ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended under s67A on 6 September 2007
Date Signed: 17 June 2004
Application code:
NOC03005
Application category:
Import into Containment any New Organism under section
40(1)(a) of the Hazardous Substances and New Organisms
(HSNO) Act 1996
Applicant:
Ministry of Agriculture and Forestry - National Centre for
Disease Investigation
Applicant contact:
Dr Joseph O'Keefe
Purpose:
For importation of the bacterium Melissococcus pluton (the
causal agent of European foulbrood in introduced honey bees)
for diagnostic testing purposes, including the development of
new laboratory test methods and for surveillance in New
Zealand.
Date application received
1 December 2003
Consideration date:
13 April 2004 – 30 April 2004
Considered by:
Committee of the Authority
1
Summary of Decision
The application to import into containment the following organism is approved, with
controls as detailed in Appendix 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):
Melissococcus pluton, Bailey and Collins, 1982
2
Legislative Criteria for Application
The application was lodged pursuant to section 40(1)(a) of the Act. The decision was
determined in accordance with section 45, having regard to the matters specified in section 44
and other matters relevant to the purpose of the Act, as specified under Part II of the Act.
Unless otherwise stated, references to section numbers in this decision refer to sections of the
Act.
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 Process
The application was lodged pursuant to section 40(1)(a) of the Act. It was formally received
and verified on 1 December 2003. In accordance with section 52 of the Act, the Authority
requested further information from the applicant on 3 December 2003 as M. pluton is a
notifiable organism according to sections 45 and 46 of the Biosecurity Act 1993 and the
Schedule of the Biosecurity (Notifiable Organisms) Order 2002. The application was unstalled and processing recommenced on the 9 December 2003 when the applicant faxed
ERMA New Zealand a letter stating that the Director MAF Biosecurity Authority supported
the application to import M. pluton into containment for diagnostic testing purposes,
including the development of new laboratory test methods and surveillance in New Zealand.
Under section 53(2) of the Act the Authority has discretion as to whether to publicly notify an
application to import into containment any new organism. As described in section 1.5 of the
E&R Report it was considered that there was likely to be significant public interest in this
application therefore the application was publicly notified on the 19 December 2003. An alert
notice was printed in The Dominion Post, The New Zealand Herald, The Christchurch Press
and The Otago Daily Times on the 20 December 2003. Four submissions were received on
this application.
Consideration of the application commenced on 13 April 2004. The Committee suspended
consideration pending the applicant providing information regarding the methodology of the
infection of killed bees and bee larvae. Upon receipt of this information the consideration was
resumed on the 30 April 2004.
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 Authority were notified and provided with an opportunity to comment on the
application. Their comments, and the applicant’s responses to those comments, are included
in the E&R Report.
Information Available for Consideration
The documents available for the consideration of the application by ERMA New Zealand
were:




Application NOC03005 (ER-AN-02N 10/02): To Import into Containment any New
Organism that is not genetically modified. As appendices, the application also
included:
Certificates of containment facility registration.
List of Standard Operating Procedures that apply to the containment facility.
Scientific articles – as listed in Appendix 2 of the E&R Report.

E&R Report prepared by the Agency to assist and support the Committee's decisionmaking.

Comments from DoC on the application.
Recognised techniques were used in identifying, assessing, and evaluating the relevant
information, as required under clause 24 of the Methodology. Techniques for identifying and
Environmental Risk Management Authority Decision: Application NOC03005
Page 2 of 16
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 application was considered by a sub-Committee of the Non-GM New Organisms
Standing Committee of the Authority appointed in accordance with section 19(2)(b) of the
Act. The Committee comprised the following members: Associate Professor Marie Dziadek
(Chair), Dr Max Suckling and Dr Manuka Henare.
3
Sequence of 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 risks, costs and
benefits. Interposed with this was the consideration of the adequacy of the proposed
containment regime, and the ability of the organism to escape and to form a self-sustaining
population. Management techniques were considered in relation to the identified risks (clause
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
Purpose of the Application
The Committee was satisfied that the purpose of the application fell under section 39(1)(g):
Maintaining new organisms in containment for diagnostic purposes.
The National Centre of Disease Investigation (NCDI) is part of the Ministry of Agriculture
and Forestry, in particular the Operations Group. NCDI is responsible for inter alia testing
imported honey, royal jelly and other bee products for M. pluton before the products are
released from quarantine. The purpose of developing diagnostic testing in New Zealand is to
prevent the introduction of European Foulbrood (EFB) into New Zealand and to speed up the
testing process. NCDI also carries out ongoing surveillance testing of hives and from time to
time suspect cases of EFB are investigated.
Identification of the Significant Risks, Costs and Benefits of the
Organism
The Committee considered the potential risks, costs and benefits relating to the application,
identified in the E&R Report. In accordance with sections 5 and 6 of the Act, and clause 9 of
the Methodology, the potential adverse and beneficial effects of this application were
categorised and considered in terms of their area of impact on the environment, on the
economy, and on Māori and their culture and traditions. No potential adverse effects on
human health and safety or society and the community were identified.
The Committee considered 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:
Environmental Risk Management Authority Decision: Application NOC03005
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POTENTIAL ADVERSE ENVIRONMENTAL EFFECTS

