13 November 2008
Application Code
Application Type
HSC08019
To import or manufacture a hazardous substance in containment under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Purpose of the Application
Pest-Tech Ltd
To manufacture into containment Erayse Ferret Bait as a semichronic poison for control of ferrets (field trial).
15 August 2008 Date Application Received
Consideration Date 13 November 2008
Considered by Rob Forlong, Chief Executive of ERMA New Zealand
1
1.1
The application to manufacture in containment the hazardous substance, Erayse Ferret
Bait, is approved with controls as set out in Appendix 1. The approval has been made in accordance with the legislative criteria set out in Appendix 2.
1.2
The substance has been given the following unique identifier for the ERMA New
Zealand Hazardous Substances Register:
Erayse Ferret Bait
2
2.1
The applicant states the purpose of this application is to assess the efficacy of a new semi-chronic poison in long-life bait for the control of ferrets. The product is a combination of two toxicants, cholecalciferol and coumatetralyl, and has been referred to as Erayse Ferret Bait. This application is to allow testing on ferrets in a field trial to provide efficacy data on wild ferrets and residue data in carcasses.
3
3.1
The application was formally received on 15 August 2008.

3.2
The consideration date was postponed until 13 November 2008 while the applicant contacted Ngai Tahu regarding the proposed trial.
3.3
Project Team:
Jo Prankerd
Sue Scobie
Zack Bishara
Noel McCardle
Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances)
Advisor (Māori Unit)
Senior Advisor (Hazardous Substances).
3.4
3.5
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing:
the management plan;
one report as supporting documentation;
a map specifying the boundaries of the trial blocks.
The following government departments were advised of the receipt of the application and given the opportunity to comment:

The Department of Conservation;

The Department of Labour (Workplace Group); and

The Agricultural and Veterinary Medicines (ACVM) Group of the New Zealand
Food Safety Authority (NZFSA).
3.6
3.7
No responses were received.
The applicant was provided with a copy of the proposed controls for Erayse Ferret Bait and given the opportunity to comment on them. The applicant raised no concerns with the proposed controls.
4
4.1
As the purpose (see section 2.1) amounts to “research on any hazardous substance to acquire information for use in assessing that substance”, the project team considers that the application qualifies for consideration under section 30(b).
4.2
Prior to manufacture the toxicants will be locked in a poisons store. All the toxic substances are currently registered in New Zealand as unrestricted poisons.
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4.3
The manufacture of Erayse Ferret Bait is confined to an enclosed building that has resource consent to manufacture toxic bait. It has a 6 foot wire-mesh fence around it and appropriate signage on the perimeter gate, on the door to the building and on the locked storeroom. The closest dwelling to the place of manufacture is 400m.
4.4
4.5
The toxicants are mixed into rabbit mince with a 40-quart mixer. The toxic mince will be stored in a locked storeroom.
Erayse Ferret Bait will be transported in labelled sacks, in a lockable compartment of a vehicle. In the event of an accidental spillage, the bait will be swept up and placed in bags or bins for disposal. The applicant recommends persons cleaning up the spill to wear gloves and a face mask.
4.6
Two sites have been identified in the McKenzie Basin as field sites. The field trials will be undertaken in accordance with the Management Plan in the confidential appendix to the application. Public access to the field sites is restricted as the field trials will be carried out on private property, with entry by landowner consent only.
4.7
The landowners of adjoining properties will be contacted in person, sent a letter describing the field trials, warned of risks to livestock and children that may trespass into the field site and given the dates that toxic bait will be applied in bait stations.
4.8
Warning signs will be displayed at points of entry to each field site during the period that toxic bait is applied in bait stations and for 4 months thereafter.
4.9
The sites are fenced with rabbit proof netting which will prevent domestic animals entering treatment areas and also slow the immigration and emigration of ferrets from treatment areas.
4.10
The bait will be applied in ferret tunnels or down rabbit burrows. Approximately 120 kg of Erayse Ferret Bait will be required to control ferrets over the two treatment areas.
4.11
At the completion of the trials any bait remaining will be recovered from the field sites.
The bait will be buried at least 60 cm below ground-level. The applicant advises that neither cholecalciferol nor coumatetralyl are mobile in soils and will not be leached into groundwater.
4.12
The ferret carcasses will be collected to provide data on residue levels.
4.13
The project team notes that the understanding of the hazardous properties of the substance only needs to be sufficient enough to ensure that any risks can be managed by the containment controls.
4.14
The applicant has examined the hazardous nature of the baits and considers the risks associated with the substance are primarily from primary poisoning and ecotoxicity.

