ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Date Signed: 21 February 2007
Application code:
NOC06011
Application category:
Import into Containment any New Organism under
section 40(1)(a) of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Applicant:
Hamilton Zoo
Purpose:
Importation of fishing cats (Prionailurus viverrinus,
Bennett 1833) into containment at Hamilton Zoo, and
potentially other zoos in the future, to aid
conservation through display and captive breeding
Date application received:
11 January 2007
Date of consideration
21 February 2007
Considered by:
A Committee of the Authority
1
Summary of Decision
1.1
The application to import into containment fishing cats Prionailurus viverrinus
(Bennett 1833) (Family: Felidae) is approved, with controls, having being
considered in accordance with the relevant provisions of the Hazardous
Substances and New Organisms Act 1996 (the Act) and the HSNO
(Methodology) Order 1998 (the Methodology).
2
Legislative Criteria
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 40(1)(a) of the Act. The
application was determined in accordance with section 45, having regard to the
matters specified in section 44 and 37 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
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 NOC06011 was determined to be in compliance with section 40(2)
of the Act and was formally received on 11 January 2007.
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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
import into containment any new organism. In this case the application was not
publicly notified (following ERMA New Zealand guidelines) because the
importation into containment for public display and captive breeding of
conventional vertebrate zoo animals is not expected to be of significant public
interest. The fishing cats meet this criterion and no exceptional circumstances
exist.
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. Neither of the
agencies raised any issues with the application.
Decision Making Committee
3.4
The application was considered by a sub-Committee of the New Organism (Non
GMO) Committee of the Authority appointed in accordance with section
19(2)(b) of the Act. The Committee comprised of the following members: Dr
Max Suckling (Chair), Dr Manuka Henare and Helen Atkins.
Information Available for Consideration
3.5
The documents available for the consideration of the application by the
Committee were:

Application NOC06011 (Form NO2N).

Appendices attached to the application.

