Application code:
Application category:
Applicant:
Date signed: 8 March 2007
GMC06001
Import into Containment any New Organism under the Hazardous
Substances and New Organisms (HSNO) Act 1996
Institute of Environmental Science and Research
Purpose:
Date received
Consideration date
Considered by
To import into PC3 containment apathogenic reference strains of influenza A viruses generated by reverse genetics, for diagnostic and reference studies.
21 December 2006
26 February 2007
A Committee of the Environmental Risk Management Authority
1.1
Application GMC06001 to import into containment genetically modified apathogenic reference strains of influenza A viruses generated by reverse genetics, for diagnostic and reference studies is approved with controls (specified 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 and of the HSNO (Methodology)
Order 1998.
Organism description
1.2
The apathogenic reference strains of influenza A that are the subject of this approval are live, attenuated viruses produced by reverse genetics (the generation of viruses possessing a genome derived from cloned cDNAs). They contain two gene segments (HA and NA) from highly pathogenic avian influenza A strains. In these reference strains the polybasic region of the HA segment (which is known to determine pathogenicity) has been deleted.
The further six gene segments in these apathogenic reference strains are derived from
A/PR/8/34 (PR8). PR8 is a well characterised human influenza virus. It is a high yield donor virus routinely used for generating human influenza vaccines.

2.1 The application was lodged by the Institute of Environmental Science and Research pursuant to section 40(1)(a) of the Hazardous Substances and New Organisms Act
(HSNO) Act 1996 (the Act). The decision was made in accordance with section 45 of that Act taking into account additional matters to be considered under section 44, and other matters relevant to the purpose of the Act, as specified under Part II of the Act.
Unless otherwise stated, references to section numbers in this decision refer to sections of the Act.
2.2 Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (the Methodology), as specified in more detail below. Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology.
Application Receipt
3.1 The application was determined to be in compliance with section 40(2) of the Act and was formally received on 21 December 2006.
Notification
3.2
The Authority has discretion, upon receipt of applications to import into containment any new organism, to decide whether or not they are publicly notified (section 53(2) of the Act). Application GMC06001 was not notified as it was considered that there would not be significant public interest in the application.
3.3
In accordance with sections 53(4) and 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 the opportunity to comment on the applications. DoC raised no issues with the application.
Comments from MAF were taken into consideration.
Decision Making Committee
In accordance with section 19(2)(b) of the Act and clause 43 of the First Schedule to the
Act, the Environmental Risk Management Authority (the Authority) appointed a committee (“the Committee”) of its members to hear and determine the applications.
The Committee comprised: Kieran Elborough (Chair), Max Suckling and Deborah Read.
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Information available for the consideration
3.4
The information available for the consideration comprised:
• Application GMC06001 (Form NO2G) submitted by the Institute of
Environmental Science and Research (the applicant);
•
•
References as listed in the application;
A memo from the Agency to the Committee to assist and support the
Committee’s decision making; and
• Comments received from MAF.
3.5
MAF supports the proposed containment system but suggested alignment with the controls attached to NOC04012 and clarification of responsibility for containment as stated in the lease agreement.
4.1
As this approval is not specific to the applicant, the Committee imposed a control requiring any approval user exercising this approval to notify ERMA New Zealand, and the MAF inspector responsible for the supervision of the facility when they first exercise the approval (Additional control 8.1, Appendix 1 of this decision). This is for compliance monitoring purposes and the need to know who is using the approval in case a reassessment (section 62 of the Act) or amendment (section 67A of the Act) of the approval is warranted.
5.1
In accordance with clause 24 of the Methodology, the Committee considered the information provided by the sources listed above. The approach adopted by the
Committee was to look sequentially at identification, assessment and the combined evaluation of risks and of costs and benefits. Techniques for identifying and assessing 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 potentially significant were assessed in accordance with clause 12 of the Methodology.
Management techniques were considered in relation to the assessed 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.
5.2
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
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because the former interacts with the latter and this is recognized in clause 12(d) of the
Methodology and in section 45(1)(a)(ii) of the Act.
5.3
The Committee set controls to satisfactorily provide for the matters in the Third Schedule
(Part I) of the Act (see Appendix 1 of this decision).
5.4
Benefits associated with these applications were considered in accordance with clauses 9,
10, 13 and 14 of the Methodology and section 6(e) of the Act.
5.5
Finally, taking account of the risk characteristics established in accordance with clause 33 of the Methodology, the combined impact of risks, costs and benefits was evaluated in accordance with clause 34.
6.1
In accordance with section 40(1)(a) of the Act, the Institute of Environmental Science and Research seeks to import into containment genetically modified apathogenic strains of the influenza A virus for diagnostic and reference studies.
6.2
In accordance with section 45(1)(a)(i), the Committee is satisfied that the purpose of these applications falls within the scope of section 39(1)(g) of the Act: “maintaining new organisms in containment for diagnostic purposes.”
