects of this
research as increasing research skills and knowledge, and enhancing the
reputation of staff. The applicant noted that this research is essential for the
continuation of a research programme that is currently funded by the Foundation
for Research, Science and Technology (FRST). The applicant also noted that the
approval of this application will be important for current and future funding
rounds.
8.12
The applicant noted that a potential long term economic and social benefit of this
research is the development of an efficient, low-cost, high production system for
producing valuable proteins for diagnostic tests.
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8.13
The Committee considers that, should this application be approved, the short
term potential benefits are likely to be realised and are potentially of minor to
moderate magnitude. The potential benefits are therefore considered to be
significant.
9 Establishment of the Approach to Risk in the Light of Risk
Characteristics
9.1
Clause 33 requires the Authority to have regard for the extent to which a
specified set of risk characteristics exist when considering applications. This
provision provides a route for determining how cautious or risk averse the
Authority should be in weighing up risks and costs against benefits. In the
present application clause 33 is influenced by the application being “in
containment” and the conclusion that the containment provisions and controls
will reduce most biological and physical risks to a low level.
9.2
In relation to the biological and physical risks considered (and the risks to human
health), the containment measures limit the extent to which exposure to the risks
is involuntary. The Committee also considers that there are no significant risks
which are not known or understood by the general public. It is considered that
the potential risks are dependent upon escape from containment of the
organisms and the establishment of an undesirable self-sustaining population.
Given the Committee's finding that escape from containment is highly
improbable the extent to which these risk characteristics are present does not
warrant caution additional to that required by section 7.
10 Overall Evaluation of Risk, Costs and Benefits
Precautionary approach
10.1
Section 7 requires the Committee to take into account the need for caution in
managing adverse effects where there is scientific and technical uncertainty about
those effects. The Committee used scenarios to set upper and lower bounds on
the assessment of risks and the evaluation was based on the higher value of the
risk. Clause 29 notes that where there is scientific and technical uncertainty the
Authority must consider the materiality of the uncertainty to the decision. Since
none of the risks was assessed as being significant, the Committee concluded that
this uncertainty was not material to the decision.
Approach to risk
10.2
Clause 33 requires the Authority to have regard for the extent to which a
specified set of risk characteristics exist when considering applications. This
provision provides a route for determining how cautious or risk averse the
Authority should be in weighing up risks and costs against benefits. In the
present applications clause 33 is influenced by the applications being “in
containment” and the conclusion that the containment provisions and controls
will reduce most biological and physical risks to a low level.
Environmental Risk Management Authority Decision: Application GMD06057
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10.3
The Committee considers that as the identified biological, physical, or human
health risks were assessed as being not significant, caution in addition to that
required by section 7 is not warranted.
Aggregation and comparison of risks, costs and benefits
10.4
The overall evaluation of risks, costs and benefits set out below was carried out in
accordance with section 45 and clause 26, having regard to clauses 22 and 34.
10.5
The Committee assessed the potential risks of developing the organisms,
described in section 1.1 of this decision, in containment, as negligible.
10.6
The potential benefits associated with the development of these organisms
include, the enhancement of skills, knowledge, and reputation of staff with
potential for economic benefits in the long term. The Committee considered
that these benefits are likely to eventuate and would be of minor to moderate
value.
10.7
The Committee evaluated the potential of the organisms described in table 1 to
establish undesirable self-sustaining populations. Given the biological
characteristics of the organisms, the Committee considered it highly improbable
that the organisms could escape from containment and form a self-sustaining
population. In the highly improbable event that the organisms did escape and
form a self-sustaining population, the Committee considers it highly improbable
that these organisms would cause adverse environmental effects.
10.8
The Committee was unable to find common units of measurement with which to
combine risks, costs, and benefits in accordance with clause 34(a) and there were
no dominant sources of risk (clause 34(b)). Because the risks as a whole are
negligible, the decision is made in accordance with clause 26 (not clause 27) of
the Methodology.
10.9
The Committee considered all of the controls, set out in Appendix 1, and did so
in the context of both preventing the escape of the organisms and effectively
managing any risks. The Committee, having regard to these matters, is satisfied
that the organisms can be adequately contained, and that it is evident that the
benefits of the application outweigh the costs.