Notes for the Committee to assist and support the Committee’s decision
making.
3.6
Recognised techniques were used in identifying, assessing, and evaluating the
relevant information, as required under clause 24 of the Methodology.
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.
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 first examine the scope and
purpose of the application, and the organisms applied for, then to look
sequentially at identification, assessment and evaluation of risks, costs and
benefits. Those risks identified as potentially significant were assessed in
accordance with clause 12 of the Methodology. 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.
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4.2
Interposed with the assessment of risks, costs and benefits was the consideration
of the adequacy of the proposed containment regime, and the ability of the
organisms to escape and establish self-sustaining populations (as required by
sections 37 and 44 and clause 10(e)). Management techniques were considered in
relation to the identified risks. The containment regime was considered in the
context of a risk management regime for controlling the identified risks and costs
(clauses 12(d) and 24). In doing so, the Committee set controls to satisfactorily
provide for the matters in the Third Schedule (Part II) of the Act and additional
controls were considered in relation to residual risks that required further
consideration.
4.3
Benefits associated with this application were considered in accordance with
clauses 9, 10, 13 and 14 of the Methodology and section 6(e) of the Act.
4.4
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. The approach to the consideration
follows the decision path outlined in Appendix 3 of this decision.
5
Purpose of the Application
5.1
Hamilton Zoo wishes to import fishing cats Prionailurus viverrinus (Bennett
1833) (Family: Felidae) into containment for public display and for captive
breeding. Fishing cats are CITES Appendix II1 species and the importation of
such animals will allow Hamilton Zoo to contribute to international conservation
efforts by: participating in international captive breeding programmes; enhancing
staff skills in felid husbandry; and enhancing public awareness of the
conservation programmes for vulnerable, endangered or at risk animals. The
increased gate revenues expected from increased numbers of visitors will also
enable the zoo to contribute towards other conservation programmes for
endangered or native animals.
5.2
In accordance with section 45(1)(a)(i) of the Act, the Committee determined that
this application was for a valid purpose within the scope of section 39(1)(e) of the
Act being the public display of any organism including, but not limited to, display in a circus
or zoological garden.
6
Adequacy of Containment Regime
6.1
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 likelihood 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) of the Methodology and in section 45(1)(a)(ii) of
the Act. For convenience in setting out the decision the adequacy of
containment is discussed first.
CITES Appendix II includes vulnerable species in which trade must be controlled in order to avoid
utilisation incompatible with their survival.
1
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Ability to adequately contain the organisms
6.2
In considering the adequacy of the containment regime and the ability of the
organisms to escape from containment, the Committee considered the following:
i.
the biological characteristics of the organisms;
ii. the containment regime; and
iii. potential pathways for escape of the organisms from the containment facility.
i.
Biological characteristics of the organism
6.3
Fishing cats are powerful sturdily built cats that are brownish grey in colour with
black spots on their bodies that can merge to form stripes on the face, neck and
back. The average length and weight of a fishing cat is 67cm, 6 kg for females
and 72cm, 15 kg for males respectively. Fishing cats reach adult size at
approximately 8 months and sexual maturity at 18 months.
6.4
Fishing cats are native to specific regions of Asia including India and Nepal.
Fishing cats are adapted to the wetland environment and are typically found in
areas of dense vegetation near slow-moving water for example small streams,
marshy thickets and swamp margins. Unlike most felines, fishing cats are not
fearful of water and are strong swimmers in deep water and over long distances.
Fishing cats have been known to dive into the water while hunting and have been
known to remain submerged to capture surface-dwelling prey such as water fowl.
Fishing cats have not been observed to have notable climbing or jumping
abilities.
6.5
The diet of the fishing cat primarily consists of fish but these animals will also
feed on other water-based species such as birds. Fishing cats are opportunistic
hunters and on land can hunt small mammals such as rats, wild pigs and goats.
ii.
Containment regime
6.6
The MAF/ERMA New Zealand Standard 154.03.04: Containment Facilities for Zoo
Animals has a specific schedule (Carnivores C1: Felids and Ursidae (excluding
cheetah)) in Schedule 1, which details the physical containment and operational
procedure required to contain the animal given its physical abilities and
behavioural factors. The standard requires the facility’s containment manual to
be updated to demonstrate how the physical construction of the facility and the
operational procedures will contain the new species, and contingency plans for
recovery should any escapes occur. The Committee notes that fishing cats have
been successfully kept in containment in overseas zoos. The Committee also
notes that Hamilton Zoo currently holds other felids, including the Asiatic golden
cat, leopard cat and bobcat in similar enclosures with no breaches of containment
at this time.
iii.
Potential pathways for escape of organisms from the containment facility
6.7
The Committee considered the potential pathways of escape of fishing cats as:

escape during transport to containment facilities;

accidental or deliberate escape from enclosure within the containment facility;
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6.8

escape due to accidental/unintentional or deliberate removal by people
(during their containment at the zoo); and