Decline of Apis mellifera (introduced bee species in New Zealand) resulting in
adverse effects on flowering plants dependent on A. mellifera for pollination.

Adverse effects on ecosystems that are made up of flowering plants dependent on A.
mellifera for pollination.
POTENTIAL ADVERSE EFFECTS ON THE ECONOMY

Costs to the pastoral sector (general pollination of clover).

Costs to the horticultural sector (crops requiring pollination using commercial hives).

Costs to the bee industry (reduced productivity, increased maintenance costs, possible
increased consumer resistance, and loss of any perceived advantage of NZ bee
products being M. pluton free).

Costs of undertaking an eradication response or control measures on an outbreak of
M. pluton.
POTENTIAL ADVERSE EFFECTS ON MĀORI AND THEIR CULTURE AND
TRADITIONS

Potential for the M. pluton to have adverse effects on the mauri of native ecosystems.

Potential for the M. pluton to affect the ability of Māori to fulfil their kaitiakitanga
responsibilities in relation to native ecosystems.
The Committee considered the beneficial effects associated with the application, in
accordance with sections 5 and 6(e) of the Act and clauses 9, 10, 13, and 14 of the
Methodology. The following beneficial effects were identified:
POTENTIAL BENEFICIAL EFFECTS ASSOCIATED WITH THE IMPORT INTO
CONTAINMENT OF THE ORGANISM
5

The accuracy, speed and capability of the current testing regime will be improved as a
result of having M. pluton as a positive control.

The applicant also outlines that the development and validation of this assay will have
positive impacts on the trade in bee products (imports and exports) due to the ability
to prevent, identify and control suspected M. pluton outbreaks in New Zealand.
Adequacy of the Proposed Containment Regime
In carrying out its consideration the Committee considered the adequacy of containment in
accordance with section 45(1)(a)(iii) of the Act, and the magnitude and probability of the
risks, costs and benefits alongside each other and in an integrated fashion. This is 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.
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Ability to adequately contain the organism
In considering the ability of the organism to escape from containment, the Committee
considered the:
i.
biological characteristics of the organism
ii. potential pathways for escape of organism from the containment facility
iii. proposed containment regime
iv. ability of the organism to establish a self-sustaining population.
(i) Biological characteristics of the organism
The biological characteristics of the bacteria M. pluton are described in section 2 of the E&R
Report. In summary, this bacterium is responsible for the outbreak of the disease EFB in
bees. The bacteria is thought to be transmitted by feeding infected foodstuff to larvae, by
swarms of bees, by infected honeycombs and by infected beekeeper accessories. Once
infected with M. pluton, EFB can result in the death of the larvae. The larvae may be ejected
before they are visibly infected and therefore, the infection may persist for many years before
becoming visible within a hive. It is thought that M. pluton would only infect one species of
bee, that of A. mellifera, an introduced bee species found in New Zealand.
(ii) Potential pathways for escape of organism from the containment facility
The possible routes by which the M. pluton could escape containment were identified section
4.3 of the E&R Report:

escape on contaminated fomite

escape on contaminated waste generated by the laboratory

escape by vector, human carriage

accidental or deliberate breach of containment

escape during transportation.
The E&R Report had evaluated all the above possible escape routes as highly improbable to
occur given the scope of the experiments as outlined in the application, the containment
regime and the proposed controls.
The application gave the impression that a reference culture of M. pluton would be imported
and then primarily used for media checks to ensure that the media required to grow M. pluton
had not expired and to enable the development of a molecular DNA test for use on bee
products such as honey and royal jelly.
However, the Committee considered that the applicant had not provided adequate information
in their application regarding the methodology that would be used in developing the
molecular DNA test to detect M. pluton, particularly the use of positive controls. The
application did not elaborate that validation of the molecular DNA test would necessitate the
Environmental Risk Management Authority Decision: Application NOC03005
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inoculation of killed bees and killed larvae with M. pluton and the use of honey and other
products derived from hives. In light of this, the Committee expressed concerns that there
was a possibility that live bees and larvae may be brought in to the laboratory where the bees
were held, killed and then subsequently inoculated with M. pluton. The Committee
considered that live wild bees were more likely to be attracted to killed bees and bee larvae.
The Committee considered that this scenario substantially changed the risks associated with
potential escape from containment and subsequent establishment of M. pluton from that given
in the application and the E&R Report. In view of this, the Committee requested that the
applicant provide further information regarding their proposed methodology surrounding the
development of the positive controls utilising killed bees and killed larvae. The additional
information supplied by the applicant validated the need to use experimental methods
including, inoculating killed bees and killed larvae. No live bees or bee larvae would need to
be inoculated thereby assuaging the Committee’s concern that live bees could potentially be
infected with M. pluton and subsequently escape containment. Therefore, the Committee
endorsed additional control 7.1 “No live bees or live bee larvae shall be infected with M.
pluton while the M. pluton remains in containment”.
The Committee then considered the ability of the bacteria to escape containment by incorrect
handling of experimental material or equipment by personnel. Alternatively, accidental
escape could occur through incorrect disposal of laboratory waste and biological material that
has been in contact with the bacterium.
Barriers to the escape of the bacterium by these pathways are instituted by the operation of
the facilities in accordance with the MAF Biosecurity Authority/ERMA New Zealand
Standard 154.03.02 Containment Facilities for Microorganisms and Australian New Zealand
Standard AS/NZS 2243.3:2002 Safety in Laboratories: Part 3: (Microbiology), at physical
containment level 3 (PC3) (Controls 1.2 and 1.3). The Standard specifies the use of
procedures to ensure that no accidental or unintended removal of microorganisms from the
facility occurs. These procedures cover all aspects of laboratory management including waste
disposal, dealing with spills and staff training.
Section 4.6 of the Standard requires all biological waste and culture material to be disposed
of in accordance with AS/NZS Standard 2243.3:2002 Safety in Laboratories Part 3
Microbiological Aspects and Containment Facilities. Under this regime infectious material
must be sterilised before disposal. Before exiting the facility, all waste is collected by the
commercial waste contractor and autoclaved, macerated and then buried in a landfill. Given
the above waste treatment the Committee considered that it was highly improbable that M.
pluton would escape containment via laboratory waste.
The Committee also considered the possibility of intentional removal of the bacteria from the
containment facility. This is considered to be highly improbable because access to the facility
is restricted to authorised personnel only.
The Committee considered that, given the design and management of the containment
facility, as well as the experience of the operators, it was very unlikely that the bacteria would
be accidentally removed from the facility.
The Committee noted that NCDI had lodged contingency plans in the event of M. pluton
escaping containment within the facility, or to the outside, and found it to be acceptable.
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The Committee considers an escape of the bacteria from the facility to be highly improbable,
based upon an assessment of the containment measures discussed in the E&R report, the
controls, the biological characteristics of the bacteria and the pathways by which the bacteria
could escape.
(iii) Proposed containment regime
The bacteria will be imported into the NCDI containment laboratories at the Wallaceville
Agricultural Research Centre which is registered (Ref. No. 396) as a PC2/PC3 containment
facility operated according to:

MAF Biosecurity Authority/ ERMA New Zealand Standard 154.30.20
Containment Facilities for Microorganisms;

Australian and New Zealand Standard AS/NZS 2243.3:2002 Safety in
Laboratories Part 3: Microbiological Aspects and Containment Facilities;