7.1
In assessing the ability of the genetically modified apathogenic influenza A virus strains to escape from containment, the Committee considered the:
 Biological characteristics of the organisms;
 Proposed containment regime; and
 Potential pathways for the escape of the organisms from the containment facility.
Biological characteristics of the organisms
7.2
Influenza A viruses are enveloped viruses made up of segments of negative-sense, singlestranded RNA. Influenza A viruses infect a wide variety of avian and mammalian species. However, host cellular receptor specificity plays a major part in determining host species restriction. For example, human influenza strains preferentially bind to sialic acid residues linked to galactose by an alpha- 2,6 linkage. This is the predominant linkage found in human respiratory epithelial cells. In contrast, avian influenza strains recognize sialic acid linked to galactose by an alpha- 2,3 linkage, as is found in avian host cells
7.3
The influenza A viral genome consists of 8 RNA segments which encode for 10 genes.
Two of the RNA segments encode the envelope glycoproteins, hemagglutinin (HA) and
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neuraminidase (NA). These envelope glycoproteins interact with host cell surfaces and proteases. HA and NA are important for viral pathogenicity and are the main antigenic determinants of influenza A. HA and NA undergo antigenic variation to evade immune responses.
7.4
Influenza viruses can evolve rapidly through antigenic drift and antigenic shift allowing influenza viruses to evade the immune system. Antigenic drift is the result of point mutations leading to amino acid substitutions in the surface glycoproteins. The segmented nature of the influenza virus genome also allows for unpredictable evolutionary leaps through the formation of reassortant viruses in a process called antigenic shift. Antigenic shift can occur when one cell is infected with more than one influenza virus. The viruses can exchange RNA segments and form new reassortant viruses containing a combination of gene segments derived from the parental virus strain.
7.5
Influenza viruses can cause a spectrum of disease ranging from asymptomatic infection, or mild respiratory illness, through to severe and rapidly fatal systematic failure.
Depending on the severity of disease, avian influenza A viruses have been classified into three categories. They are designated highly pathogenic if they cause higher than 75% mortality rates in eight experimentally inoculated chickens, mildly pathogenic if they kill between one and five, and non-pathogenic (or apathogenic) if all chickens survive.
7.6
While the factors contributing to the pathogenicity of influenza are not fully understood, the post-translational cleavage of HA is one important determinant of pathogenicity.
Cleavage is necessary for the spread of infection through the organism. Non-pathogenic avian influenza strains typically express HAs that are cleaved in only a few cell types.
Therefore, these viruses only cause local infection. In contrast, the pathogenic avian influenza strains have polybasic HAs that are cleaved in a broad range of host cells.
Therefore, they can cause systemic infection.
7.7
The apathogenic reference strains of influenza A that are the subject of this approval are live, attenuated viruses generated by reverse genetics. Reverse genetics allows for the development of live attenuated vaccine virus strains by introducing attenuating mutations and/or genome rearrangement. These apathogenic viruses contain two gene segments
(HA and NA) from highly pathogenic avian influenza A strains. However, in the reference strains to be imported under this approval, the polybasic region of the HA segment has been deleted to reduce the pathogenicity. The further six gene segments in these apathogenic reference strains are derived from A/PR/8/34 (PR8). PR8 is a well characterised human influenza virus. It is a high yield donor virus routinely used for generating human influenza vaccines.
7.8
The applicant has stated that, the apathogenic reference strains of influenza A will be obtained from the National Institute of Biological Standards and Control (NIBSC).
NIBSC’s core work is to prepare, store and distribute World health organisation (WHO)
International standard and reference materials. Prior to importation into New Zealand the apathogenicity of these reference strains will be verified by the NIBSC using scientifically validated tests. Furthermore, the stability of the deletion of the polybasic cleavage site will be verified by sequencing and further pathogenicity tests after serial passage. The applicant has stated that, as is standard laboratory practise, once in New
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Zealand the number of passages from the stock virus will be limited to minimise the risk of reversion to a more pathogenic virus.
7.9
The apathogenic reference strains of influenza A require cell culture for propagation and survival in the laboratory. The virus would lose viability quickly (within days) in an ambient environment outside of a susceptible host.
Containment regime
7.10
The genetically modified apathogenic reference strains of influenza A will be imported into 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 Microorgansims (Standard 154.03.02) and operated at Physical Containment level 3 (see controls 1.1, 1.2 and 1.4 in Appendix 1 of this decision). The minimum requirements for PC3 containment are specified in the Australian/New Zealand
Standard 2243.3:2002: Safety in Laboratories Part 3: Microbiological aspects and containment
facilties, fifth edition 2002 (AS/NZS 2243.3:2002).
7.11
The Committee notes that the AS/NZS 2243.3:2002 standard stipulates that pathogenic strains of avian influenza viruses should be held under quarantine conditions at the
CSIRO Australian Animal Health Laboratory. However, the Committee notes that the
AS/NZS 2243.3:2002 does not stipulate what level of containment is appropriate for apathogenic reference strains of influenza A.