escape from containment following natural disaster (such as flood,
earthquake) or fire.
The Committee concluded that escape of the organism via any of these pathways
is highly improbable. This conclusion was formed on the basis of the
provisions of the containment standard 154.03.04 which requires measures to be
taken to prevent escape by any of these pathways. No additional controls were
considered necessary to ensure the containment of the fishing cats.
Conclusion on adequacy of the containment regime
6.9
The Committee has considered the ability of the fishing cats to escape
containment given its biological characteristics, the proposed containment regime
and the potential pathways of escape. Taking all of these considerations into
account the Committee concludes that it is highly improbable that fishing cats
would be able to escape from containment.
6.10
In order to ensure that any subsequent users of the approval have adequate
containment regimes, additional control 6.1 (Appendix 1) has been included
requiring any person using this approval for the first time to notify ERMA New
Zealand and the MAF Inspector responsible for supervision of the facility of
their intention to do so in writing.
7
Ability of the Organism to Establish a Self-Sustaining
Population
7.1
In accordance with sections 44 and 37 and clause 10(e) the Committee
considered the ability of the fishing cats to form self-sustaining populations
should they escape containment, and the ease of eradication of such populations.
7.2
In the event of an escape from containment, it is likely that a fishing cat would
attempt concealment on the zoo site and this natural caution would assist in the
early recapture of any escapees. As captive animals, the fishing cats will be
conditioned to approach the keepers for food and would be expected to show
high affinity to their enclosure. Therefore, in the highly improbable event of an
escape, the escapee could be easily retrieved by zoo staff and returned to
containment.
7.3
As fishing cats are adapted to wetland environments, it is expected that these
animals may not readily thrive outside of such environments. In the New
Zealand environment, wetlands cover less than 2% of New Zealand’s land area
(Statistics New Zealand 2006). Therefore even in the highly improbable event
of escape from containment, due to the limited availability of this favoured
wetland habitat in New Zealand it is highly improbable that an escaped fishing
cat would find an appropriate habitat to survive and thrive.
7.4
Taking into account the ease of recapture and the limited availability of suitable
habitats, in event of escape the Committee considers the establishment of a selfsustaining population is highly improbable.
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8
Identification and assessment of potentially significant
adverse effects (risks and costs)
8.1
In accordance with clause 9(c) the Committee has categorised potential adverse
effects into environmental, human health, Māori culture, market economy and
social categories. These adverse effects have been considered in terms of the
requirements of clauses 12, 13, and 14 including the probability of occurrence
and the magnitude of adverse effects, whether or not they are monetary, and the
distribution of costs and benefits over time, space and groups in the community.
Risk characteristics are considered in terms of clause 33. The degree of
uncertainty attached to evidence is taken into account, as required under clauses
25, 29 and 30.
The Environment
8.2
Fishing cats are a wetland species whose diet primarily consists of water-based
organisms such as fish and birds. In the highly improbable event of an escape
and equally highly improbable event of a self-sustaining population establishing
in the wild, local adverse effects on the New Zealand biota as well as the
immediate ecosystem is possible. However, due to the limited availability of the
favoured wetland habitat in New Zealand and taking into account the ease of
recapture, any effects are likely to be localised and of short term duration. The
magnitude of effect is therefore considered to be minimal to minor, and the
long term establishment of an undesirable self sustaining population in the wild is
considered highly improbable. The Committee concludes the potential adverse
effects on the environment are negligible.
Human Health and Safety
8.3
The Committee noted that although small felids generally avoid direct
confrontation, fishing cats may show aggression to humans when feeling
threatened. As the general public will not have direct access to the fishing cats
and the handling procedures by staff with the animals is detailed in the
containment manual, the Committee concludes the potential adverse effects on
public and occupational human health and safety to be negligible.
Māori and their Culture and Traditions
8.4
The Committee has considered the potential Māori cultural effects in accordance
with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the Act using the
assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996” in assessing this application.
8.5
Fishing cats would need to first escape from containment and then successfully
establish a self sustaining population before any negative impacts upon the native
biota could occur. If this chain of events did eventuate then fishing cats could
have adverse effects on the mauri of native ecosystems. However, as concluded
previously it is highly improbable that these species of fishing cats will escape
containment and/or establish a population without detection. In the short time
that escaped fishing cats remain at large the magnitude of any impact on mauri is
considered to be negligible.
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8.6
Therefore, due to the highly improbable nature of possible escape the
Committee considers the potential adverse effect on the mauri of native ecosystems and therefore to Māori from the importation into containment of fishing
cats into Hamilton Zoo and/or similar containment facilities in New Zealand to
be negligible.
The Market Economy
8.7
The Committee considered the information available and did not identify any
adverse effects to the market economy.
Society and Communities
8.8
The Committee considered the information available and did not identify any
adverse effects to society and the community.
9
Identification and assessment of potentially significant
beneficial effects
9.1
The Committee considered the potential beneficial effects associated with the
application, in accordance with sections 5 and 6(e) of the Act and clauses 9(c), 10,
13, and 14 of the Methodology. The Committee identified the following
beneficial effects:
The Environment

9.2
The development of a self-sustaining population will maintain fishing cats in
captivity which will aid in the conservation of this vulnerable species.
The Committee considered this benefit of minor to moderate value and likely
to be realised and therefore non-negligible.
Society and communities

The increased numbers of visitors to zoos will result in the education of the
public and enhanced generation of revenue which can be used for additional
conservation efforts.

