19 September 2006
Application Code
Application Type
Applicant
HSC06014
To import hazardous substances into containment under
Section 31 of the Hazardous Substances and New Organisms
(HSNO) Act 1996 (the Act)
Landcare Research New Zealand Limited
Private Bag 6
Nelson 7001
Purpose of the Application
To develop pesticides for the control of social wasps,
Argentine ants, Darwin's ant and possibly other pest ant species (field trial).
Date Application Received
Consideration Date
Considered by
11 August 2006
19 September 2006
Rob Forlong, Chief Executive of ERMA New Zealand
1.1
The application to import into containment the hazardous substance Experimental
Wasp and Ant Baits is approved with controls in accordance with the relevant provisions of the Act and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Experimental wasp baits - HSNO Approval Number HSC000246
Experimental ant baits - HSNO Approval Number HSC000245
2.1
The application was lodged pursuant to section 31. The decision was determined in accordance with section 32, taking into account additional matters to be considered in that section and matters specified under Part II of the Act and the provisions of
Part III of the Third Schedule 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. Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology.

3.1
The application was formally received on 11 August 2006.
3.2
Project Team:
Brendon Noonan/Nicola Reeves Advisors (Hazardous Substances)
Chris Geering
Zack Bishara
Report review and sign-out by:
Advisor (Hazardous Substances)
Advisor (Māori Unit)
Noel McCardle Senior Advisor (Hazardous Substances)
3.5
3.6
3.3
3.4
The applicant supplied the following documents:
 the application; and
 confidential appendices including details of the formulations of the baits, potential field site scenarios and bait station details.
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; and
 the Department of Labour (Workplace Group).
No responses were received.
The applicant was provided with a copy of the proposed controls for Experimental
Wasp and Ant Baits and given the opportunity to comment on them. No response was received.
4.1
This application was considered by the Chief Executive of ERMA New Zealand under delegated powers from the Authority (section 19(2)(e)).
4.2
In accordance with section 32, 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 Act.
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4.3
The purpose of the application is to manufacture in containment, for the purpose of field testing, Experimental Wasp and Ant Baits for the control of social wasps
( Vespula germancia and common Vespula vulgaris ), Argentine ants ( Linepithema hurrile ), Darwin's ant ( Doleromyma darwiniana ) and possibly other pest ant species.
4.4
The experimental baits, which will contain 0.02 to 0.5 g/kg indoxacarb, will be manufactured and field tested to determine palatability and efficacy. Baits containing 0.02 to 0.2 g/kg indoxacarb will be tested as ant baits, while baits with
0.1 to 0.5 g/kg indoxacarb will be tested as wasp baits.
4.5
As the purpose amounts to “research and development on any hazardous substance”, the Agency considers that the application qualifies for consideration under section 30(ba).
4.6
The applicant advises that the active ingredient will be imported into New Zealand.
The experimental baits will be manufactured in the Landcare Research Ltd laboratory in Nelson. The applicant advises that this laboratory meets the requirements of the Hazardous Substances (Exempt Laboratories) Regulations
2001. The baits will be packaged in HDPE (high density polyethylene) buckets with press-on lids, plastic vacuum packed, and then frozen.
4.7
The applicant states that most of the field trials will be carried out in the Nelson region; however, some trials may be carried out at alternative sites around New
Zealand, depending on the design of the trial. Medium- to high-density wasp numbers are needed to carry out the field trials and, as wasp numbers appear to be affected by spring weather conditions, wasp trials may need to be at alternative sites. The applicant advises that large scale ant bait trials will probably need to be carried out further north, as the warmer climate may mean higher density ant populations and a longer period in the year that the ants are active. These trials will possibly be conducted in the Auckland region.
4.8
Baits shall either be applied using bait stations or by direct application to the ground. Baits will be recovered from the environment where feasible. The applicant advises that as part of the protocol for baiting large areas to control wasps, the bait is removed after 3 days. After this time the bait is less attractive to wasps and it is more likely that non-target species will take the bait. The protocol for baiting large areas to control pest ants does not include removing any waste bait as it is not considered feasible. The bait is applied using a caulking gun directly onto the ground under natural cover to prevent non-target species visually finding the bait and to stop it from drying out.
4.9
The applicant states that a tracking system will be used to record the amount of bait manufactured (weight, toxin concentration), field trials carried out (location, area, number of baits, toxin concentration) and fate of waste bait.
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4.10
Waste bait containing indoxacarb is stored sealed in a freezer until disposal by a company specialising in the handling and disposal of hazardous wastes.
4.11
It is noted that a containment application requires only sufficient understanding of the hazardous properties to ensure that any risks can be managed by the containment controls.
4.12
The applicant has examined the hazardous properties of the active insecticidal ingredient, indoxacarb, and the experimental baits and considers that the baits will trigger several HSNO thresholds for toxicity and ecotoxicity. The Agency notes that because of the low indoxacarb concentrations not all these hazards may be triggered by the baits.
