ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
10 May 2006
Application Code
HSC06004
Application Type
To import hazardous substances into containment under
Section 31 of the Hazardous Substances and New
Organisms (HSNO) Act 1996
Biosecurity New Zealand Limited
P O Box 2526
Wellington
Applicant
Purpose of the Application
Sentricon Termite Bait: to import this hexaflumuron
containing bait into containment for use to evaluate the
product for a subterranean termite incursion at a few
termite infested properties in Nelson (field trial)
Date Application Received
4 April 2006
Consideration Date
10 May 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into containment the hazardous substance Hexaflumuron
(Sentricon Termite Bait) (referred to as ‘Sentricon Baits’ throughout this decision) is
approved with controls in accordance with the relevant provisions of the Hazardous
Substances and New Organisms Act 1996 (the HSNO Act) and the HSNO
(Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Hexaflumuron (Sentricon Termite Bait)
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision was
determined in accordance with section 32, taking into account additional matters to be
considered in that section and matters relevant to the purpose of the HSNO Act, as
specified under Part II of the HSNO Act and the provisions of Part III of the Third
Schedule of the HSNO Act. Unless otherwise stated, references to section numbers in
this decision refer to sections of the HSNO Act.
2.2
Consideration of the application followed the relevant provisions of the Methodology.
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
3
Application Process
3.1
The application was formally received on 4 April 2006.
3.2
Project Team:
Nicola Reeves
Applications Advisor (Hazardous Substances)
Sue Scobie
Senior Science Advisor (Hazardous Substances)
Peter Jackson
Advisor (Māori Unit)
Report review and sign-out by:
Noel McCardle
Applications Team Leader (Hazardous
Substances)
3.3
The applicant supplied the following documents:
 The application
 Confidential appendices.
3.4
The following Government departments were advised of the receipt of the application
(in accordance with clause 2(2)(e)) and given the opportunity to comment:
 The Ministry of Health
 The Department of Labour (Workplace Group).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for Sentricon Baits
and given the opportunity to comment on them. The comments received from the
applicant were taken into account when considering this application.
4
Consideration
Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e) of the HSNO Act).
4.2
In accordance with section 32 of the HSNO Act, the approach adopted when
considering this application was to confirm whether the application was for one of the
purposes specified in section 30, to identify and assess the risks and to determine
whether the substance could be adequately contained by controls to provide for each of
the matters specified in Part III of the Third Schedule of the HSNO Act.
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Purpose of the Application
4.3
The purpose of the application is to import in containment, for the purpose of field
testing, the hazardous substance Senticon Baits for use to evaluate the product for a
subterranean termite incursion at a few termite infested properties in Nelson.
4.4
As the purpose amounts to “research and development on any hazardous substance”, I
consider that the application qualifies for consideration under section 30(ba) of the
HSNO Act.
4.5
The termite species to be targetted with Sentricon Baits is Coptotermes acinaciformis,
an Australian species which has occasionally been accidentally imported into New
Zealand in hardwood timber. Termite colonies have recently been identified in Nelson.
The trial sites are two residential properties in this area.
4.6
Additionally, I note that the applicant indicates that this substance is intended for use in
an emergency. I note, however, that the termite infestations this substance is intended to
treat have not been declared an emergency under the HSNO Act or any other Acts, as
specified under section 30(c) of the HSNO Act.
Life Cycle
4.7
4.8
4.9
Storage
Once imported Sentricon Baits will be stored at Biosecurity New Zealand’s facilities in
St. Johns, Auckland. The substance will only be stored in this facility for a short
duration as the intention is to use this substance as soon as possible.
Transport
Sentricon Baits will be transported within New Zealand by air and/or road.
Presentation of the baits
Sentricon baits are available in two forms: one in the form of a tube (referred to as
Baitubes) for use in Sentricon In-Ground (IG) Termite Bait stations and on in the form
of the bait matrix contained in a polyethylene bag for use in Sentricon Above-Ground
(AG) Bait stations. While the presentation of the two baits differs, the composition is
the same (0.5% hexaflumuron and 99.5% cellulose).
4.10
The active ingredient, hexaflumuron, is an insect growth regulator. The mode of action
of this substance is to inhibit chitin synthesis which inhibits the moulting process in
termites resulting in colony eradication.
