ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 6 September 2007
Date Signed: 22 April 2003
Application code:
NOC02004
Application category:
Import into Containment any New Organism under the
Hazardous Substances and New Organisms (HSNO) Act 1996
Applicant:
Landcare Research
Applicant contact:
Hugh Gourlay
Purpose:
This root and stem boring weevil may be considered for
eventual release as a biocontrol agent for the problem pastoral
and environmental weed Californian thistle (Cirsium arvense)
found throughout New Zealand.
Consideration date:
4 April 2003
Considered by:
Lin Roberts (Chair), Max Suckling, Jane Lancaster
1
Summary of Decision
The application to import into containment Apion onopordi is approved, with controls (as
detailed in Annex 1 of this decision), having being considered in accordance with the
relevant provisions of the Hazardous Substances and New Organisms (HSNO) Act 1996 (the
Act) and the HSNO (Methodology) Order 1998 (the Methodology).
In accordance with section 45(3) of the Act, the Committee’s reasons are given in the
following sections of this decision.
2
Summary of consideration Process and Relevant Legislative
Criteria
The application was lodged pursuant to section 40(1)(a) of the Act. The decision was
determined in accordance with section 45, and other matters relevant to the purpose of the
Act, as specified under Part II of the Act. Unless otherwise stated, references to section
numbers in this decision refer to sections of the Act.
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.
Application Receipt
The application was lodged pursuant to section 40(1)(a) of the Act. It was formally received
on 27 January 2003 and verified on 18 February 2003. 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, as it was not considered to exhibit any
circumstances that warranted public notification. The Committee notes, in particular, that:



Host-specificity testing of potential biological control agents is not a novel use of new
organisms in containment.
The applicant is experienced in host-specificity testing of potential biological control
agents.
Any subsequent application for release from containment of the organisms that are the
subject of the present application must be publicly notified.
In accordance with clauses 2(2)(e) and 5 of the Methodology and section 58(1)(c) of the Act,
departments and Crown entities that were likely to have an interest in the application were
provided with an opportunity to comment on the application. The Department of
Conservation (DoC) and the Ministry of Agriculture and Forestry (MAF) Biosecurity
Authority were consulted. Their comments and the applicant’s responses to those comments
were included in Appendix 2 of the Evaluation and Review Report in Appendix 2.
Information Available for Consideration
The documents available for the consideration of the application by ERMA New Zealand
were the application (including copies of Landcare Research’s containment facility manual),
published references as cited in the application, and an Evaluation and Review (E&R) report
prepared by ERMA New Zealand to assist and support the Committee's decision-making. The
E&R report consolidated and evaluated the relevant information in a format and sequence
consistent with the decision-making requirements of the Act and of the Methodology.
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.
Decision Making Committee
The applications were considered by the Non-GMO New Organisms Standing Committee of
the Authority appointed in accordance with section 19(2)(b) of the Act. The Committee
comprised the following members: Dr Lin Roberts (Chair), Dr Max Suckling and Ms Jane
Lancaster.
Purpose of the Application
The Committee was satisfied that the purpose of the application fell under section 39(1)(h) of
the Act 1996: The importation of any new organism into containment for such other purposes
as the Authority thinks fit.
The purpose of this work is to examine the host-specificity of the weevil Apion onopordi, in
preparation for a further application for it to be released as a biocontrol agent for Californian
thistle.
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3
The Sequence of Steps in the Consideration
In accordance with clause 24 of the Methodology, the approach adopted by the Committee
was to look sequentially at identification, assessment and evaluation of risk, costs and
benefits. Interposed with this was the consideration of the adequacy of the proposed
containment regime, and the ability of the organisms to escape and to form self-sustaining
populations. Management techniques were considered in relation to the identified risks
(clauses 24) and those risks identified as significant were assessed (clause 12). Costs and
benefits were assessed in accordance with clause 13 of the Methodology.
Risk characteristics were then established, in accordance with clause 33 of the Methodology.
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.
4
Identification of the Significant Risks, Costs and Benefits of
the Organism
The Committee conducted an identification of potential risks, costs and benefits relating to
the application, based on the requirements of the Act and the Methodology. Adverse and
beneficial effects were considered in terms of their area of impact on the environment Māori
culture, the economy, human health and safety, and society and community.
The Committee identified the following potential adverse effects in accordance with clauses 9
and 10 of the Methodology that reflect sections 5, 6, 8 and 44 of the Act:

Potential for the weevils to have an adverse effect on the environment following
escape from containment and to establish self-sustaining populations by :
o Predating upon valued flora
o Competing with existing fauna, and possibly dislodging them from an
ecological niche.

