ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Date Signed: 07 May 2007
Application Code
NOC07006
Application Category
Import into Containment any New Organism under section
40(1)(a) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Applicant
AgResearch Limited
Application Purpose
To import into containment Risk Group 2 anaerobic
microorganisms associated with the human body, for
research purposes to enhance knowledge of human intestinal
function and health.
Date Application Received
29 March 2007
Consideration Date
07 May 2007
Considered By
A Committee of the Environmental Risk Management
Authority (the Authority)
1
Summary of Decision
1.1
The application to import into containment cultures of the following new organisms:
Risk Group 2 anaerobic commensal microorganisms associated with the human body
for research purposes 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
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 NOC07006 was determined to comply with section 40(2) of the Act and
formally received on 29 March 2007.
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 of
these anaerobic Risk Group 2 microorganisms is not expected to be of significant public
interest, nor is it likely that public notification would result in additional information
relevant to the consideration of this application.
3.3
In accordance with section 58(1)(c) of the Act and clauses 2(2)(e) and 5 of the
Methodology, the Ministry of Agriculture and Forestry (MAF) Biosecurity New Zealand
and the Ministry of Health were notified and provided with an opportunity to comment
on the application. Neither agency raised any issues with this application. MAF agreed
that the organisms described under this approval do not pose a significant risk to the
population.
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 Val
Orchard and Dr Deborah Read.
Information Available for Consideration
3.5
The information available for the consideration of the application by the Committee
included:

Application NOC07006 (Form NO2N) prepared by the applicant.
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 procedures
specified in the ERMA New Zealand Technical Guides.
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 first to 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
Decision NOC07006
Page 2 of 24
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 provide satisfactorily 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
The purpose of the application was to import into containment Risk Group 2 anaerobic
commensal microorganisms associated with the human body for research purposes.
AgResearch Limited is the applicant.
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)(h) of the Act being
such other purposes as the Authority thinks fit.
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
i.
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.
the potential pathways for escape of the organisms from the containment facility.
Biological characteristics of the organism
6.3
The microorganisms to be imported are commensal organisms isolated from healthy
humans, in particular from the intestinal tract.
6.4
A commensal relationship exists when one organism derives food or other benefits from
another living organism without harming or helping it. In the case of these commensal
microorganisms (the human intestinal micro-flora), the benefactor is the human host, as
the bacteria help break down food and supply the host with the extracted nutrients and
energy.
Decision NOC07006
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6.5
Microorganisms can fall into one of three categories depending on the method they use
for energy production: aerobes, facultative anaerobes, or strict/obligate anaerobes.
6.6
Aerobes use oxygen as the terminal electron acceptor for energy production (aerobic
respiration), and cannot grow without it. Facultative anaerobes are aerobic
microorganisms that can use fermentation or anaerobic respiration when molecular
oxygen is absent, but use aerobic cellular respiration when oxygen is present.
6.7
Obligate anaerobes are microorganisms that are unable to use oxygen as a terminal
electron receptor in energy production. Strict anaerobes cannot live in the presence of
oxygen. Aerotolerant anaerobes are non-facultative anaerobes that are able to grow in
the presence of molecular oxygen. Microaerophiles have low oxygen requirements and
tolerance, meaning they are unable to grow with normal air concentrations of oxygen
(20%), but do require some oxygen (2-10%) for normal growth. For example, nitrogen
fixing bacteria have a growth preference for lower than normal atmospheric levels of
oxygen.
6.8
The microorganisms to be imported are anaerobic; therefore, they do not require oxygen
for growth. The presence of oxygen will kill or inhibit the growth of obligate anaerobes.
Anaerobes therefore require a controlled environment with limited or no molecular
oxygen for culturing.
6.9
The microorganisms to be imported are commensal; therefore do not cause disease in the
normal course of inhabiting the human gastrointestinal tract. However, if they gain
access to other areas of the body they may be able to cause disease; therefore, they are
considered Risk Group 2 organisms.
6.10
The generic organism description could include bacteria belonging to the following
genera: Actinomyces, Bifidobacterium, Eubacterium, Propionibacterium, Clostridium, Fusobacterium,
and Veillonella. Many species of these anaerobes are commonly isolated from the human
intestinal tract (or mouth), and are not commonly associated with disease in the gut
environment. However, these organisms may be capable of causing infections in
wounds, abscesses, bacteraemia, endocarditis (inflammation of the inside lining of the
heart chambers and heart valves) and pleuropulmonary infections (the lungs, and
associated membranes and chest cavity) if they are able to gain access to other areas of
the body, for example through trauma. Some species are also linked to gingivitis, oral
infections and dental caries.
6.11
It is likely that many of the organisms to be imported are established within humans in
the New Zealand population, however, this group of organisms is not always well
documented or identified, therefore an application has been made under the HSNO Act.
For this reason, specific bacteria are not identified in this approval; the approval is to
cover unknown or unidentified organisms that may be transitory in the human intestinal
tract, or uncharacterised at the time of import.
ii.
Containment regime
6.12
The microorganisms will be imported into a containment facility registered by MAF
under the MAF Biosecurity/ERMA New Zealand Standard 154.03.02 Containment
Facilities for Microorganisms (Standard 154.03.02) at Physical Containment Level 2 (PC2).
The requirements for PC2 are set out in the Australian New Zealand Standard AS/NZS
2243.3:2002 Safety in Laboratories: Part 3: (Microbiological aspects and containment facilities).
6.13
The Committee consider that PC2 is appropriate for these organisms because many of
the organisms are not well characterised. Further research may result in some of the
organisms being defined as Risk Group 1, at which time the organism could be
transferred to another approval if appropriate.
Decision NOC07006
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6.14
Standard 154.03.02 requires the facility’s containment manual to demonstrate how the
physical construction and the operational procedures of the facility will contain the
organisms, limit access to the facility and contingency plans for recovery/destruction
should any escape from containment occur.
6.15
The Committee noted that in most cases, work with these organisms must be carried out
within an anaerobic glove box for the survival of the organisms. An anaerobic glove box
consists of an anaerobic chamber, where the oxygen levels can be strictly controlled,
often accessed through an air-lock chamber. Work is carried out using sealed gloves;
therefore, staff will not have direct contact with the organisms while working with them
except during the transfer from storage and the anaerobic glove box. The Committee
noted that the use of a gloveless anaerobic chamber would also be possible, with the use
of gloves to protect the laboratory worker.
6.16
The Committee noted that in the case of aerotolerant anaerobes, work could be done
outside the anaerobic chamber. The Committee consider that in such cases all ‘open
container’ manipulations must be carried out in a class II biological safety cabinet. The
Committee concluded that ‘open container’ manipulations must be carried out within an
anaerobic chamber or a class II biological safety cabinet as per control 6.3.
iii.
6.17
Potential pathways for escape of organisms from the containment facility
The Committee considered the potential pathways of escape of the anaerobic
microorganisms as:

escape during transport to/from the containment facility;

escape due to accidental/unintentional or deliberate removal from the containment
facility by authorised people;

escape due to accidental/unintentional or deliberate removal from the containment
facility by unauthorised people; and