4.13
The Agency has reviewed the applicants’ hazard information and additional information available to it and considers that there is sufficient information to determine that any risks posed by the can be managed by the containment controls.
4.14
In accordance with sections 5, 6, and 8 and clauses 9 and 11, the potential risks of escape from containment under the headings of environmental, human health and welfare and Māori issues and concerns were considered.
4.15
In the application, the applicant identified and assessed potential risks, and detailed proposals for, and impacts of risk management. The Agency has reviewed the applicants’ assessment of risks and agrees that that it is suitable for the consideration below.
Risks to the environment
4.16
Given the substance’s ecotoxicity the potential exists for harm to be caused to organisms in the aquatic environment and to terrestrial vertebrates and invertebrates if exposed to the substance.
4.17
On the basis of the substance’s lifecycle, as outlined in paragraphs 4.6 to 4.10, adverse environmental effects could arise from:
 an incident during manufacture, storage or transportation resulting in the substance’s release into the environment and it 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 application and controls, resulting in release of the substance; or
 access to the bait by non-target species either during the trial or post trial if not recovered.
4.18
The Applicant has identified that birds foraging on the ground may be exposed to the baits; however, they consider that bird would need to consume a large number of baits to suffer adverse effects. The applicant considers that the risk posed by the
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baits is low because they will be hard to locate visually given that they are laid under ground cover and the size of the baits is small meaning that birds would need to consume a large number of baits for adverse effects to occur. As a measure to protect indigenous fauna the applicant will colour the baits green and will not conduct trials in areas frequented by weka.
4.19
The Agency considers that the risk posed to the environment, through non-recovery of bait post trial (large scale ant trial), is insignificant given the small quantities of the invertebrate toxic agent used and the highly localised nature of the bait sites even thought it has an attractant protein base. The Agency notes that the indoxacarb is currently approved for wide dispersive application in selected agricultural crops. As such it is considered that the leaving remnants of unconsumed bait post trial, even with the protein base, would not significantly impact on non-target species.
4.20
Taking into account the properties of the substance, the quantities involved, the containment regime proposed by the applicant, the containment controls specified in Appendix 1 and controls in place under other legislation, the Agency considers that there are no significant risks to the environment.
Risks to human health and welfare
4.21
Given the toxic nature of indoxacarb the experimental bait formulations may have the ability to adversely affect human health in the event of exposure(s).
4.22
On the basis of the substance’s lifecycle, as outlined in paragraphs 4.6 to 4.10, adverse effects could arise from:
 an incident during manufacture, storage and transport that resulted in the substance’s release allowing for subsequent human exposure;
 failure to follow the specified disposal procedures outlined in the application;
 failure to following the correct operational and handling procedures outlined in the application and in Appendix 1; or
 access, by persons (eg children) to bait within the trial sites.
4.23
Taking into account the properties of the substance, the quantities involved, the containment regime proposed by the applicant, the containment controls specified in Appendix 1 and controls in place under other legislation, the Agency considers that no significant risks are posed to human health by the substance.
Māori issues and concerns
4.24
The Agency has considered the potential Māori cultural effects of this application in accordance with clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8, and the assessment framework contained in the ERMA New Zealand User Guide “Working with Māori under the Act 1996”.
4.25
It is noted that the substance has hazardous properties that trigger several HSNO toxicity and ecotoxicity thresholds. Consequently, the potential exists for the substance to have a negative impact on Māori and mauri of iwi, cultural tãonga and the environment.
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4.26
The Agency is 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 tãonga. There is no evidence to suggest that the controlled containment-trial use of the substance will breach the principles of the
Treaty of Waitangi and the Agency sees no requirement for the applicant to consult with Māori regarding this application.
4.27
This assessment is made on the condition that the substance is manufactured, 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.
5.1
The Agency has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and considers that these cover the matters set out in Part III of the Third Schedule of the Act, being
 to limit the likelihood of escape of any contained hazardous substance or contamination by hazardous substances (for example, control 6);
 to exclude organisms from a facility (for example, control 3);
 to exclude unauthorized people from the facility (for example, control 9);
 to prevent unintended release of the substance by experimenters working with the substance (for example, control 21);
 to control the effects of any accidental release of the substance (for example, control 24);
 inspection and monitoring requirements (for example, control 29); and
 qualifications required of the person responsible for implementing the controls
(for example, control 20).
5.2
The Agency is satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, that the substance can be adequately contained.
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) ie for purposes of “research and development” on the experimental wasp and ant baits.
6.2
Having considered the risks associated with the lifecycle of Experimental wasp and ant baits, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substance being adequately contained. Further, I consider that the controls applied are not too onerous to be complied with.
6.3
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have applied the criteria specified in section 32.
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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 manufacture and field trial, in containment the, hazardous substance
Experimental wasp and ant bait is thus approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong Date 19 September 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Experimental wasp bait:
Experimental ant bait:
HSC000246
HSC000245
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General
1.