4.11
Sentricon IG Bait stations will be installed around the perimeter of the trial sites.
Initially when installed, these bait stations will only contain wooden monitoring
devices. These monitoring devices will be inspected periodically for evidence of
termites and only when termites are detected will the monitoring devices be replaced by
Baitubes.
4.12
Before use, the unopened Baitube is placed in a shallow dish containing 100 – 150 ml
water. The operator removes the outer covering from the Baitube while holding it
ERMA New Zealand Decision: Application HSC06004
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submerged, allowing water to penetrate the slots and wet the matrix to a dough-like
consistency. The Baitube is then inserted into the in-ground bait station, with any
excess water, and the lid loosely replaced.
4.13
Sentricon IG Bait stations will be monitored every 2 to 6 weeks and the Baitube
replaced with a new one, just before it is fully consumed.
4.14
Sentricon AG Bait stations consist of a secure plastic box containing hexaflumuron in a
cellulose matrix and will be installed only in those locations above ground where
termite feeding is detected.
4.15
The Sentricon AG Bait stations will be prepared by making a small slit in the
polyethylene bag containing the bait matrix. A plastic syringe will be used to inject
approximately 250 ml of water through the slit. Operators will ensure the bait is evenly
wetted. Once the bait station is installed, the fully wetted bait is placed in the station
with the slit towards the surface and the station cover replaced. I note that sugar
solutions can be used to wet the bait in addition to plain water.
4.16
Biosecurity New Zealand will import 80 Sentricon IG Baits (equivalent to 24 g of
hexaflumuron) and 20 Sentricon AG Baits (equivalent to approximately 8.5 g of
hexaflumuron). The total quantity of hexaflumuron sought to be imported under this
approval is approximately 32.5 g.
4.17
Once termite feeding has ceased the Sentricon AG Bait stations will be removed and
the bait will be removed from the Sentricon IG Bait stations. Wooden monitoring
devices will be placed in the in-ground stations.
4.18
Disposal
Disposal of the used Baitubes and plastic Baitube coverings will be through local
landfills. Any contaminated materials will also be disposed of in this manner.
Hazardous Properties
4.19
I note that a containment application requires only sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.20
The applicant has examined the properties of the components, and considers that the
substance will trigger thresholds for eye irritancy, target organ systemic toxicity (due to
reported effects of hexaflumuron on blood, kidney, liver and spleen and potential for
methaemoglobinemia following excessive exposure). With regards to adverse effects in
the environment, the applicant indicates that hexaflumuron in very highly toxic to
aquatic invertebrates on an acute basis and is slightly toxic to birds on a dietary basis.
4.21
I have reviewed the applicant’s hazard information and I consider that the information
is sufficient for me to determine that any risks can be managed by the containment
controls.
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Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.22
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of escape from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.23
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of risk management. I have reviewed the applicant’s
assessment of the risks and agree that it is suitable for the consideration below.
Risks to the Environment
4.24
If released off target, the substance has the potential to cause adverse effects to the
aquatic environment and terrestrial vertebrates.
4.25
On the basis of the lifecycle of the substance outlined in paragraphs 4.7-4.18, adverse
effects could arise from:
 An accident during storage, use or transportation, resulting in baits being released
into the environment and not being recovered;
 Failure to follow correct disposal procedures as outlined in the management controls
specified in the application;
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance;
 Access to the bait station by non-target species.
4.26
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
in Appendix 1 and controls in place under other legislation, there are no significant
risks to the environment. I consider that the controls in place are not too onerous to be
complied with and therefore the risks to the environment are negligible.
Risks to Human Health and Welfare
4.27
If the substance is ingested there is the potential to cause adverse effects on human
health.
4.28
On the basis of the lifecycle of the substance outlined in paragraphs 4.7-4.18, adverse
effects could arise from:
 An incident during storage, use or transportation, resulting in the baits being
released into the environment and not being recovered, giving rise to potential for
human exposure;
 Failure to follow correct disposal procedures as outlined in the management controls
specified in the application;
 Failure to follow the correct operational procedures as set out in the controls,
resulting in release of the substance;
 Access to the bait stations by persons (e.g. children) at the trial sites.
