ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
13 November 2008
Application Code
HSC08021
Application Type
To import or manufacture a hazardous substance in containment
under Section 31 of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Pest-Tech Ltd
Purpose of the Application
To manufacture in containment Erayse ZP Rodent paste to
assess the efficacy of encapsulated zinc phosphide for rat control
(Field trial).
Date Application Received
15 August 2008
Consideration Date
13 November 2008
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand.
1 Summary of Decision
1.1
The application to manufacture in containment the hazardous substance, Erayse ZP
Rodent Paste, 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 ZP Rodent Paste
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to manufacture and assess the
efficacy of encapsulated zinc phosphide for the control of rats. This application is to
allow testing on rats in a field trial to provide efficacy data on rats and residue data in
rat carcasses.
3 Application process
3.1
The application was formally received on 15 August 2008.
3.2
3.3
Project Team:
Matthew Allen
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Zack Bishara
Senior Advisor (Māori Unit)
Noel McCardle
Senior Advisor (Hazardous Substances).
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing:
-
3.4
the management plan;
five reports as supporting documentation;
a map specifying the boundaries of the trial blocks;
a copy of ACVM application;
a copy of Animal Ethics Committee (AEC) application.
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).
3.4.1
3.5
The applicant was provided with a copy of the proposed controls for Erayse ZP
Rodent Paste and given the opportunity to comment on them.
3.5.1
3.6
No responses were received.
The applicant indicated that the proposed controls were satisfactory.
The consideration date was postponed until 13 November 2008, while the applicant
contacted Ngai Tahu regarding the proposed trial.
4 Consideration
Eligibility
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).
Lifecycle
4.2
Prior to manufacture the toxicant will be locked in a poisons store.
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4.3
The manufacture of Erayse ZP Rodent Paste will be 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 200
m.
4.4
The active ingredient will be mixed with a cereal mix and lipids, using a 40-quart
mixer. 20 g of the mixed paste will be packed into paper bags. The manufactured
paste bait will be stored in a locked storeroom.
4.5
The manufactured paste bait will be transported in labelled plastic pails, in a lockable
compartment of a vehicle.
4.6
The field efficacy trials will be undertaken on private land, with landowner consent.
The field trials will be carried out at two locations on Banks Peninsula and undertaken
in accordance with the Management Plan in the confidential appendix to the
application. Public access will be by landowner consent only, which will restrict
public access to the field sites and baits.
4.7
The landowner of both field sites and 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 four months thereafter.
4.9
The paste bait will be applied in paper bags, attached to trees just above ground level,
at a rate of 222 g Erayse ZP Rodent paste / ha. A total of 10 kg of Erayse ZP Rodent Paste
bait will be used across two sites.
4.10
The bait will be recovered from the trial sites upon completion of the trials, and buried
at least 60 cm below ground-level. The applicant advises that zinc phosphide is not
mobile in soils and will not be leached into groundwater. The rate of degradation in
soil is dependent on soil moisture, but is typically in a range of 10-20 days.
4.11
A sample of eight rat carcasses will be collected to provide data on residue levels.
Hazardous properties
4.12
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.
 Acute toxicity (oral) - 6.1B
 Acute toxicity (dermal) – 6.1D
 Mutagenicity - 6.6B
 Target organ toxicity - 6.9B
 Aquatic ecotoxicity - 9.1A
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 Terrestrial ecotoxicity - 9.3A.
4.13
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.
Identification and evaluation of the significant risks of the substance in
containment
4.14
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
4.15
The proposed substance is very ecotoxic to the aquatic and terrestrial environments.
Thus, if released into the environment, the substance has the potential to result in
adverse effects on non-target species.
4.16
On the basis of the lifecycle of the substance, adverse environmental effects could
arise from:
 an accident during manufacture, storage, use or transportation, resulting in
release of the active ingredient and/or paste bait;
 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
active ingredient and/or paste bait; or
 failure to follow correct disposal procedures.
4.17
The containment system proposed by the applicant shows that the likelihood of
adverse environmental effects occurring is low, as the baits will be manufactured and
stored in secure environments, transported in polypails and in a lockable compartment
of a vehicle.
4.18
The applicant has also indicated that there is a low risk of secondary poisoning, in
particular to cats, from feeding on dead rodents that have eaten Erayse ZP Rodent
Paste. The residues in carcasses will be monitored during the research, to enable the
risks that the poisoned rats pose to non-target species to be modelled. Adjoining
landowners will be 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. The bait will be dyed blue/green and packed into blue paper bags
in order to reduce the likelihood of birds feeding on the bait.
4.19
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
4.20
The project team considers that adverse effects to human health and welfare may
result from exposure to the baits, given the substance’s toxic properties.
4.21
On the basis of the lifecycle of the substance adverse effects could arise from:
 an accident during manufacture, storage, use or transportation, resulting in
release of the active ingredient and/or paste bait;
 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.
4.22
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
4.23
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”.
4.24
The applicant and the project team noted that Erayse ZP Rodent Paste 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.
4.25
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.
4.26
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 Containment and controls
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 Erayse ZP Rodent Paste bait
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 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 ZP Rodent Paste, 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 ZP
Rodent Paste 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
Date: 13 November 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC08021
HSC000353
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
ERAYSE ZP RODENT PASTE
General
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:
Manufacture
4.
Pest-Tech Ltd shall manufacture a maximum of 10 kg of Erayse ZP Rodent Paste
under this approval.
5.
Erayse ZP Rodent Paste must be dyed blue/green, and packed into blue paper bags.
Packaging and Information
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.
Storage
9.
The baits shall be held in locked storage when not in use.
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 and
the Maritime Transport Act 1994.
General Handling of the Substance
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).
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Trial Site
12.
The field trials shall be carried out on Banks Peninsula, on the areas 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.
Trial Conditions
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 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 four of the application and in the Management Plan.
17.
The location of the Erayse ZP Rodent Paste and toxic bait shall be recorded at each
stage of the lifecycle from manufacture to disposal.
18.
Upon completion of the trials, any remaining Erayse ZP Rodent Paste bait shall be
recovered from the trial sites.
Emergency Management
19.
Any accidental spillage of the substance shall be swept up and placed in bags or
bins for disposal.
Disposal
20.
Any surplus Erayse ZP Paste bait (including bait recovered from trial sites upon
completion of the trials) will be returned to Pest-Tech Ltd., to be buried at least 60
cm below the ground.
21.
In the case of accidental spillage, the Erayse ZP Paste bait shall be swept up, placed
in sealed containers and returned to Pest-Tech Ltd. to be buried at least 60 cm
below the ground.
22.
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.
23.
Any dead rats that are seen shall be collected for evaluation of residues and
ultimately disposed of by burial at least 60 cm below the ground.
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24.
Any dead non-target species that are seen shall be collected for residue analysis.
Notification and Inspection
25.
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
Erayse ZP Rodent Paste
HSC08021
HSC000353
Matthew Allen
26.
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.
27.
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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APPENDIX 2: LEGISLATIVE CRITERIA FOR THE
APPROVAL
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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