ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under s67A on 6 September 2007
4 October 2006
Application code:
NOC06007
Application category:
Import into Containment any New Organism under
section 40(1)(a) of the Hazardous Substances and
New Organisms (HSNO) Act 1996
Applicant:
Wellington Zoo Trust
Purpose:
To import Emperor tamarins (Saguinus imperator
(Goeldi, 1907)) into containment for public display,
captive breeding, and to contribute to conservation
of the species.
Date application received:
28 August 2006
Date of decision
4 October 2006
Considered by:
A Committee of the Authority
1
Summary of Decision
1.1
The application to import into containment Emperor tamarins Saguinus
imperator (Goeldi, 1907) 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 NOC06007 was determined to be in compliance with section
40(2) of the Act and formally received on 28 August 2006.
Notification
3.2
Under section 53(2) of the Act the Environmental Risk Management Authority
(the Authority) has discretion as to whether to publicly notify an application to
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 Emperor tamarins 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:
Max Suckling (Chair), Kieran Elborough and Val Orchard.
Information Available for Consideration
3.5
3.6
The documents available for the consideration of the application by the
Committee were:

Application NOC06007 (Form NO2N)

Appendices attached to the application

Notes for the Committee to assist and support the Committee’s decision
making.
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.
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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.
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
Wellington Zoo wishes to import Emperor tamarins into containment for
public display in their zoological gardens and for captive breeding. This will
provide an opportunity to promote international conservation efforts with
regard to this CITES Appendix II1 species. This will be achieved through the
generation of revenue (from increased zoo gate takings), developing and
perfecting husbandry techniques and establishing a sustainable breeding
population in containment.
1
CITES Appendix II includes species not necessarily threatened with extinction, but in which trade
must be controlled in order to avoid utilisation incompatible with their survival.
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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.
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
Emperor tamarins are diurnal, arboreal and native to south-eastern Peru, northwestern Bolivia and south-western Brazil, where the climate is predominantly
tropical (18-35°C). Named for their long, white moustache, Emperor tamarins
have black heads, greyish brown bodies with white underparts and red-orange
tails. They weigh less than 500g and grow to 230-255mm long (excluding the
390-415mm tail). Emperor tamarins movement is quadrupedal, with leaping
and vertical clinging.
6.4
Emperor tamarins social structure and group size is variable, usually
consisting of an adult male, an adult female and offspring from successive
births (usually twins). Members of the group sleep together at night and stay in
close contact in dense bush by shrill chirruping calls. They reach sexual
maturity at about 18 months and can live up to 17 years in captivity.
6.5
Emperor tamarins diet consists primarily of fruit along with a small proportion
of nectar, sap, gum, fungi, flowers, invertebrates and small animal prey.
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ii.
Containment regime
6.6
MAF/ERMA New Zealand Standard154.03.04:Containment Facilities For
Zoo Animals has a specific schedule (P2 Primates) set out in Schedule 1,
which details the physical containment and operational procedure required to
contain the organism 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 Emperor tamarins have
been successfully kept in containment in overseas zoos, including in Australia.
The Committee also notes that Wellington Zoo currently holds three groups of
tamarins, Cotton-Top tamarins (9) and Golden Lion tamarins (2), 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 Emperor
tamarins as:
6.8

escape during transport to containment facilities,

accidental or deliberate escape from enclosure within the containment
facility,

escape due to accidental/unintentional or deliberate removal by people
(during their containment at the zoo), and