7.12
The applicant has obtained a personal opinion from the chairman of Australian/New
Zealand Standard committee who suggested PC3 containment would provide adequate containment. Based on this information, the Committee considers containment in a PC3 facility to be sufficient to contain the vaccine reference strains.
7.13
The Committee notes that ESR has signed a lease with the MAF investigation and diagnostic centre (IDC) to use facilities in the PC3 facility at Wallaceville, Upper Hutt.
This lease specifies that ESR will follow all the health and safety procedures and relevant standard operating procedures to satisfy the requirements in relation to PC3 operations.
As requested in MAFs submission, the applicant has undertaken to provide a copy of this lease agreement to MAF. This lease agreement will include information on who is ultimately responsible for containment of the organism
7.14
The Committee notes that the applicant has several years experience in working with infectious diseases and became the head of the WHO National Influenza Centre at ESR in 1998.
7.15
The Committee notes that IDC’s PC3 facility has been operating without serious incident since 2000 and that this containment facility structure in some respects exceeds the requirements for a PC3 facility as defined in the AS/NZS 2243.3:2002. The building structure is designed to form a physical barrier for microorganisms, where the concept of containment is a sealed building in which individual rooms are maintained at different negative air pressures in relation to the external environment.
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7.16
In summary, the Committee is satisfied that the containment regime proposed will be effective in containing the genetically modified apathogenic reference strains of influenza
A viruses. The Committee considers that the MAF Biosecurity Authority/ ERMA New
Zealand Standard 154.03.02: Containment Facilities for Microorganisms at PC3 is an appropriate containment standard and level (control 1.2). The Committee notes that
Standard 154.03.02 requires the facility to be constructed and operated in a manner to ensure that organisms are securely contained and held only within the facility. The provisions in Standard 154.03.02 that ensure that containment is maintained cover access to the facility, staff training, contingency plans, waste disposal, record keeping and packaging for organisms in transit.
Potential pathways for escape of organisms from the containment facility
7.17
The Committee considered the following potential pathways of escape of the genetically modified organisms: i) Escape during transport from the border to containment facilities. ii) Escape from containment facilities by intentional removal by staff or unauthorized persons. iii) Escape from containment facilities by accidental or unintentional removal by staff or unauthorised persons, for example:
 Via infection of personnel working with the microorganisms;
 Through passive vectoring (eg on clothing or skin of personnel);
 Contaminated liquid or solid waste leaving the containment facility;
 Through air discharged from the containment facility. iv) Escape from containment following natural disaster (such as flood and earthquakes) or fire.
7.18
The Committee concluded that escape of the organisms via pathways i - iv is highly improbable.
7.19
This conclusion was formed on the basis of the provisions of Standard 154.03.02 and the
AS/NZS 2243.3:2002 imposed by control 1.2 that relate to packaging of the organisms for transport, waste disposal, management of the facility (including access to the facility and staff training) and contingency plans. To enhance staff training, the Committee imposed control 1.3 that requires the person responsible for the operation or particular research area of the facility to ensure that all staff are aware of the containment controls for this approval.
7.20
The Committee notes that all organisms shall be transported to and within New Zealand in packages complying with the packaging (Packing Instruction No 602) and labelling requirements of the most recent version of the IATA Dangerous Goods Regulations and the packaging requirements of Standard 154.03.02 and AS/NZS 2243.3:2002.
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7.21
This conclusion was also formed based on the strict laboratory operating procedures, the apathogenic nature of the virus, the diagnostic nature of the work proposed in the application and the controls imposed by this decision. The Committee considers that it is highly improbable that escape from containment would occur by inadvertent removal by laboratory workers or other persons (eg on skin, clothing, or via infection).
7.22
The ventilation system and the laboratory procedures in a PC3 facility ensure that all air, infectious waste, equipment and clothing is decontaminated in accordance with the requirements of the AS/NZS 2243.3:2002, before leaving the containment facility, and the Committee considers it highly improbable that the organisms would escape from containment via these pathways.
7.23
Standard 154.03.02 requires contingency plans to be in place for use in the event of accidental release of new organisms outside the facility and for fire and other emergencies. Section 4.9 Contingency Plans, states “…action shall be immediately taken to prevent further release and where possible destroy the escaped microorganisms”. The
Committee further enhanced this measure with controls that require the contingency plan to 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).
Conclusion on adequacy of the containment regime
7.24
The Committee considered the ability of the genetically modified apathogenic strains of influenza A viruses to escape from containment, the containment conditions, the biological characteristics of the organism and the potential pathways of escape. Taking all of these into consideration the Committee concludes that it is highly improbable that the apathogenic strains of influenza A would be able to escape from containment.
8.1
In accordance with sections 44 and 37 and clause 10(e), the Committee considered the ability of genetically modified apathogenic strains of influenza A to form a self-sustaining population should they escape from containment and the ease of eradication of such populations.