escape from containment following natural disaster (flood, earthquake etc.) or fire.
6.18
The Committee considered that given the nature of the organisms and the specific
environmental conditions required for growth, and in many cases survival, escape from
containment of these organisms would require a deliberate human act. The Committee
therefore considered that escape from containment during transport or following a
natural disaster is highly improbable.
6.19
The Committee considered that escape by deliberate or accidental removal by authorised
or unauthorised persons, is limited by the containment regime, particularly the security
measures and audit components. In light of this, the Committee considered that escape
by these pathways is highly improbable.
6.20
The Committee concluded that escape from containment, by the anaerobic commensal
microorganisms in this approval, via the identified pathways, is highly improbable.
Conclusion on adequacy of the containment regime
6.21
The Committee has considered the ability of the organisms to escape containment given
their biological characteristics, the proposed containment regime and the potential
pathways of escape. Taking all of these considerations into account the Committee
concluded that it is highly improbable that the organisms would be able to escape from
containment by deliberate or accidental means and that the proposed containment regime
is adequate to contain these organisms.
Decision NOC07006
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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 organisms to form self-sustaining populations should they escape
containment, and the ease of eradication of such populations.
7.2
The Committee noted that the organisms to be imported have the potential to form selfsustaining populations within a host’s intestinal tract. These organisms have very specific
environmental requirements for survival and growth, in particular absence or very low
levels of oxygen.
7.3
The organisms are isolated from the human intestinal tract, and are therefore capable of
colonising this environment. However, the potential for these organisms to escape from
containment and gain access to this type of environment is limited by the containment
regime and good laboratory management practices. The potential is further limited by the
inability of the organisms to survive outside this environment, and the competition they
would face from the hosts native micro-flora.
7.4
The Committee also considered that it would be difficult to identify such a population if
it were to establish, as it could not be distinguished from the hosts indigenous microflora. The Committee noted that intestinal micro-flora differs between individuals and
changes can occur depending on diet or lifestyle changes including the use of antibiotics.
7.5
The Committee concluded that the establishment of a self-sustaining population is
improbable and such a population would be difficult to distinguish from the host’s native
micro-flora.
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.
8.2
The Committee noted that the organisms are classified as Risk Group 2 organisms. Risk
Group 2 organisms are defined by AS/NZS 2243.3:2002 as pathogens that can cause
human, plant or animal disease, but are unlikely to be a serious hazard to laboratory
workers, the community, livestock, or the environment; laboratory exposures may cause
infection, but effective treatment and preventative measures are available, and the risk of
spread is limited.
Potential adverse effects on human health and safety
8.3
The Committee considered the ability of the organisms to cause adverse effect to human
health and safety and noted that the organisms are isolated from humans, and are
classified as Risk Group 2. The Committee noted that any adverse effects were
dependent on the highly improbable event of the organisms escaping containment.
Decision NOC07006
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8.4
The Committee considered that the ability of the organisms to cause disease is dependent
on accessing a suitable site in the body to cause disease, ie a wound or entering the blood
stream. The Committee noted that the organisms normally inhabit the human intestinal
tract, and do not cause disease in this capacity, but have a commensal relationship with
the human host. The pathogenic ability of these organisms only becomes apparent when
they gain access to other parts of the body, resulting in infection. The Committee also
noted that such infections can be treated with antibiotics, and are normally limited to
individuals, rather than groups of people or whole communities. The potential adverse
effects can therefore be considered minimal.
8.5
The likelihood of these adverse effects occurring is limited by the escape of the organisms
and the ability to access a suitable host. The protective barriers of the human body,
including the skin and the mucosal membranes, limit access by the anaerobes to suitable
sites of infection. The Committee considered that the likelihood of any potential adverse
effects on human health and safety occurring is highly improbable.
8.6
The Committee considered that the potential magnitude of adverse effects on human
health and safety is minimal and the likelihood of those effects occurring is highly
improbable. The Committee concluded that the potential adverse effects on human
health and safety are negligible.
Potential adverse effects on the environment
8.7
The Committee considered that the potential for the organisms to cause adverse effects
to the environment was dependent on escape from containment, and pathogenic
infection of a suitable host. The Committee considered that the likelihood of escape
from containment was highly improbable.
8.8
The Committee considered the organisms may inhabit the intestinal tract of many
animals, and do not cause disease in this capacity. The Committee also noted that as with
humans, the organisms could potential cause disease in animals. In addition, such a
disease could also be treated, and would be limited to individuals rather than whole
populations of animals. The Committee therefore, considered the magnitude of any
potentially adverse effects on animals to be minimal.
8.9
The Committee considered the likelihood of these potential adverse effects occurring to
be highly improbable as they are dependent on escape from containment and infection of
a suitable host.
8.10
The Committee did not identify any potential adverse effects on plants or other aspects
of the environment.
8.11
The Committee considered that the magnitude of any potential adverse effects on the
environment is minimal, and likelihood of any potential environmental effects is highly
improbable. The Committee concluded the potential adverse effects on the environment
are negligible.
Potential adverse effects on Māori and their culture and traditions
8.12
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.
8.13
The Committee noted that the potential adverse effects on Māori and their culture and
traditions are dependent on escape from containment and that the magnitude of such
effects would be minimal. The Committee agreed with the assessment of the project
Decision NOC07006
Page 7 of 24
team that the potential adverse effects on Māori and their culture and traditions are
negligible.
Potential adverse effects on the market economy
8.14
The Committee considered the information available and did not identify any potential
adverse effects on the market economy.
Potential adverse effects on society and communities
8.15
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 direct beneficial effects:

Increased knowledge of key signalling mechanisms between intestinal cells in
response to commensal anaerobes

Increased understanding of the human intestinal tract

Generation of intellectual property relating to the points above
9.2
An indirect benefit is the potential to develop novel functional food products with sound
scientific basis for maintaining or enhancing intestinal health.
9.3
The Committee consider these benefits combined are 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
assessed, individually and collectively, 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 MAF

Registration of the facility as a containment facility by MAF.
Decision NOC07006
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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
the anaerobic microorganisms in New Zealand, should they escape, is improbable. The
proposed containment regime, based on Standard 154.03.02 and additional controls, is
adequate considering the risks posed by the organisms. Additionally, it is 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 section 39(1)(h):
such other purposes as the Authority thinks fit.
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
these organisms 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:




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.
Decision NOC07006
Page 9 of 24
13.5
The Committee has also applied the following criteria in the Methodology:













13.6
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;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
The application to import into containment cultures of the following organisms:
Risk Group 2 anaerobic commensal microorganisms associated with the human body
for research purposes 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.
____________________
07 May 2007 ______
Dr Val Orchard
Date
Acting Chair of the Committee
Approval code: NOC002493
Decision NOC07006
Page 10 of 24
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 organisms, of the Act, and other matters in order
to give effect to the purpose of the Act, the approved organisms are subject to the following
controls:
1
To limit the likelihood of any accidental release of any organism or any viable
genetic material:
1.1
The approved organisms shall be imported into a containment facility that complies with
these controls.
1.2
The construction, operation, and management of the organism containment facility for
the import of new organism shall be in accordance with the:
1.2.1
MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02:
Containment Facilities for Microorganisms1.
1.2.2
Australian New Zealand Standard AS/NZS 2243.3:2002 Safety in Laboratories:
Part 3: (Microbiological aspects and containment facilities)1.
1.2.3
Physical Containment Level 2 (PC2) requirements of the above Standards.
1.3
The person responsible for the operation of the containment facility shall inform all
personnel involved in the handling of the organisms of the Authority’s controls.
1.4
The containment facility shall be approved by Ministry of Agriculture and Forestry
(MAF), in accordance with section 39 of the Biosecurity Act.
2
2.1
3
To exclude unauthorised people from the facility:
The identification of entrances, numbers of and access to entrances, and the security
requirements for the entrances and the facility shall comply with the standards listed in
Control 1.2 of this document.
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 standards listed in control 1.2 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
shall be implemented immediately. The contingency plan shall be included in the
containment manual in accordance with the requirements of standards listed in control
1.2.
Any reference to this standard in these controls refers to any subsequent version approved or endorsed
by ERMA New Zealand.
1
Decision NOC07006
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3.4
4
The applicant shall comply with the requirements of the standards listed in control 1.2
listed above relating to the maintenance of records demonstrating compliance with the
standards, as required by the quality assurance programme, and documented in the
containment manual.
Inspection and monitoring requirements for containment facilities:
4.1
The inspection and monitoring requirements for the containment facility shall comply
with the standards listed in control 1.2 of this document.
4.2
The containment manuals shall be updated, as necessary, to address the implementation
of the controls imposed by this approval, in accordance with standards listed in control
1.2.
5
5.1
6
Qualifications required of the persons responsible for implementing these controls:
The training of personnel working in the facility shall comply with the standards listed in
Control 1.2.
Additional Controls:
6.1
Any person using this approval for the first time shall notify ERMA New Zealand and
the MAF Inspector responsible for the supervision of the facility of their intention to do
so in writing.
6.2
All packages of organisms imported in accordance with this application shall be clearly
labelled with the relevant ERMA New Zealand approval code and the direction that the
primary package should not be opened at the border. This documentation should be