escape from containment following natural disaster (flood, earthquake etc.)
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 measure
to be taken to prevent escape by any of these pathways. No additional controls
to ensure containment are considered necessary.
Conclusion on adequacy of the containment regime
6.9
The Committee has considered the ability of the Emperor tamarins 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 Emperor tamarins 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 user of the approval to notify ERMA New Zealand and MAF
Biosecurity New Zealand in writing of their intention to do so when they first
activate use of the approval (i.e. a one-off requirement).
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7
Ability of the Organism to Establish a SelfSustaining Population
7.1
In accordance with sections 44 and 37 and clause 10(e) the Committee
considered the ability of the Emperor tamarins 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, escapees would only survive for a
limited time in the New Zealand forest because of lower temperatures,
especially in the winter, compared to their natural tropical habitat.
7.3
Emperor tamarins will be conditioned to approach the keepers for food and
show high affinity to site. They also have strong ties to their family groups,
sleeping together and staying in close contact in dense bush by shrill
chirruping calls. Therefore, in the highly improbable event of an escape, the
escapee could be easily retrieved by zoo staff and returned to containment.
7.4
To further reduce the likelihood of escape and ability to form a self-sustaining
population on escape from containment the Committee has included an
additional control 6.2 (Appendix 1) that limits this approval to the importation
of captive bred individuals. Individuals bred in captivity are conditioned to the
captive environment and are less likely to escape or have foraging skills
necessary to survive outside of the containment facility.
7.5
Given the limited suitability of the New Zealand environment to the
requirements of Emperor tamarins and taking into account the ease of
recapture in event of escape the Committee considers the establishment of a
self-sustaining population is highly improbable.
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
Emperor tamarins diet consists mainly of fruit (97%), nectar, sap and fungi
and to a lesser extent invertebrates and small animal prey. In the highly
improbable event of an escape and equally highly unlikely event of a selfsustaining population establishing in the wild, local adverse effects on the
New Zealand biota as well as the immediate ecosystem is a possibility.
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However, given the limited suitability of the New Zealand environment to the
requirements of Emperor tamarins 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 the ability of Emperor tamarins to inflict bites on
members of the public when threatened. Given the low likelihood of an
encounter with a member of the public and that bites are likely to be minor,
the Committee concludes the potential adverse effects on human health and
safety to be negligible.
Māori and their Culture and Traditions
8.4
The Committee considered the potential Māori cultural effects of this
application in accordance with clauses 9(b)(i) and 9(c)(iv) of the Methodology
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
The Emperor tamarins would first need to escape from containment and then
successfully establish a self-sustaining population, before any negative
impacts upon the native arboreal ecosystem could occur. If this chain of events
did eventuate then Emperor tamarins could have adverse effects on the mauri
of native forest ecosystems. However, as previously concluded, it is highly
improbable that Emperor tamarins will escape containment and/or establish a
population without detection. In the short time that escaped Emperor tamarins
remain at large the magnitude of any impact on mauri is considered to be
minimal.
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
Emperor tamarins into Wellington 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.
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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

Perfection of husbandry techniques of this CITES Appendix II species of
which trade must be controlled; and

Development of a self-sustaining captive population to maintain the species.
9.2
The Committee consider these benefits are of minor to moderate value and
likely to be realised and hence non-negligible.
Society and communities

Increase numbers of visitors to zoos, resulting in education of the public and
revenue generation for conservation efforts.
9.3
The Committee considers this benefit is of minor to moderate value and
likely to be realised and hence 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.
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 designated to mitigate the risk
of any associated organisms.
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
As Emperor tamarins are classed as CITES Appendix II, a permit from the
country of export is 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 nonnegligible.
12.4
The Committee has concluded that the establishment of self-sustaining
populations of Emperor tamarins in New Zealand, should they escape, is
highly improbable. The proposed containment regime, based on the
MAF/ERMA Standard 154.03.04 and additional controls are 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).
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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 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 Emperor tamarins
Saguinus imperator (Doeldi, 1907) (Family: Callitrichidae) 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 2, 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;
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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;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
13.6
The application to import into containment: Emperor tamarins
Saguinus imperator (Doeldi, 1907) (Family: Callitrichidae) 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.
___________________________
4 October 2006
Dr Max Suckling
Date
Chair, New Organisms Standing Committee of the Authority Committee
Approval code: NOC002482
Amendment: November 2006
Changes to controls:




Standardise the wording of the breach of containment control
Standardise the wording for the notification of the first time use of this
approval
Removal of the control regarding inspection of facilities by the Authority, its
agent or enforcement officers
Removal of the control that required imported animals to have been bred in
captivity
____________________________
Date: 6 September 2007
Dr Max Suckling
Chair, New Organisms Standing Committee
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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 154.03.044: 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.
2
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.
3
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.
4
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand
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3.2
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 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 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
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Minor
Mild short term beneficial health effects to identified and
isolated groups
Localised and contained beneficial environmental impact,
no discernible ecosystem impact or species damage
Dollar benefit in order of $5,000-$50,000
Minor localised community benefit
Moderate
Minor health benefits to individuals and/or medium term
health impacts on larger (but surrounding) community and
health status groups
Measurable benefit to localised plant and animal
communities expected to pertain to medium term.
Dollar benefit in order of $50,000-$500,000,
Local community and some individuals beyond immediate
community receive social benefit.
Major
Significant beneficial health effects to localised
community and specific groups in wider community
Long term benefit to localised ecosystem(s)
Dollar benefit in order of $500,000-$5,000,000
Substantial social benefit to surrounding community, and
individuals in wider community.
Massive
Significant long term beneficial health effects to the wider
community
Long term, wide spread benefits to species and/or
ecosystems
Dollar benefit greater than $5,000,000
Major social benefit affecting wider community
Likelihood of effect occurring
Likelihood in this context applies to the composite likelihood of the end effect, and not
either to the initiating event, or any one of the intermediary events. It includes:
 the concept of an initiating event (triggering the hazard), and
 the exposure pathway that links the source (hazard) and the area of impact (public
health, environment, economy, or community).
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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).
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.
7
Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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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 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.
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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
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NOTES to Figure 9- Decision path for applications to import into containment a new
organism (non GMO) (application made under Section 40 of the Act and determined
under Section 45 of the Act)
An application may include a number of organisms or may be for a “generic”
application. In both of these cases the organisms having similar risk profiles should
be grouped into categories. Each category should be considered separately via the
path below.
Items 1,
2 & 3:
Information that should be reviewed includes that in the application, the advice
from the Agency, from experts and in submissions (where relevant). Review
should occur in terms of section 40(2) of the Act and clauses 8, 15, 16, 20 and 22
of the Methodology. Additional information may need to be sought under s58 of
the Act.
If the applicant is not able to provide sufficient information for consideration then
the application is not approved. In these circumstances the Authority may choose
to decline the application, or the application may lapse.
Item 4:
Acceptable purposes are set out in section 39 of the Act
Item 5:
Clearly identify the scope of the organism description with particular reference to
where the application is generic, or refers to a number of organisms.
Item 6:
The range of risks, costs and benefits to be identified should be that covered by
clauses 9, 10 and 11 of the Methodology. This is a two step process.
Item 7:
Step 1:
Identify all possible risks, costs and benefits
Step 2:
Eliminate those risks, costs and benefits that can be readily concluded
to be negligible
The assessment of risks and costs should be carried out in accordance with
clauses 12 to 14, 22, 25, and 29 to 32 of the Methodology. The process of risk
assessment includes the estimation of the likelihood and magnitude of each
effect. The assessment is carried out with the controls proposed by the applicant
and any controls required to meet the provisions of the 3rd Schedule of the Act in
place.
The assessment also includes the following steps.
Step 1:
Consideration of the extent to which the risk will be mitigated by the
default controls.
Step 2:
Consideration of how risk averse or cautious the Authority should be in
giving weight to the residual risk (clause 33 of the Methodology),
where residual risk is the risk remaining after the imposition of
controls.
Note that only risks and costs are assessed at this stage, since assessment of
benefits depends on whether the decision follows the clause 26 or clause 27 path.
The process of risk assessment is not linear. It is very iterative. In essence all of
the steps (including the steps in items 8 & 9) must be repeated until a satisfactory
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conclusion is reached.
Item 8:
Determine the ability of the organism to escape from containment and consider
any addition controls that might be imposed that would reduce the likelihood of
escape (Section 44).
Item 9:
Determine the ability of the organism to form a self-sustaining population and
ease of eradication of this occurred (Section 37)
Item 10:
Once the risks and costs have been assessed individually, consider all risks and
costs together, taking account of the proposed controls (item 7) and any
additional controls proposed in Item 8.
Item 11:
Consider whether any residual risks are negligible. An holistic perspective
should be adopted, taking into account the particular characteristics of the
substance and the feasibility of the proposed controls.(if necessary, review the
controls).
Item 12:
This item constitutes a decision made under clause 26 of the Methodology. If
risks are negligible and there are no external costs (costs accrue only to the
applicant), then the fact that the application has been submitted is deemed to
demonstrate existence of benefit, and no further benefits need be considered.
However, if external costs exist then all benefits need to be assessed.
Item 13:
Although ‘risk averseness’ is considered as a part of the assessment of individual
risks, it is good practice to consolidate the view on this if risks are non-negligible.
Clause 33 of the Methodology applies, as does section 7 of the Act dealing with
caution in the face of scientific and technical uncertainty.
Item 14:
Assess benefits in terms of clause 13 of the Methodology.
Item 15:
In weighing up adverse and beneficial effects, clause 34 of the Methodology
applies.
Where this item is taken in sequence from items 13 and 14 (i.e. risks are not
negligible) it constitutes a decision made under clause 27 of the Methodology,
and adverse effects comprise risks and costs.
Where this item is taken in sequence from items 12 and 14 (i.e. risks are
negligible, and costs do not accrue only to the applicant) it constitutes a decision
made under clause 26 of the Methodology, and adverse effects comprise costs
only.
At this step the scope of the organism description for generic application should
be reviewed. If changes are made to the organism description, items 6 to 14
above should be repeated for the revised organism description. Then the
weighing up process in this item for the revised organism description should also
be repeated.
Item 16:
The meaning of the phrase “adequacy of containment” needs to be extended so
that it covers both the satisfactory biological and/or physical containment of the
organisms. 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
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required, the determination as to whether the organisms can be adequately
contained should be repeated for the new organism description.
Item 17:
The scope of the organism description has been identified in item 5. This step in
the decision-making process confirms the scope of the organism description in
such a way that the risk boundaries are defined.
Item 18:
Controls have been considered at the earlier stages of the process (items 7, 8, 10
and 16). However, this step confirms and sets the controls. Controls flow from,
but are considered in conjunction with, the organism description. If controls are
changed at this point, the previous steps need to be repeated.
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