11 Decision
11.1
Pursuant to section 45(1)(a)(i), the Committee is satisfied that this application is
for one of the purposes specified in section 39(1), namely 39(1)(a): “the development
of any [new] organism.”
11.2
Having considered all the possible effects in accordance with sections 45(1)(a)(ii),
45(4) and 43 and pursuant to clause 26, and based on consideration and analysis
of the information provided and taking into account the application of risk
management controls specified in this decision, the view of the Committee is that
the risks (or costs) of adverse effects associated with developing in containment
the organisms, outlined in section 1.1 of this decision, are outweighed by the
benefits.
Environmental Risk Management Authority Decision: Application GMD06057
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11.3
The Committee is satisfied that the containment regime, as set out in Appendix 1,
will adequately contain the organisms (section 45(1)(a)(iii)).
11.4
In accordance with clause 36(2)(b) of the Methodology the Committee records
that, in reaching this conclusion, it has applied the balancing tests in section 45 of
the Act and clause 26 and has relied in particular on the criteria set out in the
following sections of the Act:




11.5
section 43 additional matters to be considered;
section 45 determination of application;
section 37 additional matters to be considered; and
the Third Schedule (Part I), matters to be addressed by containment controls
for [importing, developing or field testing] of genetically modified organisms.
The Committee has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 10 – equivalent of sections 36 and 37;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 20 – information produced from other bodies;
 clause 21 – the decision accords with the requirements of the Act and
regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation
and management techniques;
 clause 25 – the evaluation of risks;
 clause 26 – the risks are negligible and benefits evidently outweigh costs;
 clause 29 and 32 – considering uncertainty;
 clause 33 – the risk characteristics; and
 clause 34 – the aggregation and comparison of risks, costs and benefits.
Environmental Risk Management Authority Decision: Application GMD06057
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11.6
The application GMD06057 to develop in containment genetically modified
organisms (as described in Table 1 of this decision) is thus approved, with
controls, in accordance with section 45(1)(a) of the Act. As required under
section 45(2) the approval is subject to the controls listed in Appendix 1 of this
decision.
_____________________
12 February 2007
Neil Walter
Date:
Acting Chair of New Organisms (GMO) Committee of the Authority
Approval codes (BCH codes): GMD004565 – 68 (30984 – 87)
Amended under Section 67A of the HSNO Act in August 2008 to add the
University of Otago as an applicant:
_____________________
Dr Val Orchard
Date: 21 August 2008
Chair of the Decision-making Committee of the Authority
Environmental Risk Management Authority Decision: Application GMD06057
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References
Bishop, DHL, Harris, MGP, Merryweather, AT, Possee, RD 1989. Progress and
prospects in insect control. BCPC Monograph No. 43.
Groener, A 1986. Specificity and safety of baculoviruses. In: Granados, RR, Federici,
BA (Eds.) The Biology of Baculoviruses, Vol.I, Biological Properties and Molecular Biology, CRC
Press, Boca Raton pp. 177-202.
Gatehouse, LN, Markwick, NP, Poulton, J, Christeller, JT 2003. Avidin expression does
not increase speed of kill of Spodoptera litura by baculovirus. New Zealand Plant Protection
Conference 56: 194-200.
Hyink, O, Dellow, RA, Olsen, MJ, Caradoc-Davies, KMB, Drake, K, Herniou, EA, Cory,
JS, O’Reilly, DR, Ward, VK 2002. Whole genome analysis of the Epiphyas postvittana
nucleopolyhedrovirus Journal of General Virology 83: 957–971.
Markwick, NP, Graves, S, Fairbairn, SL, Docherty, C, Poulton, J, Ward, VK 2002.
Infectivity of Epiphyas postvittana nucleopolyhedrovirus for New Zealand leafrollers.
Biological Control 25: 207-214.
Miyajima, A, Schreurs, J, Otsu, K, Kondo, A, Arai, K, Maeda, S 1987. Use of the
silkworm, Bombyx mori, and an insect baculovirus vector for high-level expression and
secretion of biologically active mouse interleukin-3. Gene 58: 273-81.