4.29
I consider that, taking into account the properties of the substance, the quantity
involved, the containment regime proposed by the applicant, the containment controls
ERMA New Zealand Decision: Application HSC06004
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in Appendix 1 and controls in place under other legislation, there are no significant
risks to human health and welfare. I consider that the controls in place are not too
onerous to be complied with and therefore the risks to human health and welfare are
negligible.
Māori issues and concerns
4.30
I have considered the potential Māori cultural effects of this application in accordance
with the Methodology clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO
Act, and the assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996”.
4.31
I note that the substance has hazardous properties that trigger HSNO toxicity and
ecotoxicity thresholds. There is the potential for this substance to have a negative
impact on Māori and the mauri of iwi, cultural tāonga and the environment.
4.32
I am unaware of any impacts that the substance could have on Māori culture, or, on
traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and
fauna or other taonga. I have no evidence to suggest that the controlled containmenttrial use of the substance will breach the principles of the Treaty of Waitangi and see no
requirement for the applicant to consult with Māori regarding this application.
4.33
This assessment is made on the condition that the substance is handled, stored,
transported, used and disposed of, in accordance with the explicitly stated controls, and
any controls stipulated in other applicable Acts. However, should inappropriate use, or
an accident, result in the contamination of waterways or the environment, it is
recommended that the appropriate authorities be notified including the relevant iwi
authorities in that region. This action should include advising them of the
contamination and the measures taken to contain and remedy it.
5
Containment and Controls
5.1
I have evaluated the adequacy of the containment arrangements proposed by the
applicant and the controls listed in Appendix 1, and note that these cover the matters set
out in Part III of the Third Schedule of the HSNO Act, being
 To limit the likelihood of escape of any contained hazardous substance or
contamination by hazardous substances (for example, control 9)
 To exclude organisms from a facility (for example, control 20)
 To exclude unauthorized people from the facility (for example, control 6)
 To prevent unintended release of the substance by experimenters working with the
substance (for example, control 11)
 To control the effects of any accidental release of the substance (for example,
control 23)
 Inspection and monitoring requirements (for example, control 28)
 Qualifications required of the person responsible for implementing the controls (for
example, control 15).
ERMA New Zealand Decision: Application HSC06004
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5.2
I am satisfied that, with adherence to the controls listed in Appendix 1 and those
controls in place under other legislation, Sentricon Baits can be adequately contained.
6
Decision
6.1
I have considered this application made under section 31, and pursuant to section 32, I
am satisfied that this application is for a purpose specified in section 30(ba).
6.2
Having considered the risks associated with the lifecycle of Sentricon Baits, I am
satisfied that the controls imposed, including those in place under other legislation, will
result in the substance being adequately contained.
6.3
In accordance with clause 36(2)(b) of the Methodology I record that, in reaching this
conclusion, I have applied the criteria specified in section 32 of the HSNO Act.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
6.5
The application to import into containment the hazardous substance Sentricon Baits is
thus approved pursuant to section 32 of the HSNO Act, with controls as set out in
Appendix 1.
Rob Forlong
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Hexaflumuron (Sentricon Termite Bait): HSC000231
ERMA New Zealand Decision: Application HSC06004
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Appendix 1: List of controls that apply to the
hazardous substance Hexaflumuron (Sentricon
Termite Bait)
1. The trials shall be undertaken in accordance with the site management plan specified in
the application. Modifications of the management controls may be approved in writing
by ERMA New Zealand providing that they comply with the following controls.
2. Notwithstanding the requirements of control 1 above, the trials shall also comply with the
following controls:
3. Trials shall be carried out only in the two residential properties in Nelson, identified to
ERMA New Zealand at the time this application was submitted.
4. Notwithstanding the requirements of control 3 above, the trials may be carried out at a
property within Nelson that will not be defined until an infestation of the target pest has
been found. Any additional trials will follow, and be enforceable, as per the Biosecurity
Act 1993, specifically:
 Section:121A Power to apply article or substance to place: An inspector
or authorised person may, for ascertaining the presence of any pest or
unwanted organism, bring onto and leave for a reasonable time at any
place, any article or substance;
 Under the Biosecurity Act (Section 114) an inspector or authorised person
who has lawfully entered a property under section 109 or section 111 may
do on or in respect of that property all such acts and things as appear to
the inspector or authorised person to be necessary or expedient for
eradicating or managing a pest or unwanted organism on the place or
preventing the spread of a pest or unwanted organism from or to the
place;
 As a courtesy permission shall first be sought from the property owner;
 ERMA New Zealand shall be notified of the location as per control 24.