8.2
Based on the biological characteristics of the organism, in particular its limited ability to survive outside of host cells, the Committee considers it highly improbable that, should an escape from containment occur, a susceptible host would be in the vicinity of the PC3 facility, and be exposed to a dose of viable pathogen sufficient to lead to an infection. In the highly improbable event that an infection did establish, the infected animal would need to come into contact with other susceptible animals for the establishment of a selfsustaining population. There is some uncertainty as to the range of susceptible hosts. In the highly improbable event of escape, the virus is likely to be able to infect avian species (given that the reference strains contain avian HA and NA gene segments).
However, the virus is only likely to infect humans exposed to extremely large doses of virus. There is further uncertainty around the ability of these apathogenic influenza
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viruses to be infectious. However, as these viruses contain avian HA and NA gene segments, it is likely that transmission may occur between avian species. As the
Committee had previously concluded that it is highly improbable that the imported apathogenic strains of influenza A would be able to escape containment (section 7.24), the Committee considers that it is highly improbable that a self-sustaining population would form since it requires a combination of two highly improbable events.
8.3
The Committee considers that in the event that a population did establish, it would be difficult to detect as it would be asymptomatic and would be almost impossible to eradicate.
9.1
The Committee considered the potential risks, costs and benefits relating to the application. In accordance with sections 5 and 6 of the Act, and clause 9 of the
Methodology, the potential adverse effects of these applications were categorised and considered in terms of their area of impact on the environment, on human health and safety, Māori and their culture and traditions, the market economy and society and the community.
9.2
The potential risks, costs and benefits assessed here are those identified as significant, having regard for those matters set out in clauses 9 and 10 of the Methodology, which reflect sections 5, 6, 8 and 44 of the Act. Risks were considered in terms of the requirements of section 45(4) of the Act and clause 12 of the Methodology, including the assessment of consequences and probabilities, the impact of uncertainty and the impact of risk management. Costs and benefits were considered in terms of clause 13 of the
Methodology. A “cost” is defined in clause 2 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
Potential for reference strains of influenza A to be pathogenic to native and valued animals in New Zealand
9.3
The Committee considered the potential for the genetically modified apathogenic strains of influenza A to be pathogenic to native and valued animals in New Zealand.
9.4
The Committee notes that imported apathogenic reference strains of influenza A viruses generated by reverse genetics will not cause disease as they will be tested for apathogenicity prior to importation.
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9.5
However, the Committee notes that in the highly improbable event that the virus was to escape containment and establish a self-sustaining population, the apathogenic strains of influenza A viruses may be able to undergo both antigenic drift and antigenic shift which could result in increased pathogenicity. There is some uncertainty regarding the likelihood and magnitude of this effect due to the lack of experimental data. However, the reference strains of influenza A have been made apathogenic through deletion of the polybasic region of the HA and this deletion has been demonstrated to be stable over serial passage (section 7.8). The committee notes that if the virus were to become pathogenic through antigenic drift or antigenic shift the magnitude of effect would range from minor, if mild disease developed, to major, if severe disease developed leading to loss of genetic diversity. The level of effect therefore ranges from A-C. However, the
Committee notes that for this risk to eventuate the virus must first escape and form a self-sustaining population, the likelihood of which has been assessed as highly
improbable (section 7.24 and 8.2). Therefore, this risk was assessed as negligible if the described containment regime and the controls imposed in Appendix 1 of this decision are adhered to.
Human health and safety
Potential for reference strains of influenza A to be pathogenic to humans
9.6
The Committee considered the potential for the genetically modified apathogenic reference strains of influenza A viruses to be pathogenic to humans.
9.7
The Committee notes that if the virus remains in containment, the primary potential for such an infection to occur would be through laboratory workers through occupational exposure. However, the potential for human infection is limited due to the use of safety equipment such as biological safety cabinets, the use of protective clothing such as gowns, face masks and gloves, training in, and following, safety procedures. Therefore, safety precautions, protective equipment and trained staff will make such infection extremely unlikely. The primary potential for adverse health effects on the laboratory workers is limited since this virus will be apathogenic (section 7.8) to humans.
9.8
Based on the biological characteristics of the organism, the diagnostic nature of the work proposed, and the proposed containment regime, the Committee considers it is highly
improbable that staff would become infected with apathogenic strains of influenza A.
Should an infection occur, the effects would be minimal since the virus is apathogenic.
The level of risk is A. The Committee concludes that the risk is negligible.
Māori culture and traditions
9.9
The Committee considered the potential Māori cultural effects of these applications in accordance with clauses 9(b)(i) and 9(c)(iv) of the Methodology and sections 6(d) and 8 of the Act. 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.
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9.10
The committee noted no native DNA samples from taonga species are used in this application and no use of human DNA derived from Māori also. The committee notes also that no significant issues were identified between the applicant and local Iwi/Māori during informal communication regarding this application. Taking into account the assessment of the potential adverse environmental effects associated with this application, the Committee considers that this application presents 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
9.11
The Committee considered that there are no adverse effects on the market economy of approving the importation of genetically modified apathogenic reference strains of influenza A for reference and diagnostic studies.