attached to that package in such a way that the primary package does not have to be
opened to access the documentation.
6.3
All ‘open container’ manipulations of all organisms covered by this application shall be
performed in a class II biological safety cabinet operated in accordance with AS/NZS
2243.3:2002, until such time that the user has assessed and documented that aerial
dispersal propagules are not formed by the organism being examined. For the purposes
of this approval, ‘open container’ manipulations do not include those carried out inside
an anaerobic chamber.
Decision NOC07006
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Appendix 2: Qualitative scales for describing adverse effects
Modified from the ERMA New Zealand Technical Guide to Decision Making.
Qualitative Risk Assessment
This section describes how the Agency staff and the Authority address the qualitative
assessment of risks, costs and benefits.
Risks and benefits are assessed by estimating the magnitude and nature of the possible
effects and the likelihood of their occurrence. For each effect, the combination of these
two components determines the level of the risk associated with that effect, which is a
two dimensional concept. Because of lack of data, risks are often presented as singular
results. In reality, they are better represented by ‘families’ of data which link probability
with different levels of outcome (magnitude).
The magnitude of effect is described in terms of the element that might be affected. 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 and beneficial effect. 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 to illustrate how qualitative tables may
be used to represent levels of adverse and beneficial effect.
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Table 1 Magnitude of adverse effect (risks and costs)
Descriptor
Examples of descriptions - ADVERSE
Minimal
Mild reversible short term adverse health effects to individuals in highly
localised area
Highly localised and contained environmental impact, affecting a few (less
than ten) individuals members of communities of flora or fauna, no
discernible ecosystem impact
Local/regional short-term adverse economic effects on small organisations
(businesses, individuals), temporary job losses
No social disruption
Minor
Mild reversible short term adverse health effects to identified and isolated
groups
Localised and contained reversible environmental impact, some local plant or
animal communities temporarily damaged, no discernible ecosystem impact or
species damage
Regional adverse economic effects on small organisations (businesses,
individuals) lasting less than six months, temporary job losses
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
Medium term (one to five years) regional adverse economic effects with some
national implications, medium term job losses
Some social disruption (e.g. people delayed)
Major
Significant irreversible adverse health effects affecting individuals and
requiring hospitalisation and/or reversible adverse health effects reaching
beyond the immediate community
Long term/irreversible damage to localised ecosystem but no species loss
Measurable adverse effect on GDP, some long term (more than five years) job
losses
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
Significant on-going adverse effect on GDP, long term job losses on a
national basis
Major social disruption with entire surrounding area evacuated and impacts on
wider community
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Table 2 Magnitude of beneficial effect (benefits)
Descriptor
Examples of descriptions -BENEFICIAL
Minimal
Mild short term positive health effects to individuals in highly localised area
Highly localised and contained environmental impact, affecting a few (less
than ten) individuals members of communities of flora or fauna, no
discernible ecosystem impact
Local/regional short-term beneficial economic effects on small organisations
(businesses, individuals), temporary job creation
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
Regional beneficial economic effects on small organisations (businesses,
individuals) lasting less than six months, temporary job creation
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.
Medium term (one to five years) regional beneficial economic effects with
some national implications, medium term job creation
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)
Measurable beneficial effect on GDP, some long term (more than five years)
job creation
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
Significant on-going effect beneficial on GDP, long term job creation on a
national basis
Major social benefit affecting wider community
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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).
Thus, the likelihood is not the likelihood of an organism escaping, or the frequency of
accidents for trucks containing hazardous substances, but the likelihood of the specified
adverse effect2 resulting from that initiating event. It will be a combination of the
likelihood of the initiating event and several intermediary likelihoods3. The best way to
determine the likelihood is to specify and analyse the complete pathway from source to