Potential for the weevils to have adverse effects on Māori and their taonga,
especially if weevils escape and predate on valued species such as puha

Potential for the rust P. punctiformis which is an associated organism to escape
from containment and to have adverse effects on the environment, public health or
Māori and their taonga.
The Committee also considered potential risks to public health. As discussed in the E&R
report (pg. 13), this was not considered to be a significant risk and is not further assessed in
this decision.
The Committee considered the beneficial effects associated with the application, in
accordance with the Methodology clauses 9, 10, 13, and 14 and sections 5 and 6(e) of the
Act. The following beneficial effects were identified:
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5

New knowledge about the phenology/biology of this weevil

Improved knowledge of biocontrol of Californian thistle

Possible improved biocontrol of Californian thistle in New Zealand

Better training and experience for staff in the Biological Control of Weeds Group

Income for Landcare Research from biocontrol contracts in New Zealand and
overseas.
Adequacy of the Proposed Containment Regime
In carrying out its consideration the Authority considered the adequacy of containment in
accordance with section 45(1)(a)(iii) of the Act, and the magnitude and probability of the
risks, costs and benefits alongside each other and in an integrated fashion. This is because the
former interact with the latter and this is recognised in clause 12(d) 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 contain the organisms
In considering the ability of the organisms to escape from containment, the Committee
considered the:
i.
proposed containment regime
ii. accidental removal of organisms from the facility, and
iii. removal by unauthorised persons gaining entry to the containment facility.
iv. ability to establish a self-sustaining population
i Proposed containment regime
The Committee considers that Landcare Research’s Transitional and Containment Facility at
Lincoln (PC2)1 is very likely to contain the imported insects and any inseparable organisms.
Triple barriers within the facility provide secure containment and escape of insects from
containment would be very unlikely. A light trap operates continually between the double
doors in the access corridor to the containment rooms; this trap is likely to capture any insects
that may escape from their containment rooms.
The Committee noted the provisions of the containment manual relevant to the transport of
the insects to be imported to the containment facility at Lincoln, and considered them to be
satisfactory.
1
Physical Containment level 2 as described in the AS/NZS 2243.3:2002
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An additional control specifying that all biological material leaving the facility is autoclaved
will further ensure no accidental escapes from the containment facility.
The Committee considers that it would be difficult to manage the risks associated with an
undetected escape of the insects from containment. An additional control is imposed, limiting
the research to the Landcare Research quarantine and containment facility at Lincoln. The
Committee considers that this will help minimise the likelihood of any escape from
containment, due to the design, the management and the experienced staff of the containment
facility,
ii) Accidental removal of organisms from the facility
The Committee considered the possibility of accidental removal of the weevils from the
facility. The Committee considered that with the design and management of the containment
facility, as well as the experience of the operators it was very unlikely that the weevils would
be accidentally removed from the facility.
The Committee considered the contingency plan for escapes from containment within the
facility, or to the outside, and found it to be acceptable. It notes the difficulties anticipated in
removing the weevil from the environment that would arise should the weevil escape
containment.
iii) Removal by unauthorised persons gaining entry to the containment facility
The Committee considered the likelihood of an authorised person gaining entry to the facility
and removing the insects. This was considered to be very unlikely, due to the design and
security of the containment facility.
iv) Ability to establish a self sustaining population
The Committee considered the ability of the weevil to establish a self sustaining population in
the unlikely event of it escaping from containment. This was considered to be highly likely
given that the weevils come from a temperate environment which has greater temperature
extremes than that experience at the containment facility, that there are many Californian
thistle plants in the vicinity of the facility to act as a host, and that the weevils are likely to be
able to travel to a suitable host should they escape.
6
Assessment of the Risks (Magnitude and Probability of
Adverse Effects) and Costs
The risks and costs assessed here were those identified on page 3 of this decision as
potentially significant, having regard for those matters set out in clauses 9 and 10 of the
Methodology. Risks were considered in terms of the requirements of clause 12 of the
Methodology, including the assessment of consequences and probabilities, the impact of
uncertainty and the impact of risk management. Costs were considered in terms of clause 13
of the Methodology.
The evidence available was scientific in nature and was considered in terms of clause 25(1)
of the Methodology. This evidence comprised principally that provided by the applicant and
additional evidence set out in the Evaluation and Review Report prepared by the staff.
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Escaped weevils establishing a population and having an adverse effect on the
environment
In assessing the risk to the environment in the unlikely event of an escape, two issues must be
addressed, being the possibility that the weevils will predate upon valued flora (such as