OECD 2002. Consensus document on information used in the assessment of
environmental applications involving Baculovirus. OECD Environment, Health and Safety
Publications 20: 90.
Environmental Risk Management Authority Decision: Application GMD06057
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Appendix 1: Controls Required by this Approval
In order to satisfactorily address the matters detailed in the Third Schedule Part I:
Matters to be Addressed by Containment Controls for [Importing, Developing and Field
Testing] of Genetically Modified Organisms4, of the Act, and other matters in order to
give effect to the purpose of the Act, 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 developed and maintained within a
containment facility which complies with these controls.
1.2
The construction, operation, and management of the microorganism
containment facility shall be in accordance with the:
a)
Ministry of Agriculture and Forestry (MAF) Biosecurity Authority/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 Standard 154.03.02.
c)
Physical Containment Level 1 (PC1) requirements of the above Standards
for the developments in E. coli (except those described in 1.2 (d)),
bacteriophage lambda and disarmed EppoNPV.
d) Physical Containment Level 2 (PC2) requirements of the above standards
for manipulations involving wild-type EppoNPV (in E.coli and
E. postvittana cell lines) and infections of E. postvittana insect larvae with
disarmed EppoNPV.
1.3
The person responsible for the operation of the containment facility shall inform
all personnel involved in the handling of the organisms of the Authority’s
controls.
1.4
The containment facility shall be approved by Ministry of Agriculture and
Forestry (MAF), in accordance with section 39 of the Biosecurity Act and the
Bold headings refer to matters to be addressed by containment controls for [importing,
developing or field testing] of genetically modified new organisms, specified in the Third Schedule
(Part I) of the HSNO Act 1996.
4
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 sublethally
damaged by being frozen, dried, heated, or affected by chemicals.
5
Any reference to this standard in these controls refers to any subsequent version approved or
endorsed by ERMA New Zealand.
6
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MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02:
Containment Facilities for Microorganisms.
2
2.1
3
3.1
4
To exclude unauthorised people from the facility:
The identification of entrances, numbers of and access to entrances, and the
security requirements for the entrances and the facility shall be in compliance
with the standards listed in control 1.2 of this document.
To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
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 of this document.
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
of this document.
5
To control the effects of any accidental release or escape of an organism:
5.1
Control of the effect of any accidental release or escape of the organism shall be
in compliance with the standards listed in control 1.2.
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 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 the standards listed
in control 1.2.
6
Inspection and monitoring requirements for containment facilities:
6.1
The inspection and monitoring requirements for the containment facility shall be
in compliance with the standards listed in control 1.2.
6.2
The Authority, or its authorised agent or properly authorised enforcement
officers, may inspect the facilities at any reasonable time.
6.3
The containment manual 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 154.03.02.
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7
7.1
8
Qualifications required of the persons responsible for implementing these
controls:
The training of personnel working in the facility shall be in compliance with the
Standards listed in control 1.2.
Additional controls:
8.1
Microinjection of live insect (E. postvittana) larvae with the disarmed virus will
be undertaken in a Class II biological safety cabinet, within a PC2 laboratory,
registered to MAF/ERMA Standard 154.03.02 Containment Facilities for
Microorganisms.
8.2
All E. postvittana larvae injected with the recombinant baculovirus will be
maintained individually in sealed containers, on trays. Trays will be sealed inside
a second bag or container within an incubator.
8.3
No larvae injected with the recombinant baculovirus will be allowed to survive to
adulthood. Any larvae that survive baculovirus infection will be killed before
pupation by a scientifically validated method.
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Appendix 2: Qualitative scales for describing adverse effects
Qualitative Risk Assessment
Risks and benefits are assessed by estimating the magnitude of the possible effects
and the likelihood of their occurrence. For each effect, the combination of these two
components determines the level of that effect, which is a two dimensional concept.
Risk assessment may be qualitative or quantitative. Qualitative assessment is
informed by quantitative data where this is available.
Qualitative matrices are used to prioritise risks (and benefits), and to identify any
risks that are unacceptable. The measure of the level of risk (combination of
magnitude and likelihood) is specific to the application therefore measures of the
level of risk should not be compared between applications. However, the measures
(descriptors) for different types of risk (human health, ecological etc) should be
established so that they represent relative orders of magnitude.
