ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Amended by section 67A of the HSNO Act on 22 April 2009
18 November 2008
Application Code
HSC08020
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 Rodent baits as semichronic poisons for the control of rats (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 Rodent
baits, 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 Rodent baits
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to assess the efficacy of a new
semi-chronic poison for the control of rats. The product is a combination of two
toxicants, cholecalciferol and coumatetralyl, and has been referred to as Erayse Rodent
baits. This application is to allow testing on rodents in a field trial to provide efficacy
data on wild rats and residue data in rat carcasses.
3 Application process
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:
3.4
Jo Prankerd
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:
- the management plan;
- a map specifying the boundaries of the trial blocks.
3.5
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
No responses were received.
3.7
The applicant was provided with a copy of the proposed controls for Erayse Rodent
baits and given the opportunity to comment on them. The applicant raised no issues with
the proposed controls.
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 toxicants will be locked in a poisons store. All the toxic
substances are currently registered in New Zealand as unrestricted poisons.
4.3
The manufacture of Erayse Rodent baits 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
Erayse Rodent bait will be manufactured in both a paste and a block formation. To
manufacture the paste bait, cereal mix, toxicants and lipid are mixed and 30g of paste
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will be packed into paper bags. To manufacture the extruded bait, the toxicants will be
mixed into a cereal mix and then formed into extruded baits weighing 5g. The
manufactured baits will be stored in a locked storeroom.
4.5
Erayse Rodent baits 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 for the rodent trials, which are situated on Department of
Conservation Land in Whataroa. However, access to the trial sites is over farmland and
requires permission from the landowners. This will restrict access to field sites and bait.
One area will be treated with the two toxicants in extruded bait and the other area will
be treated with the two toxicants in paste bait. The field trials will be undertaken in
accordance with the Management Plan in the confidential appendix to the application.
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 4 months thereafter.
4.9
The bait will be applied in tamper-proof ‘Set-n-Forget’ bait stations (a tunnel bait
station that sequentially delivers extruded bait) or in paper bags. The extruded bait will
be applied in rat tunnels where non-target exposure to poisons is very restricted, and the
paste bait will be applied in paper bags that will be attached to trees just above ground
level.
4.10
It is anticipated that 20 kg of extruded rodent bait and 14 kg of rodent paste bait will be
applied during the field trials. After 1 week, the ‘Set-n-Forget’ bait stations will be
inspected and any bait that is completely eaten will be replaced.
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
A sample of rat carcasses will be collected from each site to provide data on residue
levels.
Hazardous properties
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.
ERMA New Zealand Decision: Application HSC08020
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 Target organ toxicity (6.9B)
 Aquatic ecotoxicity (9.1D).
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.
Identification and evaluation of the significant risks of the substance in
containment
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 delivery systems used limit non-target exposure to bait.
4.20
The applicant has also indicated that the risk of secondary poisoning of Erayse Rodent
baits is low. It is noted that cage trials conducted previously indicate residue levels are
low and the 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. The applicant notes that during previous field trials
undertaken there have been no reported dog, cat or bird deaths.
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 Rodent baits 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 Containment and controls
5.1
5.2
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.
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
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 Rodent 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
The application to manufacture in containment the hazardous substance Erayse Rodent
baits 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: 18 November 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Erayse Rodent baits (HSC08020)
ERMA New Zealand Decision: Application HSC08020
HSC000357
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Amendment April 2009
Originally, the location of trial sites for this substance was in the Banks Peninsula. Trials will
now take place in Whataroa. The exact locations of the trial sites can be found in the confidential
appendix of this decision.
This is considered minor in effect as there is no increase in residual risk. Although it is on
Department of Conservation land, access to trial sites is via private land and therefore requires
permission from the landowner.
The controls imposed at the original trial site will still apply for the new trial site. No controls are
to be affected by this change.
This change has been made under section 67A of the HSNO Act under the category of ‘minor in
effect’ as there is no increase in cost or residual risk.
Rob Forlong
Chief Executive
ERMA New Zealand
ERMA New Zealand Decision: Application HSC08020
Date: 22 April 2009
Page 7 of 11
APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
ERAYSE RODENT BAITS
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 20 kg of Erayse Rodent baits in the
extruded bait formation and a maximum of 14 kg of Erayse Rodent baits in the paste
formation under this approval.
5.
Erayse Rodent baits must be dyed green and packed into blue or green 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.
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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).
Trial Site
12.
The rodent field trials shall be carried out in Whataroa on the two 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 rodent 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 Rodent baits shall be recorded at each stage of the lifecycle
from manufacture to disposal.
Emergency Management
18.
Any accidental spillage of the substance shall be swept up and placed in bags or bins for
disposal.
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 rodents 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.
Notification and Inspection
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
ERMA Application number
ERMA Approval number
ERMA Applications Advisor
Erayse Rodent baits
HSC08020
HSC000357
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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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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