lettuce) and that they will compete with existing (unknown) fauna. These can be considered
together. The likelihood of such effects are very low (clause 12(b)), given the containment
regime proposed and the attached controls (clause 12(d)) and what is already known about
the host range of the insect, but the magnitude of such an effect if it were to occur could be
high, especially as it is unlikely the weevils could be recaptured or eliminated outside of
containment (clause 12 (b)) and there is no reason to expect they could not survive in the
New Zealand environment. Overall, the risk is considered to be low (clause 12 (c)).
Risk of the rust establishing a population outside of containment
This rust already exists in the New Zealand environment, and is well established on
Californian thistle. In the unlikely event of the rust escaping from containment, the escape
would only be significant if it was a new biotype with a different host range. The likelihood
of such an effect is very low (clause 12(b)), given the containment regime proposed and the
attached controls (clause 12(d)), but the magnitude of such an effect if it were to occur could
be high, especially as it is unlikely the rust could be eliminated from the environment (clause
12 (b)) and there is no reason to expect a new biotype of an already established species could
not survive in the New Zealand environment. Overall, the risk is considered to be low (clause
12(c)).
Risks to Māori and their culture
In assessing the risks to Māori, the above considerations apply, but with particular
significance of adverse effect were to accrue to a species valued by Māori. Two such species
identified are the introduced and the native puha. Again the likelihood of such an effect is
very low (clause 12(b)) given the containment regime proposed and the attached controls
(clause 12 (d)), the distant relationship of puha to Californian thistle (the natural host of the
weevil) but the magnitude of such an effect if it were to occur could be high (clause 12 (b)).
Overall, the risk is considered to be low (clause 12 (c)). Because of the potential significance
of puha as a host to Apion onopordi, the Committee believes that both the native and
introduced species should be included in the first round of the host specificity, and has
imposed a control accordingly in accordance with section 45 (2)(b).
Assessment of Costs
A “cost” is defined in clause 2 as “the value of a particular adverse effect expressed in
monetary or non-monetary terms”. The Committee was not able to ascribe values to the
adverse affect discussed above in quantitative terms.
The immediate costs of the importation of the weevil into containment and of the research
are borne by the applicant, however the costs of non-negligible risks from approval of the
application, and in particular costs associated with escape and eradication of the insects
should an escape occur and lead to a self-sustaining population, would be borne by the wider
community.
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Assessment of Benefits
A “benefit” is defined in clause 2 as “the value of a particular positive effect expressed in
monetary or non-monetary terms”. Benefits that may arise from any of the matters set out in
clauses 9 and 10 were considered in terms of clause 13.
The immediate benefits of this application will accrue primarily to the applicant, in the form
of raised national and international profile in the research on biological control of Californian
thistle, possibly leading to increased income to Landcare Research.
Wider benefits are likely to emerge from the research through new knowledge about the host
specificity of the insects and their suitability as biocontrol agents in New Zealand, possibly
leading to them being released, and there being a subsequent reduction in the population of
Californian thistles. The value of these benefits has not been quantified.
Establishment of the Approach to Risk in the Light of Risk Characteristics
Clause 33 of the Methodology requires the Authority to have regard for the extent to which a
specified set of risk characteristics exist when considering applications. This provision
provides a route for determining how cautious or risk averse the Authority should be in
weighing up risks and costs against benefits. In the present application clause 33 is influenced
by the application being “in containment” and the conclusion that the containment provisions
and other controls will reduce most biological and physical risks to a low level.
In terms of clause 33, the Committee considered that should adverse effects occur as a result
of the (unlikely) escape from containment, then exposure to the risk would be involuntary,
would persist over time, and would be subject to uncontrollable spread, and to all intents and
purposes would be irreversible. A cautious approach to risk was therefore adopted.
7
Overall Evaluation of Risk, Costs and Benefits
The overall evaluation of risks, costs and benefits set out below was carried out having regard
to Clauses 22 and 34 and in accordance with the tests in clause 27 and in section 45.
Clause 34 sets out the approaches available to the Authority in evaluating the combined
impact of risks costs and benefits i.e. weighing up risks, costs and benefits.
The Committee considered that the escape of the weevil and associated rust was unlikely, but
that the potential ecological and environmental effects should such an escape occur were of a
sufficient magnitude that the risks associated with the escape of these are not negligible.
Because the risks as a whole are non-negligible, the decision is made in accordance with
clause 27 (not clause 26) of the Methodology.
It is evident that there are no common units of measurement available for the weighing up of
risks, costs and benefits so clause 34(a) does not apply. Instead, the Committee used clause
34(b) to identify and rank the dominant risks in order of decreasing significance as follows:
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
that the weevils escape, and would be very difficult to eradicate, and that the plant
host range is wider than anticipated