Magnitude of effect
The magnitude must be a measure of the endpoint (specified by the Act and the
Methodology), and is described in terms of the element that might be affected. The
magnitude of the effect is not the same as the effect itself. The qualitative
descriptors for magnitude of effect are surrogate measures that should be used to
gauge the end effect or the ‘what if’ element.
Tables 1 and 2 contain generic descriptors for magnitude of adverse effects (risks and
costs) and beneficial effects (benefits). These descriptors are examples only, and
their generic nature means that it may be difficult to use them in some particular
circumstances. They are included here simply to illustrate how qualitative tables may
be used to represent levels of risk.
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Table 2
Magnitude of adverse effect
Descriptor
Examples of descriptions
Minimal
Mild reversible short term adverse health effects to individuals in
highly localised area
Highly localised and contained environmental impact, affecting a
few (less than ten) individuals members of communities of flora
or fauna, no discernible ecosystem impact
Low dollar cost of containment/cleanup/repair (<$5,000)
No social disruption7
Minor
Mild reversible short term adverse health effects to identified and
isolated groups8
Localised and contained reversible environmental impact, some
local plant or animal communities temporarily damaged, no
discernible ecosystem impact or species damage
Dollar cost of containment/cleanup/repair in order of $5,000$50,000
Potential social disruption (community placed on alert)
Moderate
Minor irreversible health effects to individuals and/or reversible
medium term adverse health effects to larger (but surrounding)
community (requiring hospitalisation)
Measurable long term damage to local plant and animal
communities, but no obvious spread beyond defined boundaries,
medium term individual ecosystem damage, no species damage
Dollar cost of containment/cleanup/repair in order of $50,000$500,000,
Some social disruption (e.g. people delayed)
Major
Significant irreversible adverse health effects affecting individuals
and requiring hospitalisation and/or reversible adverse health
effects reaching beyond the immediate community
Long term/irreversible damage to localised ecosystem but no
species loss
Dollar cost of containment/cleanup/repair in order of $500,000$5,000,000
Social disruption to surrounding community, including some
evacuations
Massive
Significant irreversible adverse health effects reaching beyond the
immediate community and/or deaths
Extensive irreversible ecosystem damage, including species loss
Dollar cost of containment/cleanup/repair greater than
$5,000,000
Major social disruption with entire surrounding area evacuated
and impacts on wider community
The concept of social disruption includes both physical disruption, and perceptions leading to
psychological disruption. For example, some chemicals may have nuisance effects (through odour)
that result in communities feeling threatened.
7
Note that the reference to ‘groups’ and ‘communities’ in the context of human health effects
includes the notion of groups defined by health status.
8
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The economic effects category has been given a surrogate magnitude. This is for
demonstration as a means of illustrating the type of magnitudes that might be encountered.
Table 3
Magnitude of beneficial effect
Descriptor
Examples of descriptions
Minimal
Mild short term positive health effects to individuals in
highly localised area
Highly localised and contained environmental impact,
affecting a few (less than ten) individuals members of
communities of flora or fauna, no discernible ecosystem
impact
Low dollar benefit (<$5,000)
No social effect
Minor
Mild short term beneficial health effects to identified and
isolated groups
Localised and contained beneficial environmental impact, no
discernible ecosystem impact or species damage
Dollar benefit in order of $5,000-$50,000
Minor localised community benefit
Moderate
Minor health benefits to individuals and/or medium term
health impacts on larger (but surrounding) community and
health status groups
Measurable benefit to localised plant and animal
communities expected to pertain to medium term.
Dollar benefit in order of $50,000-$500,000,
Local community and some individuals beyond immediate
community receive social benefit.
Major
Significant beneficial health effects to localised community
and specific groups in wider community
Long term benefit to localised ecosystem(s)
Dollar benefit in order of $500,000-$5,000,000
Substantial social benefit to surrounding community, and
individuals in wider community.