MAF Biosecurity Authority Transitional Facilities for Biological Products
154.02.17.containment facility
The Committee considered that physical containment level 3 (PC3) (according to the MAF
Biosecurity Authority/ ERMA New Zealand Standard 154.30.20 Containment Facilities for
Microorganisms ) was appropriate where work will be carried out with an exotic microorganism of risk group two status where there is a risk of serious infection to animals should
the organism escape containment. A PC3 laboratory provides safeguards to minimise the risk
of infection to the environment.
The Committee noted section 4.2 of the E&R Report and in particular DoC’s request that the
approval be site specific to the containment facility and that ERMA New Zealand’s approval
be sought for the transfer of bacteria to another facility. The Committee considered that there
was no merit in the approval remaining site specific to Wallaceville Agricultural Research
Centre. The Committee noted that in the event of loss of the use of facility (through
triggering of contingency plans or through sale of the campus) that NCDI may wish to
transfer the organism to another facility. The Committee concurred with the E&R Report that
there is no justification for the approval remaining site specific provided that the new facility
operated under the controls of this decision.
The Committee then considered the issue of whether ERMA New Zealand should be
informed when the bacterium was transferred to another facility. The Committee noted that
the MAF Biosecurity Authority/ERMA New Zealand Standard 154.03.02 Containment
facilities for Microorganisms required that “the supervisor shall seek approval from a chief
technical officer for transfers of micro-organism having a containment requirement of PC3 or
above”. The Committee considered that ERMA New Zealand does not have to ‘approve’ the
transfer per sec but would like to be informed when the applicant proposes to transport M.
pluton. The Committee noted that in the event of the organism being transferred the applicant
would have responsibility for ensuring that the facility to which the organism was being
transferred met all the requirements of this approval. The Committee endorsed additional
control 7.3 “Prior to transfer of the organism to another registered containment facility other
than AgResearch Wallaceville the applicant must inform ERMA New Zealand”.
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The Committee considered whether the approval should be limited to use of NCDI. The
Committee considered that the applicant’s level of experience combined with their
knowledge of handling microorganisms was material to the Committee’s satisfaction that the
organism will be adequately contained. Therefore, the Committee are only allowing NCDI to
operate this approval and not any organisation that met the controls as is normally the case
for organisms approved for import under section 40(1)(a) of the HSNO Act. Therefore, the
Committee restricts this approval to NCDI, additional control 7.2 “This approval is specific
to National Centre for Disease Investigation (NCDI) of Ministry of Agriculture and Forestry;
no other organisation may use this approval”.
(iv) Ability of the organism to establish a self-sustaining population
The Committee noted at this stage in New Zealand, it is thought that M. pluton would only
infect one species of bee (as stated earlier), that of A. mellifera, which is an introduced
species in New Zealand. As noted in section 4.5.1 of the E&R Report, in order for an
infection of M. pluton to establish a self sustaining population the following steps would need
to occur (as discussed in section 4.4 of the E&R Report):

Step1: M. pluton would need to escape containment;

Step 2: M. pluton would need to survive in the environment long enough (i.e. right
temperature, in anaerobic conditions and on a viable food source);

Step 3: A bee would need to be attracted to the bacteria or the media within which the
bacteria was growing;

Step 4: M. pluton would then need to come into contact with larvae of a susceptible
bee species;

Step 5: M. pluton would need to be fed to larvae of a susceptible bee species in
sufficient numbers in order to infect it.
The Committee noted that transmission is thought to occur by: the feeding of infected
foodstuffs to larvae; transfer to neighbouring colonies by swarms of bees; transfer by infected
honeycombs; transfer by infected beekeeper accessories. M. pluton is not known to be
transmitted as an aerosol or in water.
The Committee considered the establishment of the bacteria, should it escape from
containment and noted section 4.5 of the E&R Report. The Committee considered it likely
that if M. pluton escaped containment and it survived long enough and came into contact with
a host that it could establish a self-sustaining population. The Committee recognised the
uncertainty concerning assigning probabilities to the steps that would need to occur to result
in a susceptible bee becoming infected with M. pluton.
The Committee considers that eradication of the bacteria if it became established within a
susceptible host population is uncertain, as it would depend on whether it was detected and
whether MAF Biosecurity Authority chose to mount an incursion response in the event of the
discovery of an outbreak of EFB. The Committee noted that an infection of M. pluton may
persist for many years before becoming visible in bee hives.
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6
Assessment of the Risks, Costs and Benefits
The potential risks and costs assessed here are those identified as 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 E&R Report.
The Committee noted all the potential adverse and beneficial effects discussed in section 5 of
the E&R Report. Regarding human health and safety and potential adverse effects to society
and the community, the Committee concurred with the E&R Report and considered there
were no potentially significant adverse effects that warranted their attention. The Committee
then chose to focus their discussion on the potential adverse effects which they considered to
be most significant, potentially those to the environment, the economy and Māori.
Potential adverse effects to the environment
The Committee records that risks to the environment were considered, in accordance with
clauses 9(a)-9(c) and 10 of the Methodology.
The Committee concurred with the E&R Report in the assessment of the adverse
environmental effects:

Decline of A. mellifera (introduced bee species in New Zealand) resulting in adverse
effects on flowering plants dependent on A. mellifera for pollination;

Adverse effects on ecosystems that are made up of flowering plants dependent on A.
mellifera for pollination.
The Committee noted DoC’s submission “the risks associated with M. pluton and its
establishment in New Zealand lies primarily with the introduced honey bees. However, the
infection of hives and the resulting reduction in the bee population would have flow on
effects to the pollination of plants including numerous indigenous and introduced species.
The department notes that New Zealand’s native species have evolved without the presence
of these introduced bees and as such have developed alternative pollination mechanisms and
insect associations”.
The Committee concurred with the E&R Report in finding that there was limited information
available to assign a likely magnitude of adverse effect to, first, the decline of A. mellifera
and secondly, the potential adverse effects on ecosystems that are made up of flowering
plants dependent on A. mellifera in the event of escape and establishment of M. pluton in
New Zealand. The Committee noted the comments in the E&R Report that a decline of A.
mellifera does not necessarily result in a decline in flora dependant on it for pollination as it
may be that other native bees (or other introduced bee species or other pollinators) adapt to
fill this niche. However, the Committee concurred that there is limited information available
on bees to evaluate this possibility with any degree of certainty.
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The Committee considered that the magnitude of the potential adverse effect if A. mellifera
became infected with M. pluton would be moderate to major based on the assumption that A.
mellifera would be severely affected as would many plants dependant on it for pollination.
The Committee noted the high degree of uncertainty about the downstream effects, in the
event of a decline in the population of A. mellifera due, to the limited information about
pollination of plants in New Zealand.
Potential adverse effects on the economy
The Committee records that adverse effects to the economy were considered, in accordance
with clauses 9(a)-9(c) and 10 of the Methodology.
The Committee considered adverse effects in terms of

Pastoral sector (general pollination of clover).

Horticultural sector (crops requiring pollination using commercial hives).

Bee industry (reduced productivity, increased maintenance costs, possible increased
consumer resistance and loss of any perceived advantage of New Zealand bee
products being M. pluton free).