that the associated rust would escape in tandem with the weevils, and that it might be
a new biotype with a wider host range, possibly effecting economically valued plants
Having regard to these matters, and in terms of section 45 the Committee is satisfied that the
organism can be adequately contained, and that the beneficial effects of the application
outweigh the adverse effects.
8
Decision
The application to import into containment Apion onopordi is approved in accordance with
section 45(a) of the Act. As required under section 45(2) the approval is subject to controls
(as listed in Annex 1 of this decision).
Dr Lin Roberts
22 April 2003
Chair, Non-GMO Committee
Amendment: November 2006
Changes to controls:
 Addition of footnotes to the containment facility references and the Australian/New
Zealand containment facility references to “future proof” the decision
 Standardise the wording of the breach of containment control
 Removal of the control regarding inspection of facilities by the Authority, its agent or
enforcement officers
____________________________
Date: 6 September 2007
Dr Max Suckling
Chair, New Organisms Standing Committee
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Annex 1: Controls
In order to satisfactorily address the matters detailed in the Third Schedule Part II:
Containment controls for new organisms excluding genetically modified organisms2of the
Act, and other matters in order to give effect to the purpose of the Act (section 45(2)), the
Committee’s approval of this application is 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 containment facility shall be in
accordance with the:
a) Ministry of Agriculture and Forestry (MAF)/ERMA New Zealand Standard
154.02.084. Transitional and Containment Facility for Invertebrates;
b) Australian New Zealand Standard AS/NZS 2243:3 20024 Safety in Laboratories:
Part 3: (Microbiological aspects and containment facilities), Invertebrate
Containment Level 2 (PC2); and the controls of the Authority.
2.
To exclude unauthorised people from the facility:
2.1
The identification of entrances, numbers of and access to entrances, and the security
requirements for the entrances and the facility shall be in compliance with the standards
listed in Control 1.1.
3.
To control the effects of any accidental release or escape of an organism:
3.1
Control of the effects of any accidental release or escape of an organism shall be in
compliance with the standards listed in Control 1.1.
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 organisms, 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 1.1.
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 procedures 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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4.
Inspection and monitoring requirements for containment facilities:
4.1
The inspection and monitoring requirements for containment facilities shall be in
compliance with the standards listed in Control 1.1.
4.2
The containment manual shall be updated, as necessary, to address the implementation
of the controls imposed by this approval, in accordance with Ministry of Agriculture
and Forestry (MAF)/ERMA New Zealand Standard 154.02.084. Transitional and
Containment Facility for Invertebrates.
5.
Qualifications required of the persons responsible for implementing those
controls:
5.1
The training of personnel working in the facility shall be in compliance with the
standards listed in Control 1.1.
6
Additional controls:
6.1
The insects shall be free of ectoparasites before moving from quarantine into
containment.
6.2
The insects are to be held in containment, and the host specificity tests carried out, only
within Landcare Research’s Transitional and Containment Facility for Invertebrates at
the Canterbury Agriculture and Science Centre, 40 Gerald Street, Lincoln.
6.3
That the native puha and introduced puha are included in the first round of host plant
testing.
6.4
Screen mesh shall be cleaned weekly with an alcohol and janola spray to kill any P.
punctiformis spores present.
6.5
All plant parts, soil, packaging and associated material that has been in contact with A.
onopordi must be sealed into autoclave bags and autoclaved to destroy the immobile
stages and any possible pathogens prior to leaving containment.
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