impact.
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
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
2
The specified effect refers to scenarios established in order to establish the representative risk,
and may be as specific as x people suffering adverse health effects, or y% of a bird population being
adversely affected. The risks included in the analysis may be those related to a single scenario, or may be
defined as a combination of several scenarios.
3
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Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
Page 16 of 24
Using the magnitude and likelihood tables a matrix representing a level of risk can be
constructed.
In the example shown in Table 4, six levels of risk are allocated: A, B, C, D, E and F.
These terms have been used to avoid confusion with the descriptions used for
likelihood and magnitude, and to emphasise that the matrix is a tool to help decide
which risks (benefits) require further analysis to determine their significance in the
decision making process.
The lowest level (A) is, in most circumstances, equivalent to ‘negligible’. 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.
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. The purpose of developing the tables for
both risk and benefit is so that the risks and benefits can be compared.
Table 4 Level of risk
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
F
Extremely likely
E
F
F
F
F
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
Decision path for applications to import into containment any new organism (non GMO)
Context
This decision path describes the decision-making process for applications to import into
containment any new organism that is not a GMO. These applications are made under
section 40 of the HSNO Act, and determined under section 45 of the Act. Applications to
import a new organism into containment require consideration of section 44 (section 37 plus
ability to escape). Section 37 refers to the ability of the organism to form an undesirable selfsustaining population and ease of eradication.
Introduction
The purpose of the decision path is to provide the Authority with guidance so that all
relevant matters in the HSNO Act and the Methodology have been addressed. It does not
attempt to direct the weighting that the Authority may decide to make on individual aspects of
an application.
In this document ‘section’ refers to sections of the HSNO Act, and ‘clause’ refers to clauses of
the ERMA New Zealand Methodology.
The decision path has two parts –
Flowchart (a logic diagram showing the process prescribed in the Methodology and the
HSNO Act to be followed in making a decision), and
Explanatory notes (discussion of each step of the process).
Of necessity the words in the boxes in the flowchart are brief, and key words are used to
summarise the activity required. The explanatory notes provide a comprehensive description
of each of the numbered items in the flowchart, and describe the processes that should be
followed to achieve the described outcome.
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 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)
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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:
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.
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.
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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 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:
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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.
Approach to risk
(clause 33)
When considering applications, the Authority must have regard
to the extent to which the following risk characteristics set out in
clause 33 exist:
a)
Exposure to the risk is involuntary:
b)
The risk will persist over time:
c)
The risk is subject to uncontrollable spread and is likely
to extend its effects beyond the immediate location of incidence:
d)
The potential adverse effects are irreversible:
e)
The risk is not known or understood by the general
public and there is little experience or understanding of possible
measures for managing the potential adverse effects.
Consider each risk in terms of the factors listed and decide
whether to be risk averse by giving additional weight to that risk.
This may be done as part of estimating the magnitude of the
effect or where this is not relevant, it may be done separately.
Where the Authority chooses to be risk averse, and there is
uncertainty as well, the approach to risk may be consolidated
with the approach to uncertainty by adopting a conservative
approach such as the worst feasible case scenario.
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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.
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 nonnegligible, or the cumulative sum of the risks is non-negligible, then take the clause 27
option and move to item 13.
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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).
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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