Massive
Significant long term beneficial health effects to the wider
community
Long term, wide spread benefits to species and/or
ecosystems
Dollar benefit greater than $5,000,000
Major social benefit affecting wider community
Likelihood of effect occurring
Likelihood in this context applies to the composite likelihood of the end effect, and not
either to the initiating event, or any one of the intermediary events. It includes:
 the concept of an initiating event (triggering the hazard), and
 the exposure pathway that links the source (hazard) and the area of impact (public
health, environment, economy, or community).
The likelihood term applies specifically to the resulting effect or the final event in the chain,
and will be a combination of the likelihood of the initiating event and several intermediary
Environmental Risk Management Authority Decision: Application GMD06057
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likelihoods9. The frequency or probability solely of the initial incident or hazard event
should not be used (as it sometimes is in the safety discipline).
The best way to determine the likelihood is to specify and analyse the complete pathway of
the “chain of events” from source to the final environmental impact or effect. Each event in
the chain is dependent upon the previous event occurring in the first place.
Likelihood may be expressed as a frequency or a probability. While frequency is often
expressed as a number of events within a given time period, it may also be expressed as the
number of events per head of (exposed) population. As a probability the likelihood is
dimensionless and refers to the number of events of interest divided by the total number of
events (range 0-1).
Table 4
1
2
3
4
5
6
7
Likelihood (adverse effect)
Descriptor
Description
Highly improbable
Almost certainly not occurring but cannot be
totally ruled out
Improbable (remote)
Only occurring in very exceptional circumstances.
Very unlikely
Considered only to occur in very unusual
circumstances
Unlikely (occasional)
Could occur, but is not expected to occur under
normal operating conditions.
Likely
A good chance that it may occur under normal
operating conditions.
Very likely
Expected to occur if all conditions met
Extremely likely
Almost certain
Table 3 provides an example of a set of generic likelihood descriptors for adverse and
beneficial effect. Note that when estimating these likelihoods, the impact of default controls
should be taken into account.
The table is not symmetrical. This is to allow for classification of very low probability
adverse effects.
In practical terms, where the exposure pathway is complex, it may be conceptually difficult to
condense all the information into a single likelihood. For any risk where the likelihood is
other than ‘highly improbable’ or ‘improbable’, then an analysis of the pathway should
include identifying the ‘critical points’; the aspects that are the most vulnerable, and the
elements where controls might be used to ‘cut’ the pathway.
9
Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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Calculating the level of risk
Using these qualitative descriptors for magnitude of effect and likelihood of the event
occurring, an additional two-way table representing a level of risk (combined likelihood and
measure of effect) can be constructed as shown in Table 4, where six levels of effect are
allocated: A, B, C, D, E and F. These terms have been used to emphasise that the matrix is a
device for determining which risks (benefits) require further analysis to determine their
significance in the decision making process. Avoiding labels such as ‘low’, ‘medium’, and
‘high’ removes the aspect of perception.
The lowest level (A) may be deemed to be equivalent to ‘insignificant’. In this table ‘A’ is
given to three combinations; minimal impact and an occurrence of improbable or highly
improbable, and minor impact with a highly improbable occurrence. In some cases where
there is high uncertainty it may be preferable to split this category into A1 and A2, where
only A1 is deemed to equate to insignificant.
For negative effects, the levels are used to show how risks can be reduced by the application
of additional controls. Where the table is used for positive effects it may also be possible for
controls to be applied to ensure that a particular level of benefit is achieved, but this is not a
common approach.
Table 5
Calculating the level of risk (benefit)
Magnitude of effect
Likelihood
Minimal
Minor
Moderate
Highly improbable A
A
B
Improbable
A
B
C
Very unlikely
B
C
D
Unlikely
C
D
E
Likely
D
E
E
Very likely
E
E
F
Extremely likely
E
F
F
Major
C
D
E
E
F
F
G
Massive
D
E
E
F
F
G
G
The table presented here is symmetric around an axis from highly improbable and minimal to
massive and extremely likely, however, this will not necessarily be the case in all applications.
Impact of uncertainty in estimates
Uncertainty may be taken into account in two ways. Firstly, when describing a risk a range of
descriptors may be used. For example, a risk may be allocated a range of very unlikelyimprobable, and minor-major. This would put the range of the risk as B through E.