5. The location of bait stations at the trial sites shall be chosen so as to prevent the substance
entering any surface water or groundwater system.
6. Access to the trial sites shall be by permission of the Trial Director1 or owner of the
property on which it is located.
7. The substance shall be stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS8409: 2004.
8. The Sentricon Baits shall be stored in a locked facility where access is restricted to
approved personnel only.
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of
the trial in accordance with the management controls specified in the application and approval controls.
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9. The trial sites shall be declared Restricted Places under Section 130 of the Biosecurity
Act, thereby restricting the movement of the Sentricon Baits and all other associated
materials from the trial sites. Any movement of the Sentricon Baits from the site shall be
directed by a Ministry of Agriculture and Forestry approved Inspector or Authorised
person.
10. Operators preparing the baits prior to insertion into the bait stations shall use personal
protective clothing and equipment.
11. The baits shall only be applied by way of the inclusion in Sentricon IG Bait stations or
Sentricon AG Bait stations, as appropriate.
12. The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in accordance
with the Hazardous Substances (Identification) Regulations 2001. A Safety Data Sheet
shall accompany each shipment.
13. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005.
14. Application, inspection and monitoring of the bait stations shall be carried out only by
Biosecurity New Zealand personnel, or agents acting on behalf of Biosecurity New
Zealand.
15. The personnel applying Sentricon Baits shall be able to demonstrate that they have the
qualifications necessary to carry out the trial. Ways of demonstrating this would include
the holding of an appropriate an Approved Handler qualification. These personnel should
also be aware of the site management plan provided in the application and the controls in
place in order to adequately manage the substance.
16. Residents of properties neighbouring the trial site shall be advised in writing of the trial
and the need to restrict access to the baits by pets and children.
17. Residents of the properties to be treated shall be advised in writing of the trial and the
need to restrict access to the baits by pets and children.
18. A site map shall be kept by the Trial Director of each site, identifying the location of the
bait stations.
19. During the trial Sentricon AG Bait stations shall have their lids applied when the bait is
present in the stations.
20. Soil covers shall be used on Sentricon IG stations during the trial when the bait is present
in the stations.
21. On completion of the trial, all bait stations shall be emptied of bait. Disposal of the used
baits and plastic bait coverings shall be carried out through local landfills, subject to the
facility’s waste acceptance policy. Any contaminated materials shall also be disposed of
in this manner.
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22. Surplus substance remaining at the end of the trials shall be stored in an exempt
laboratory, exported or degraded to non-hazardous substances (note that once the trials
are complete the substance does not have approval to be present in New Zealand except
in an exempt laboratory).
23. Any spillage of the baits shall be shall be contained, prevented from entering waterways,
and recovered. These recovered baits shall be used in the trial or disposed of through
local landfills, subject to the facility’s waste acceptance policy.
24. A record shall be kept of all use of the substance. This record shall cover all matters
referred to in Regulation 6 of the Hazardous Substances (Classes 6, 8 and 9 Controls)
Regulations 2001.
25. Information on appropriate safety precautions necessary to provide safeguards against the
substance’s toxic and ecotoxic properties shall accompany the substance at all stages of
its lifecycle. Personal protective equipment shall be worn when handling Sentricon Baits
or components of the bait stations.
26. The Department of Labour [Attn. HSNO Project Manager (Workplace Group) or
equivalent position] and ERMA New Zealand shall be informed in writing (by letter, fax
or email) of the location, start, and completion of the trials. Notifications shall include
the following details:
Substance name
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
Hexaflumuron (Sentricon Termite Bait)
HSC06004
HSC000231
Nicola Reeves
27. If for any reason a breach of containment occurs, the Trial Director shall notify the
Department of Labour and ERMA New Zealand within 24 hours of the breach being
detected. It is recommended that if a breach in containment results in contamination of a
waterway, the relevant iwi authorities be advised.
28. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
29. This approval remains in place for 2 years, from the date of approval.
30. The maximum total number of Sentricon IG Baits that shall be imported under this
approval is 100.
31. The maximum total number of Sentricon AG Baits that shall be imported under this
approval is 25.
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