The enhancement of felid husbandry skills of staff.
9.3
The Committee considered these benefits of minor to moderate value and
likely to be realised and therefore non-negligible.
10
Establishment of the Approach to Risk in the Light of
Risk Characteristics
10.1
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 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 organisms being “in
containment” and the conclusion that the containment provisions and other
controls will reduce most biological and physical risks to a low level.
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10.2
The Committee determined that all identified risks and costs (adverse effects)
were individually and collectively assessed as being negligible. Therefore
additional caution was not warranted.
11
Associated Approvals
11.1
The Committee noted the need for the applicant to obtain the following
associated approvals:

An import permit from the Ministry of Agriculture and Forestry which will
require adherence to the Import Health Standard to mitigate the risk of any
associated organisms.

As fishing cats are classed as a CITES Appendix II species, appropriate
permits from the country of export are required.
12
Overall Evaluation of Risks, Costs and Benefits
12.1
The overall evaluation of risks, costs and benefits set out below 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.
12.2
The Committee has assessed the potential adverse effects (risks and costs) of
importing these organisms into containment as being negligible.
12.3
The Committee considers that the beneficial effects (benefits) are non-negligible.
12.4
The Committee has concluded that the establishment of self-sustaining
populations of fishing cats in New Zealand, should they escape, is highly
improbable. The proposed containment regime, based on the MAF/ERMA
Standard 154.03.04 is considered to be adequate considering the risks posed by
the organisms. Additionally, it is considered highly improbable that the
organisms would be able to escape from containment.
12.5
The Committee was unable to find common units of measurement with which to
combine risks, costs, and benefits in accordance with clause 34(a). 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.
12.6
The Committee considered all of the controls, set out in Appendix 1, taking into
account the cost effectiveness of the controls in 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 (beneficial effects) benefits of the application outweigh
the adverse effects (risks and costs).
13
Decision
13.1
Pursuant to section 45(1)(a)(i) of the Act, the Committee is satisfied that this
application is for one of the purposes specified in section 39(1) of the Act, being
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section 39(1)(e): public display of any organism including, but not limited to, display in circus
or zoological garden.
13.2
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 this decision, the view of
the Committee is that the adverse effects (risks and costs) associated with the
importation into containment of fishing cats Prionailurus viverrinus (Bennett
1833) are outweighed by the beneficial effects (benefits).
13.3
The Committee is satisfied that the containment regime, as set out in Appendix 1,
will adequately contain the organisms as required by section 45(1)(a)(iii) of the
Act.
13.4
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 of the Methodology and has relied in particular on the
criteria set out in the following sections of the Act:
13.5

section 44 additional matters to be considered;

section 45 determination of application;

section 37 additional matters to be considered; and

the Third Schedule-Part II, matters to be addressed by containment controls
for new 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 it is evident benefits outweigh costs;

clause 29 and 32 – considering uncertainty;
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13.6