Alternatively, the level of risk (or benefit) may be adjusted after it has been estimated on the
grounds of uncertainty.
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Appendix 3: Decision path and explanatory notes (GMD06057)
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NOTES to Figure 10 - Decision path for applications to develop or field test any
GMO in containment (application made under section 40 of the Act and
determined under section 45 of the Act)
An application may include a number of organisms or may be for a “generic” application.
In both of these cases the organisms having similar risk profiles should be grouped into
categories. Each category should be considered separately via the path below.
Items 1,
2 & 3:
Information that should be reviewed includes that in the application, the E&R
Report, from experts and in submissions (where relevant). Review should
occur in terms of section 40(2) of the Act and clauses 8, 15, 16, 20 and 22 of
the Methodology. Additional information may need to be sought under
section 58 of the Act.
If the applicant is not able to provide sufficient information for consideration
then the application is not approved. In these circumstances the Authority
may choose to decline the application, or the application may lapse.
Item 4:
Acceptable purposes are set out in section 39 of the Act
Item 5:
Clearly identify the scope of the organism description with particular reference
to where the application is generic, or refers to a number of organisms.
Item 6:
The range of risks, costs and benefits to be identified should be that covered by
clauses 9, 10 and 11 of the Methodology. However, effects arising from the
transfer of genetic elements must also be considered as set out in s44A(2) of
the Hazardous Substances and New Organisms (Genetically Modified
Organisms) Amendment Act 2002 (referred to in the further text as “the GMO
Act”).
This is a two step process.
Step 1:
The identification of every possible risk, cost and benefit that can be
thought of, to ensure that a starting position is as comprehensive as
possible.
Step 2:
The elimination of those risks, costs and benefits that can be readily
concluded to be negligible or irrelevant, having regard to the
characteristics of the organism and the circumstances of the
application.
Item 7:
Mandatory controls are set out in section 45A of the GMO Act. These relate
to removal and/or destruction of material from the site rather than to risks per
sé.
Item 8:
The phrase “characterisation” is used as convenient shorthand for all of the
aspects of risk that need to be considered in the assessment process. The
evaluation (assessment) of risks and costs should be carried out in accordance
with clauses 22 and 25, 29 to 32 (dealing with uncertainty), and 12 to 14 of the
Methodology and relevant clauses of the GMO Act.
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The process of risk assessment is not linear. It is very iterative. In essence all
of the steps must be repeated until a satisfactory conclusion is reached.
However, in general terms the steps in the assessment process should be as
follows, for each risk.
Step 1:
Characterisation of the risk in the absence of containment and other
controls, taking account of the ability of the organism to establish a
self-sustaining population where relevant, and taking account of the
requirement in the GMO Act to consider risks from “genetic
elements” (The issue of self-sustaining populations is mainly
relevant to ecological risks, and usually less so to risks to human
health and safety.)
Step 2:
Consideration of the extent to which the risk will be mitigated by the
ability to eradicate the organism if it becomes established
Step 3:
Consideration of the extent to which the risk will be mitigated by the
setting of containment and other controls, including the mandatory
controls in the GMO Act. (Controls include contingency plans for
recovering the organism or dealing with effects, in the event that
controls fail.)
Step 4:
Characterisation of the overall risk, taking account of all of the other
steps above and considering in particular the issue of whether the
consequences of breach of controls would be sufficiently serious (see
Step 1) to warrant giving this particular emphasis in the overall
characterisation.
Step 5:
Consideration of how risk averse or cautious the Authority should be
in giving weight to the resulting or remaining risk, in terms of clause
33 of the Methodology.
Item 9:
Section 37 of the Act requires that the Authority takes account of the ability of
the organism to establish an undesirable self sustaining population and the ease
of eradication. This needs to be considered in an integrated way in the
assessment process because of the reference to “undesirable”. Undesirable
means (in effect) able to create significant risks.
Item 10:
Section 44 requires the Authority to consider the ability of the organism to
escape from containment. Although strictly speaking, this requirement does
not apply to development applications, it is prudent and good practice to
consider it anyway. This element must be considered in an integrated way in
the assessment process because the ability to escape depends on the
containment controls set.