Cost of mounting an eradication program in the event of an outbreak of M. pluton.
The Committee considered the assessment of the consequences of the establishment of M.
pluton published by MAF Biosecurity Authority in 2003, regarding the import risk analysis
of honey bee genetic material. In this report, it was concluded that, although there is
uncertainty surrounding effects on honey bee colonies, there are likely to be significant
effects on hives used for commercial pollination, increased costs to honey exporters, such
that the consequences of introduction would be severe. The Committee also considered the
information that the applicant provided on the likely potential costs of establishment from a
recent West Australian publication entitled “Bee Industry Protection Plan” (Anon., 2001) and
the information about the varroa mite included in Appendix 6 of the E&R Report.
The Committee noted that although the Western Australia information was useful, it was not
as relevant to New Zealand in terms of economic costs as New Zealand already has varroa
widespread in the North Island and therefore, many of the costs associated with the various
sectors have already been incurred. The Committee considered this may have lead to a ‘worst
case scenario’ in terms of representation of costs. However, in noting this, the Committee
considered that an outbreak of EFB could still potentially result in moderate to major adverse
effects on the above sectors.
Potential for adverse effects on Māori
The Committee records that risks to Māori culture were considered in accordance with
sections 6(d) and 8 of the Act and clauses 9(b)(i) and 9(c)(iv) of the Methodology.
The Committee considered the potential effect of the mauri (life essence) of the surrounding
environment in the event of M. pluton escaping containment. However, the Committee has
considered the risk of escape from containment to be minimal and therefore, potential cultural
risks will be minimal.
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Assessment of Costs
A “cost” is defined in clause 2 of the Methodology as “the value of a particular adverse effect
expressed in monetary or non-monetary terms”. The Committee did not identify any costs
that would be incurred by the approval of the application other than those to the applicant.
The potential costs associated with the potential adverse effects described above were not
able to be quantified. However, the Committee notes that if M. pluton escaped and resulted in
an outbreak of EFB then the costs would be distributed over a wider group than the applicant
alone.
Assessment of benefits (beneficial effects)
A “benefit” is defined in clause 2 of the Methodology 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 of the Methodology were considered in terms of clause 13.
The Committee concurred with the evaluation of the benefits given in section 6.2 of the E&R
Report. The Committee noted that it is difficult to measure the benefits that validation of the
assay will have directly on New Zealand’s trade in bee products. However, the Committee
considered that clearly there is a strong economic component as there will be immediate cost
savings for the applicant who will have gained the ability to undertake diagnostic testing in
New Zealand. Furthermore, there are likely to be significant potential cost savings to the
industry from timely and accurate diagnosis and early response, in the event of the detection
of M. pluton. The availability of M. pluton in New Zealand for diagnostic purposes, if
approved, will mean that immediate benefits are realised for exporters involved in the
production of bee products in New Zealand.
7
Establishment of the Approach to Risk in the Light of Risk
Characteristics
Clause 33 of the Methodology requires the Authority to have regard to 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 relation to the biological and physical risks considered, the containment measures limit the
extent to which exposure to the risks is involuntary. The Committee also considered that
there were no significant risks which are not known or understood by the general public. It is
considered that the risks that may be difficult to control and which may be persistent and
irreversible are dependant upon escape from containment of the bacteria and its establishment
in the A. mellifera population. Given the Committee's finding that the risk of this occurring is
highly improbable, the extent to which these risk characteristics are present does not warrant
caution additional to that required by section 7 of the Act.
Environmental Risk Management Authority Decision: Application NOC03005
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8
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.
The Committee was unable to find common units of measurement with which to combine
risks and costs in accordance with clause 34(a). Therefore, it identified the dominant risk as
potential adverse effects on the environment, economy and Māori and their culture and
traditions in the event that A. mellifera became infected with M. pluton.
The Committee made the decision under clause 27 of the Methodology as it did not consider
that the risks to the economy and the environment were negligible. The Committee also
considered the uncertainty surrounding the ability of M. pluton to establish a self-sustaining
population should it escape containment and the uncertainty surrounding the magnitude of the
potential adverse effects to the economy and the environment that keeping the organism in
containment was of paramount importance.
The Committee considered all of the controls, set out in Appendix 1, and did so in the context
both of preventing the escape of the organism and of effectively managing any risks. The
Committee, having taken regard of these matters, is satisfied that the organism can be
adequately contained, and that the benefits of the application outweigh the costs.
9
Decision
1. Pursuant to section 45(1)(a)(i) of the Hazardous Substances and New Organisms Act
1996, 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)(g): Maintaining new
organisms in containment for diagnostic purposes.
Having considered all the possible effects in accordance with sections 45(1)(a)(ii) and
44 and pursuant to clause 27 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
risks (or costs) of adverse effects associated with the importation into containment of
the following organism are outweighed by the benefits:
Melissococcus pluton, Bailey and Collins, 1982.
2. The Committee is satisfied that the proposed containment regime, as set out in
Appendix 1, will adequately contain the organism as required by section 45(1)(a)(iii)
of the Hazardous Substances and New Organisms Act 1996.
3. 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
Hazardous Substances and New Organisms Act 1996 and clause 27 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;
 The Third Schedule-Part 2 matters to be addressed by containment controls for
new organisms.
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4. 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 21 – the decision accords with the requirements of the Hazardous Substances
and New Organisms Act 1996 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 27 - the risks are and costs are outweighed by benefits;
clause 33 – the risk characteristics; and
clause 34 – the aggregation and comparison of risks, costs and benefits.
5. The application for importation into containment of Melissococcus pluton, Bailey and
Collins, 1982 is thus approved, with controls, as set out in Appendix 1.
Associate Professor Marie Dziadek ____________ Date: 17 June 2004
Chairperson of Decision-making Committee
Organism approval code: NOC002260
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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Appendix 1: Controls
In order to satisfactorily address the matters detailed in the Third Schedule Part II:
Containment controls for new organisms excluding genetically modified organisms1of the
Act, and other matters in order to give effect to the purpose of the Act (section 45(2)), the
approved organism is subject to the following controls:
1 To limit the likelihood of any accidental release of any organism or any
viable genetic material2:
The organism shall be imported into and maintained in a containment facility that
complies with these controls:
1.1
The person responsible for a particular work area and/or the person responsible for the
operation of the containment facility (‘the facility’) shall inform all personnel involved
in the handling of the organism of the Authority’s controls.
1.2
The facility shall be approved by Ministry of Agriculture and Forestry (MAF), in
accordance with the MAF Biosecurity Authority/ERMA New Zealand Standard
154.03.023: Containment Facilities for Microorganisms and the controls of the
Authority.
1.3
The operation and management of the facility shall be in accordance with the:
a)
MAF Biosecurity Authority/ ERMA New Zealand Standard 154.03.023
Containment Facilities for Microorganisms including;
b) Australian New Zealand Standard AS/NZS 2243.3:20023 Safety in Laboratories:
Part 3: (Microbiology), at physical containment level 3 (PC3).
2 To exclude unauthorised people from the facility:
2.1
The identification of entrances, numbers of and access to entrances, and security
requirements for the entrances and the facility shall be in compliance with the
requirements of the Standards listed in control 1.3.
1
Bold headings refer to matters to be addressed by containment controls for new organisms excluding
genetically modified organisms, specified in the Third Schedule (Part II) of the HSNO Act 1996.
2
Viable genetic material is biological material that can be resuscitated to grow into tissues or organisms. It can
be defined to mean biological material capable of growth even though resuscitation procedures may be required,
e.g. when organisms or parts thereof are sub lethally damaged by being frozen, dried, heated, or affected by
chemical.
3
Any reference to this standard in these controls refers to any subsequent version approved or endorsed by
ERMA New Zealand.
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3 To exclude other organisms from the facility and to control undesirable and
unwanted organisms within the facility:
3.1
The exclusion of other organisms from the facility and the control of undesirable and
unwanted organisms within the facility shall be in compliance with the Standards listed
in control 1.3 .
4 To prevent unintended release of the organism by experimenters working
with the organism:
4.1
The prevention of unintended release of the organism by personnel working with the
organism shall be in compliance with the Standards listed in control 1.3.
5 To control the effects of any accidental release or escape of an organism:
5.1
Control of the effects of any accidental release or escape of the organism shall be in
compliance with the Standards listed in control 1.3.
5.2
If a breach of containment occurs, the facility operator must ensure that the MAF
Inspector responsible for supervision of the facility has received notification of the
breach within 24 hours.
5.3
In the event of any breach of containment that results in the escape of any viable
material of the organism subject to this approval, a contingency plan for the attempted
retrieval or destruction of any such material shall be implemented immediately. The
contingency plan shall be included in the Containment Manual in accordance with the
Standard 154.03.023 listed in control 1.3.
5.4
The applicant shall comply with the requirements of the Standards listed in control 1.3
relating to the maintenance of records demonstrating compliance with the Standard
154.03.023, as required by the quality assurance programme, and documented in the
Containment Manual.
6 Inspection and monitoring requirements for containment facilities:
6.1
The inspection and monitoring requirements for the containment facility shall be in
compliance with the Standards listed in control 1.3.
6.2
The Containment Manuals shall be updated, as necessary, to address the
implementation of the controls imposed by this approval, in accordance with the
Standard 154.03.023.
6.3
The training of personnel working in the facility shall be in compliance with the
Standards listed in control 1.3.
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7 Additional controls:
7.1
No live bees or live bee larvae shall be infected with M. pluton while the M. pluton
remains in containment.
7.2
This approval is specific to National Centre for Disease Investigation (NCDI) of
Ministry of Agriculture and Forestry; no other organisation may use this approval.
7.3
Prior to transfer of the organism to another registered containment facility other than
AgResearch Wallaceville the applicant must inform ERMA New Zealand.
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