Target organ toxicity (6.9B)

Aquatic ecotoxicity (9.1D).
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4.15
The project team has reviewed the summary data and other information supplied by the applicant and considers that the information is sufficient to determine that any risks posed within the defined lifecycle of the substance in New Zealand can be managed through the application of containment controls.
4.16
The applicant has identified and assessed potential risks and detailed proposals for, and impacts of, risk management. The project team has reviewed the applicant’s assessment of the risks to the environment and human health and welfare issues and concerns as set out below:
Risks to the environment
4.17
The proposed substance is slightly harmful to the aquatic environment. If released into the environment the substance has the potential to result in adverse effects on non-target species.
4.18
On the basis of the lifecycle of the substance, adverse environmental effects could arise from:
 an accident during storage, use or transportation, resulting in release of the baits;
 failure to follow the correct operational procedures as set out in the controls and containment system as described in the application, resulting in release of the baits; or
 failure to follow correct disposal procedures.
4.19
The applicant has shown in the containment system that the likelihood of adverse environmental effects occurring is low, as the baits will be manufactured and stored in secure environments, transported in sealed sacks and in a lockable compartment of a vehicle and the immigration or emigration of ferrets will be slowed due to rabbit proof fencing surrounding the field sites.
4.20
The applicant has also indicated that the risk of secondary poisoning of Erayse Ferret
Bait is low. It is noted that cage trials conducted previously indicate residue levels are low and residues in carcasses will be monitored during the research. The magnitude of the effect of non-target interference with bait is also considered by the applicant to be very low. Adjoining landowners are notified of the field trials and warned of the risk to livestock and the applicant also considers that should birds feed on the bait, it is unlikely a lethal dose will be eaten.
4.21
The project team has considered the ecotoxic properties of the substance, the quantities required for the trials, the controls listed in Appendix 1 of this decision and requirements under other legislation. Based on these considerations, the project team considers that risks to the environment from this trial can be adequately managed.
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Risks to human health and welfare
4.22
The project team considers that adverse effects to human health and welfare may result from exposure to the baits, given the substances toxic property.
4.23
On the basis of the lifecycle of the substance adverse effects could arise from:
 an accident during storage, use or transportation, resulting in release of the baits;
 failure to follow the correct operational procedures as set out in the controls and the containment system, resulting in personnel exposure while contained; or
 failure to follow correct disposal procedures.
4.24
The project team has considered the toxic properties of the substance, the quantities required for the trials, the containment regime proposed by the applicant, the controls in
Appendix 1 of this decision and requirements under other legislation. Based on these considerations, the project team considers that risks to human health and welfare can be adequately managed.
Māori issues and concerns
4.25
The project team considered this application using the framework contained in the
ERMA New Zealand user guide “Working with Māori under the HSNO Act 1996”.
4.26
The applicant and the project team noted that Erayse Ferret Bait triggers HSNO thresholds for toxicity and ecotoxicity and may therefore have adverse effects on the relationship of Māori to the environment, particularly with regard to the mauri of native and/or valued species and ecosystems. The applicant has informed Ngai Tahu of the proposed trial and was advised that further consultation was not necessary.
4.27
Taking into account the containment measures proposed, the project team considers any likely impact of the substance on the relationship of Māori to their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga to be negligible. In addition, because of the nature of the testing regime there is no evidence to suggest that the controlled use of this substance will breach the principles of the Treaty of Waitangi or inhibit the ability of iwi/ Māori to fulfil their role as kaitiaki.
4.28
This assessment is made on the condition that the substance is handled, blended, stored, transported, used, and disposed of as outlined in the trial protocols (the Management
Plan provided in the confidential appendix to the application) and in accordance with the explicitly stated HSNO 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 suggested that Pest-Tech Ltd notify the appropriate authorities 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.
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5
5.1
The project team has evaluated the adequacy of the containment arrangements proposed by the applicant and the controls listed in Appendix 1, and notes 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;
 to exclude organisms from a facility;
 to exclude unauthorised people from the facility;
 to prevent unintended release of the substance by experimenters working with the substance;
 to control the effects of any accidental release of the substance;
 inspection and monitoring requirements; and
 qualifications required of the person responsible for implementing the controls.
5.2
The project team is satisfied that, with adherence to the controls listed in Appendix 1 and those controls in place under other legislation, the baits can be adequately
6.1
contained.
6