Environmental Risk Management Authority Decision: Application GMD06057
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Item 11:
Controls additional to those mandated in section 45 of the Act will need to be
considered, in order to mitigate risks to whatever level is considered to be
appropriate, and to provide adequate containment. Controls need to provide
for the matters set out in the 3rd Schedule as well as providing for nay other
matters that are required to give effect to the purpose of the Act.
Section 45A of the GMO Act also provides for the Authority to set controls
for the removal or destruction of genetic elements, if the Authority so decides,
i.e. as a matter for the discretion of the Authority. The impact of these
controls also needs to be considered
Item 12:
Item 12 is included for completeness and is straightforward. It provides for
potential or possible benefits to be confirmed as benefits able to be considered
in making a decision. The same issue is raised again at Item 14, but at this
stage as a decision point rather than just an item of information.
Item 13:
In considering whether resulting risks are negligible, an holistic view needs to
be taken. In particular the issue of the level of risk if containment or other
controls fail needs to be considered, as well as the probability of such a failure.
Item 14:
This item taken in sequence from item 13constitutes a decision made under
clause 26 of the Methodology. If risks are negligible and there are no external
costs (costs accrue only to the applicant), then the fact that the application has
been submitted is deemed to demonstrate existence of benefit, and no further
benefits need be considered.
However, if external costs exist then all benefits need to be assessed
Item 15:
Section 44A of the GMO Act requires alternative means of achieving research
objectives to be taken account of. The word “reasonable’ is used to reflect the
availability of some discretion to the Authority, i.e. the following steps apply:
Step 1:
Are there other ways of achieving the research objectives which pose
less risk (taking account of the mitigating impact of controls as well
as the absence of controls).
Step 2:
Is the difference sufficient to justify declining the application.
Item 16:
Although “risk averseness” is considered as a part of the assessment of
individual risks, it is good practice to consolidate the view on this if risks are
non-negligible. Clause 33 of the Methodology applies, as does section 7 of the
Act dealing with caution in the face of scientific and technical uncertainty. If
risks are negligible, then risk averseness is irrelevant and need not be
consolidated.
Item 17:
Benefits should be assessed in terms of clause 13 of the Methodology.
Environmental Risk Management Authority Decision: Application GMD06057
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Item 18:
This constitutes a decision made under clause 27 of the Methodology. In
weighing up risks, costs and benefits, clause 34 of the Methodology applies.
At this step the scope of the organism description for generic application
should be reviewed. If changes are made to the organism description, items 6
to 14 above should be repeated for the revised organism description. Then the
weighing up process in this item for the revised organism description should
also be repeated.
Item 19:
The meaning of the phrase “adequacy of containment” needs to be extended
so that it covers both the satisfactory biological and/or physical containment of
the organism, and the satisfactory application of the mandatory and (if
appropriate) voluntary containment controls set out in section 45A of the Act.
If the organism description was revised in item 18, the considerations in this
item should relate to the revised organism description.
If, as a result of this consideration, further revision of the organism description
is required, the determination as to whether the organisms can be adequately
contained should be repeated for the new organism description.
Item 20:
The scope of the organism description has been identified in item 5. This step
in the decision-making process confirms the scope of the organism description
in such a way that the risk boundaries are defined.
Item 21:
Controls have been considered at the earlier stages of the process (items 7, 11,
18 and 19). However, this step confirms and sets the controls. Controls flow
from, but are considered in conjunction with, the organism description. If
controls are changed at this point, the previous steps need to be repeated.
Environmental Risk Management Authority Decision: Application GMD06057
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Appendix 4: Approval numbers and BCH numbers for Organisms in
Application GMD06057
Approval number
Organism
GMD004567
Escherichia coli (Migula 1895) Castellani
& Chalmers 1919 (GMD06057)
GMD004568
Wild-type Epiphyas postvittana
nucleopolyhedrovirus (EppoNPV)
(GMD06057)
GMD004565
GMD004566
Bacteriophage lambda (Enterobacteria
phage lambda) (GMD06057)
Epiphyas postvittana (Walker, 1863)
(GMD06057)
Environmental Risk Management Authority Decision: Application GMD06057
BCH number
30984
30985
30986
30987
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