clause 33 – the risk characteristics; and

clause 34 – the aggregation and comparison of risks, costs and benefits.
The application to import into containment: fishing cats Prionailurus viverrinus
(Bennett 1833) (Family: Felidae) is 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.
___________________________
21 February 2007
Dr Max Suckling
Date
Chair, Decision-making Committee of the Authority
Approval code: NOC002486
References
Statistics New Zealand 2006. http://www.stats.govt.nz/analytical-reports/monitoringprogress/envmt-ecosystem-resilience/land.htm Retrieved January 2007.
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Appendix 1: Controls Required by this Approval
In order to satisfactorily address the matters detailed in the Third Schedule Part II: Containment
controls for new organisms excluding genetically modified organisms2, 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 material3:
1.1
The construction, operation, and management of the zoo animal containment facility
shall be in accordance with the MAF/ERMA New Zealand Standard 154.03.044:
Containment Facilities for Zoo Animals.
1.2
The person responsible for the operation of the containment facility shall inform all
personnel involved in handling the approved organisms of the Authority’s controls.
1.3
The containment facility and operator shall be approved by Ministry of Agriculture
(MAF), in accordance with section 39 of the Biosecurity Act and the MAF/ERMA New
Zealand Standard 154.03.04: Containment Facilities for Zoo Animals.
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 standard
listed in control 1.1 of this decision.
3
To control the effects of any accidental release or escape of an organism:
3.1
Construction and operation of the containment facility shall comply with the
requirements of the standard listed in control 1.1 relating to the control of the effects of
any accidental release or escape of an organism.
3.2
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.
3.3
In the event of any breach of containment of the organism, the contingency plan for the
attempted retrieval or destruction of any viable material of the organism that has escaped
Bold heading refer to matters to be addressed by containment controls for new organisms excluding genetically
modified organisms, specified in the Third Schedule (Part II) 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 may be required, eg when
organisms or parts thereof are sublethally damaged by being frozen, dried, heated, or affected by chemical.
3
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by ERMA
New Zealand.
4
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shall be implemented immediately. The contingency plan shall be included in the
containment manual in accordance with the requirements of standard listed in control
1.1.
3.4
The applicant shall comply with the requirements of the standard listed in control 1.1
above relating to the maintenance of records demonstrating compliance with the
standard, as required by the quality assurance programme, and documented in the
containment manual.
4
Inspection and monitoring requirements for containment facilities:
4.1
The inspection and monitoring requirements for the containment facility shall be in
compliance with the standard listed in control 1.1.
4.2
The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the facilities at any reasonable time.
4.3
The containment manuals should be updated, as necessary, to address the
implementation of the controls imposed by this approval, in accordance with the
standard listed in control 1.1.
5
Qualifications required of the persons responsible for implementing these
controls:
5.1
The training of personnel working in the facility shall be in compliance with the standard
listed in control 1.1.
6
Additional controls:
6.1
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.
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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 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 1
Magnitude of adverse effect
Descriptor
Minimal
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 disruption5
Minor
Mild reversible short term adverse health effects to identified and
isolated groups6
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)
5
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.
Note that the reference to ‘groups’ and ‘communities’ in the context of human health effects includes the
notion of groups defined by health status.
6
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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 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 2
Magnitude of beneficial effect
Descriptor
Minimal
Examples of descriptions
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
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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
likelihoods7. 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).
7
Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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Table 3
Likelihood (adverse effect)
Descriptor
Description
1
Highly improbable
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
Expected to occur if all conditions met
7
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.
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
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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
Calculating the level of risk (benefit)
Magnitude of effect
Likelihood
Minimal
Minor
Moderate
Major
Massive
Highly improbable
A
A
B
C
D
Improbable
A
B
C
D
E
Very unlikely
B
C
D
E
E
Unlikely
C
D
E
E
F
Likely
D
E
E
F
F
Very likely
E
E
F
F
G
Extremely likely
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 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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Appendix 3: Decision Pathway and explanatory notes
FIGURE 12 FLOWCHART Decision path for applications to import into containment
any NO (non GMO) (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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FIGURE 12 EXPLANATORY NOTES
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:
The information that should be reviewed includes the application, the E&R
Report and supporting documentation. In addition there may in 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:
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.
Item
5:
Section 39(1) of the Act specifies the purposes for which the Authority may
approve importation of a new organism.
Item
6:
Clearly identify the scope of the organism description with particular reference to
whether the application is generic, or refers to a number of organisms.
Item
7:
i.
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 that is as
comprehensive as possible. For adverse effects this will require
identifying the hazards and pathways. For beneficial effects, this will
require identifying the nature, sources, and pathways.
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Step 2: 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.
Item
8:
Section 45(2) requires the application of controls for all applicable matters
specified in the 3rd 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.
Item
9:
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 import 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
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
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 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
and
likelihood
(probability)
Estimate the magnitude of the identified adverse effect if it
should occur, and the likelihood of it 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.
Approach to
uncertainty
(section 7
and clauses
29-32)
Uncertainty
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.
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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.
Additional controls
Controls additional to those mandated in section 45(2) 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 3rd Schedule as well as providing for any other
matters that are required to give effect to the purpose of the Act.
Item
10:
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 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.
Item
11:
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).
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Item
12:
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.
Item
13:
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.
Item
14:
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).
Item
15:
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.
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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