Society and the community
9.12
The Committee considered that there are no adverse effects on the society and community of approving the importation of genetically modified apathogenic reference strains of influenza A for reference and diagnostic studies.
Beneficial effects
9.13
The Committee considered the potential beneficial effects associated with this application, in accordance with sections 5 and 6(e) of the Act and clauses 9, 10, 13, and
14 of the Methodology.
9.14
The Committee considered that there are no beneficial environmental effects of approving the importation of genetically modified apathogenic reference strains of influenza A for reference and diagnostic studies.
Human health and safety
Improved control of human disease by more rapid diagnostic testing for the suspected presence of avian/pandemic influenza in New Zealand
9.15 The availability within New Zealand of apathogenic reference strains of influenza A will allow for safer and more rapid diagnostic testing. This will allow for more rapid implementation of therapeutic, preventive and control measures if found to be necessary.
9.16 The Committee notes that the ability to provide more rapid diagnosis will be very likely to occur. However, there is uncertainty as to the potential magnitude of this effect depending on whether there is an influenza pandemic. When there is no influenza pandemic the ability to rapidly diagnose disease would have a minor effect on human health. For example in cases where influenza is rapidly discounted as a cause of illness other avenues could be explored more rapidly In the event of an influenza pandemic, the ability to provide rapid diagnoses could have massive beneficial effects in terms of
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human health. The level of beneficial effect is E-G. The Committee concludes that this benefit is non-negligible.
Society and community
Upskilling of the workforce, scientific benefits and new technologies
9.17
The importation of apathogenic strains of influenza A into the laboratory would have beneficial effects to science and knowledge in New Zealand through upskilling of the workforce, the ability to retain skilled staff, and through increased scientific knowledge
(from research on the organisms and development of accurate diagnostic tests). The magnitude of this effect is considered by the Committee to be minor and it is very likely to eventuate. Thus the level of beneficial effect is E. The Committee concludes that this benefit is non-negligible.
Market economy
Diagnostic capability
9.18 The Committee noted that a range of potentially significant effects on the market economy related to an enhanced ability for New Zealand to respond to the threat of an influenza pandemic.
 Reduced reliance on overseas laboratories; more rapid diagnoses; the ability to repeat tests promptly; and greater control over the testing regime.
 The ability to develop and implement improved surveillance programmes, and a consequential enhanced ability to meet its obligations as a member of the WHO
National Influenza Centre.
9.19 The Committee considered these beneficial effects as one overall benefit relating to the presence of the organisms and capacity to undertake diagnostic activities. The ability to undertake diagnostic activities is very likely to occur. However, there is uncertainty as to the potential magnitude of this effect. When there is no influenza pandemic the ability to rapidly diagnose disease would have a minimal effect. In the event of an influenza pandemic, the ability to provide rapid diagnoses could have massive beneficial effects. The level of beneficial effect therefore ranges from E-G. The Committee concludes that this benefit is non-negligible.
Precautionary approach
10.1
Section 7 of the HSNO Act 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 of the Methodology notes that where there is scientific and technical
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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 of the Methodology 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.
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 of the Act is not warranted.
Aggregation and comparison of risks, costs and benefits
10.4
The overall evaluation of risks, costs and benefits was carried out in accordance with section 45 of the Act and clause 26 of the Methodology, having regard to clauses 22 and
34 of the Methodology.
10.5
The adverse effects identified by the Committee were the potential of the apathogenic reference strains of influenza A to be pathogenic to native and valued animals in New
Zealand, or be pathogenic to humans. The Committee assessed these adverse effects and concluded the risks to be negligible if the proposed containment regime and the controls in Appendix 1 are adhered to.
10.6
The significant beneficial effects identified by the Committee were improved surveillance and rapid diagnosis of suspected pandemic influenza within New Zealand, the upskilling of the workforce and benefits to the market economy including diagnostic capability and enhanced speed of response. The Committee assessed these benefits and concluded that the benefits are non-negligible.
10.7
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 individually and as a whole are negligible, the decision is made in accordance with clause 26 (not clause 27) of the
Methodology.
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11.1
Pursuant to section 45(1)(a)(i) of the Act, the Committee is satisfied that this application is for a purpose specified in section 39(1) of the Act, namely section 39(1)(g) of the Act:
“maintaining new organisms in containment for diagnostic purposes”
11.2
The Committee is satisfied that the containment regime, as set out in Appendix 1 of this decision, will adequately contain the organisms as required by section 45(1)(a)(iii) of the
Act.
11.3
The Committee evaluated the potential of imported apathogenic reference strains of influenza A to escape from containment in accordance with section 44(b) of the Act.
Having considered the proposed containment regime, the biological characteristics of the organisms and the potential pathways for escape from containment, the Committee concluded that it is highly improbable that the organisms would escape from containment.