All lifecycle stages, from manufacture to disposal, shall be undertaken in accordance with the information provided by the applicant in their application and accompanying appendices. Modification of this information may be approved in writing by ERMA
New Zealand provided that those modifications comply with the following controls.
2.
Notwithstanding the requirements of control 1 above, the manufacture and trialling of the substances shall comply with the following controls:
Manufacture
3.
Landcare Research Limited or an agent approved by Landcare Research Limited may manufacture the substances identified as, Experimental wasp bait and Experimental ant bait, in containment in a laboratory that meets the requirements of the Hazardous
Substances (Exempt Laboratories) Regulations 2001.
4.
The baits shall be coloured green to make them less attractive to birds.
5.
The maximum quantity of the active insecticidal agent, indoxacarb, that may be used in these trials is 5.0kg.
Packaging and Information
6.
The substances shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
7.
Packages shall be labelled in accordance with the Hazardous Substances (Identification)
Regulations 2001. The label must also set out instructions that any of the substance remaining after each trial must be returned in its original container to Landcare
Research limited.
8.
A Safety Data Sheet, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each shipment of the substance and be held at each trial site for the duration of the trial.
Storage
9.
The substances shall be securely stored in accordance with the Code of Practice for the
Management of Agrichemicals NZS 8409: 2004, ie be locked in facilities where access is restricted to authorised persons only.
Transport
10.
The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the
Maritime Transport Act 1994.
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General handling of the substances
11.
Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective clothing shall be worn when handling the substances, for example during manufacture, handling, application and disposal.
Trial Conditions
12.
This approval covers the field trialling of experimental wasp and ant baits to assess efficacy, effective concentration and palatability of the baits to the target species and to assess bait attractiveness to honey bees.
13.
Prior to commencement of any trial the location of the trial sites shall be identified, in writing, to ERMA New Zealand.
14.
A site map shall be kept by the Trial Director of each site, identifying the location of the trial sites and bait stations.
15.
The location of bait stations at trial sites shall be chosen so as to prevent the substance entering any surface water or groundwater system.
16.
Ground based ant bait trials shall not be conducted in areas frequented by weka
( Gallirallus australis )
17.
Baits shall be laid in accordance with the specified trial protocol.
18.
Where baits are laid in residential areas, residents within the trial site property and neighbouring properties the trial site shall be advised in writing of the trial and the need to restrict access to the baits by pets and children.
19.
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.
20.
Access to the trial sites shall be by permission of the Trial Director
1
, nominated researcher or owner of the property on which it is located. The trial sites or boundaries shall be clearly marked and distinctly visible throughout the life of the trials. The trial sites shall be signed indicating that unauthorised access is not permitted, that the site is subject to a trial, and that baits are hazardous and should not be tampered with.
21.
During use, the substance shall be under the control of experimental staff, who are trained and experienced in the handling and laying of pesticidal agents under test conditions using the specified equipment. Experimental staff should also be aware of the study protocol and the controls in place in order to adequately manage the substance.
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 Plan and approval controls.
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22.
The substances shall be mixed, diluted, prepared or otherwise handled in accordance with the relevant sections of the Code of Practice for the Management of Agrichemicals
NZS 8409: 2004.
23.
After application, any equipment used in the trial shall be disposed of in an appropriate manner or be cleaned with the residue and/or rinsate, being treated in a manner so that it is no longer hazardous.
24.
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 substances do not have approval to be present in New Zealand except in an exempt laboratory).
Emergency Management
25.
Any accidental spillage of the substances shall be contained, prevented from entering waterways and be recovered using appropriate equipment and materials. Contaminated material shall be placed in sealed containers and disposed of at an appropriate waste disposal facility (which may include a landfill), subject to the facility’s waste acceptance policy. Any equipment used shall be cleaned with any residues or rinsate being disposed of in accordance with the disposal requirements.
Disposal
26.
Any surplus substance remaining at the end of the trials shall be returned to Landcare
Research Limited where it shall be securely stored in an exempt laboratory, until needed for further analysis, or be disposed of in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001. Please note that once the trials are completed the substance does not have approval to be present in New Zealand except in an exempt laboratory unless in the process of being disposed of by the nominated disposal agent.
27.
Containers no longer used to contain the substance or residue or rinsate from equipment used to handle the substance shall be disposed of in a manner compliant with the
Hazardous Substances (Disposal) Regulations 2001.
Notification and Inspection
28.
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
Experimental wasp bait and/or
Experimental ant bait
HSC06014
HSC000
Brendon Noonan
29.
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 suggested that if a breach in containment results in contamination of a waterway, the relevant iwi authorities be advised.
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30.
The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time. Trial documentation, notwithstanding its confidential nature, shall be available for inspection by any enforcement officer, upon request.
31.
This approval remains in place for the term of any concurrent approval required under the Agricultural Compounds and Veterinary Medicines Act 1997, to a maximum of five years.
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