I have considered this application made under section 31 and, pursuant to section 32, I am satisfied that this application is for the purpose specified in section 30(b), namely research on any hazardous substance to acquire information for use in assessing that substance.
6.2
Having considered the risks associated with the lifecycle of Erayse Ferret Bait, I am satisfied that the controls imposed, including those in place under other legislation, will result in the substance being adequately contained.
6.3
The application to manufacture in containment the hazardous substance Erayse Ferret
Bait is thus approved with controls as set out in Appendix 1 and in accordance with the relevant provisions of the Act and the Methodology as more specifically set out in
Appendix 2.
Rob Forlong
Chief Executive of ERMA New Zealand
Date: 13 November 2008
ERMA New Zealand Approval Code:
Erayse Ferret Bait (HSC08019) HSC000355
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1.
The trials shall be undertaken in accordance with the Management Plan (provided in the confidential appendix to the application) and the information specified within the application addressing matters to be considered under Part III of Schedule 3 of the Act.
Modifications of these specifications may be approved in writing by ERMA New
Zealand providing that they comply with the following controls.
2.
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.
3.
Notwithstanding the requirements of control 1 above, the manufacture and trials shall also comply with the following controls:
4.
Pest-Tech Ltd shall manufacture a maximum of 120 kg of Erayse Ferret Bait under this approval.
5.
Erayse Ferret Bait must be dyed green.
6.
The substance 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.
8.
Safety Data Sheets, compliant with the Hazardous Substance (Identification)
Regulations 2001, shall accompany each despatch of the substance and be held at the trial sites for the duration of the application.
9.
The baits shall be held in locked storage when not in use.
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 and the
Maritime Transport Act 1994.
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11.
Personal Protective Equipment (e.g. glasses, gloves and protective clothing) shall be worn when handling the substance (e.g. during manufacture, bait analysis, use and disposal).
12.
The ferret field trials shall be carried out in the McKenzie Basin on the two field sites identified in the confidential section of the application.
13.
Access to the trial sites shall be by landowner’s permission only.
14.
The two trial sites shall have warning signs displayed at each of the points of entry during the period that toxic bait is applied and for 4 months thereafter. The warning signs shall comply with the details as specified in the Management Plan in the confidential appendix to the application.
15.
During use the baits shall be under the control or supervision of an Approved Handler with certification for vertebrate toxic agents and who must hold a Controlled Substances
Licence. Experimental staff shall be trained and experienced in the handling and administration of vertebrate toxic agents under test conditions using the specified equipment. Experimental staff should also be aware of the trial protocols and the controls in place in order to adequately manage the substance.
16.
Before the ferret field trials commence, notification to the landowner of the field sites as well as the landowners of adjoining properties is required in accordance with section 4 of the application and in the Management Plan.
17.
The location of the Erayse Ferret Bait shall be recorded at each stage of the lifecycle from manufacture to disposal.
18.
Any accidental spillage of the substance shall be swept up and placed in bags or bins for disposal.
19.
All bait shall be recovered from the field sites at the completion of the trials. In the case of accidental spillage, the bait shall be swept up and buried.
20.
Disposal shall be carried out in a manner compliant with the Hazardous Substances
(Disposal) Regulations 2001. Ultimately, this would involve treating the substance in a manner to render the substance, as a whole, non-hazardous; or exporting the substance from New Zealand.
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21.
Any dead ferrets that are seen shall be collected for evaluation of residues and ultimately disposed of by burying.
22.
Any dead non-target species that are seen shall be collected for residue analysis.
23.
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 Erayse Ferret Bait
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
HSC08019
HSC000355
Jo Prankerd
24.
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.
25.
Trial documentation, as described in Control 1, notwithstanding its confidential nature, shall be available for inspection by any enforcement officer, upon request.
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A2.1
Unless otherwise stated, references to section numbers in this decision refer to sections of the Act and references to clauses refer to clauses in the Methodology.
A2.2
The application was lodged pursuant to section 31. The decision was made 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 (including the
Methodology) and the provisions of Part III of the Third Schedule of the Act.
A2.3
Government departments with an interest in this type of application were advised of the receipt of the application in accordance with clause 2(2)(e).
A2.4
This application was considered by the Chief Executive of ERMA New Zealand under delegation from the Authority (section 19(2)(e)).
A2.5
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 (Clauses 9, 12, 13, 14, 22, 24,
25) 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.
A2.6
In accordance with clause 36(2)(b), it is recorded that, in reaching his decision, the
Chief Executive applied the criteria specified in section 32.
A2.7
The Chief Executive also applied the following criteria in the Methodology:
 clause 11 – characteristics of substance;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 26 – all risks negligible;
 clause 35 – the costs and benefits of the controls.
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