11.4
The Committee evaluated the potential of the organism to establish an undesirable selfsustaining population should it escape containment in accordance with section 37 of the
Act. The Committee considered that it is highly improbable that an undesirable selfsustaining population of apathogenic strains of influenza A could establish. In the event that a population did establish, it would be difficult to detect and almost impossible to eradicate.
11.5
Having considered all the possible effects in accordance with sections 45(1)(a)(ii), 45(4) and 44 and pursuant to clause 26 of the Methodology, and based on consideration and analysis of the information provided and taking into account the application of risk management controls specified in Appendix 1 of this decision, the view of the
Committee is that the risks (or costs) of adverse effects associated with the importation into containment of genetically modified apathogenic reference strains of influenza A, are outweighed by the benefits.
11.6
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 of the Methodology and has relied in particular on the criteria set out in the following sections of the Act:
 section 44 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.
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11.7
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 recognized risk identification, assessment, evaluation and management techniques;
 clause 25 – the evaluation of risks;
 clause 26 – the risks are negligible and it is evident benefits 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.
11.8
The application GMC06001 to import into containment genetically modified apathogenic reference strains of influenza A for reference and diagnostic testing, 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.
_____________________ 8 March 2007
Kieran Elborough Date
Chair New Organisms (GMO) Committee
Approval code: GMC001313 BCH number: 37773
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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 Organisms 1 , 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 material 2 :
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 154.03.02
3 : Containment Facilities for Microorganisms. b) Australian New Zealand Standard AS/NZS 2243.3: 2002
Standard 154.03.02.
3 Safety in Laboratories: Part 3:
(Microbiological aspects and containment facilities), excluding those deviations specified in c) Physical Containment Level 3 (PC3) requirements of the above Standards
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 MAF Biosecurity
Authority/ERMA New Zealand Standard 154.03.02: Containment Facilities for
Microorganisms.
2 To exclude unauthorised people from the facility:
2.1 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.
3 To exclude other organisms from the facility and to control undesirable and unwanted organisms within the facility:
1 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.
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 sublethally damaged by being frozen, dried, heated, or affected by chemicals.
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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3.1 The exclusion of other organisms from the facility and the control of undesirable and unwanted organisms within the facility shall be in compliance with the standards listed in control 1.2 of this document.
4 To prevent unintended release of the organism by experimenters working with the organism:
4.1 The prevention of unintended release of the organisms by experimenters working with the organisms shall be in compliance with the standards listed in control 1.2 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 operation of the containment facilities shall comply with the requirements contained in the standards listed in control 1.2 relating to the inspection and monitoring requirements for containment facilities.
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 standards listed in control 1.2.
7 Qualifications required of the persons responsible for implementing these controls:
7.1 The training of personnel working in the facility shall be in compliance with the
Standards listed in control 1.2.
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8 Additional controls:
Additional controls:
8.1
Any person using this approval for the first time shall notify ERMA New Zealand and the MAF Inspector responsible for supervision of the facility of their intention to do so in writing.
8.2
The person using this approval shall provide MAF BioSecurity New Zealand on each application for a permit to import, at least one calendar month before any importation
(unless and alternative date is agreed with MAF), a description that uniquely identifies the organism to be imported and evidence that the organism fits within the organism description in this approval.
8.3
The person using this approval shall notify, in writing, MAF Biosecurity New Zealand
Quarantine Service (MAF QS) (or its equivalent) with details of the proposed means and schedule of transport of each package of organisms from the New Zealand border to the containment facility, at least one calendar month before the date of each expected importation (unless an alternative date is agreed with MAF QS (or its equivalent)).
8.4
MAF QS (or its equivalent) shall notify the person using this approval, and confirm in writing, every approval of the means and schedule of transport of each package from the
New Zealand border to the containment facility. The dispatch of packages from the border shall proceed only after the person using this approval acknowledges in writing
MAF QS’s (or its equivalent) notification of the approval.
8.5
The person using this approval shall arrange for a trained member of staff, or a MAF QS
(or its equivalent) staff member, or an approved courier, eg World Courier, with expertise in secure transport of biological material, to oversee the movement of each package from the border to the containment facility, according to the approval notified by MAF QS (or its equivalent).
8.6
All packages of organisms imported in accordance with this approval shall be clearly labelled with the ERMA New Zealand application code and the direction that the package should not be opened at the border, and shall only be opened within a PC3 registered containment facility. The package should also be accompanied by the appropriate documentation specifying this direction and attached to the package in such a way that the package does not have to be opened to access the documentation.
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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 level of risk should not be compared between applications. However, the measures (descriptors) for different types of risk (human health and ecological) should be established so that they represent relative orders of magnitude.
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 1
Descriptor
Minimal
Minor
Magnitude of adverse effect
Examples of descriptions
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 disruption 4
Mild reversible short term adverse health effects to identified and
Moderate
Major isolated groups 5
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)
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 (eg people delayed)
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
Significant irreversible adverse health effects reaching beyond the Massive 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
T he 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.
4 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.
5 Note that the reference to ‘groups’ and ‘communities’ in the context of human health effects includes the notion of groups defined by health status.
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Table 2 Magnitude of beneficial effect
Descriptor Examples of descriptions
Minimal
Minor
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
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
Major
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.
Significant beneficial health effects to localised community and
Massive 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.
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 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
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likelihoods 6 . 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 3 Likelihood (adverse effect)
Descriptor
1 Highly improbable
Description
Almost certainly not occurring but cannot be totally ruled out
2 Improbable (remote) Only occurring in very exceptional circumstances.
3 Very unlikely Considered only to occur in very unusual circumstances
4 Unlikely (occasional) Could occur, but is not expected to occur under normal operating conditions.
5 Likely A good chance that it may occur under normal operating conditions.
6 Very likely
7 Extremely likely
Expected to occur if all conditions met
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.
6 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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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 4
Likelihood
Highly improbable A
Improbable
Very unlikely
Unlikely
Likely
Very likely
Extremely likely
Calculating the level of risk (benefit)
Magnitude of effect
Minimal Minor
A
B
C
D
E
E
A
B
C
D
E
E
F
Moderate Major
B
C
D
E
E
F
F
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 .
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 unlikely- improbable, 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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FIGURE 13 FLOWCHART: Decision path for applications to import any GMO into containment (application made under section 40 of the Act and determined under section 45 of the Act)
For proper interpretation of the decision path it is important to work through the flowchart in conjunction with the explanatory notes
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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 &
The information that should be reviewed includes the application, the
E&R Report and supporting documentation. In addition there may in
3: some cases be information provided by experts and submitters.
The review of information should occur in terms of section 40(2) of the
Act and the following clauses of the Methodology – 8 (relevance and appropriateness of information), 15 and 16 (submissions), 20 (information from other jurisdictions), and 23 (further information). Additional information may need to be sought under section 52 or 58 of the Act.
Item
4:
Item
5:
Item
6:
Item
7:
If the applicant is unable 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.
Section 39(1) of the Act specifies the purposes for which the Authority may approve importation of a new organism.
Clearly identify the scope of the organism description with particular reference to whether the application is generic, or refers to a number of organisms.
Identify risks, costs and benefits
The range of risks, costs and benefits to be identified should be that covered by clauses 9 and 10 of the Methodology (sections 5 and 6 of the
Act).
There are two steps within this part of the process:
Step
1:
Identify all risks, costs and benefits (adverse and beneficial effects) that can be thought of, to provide a starting position
Step
2: that is as comprehensive as possible. To be comprehensive all the aspects listed in sections 5 & 6 of the Act should be considered. For adverse effects this will require identifying the hazards and pathways. For beneficial effects, this will require identifying the nature, sources, and pathways.
Undertake a preliminary evaluation of all risks, costs and benefits and remove from further consideration all those that can be readily concluded to be not potentially significant, having regard to the characteristics of the organism and the circumstances of the application.
All risks, costs and benefits that are not judged to be potentially significant and which are not carried through to assessment should be documented and a record of why they have not been carried through to assessment maintained.
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Item
8:
Item
9:
Section 45(2) requires the application of controls for all applicable matters specified in the 3 rd Schedule. The Authority may consider other controls to give effect to the purpose of the Act. The impact of these controls also needs to be considered. Where relevant consider section 45A.
Assess risks (and costs)
Assess all risks (and costs) identified in Item 7 as being potentially significant. Most of these risks and costs will relate to matters in sections
5 & 6 of the Act. In undertaking this assessment the Authority must take into account the principles of the Treaty of Waitangi (section 8, and clause
9(c)(iv)).
The assessment should also consider the following matters listed below that have particular relevance for these types of applications.
The ability of the organism to escape from containment (section 44)
Although strictly speaking, this requirement applies only to field test applications and not to importation or development applications (see section 45(1)(a)(ii)), 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.
Self-sustaining population (section 37).
Section 37 of the Act requires the consideration to have regard to the
 ability of the organism to establish an undesirable self sustaining population and the ease of eradication if it were to establish such a population. Undesirable means (in effect) able to create significant risks.
Additional matters
Other matters to be considered in the assessment are: the extent to which the risk will be mitigated by the setting of containment and other controls, including the mandatory controls in the Act; and
 the extent to which the risk will be mitigated by the ability to eradicate the organism if it becomes established.
The Methodology
The assessment of risks (and costs) should be carried out in accordance with the following clauses of the Methodology - 22 (risks, costs and benefits), 25 (scientific information, uncertainty and other values), 29 to 32
(scientific and technical uncertainty), 12 to 14 (assessment of risks, costs and benefits and relevant risks, costs and benefits), 24 (recognised techniques) and 33 (approach to risk).
Each risk (and associated cost) should be assessed individually, considering also the level of risk if containment or other controls fail, as well as the probability of such a failure.
The approach to risk and the approach to uncertainty are addressed separately. Although the issue of how risk averse to be and that of dealing
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with uncertainties are different, in practical terms they are often addressed using similar approaches.
The following three steps are not sequential and must be taken together for each risk:
Estimate magnitude
Estimate the magnitude of the identified adverse effect if it should occur, and the likelihood of it and likelihood
(probability) occurring (pathway).
In estimating the magnitude of the adverse effect take into account the extent to which the risk might be mitigated by how or whether it might be possible to eradicate the organism if a significant adverse effect eventuated (section 37).
The risk characteristics listed below under
‘approach to risk’ will affect the estimate of the magnitude of the effect.
When estimating the likelihood of the effect occurring, consider the full pathway, that is, all the possible steps that must occur before the final identified effect is realised. Estimating the likelihood requires combining (multiplying) all of the individual likelihoods for each link in the chain of events.
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Approach to risk (clause
33)
When considering applications, the Authority must have regard to the extent to which the following risk characteristics set out in clause 33 exist: a) Exposure to the risk is involuntary: b) The risk will persist over time: c) The risk is subject to uncontrollable spread and is likely to extend its effects beyond the immediate location of incidence: d) The potential adverse effects are irreversible: e) The risk is not known or understood by the general public and there is little experience or understanding of possible measures for managing the potential adverse effects.
Consider each risk in terms of the factors listed and decide whether to be risk averse by giving additional weight to that risk. This may be done as part of estimating the magnitude of the effect or where this is not relevant, it may be done separately.
Where the Authority chooses to be risk averse, and there is uncertainty as well, the approach to risk may be consolidated with the approach to uncertainty by adopting a conservative approach such as the worst feasible case scenario.
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Item
10:
Approach to uncertainty
(section 7 and clauses
29-32)
For each component (magnitude and likelihood) consider the degree of uncertainty associated with the estimation of each component. In some cases it may be clear that the uncertainty could be reduced by gathering further information
(undertaking more scientific tests, or extending the literature search). Before requesting or seeking further information it is important to consider how important the uncertainty is in terms of the decision (clause 29(a) – materiality), and to essentially consider the cost-effectiveness of gathering further information.
Another approach to addressing uncertainty is to look at a range of scenarios and consider a best feasible-worst feasible scenario range. However, where there is a large degree of uncertainty, this may not be particularly meaningful for calculating the level of risk. In other cases, calculating the level of risk for each end of the range may result in a fairly similar level of risk. Where this does not occur, rather than presenting a wide range in the level of risk it may be better to concentrate on analysing why the uncertainty occurs and whether or not there is any obvious way of resolving it.
Section 7 of the Act requires the Authority to be cautious where there is scientific and technical uncertainty. Caution may be applied by adopting a conservative approach in assessing risks, for example, adopting the worst feasible case scenario in calculating the level of risk.
Controls additional to those mandated in section 45(2) and 45A of the Act
(see item 8) 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 3
Schedule as well as providing for any other matters that are required to rd give effect to the purpose of the Act.
Consider each of the assessed risks in turn and determine whether it is negligible. Take into account the particular characteristics of the organism and the context of the application.
Consider also the cumulative effect of the assessed risks. If each of the risks is considered to be negligible, but the risks cumulatively are not negligible, then take the clause 27 path. This may not be relevant to
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Item
11:
Item
12:
Item
13:
Item
14:
Item
15: containment applications.
At this point the decision path branches. Where all risks are negligible, and the cumulative effect of the risks is considered to be negligible then take the clause 26 option and move to item 11. If one or more of the risks is considered to be non-negligible, or the cumulative sum of the risks is non-negligible, then take the clause 27 option and move to item 13.
If risks are negligible and there are no external non-negligible costs, then the fact that the application has been submitted is deemed to demonstrate existence of benefit, and no further benefits need be considered. The application can then be approved under clause 26 (via item 12).
If risks are negligible, but there are non-negligible external costs then the decision must be made under clause 27 (via items 13 and 14).
If the organism description was revised in item 15, 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 organism can be adequately contained should be repeated for the new organism description.
If some of the risks or external costs are non-negligible, or the cumulative sum of the risks and costs is non-negligible then assess the benefits in terms of clause 13 of the Methodology.
Estimate the benefits in terms of the magnitude of the beneficial effect if it should occur, and the likelihood of it occurring. As for risks, there may be uncertainty about the benefits and this should be addressed in a similar manner to that described in item 9.
Weigh up the adverse and beneficial effects (costs, risks and benefits), applying clause 34 of the Methodology (aggregation and dominant effects).
While the approach to risk has been considered for each individual risk it should also be applied to a review of the aggregate effect with respect to all risks. A similar approach should be taken to uncertainty, with reference to clause 29(b) (materiality), and section 7 (caution).
At this step the scope of the organism description for generic applications 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.
The scope of the organism description has been identified in item 6. This step in the decision-making process confirms the scope of the organism description in such a way that the risk boundaries are defined.
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Controls have been considered at the earlier stages of the process (items 8,
9, and 12). 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 from item 7 onwards need to be repeated.
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