Amended under s67A on 6 May 2008
ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
5 March 2008
Application Code
HSC07046
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”)
Connovation Ltd
Applicant
Purpose of the Application
To import or manufacture into containment CatNap to assess its
effects on weka (cage trial) and feral cats (field trial).
Date Application Received
13 February 2008
Consideration Date
5 March 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, CatNap, 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:
CatNap (in containment)
2 Purpose of the Application
2.1
The applicant states the purpose of this application is to allow for testing of a
potential vertebrate toxic agent, CatNap, a bait containing 4-aminopropiophenone
(PAPP) as the active ingredient. This application is to allow testing on weka in a
cage trial and feral cats at three field trial sites. This testing will allow the applicant
to assess the effectiveness of the substance on feral cats in the field and to assess the
potential risks of poisoning of non-target species (in this case, the weka). The
applicant has previously had containment applications approved for the testing of
CatNap against other species.
3 Application process
3.1
The application was formally received on 13 February 2008.
3.2
3.3
Project Team:
Haydn Murdoch
Advisor (Hazardous Substances)
Sue Scobie
Senior Advisor (Hazardous Substances)
Linda Faulkner
General Manager, Māori Unit
Noel McCardle
Senior Advisor (Hazardous Substances).
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing information regarding:
-
the manufacturing site and methods;
certification of the manufacturing site;
description of Connovation Ltd procedures, facilities and management;
information on what records will be kept;
the proposed formulation of the baits;
the hazardous properties of the active ingredients and baits;
a draft label;
a copy of the Animal Ethics Committee applications for both the feral cat
and weka trials;
- Māori consultation;
- trial methodology.
3.4
The following government departments were advised of the receipt of the
application and given the opportunity to comment:
 The Department of Conservation;
 The Ministry of Health;
 The Department of Labour (Workplace Group); and
 The Agricultural and Veterinary Medicines (ACVM) Group of the New Zealand
Food Safety Authority (NZFSA).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for CatNap and
given the opportunity to comment on them. The applicant had no concerns with the
controls.
ERMA New Zealand Decision: Application HSC07046
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4 Consideration
Eligibility
4.1
As the purpose (see section 2.1) amounts to “research and development on any
hazardous substance”, the Project Team considers that the application qualifies for
consideration under section 30(ba).
Lifecycle
4.2
The applicant advises that the substance will be dealt with throughout its lifecycle
in the following way:
4.2.1
Containment conditions will be given to all people involved in the
manufacture, use, storage and disposal of the experimental product. The
overall trial will be supervised by the applicant’s Study Supervisor who is
an Approved Handler.
Manufacture
4.2.2
CatNap will be manufactured at the Connovation Limited premises located
at 36B Sir William Ave. East Tamaki. This is a secure facility and the
product will be made and stored in the secure laboratory within the facility
and under the control of a person with an appropriate Approved Handler
certificate for substances that are highly toxic and used as Vertebrate Toxic
Agents. The product will be stored in labelled HDPE containers with screw
tops.
Transportation
4.2.3
The transportation of the CatNap off-site to the analytical laboratory, or
Study Supervisor and then to the study sites, will be in a labelled screw top
container within a Dangerous Goods Management box and in accordance
with all Land Transport Rules.
4.2.4
The CatNap will be transported to the Chatham Islands for the weka study
and to Canterbury and Northland for the feral cat trials. The Study
Supervisor has an Approved Handler Certificate and will store the CatNap
under lock and key or it will be under his control for the trials.
Analytical Studies
4.2.5
Prior to commencement of the trials a sample of CatNap will be sent to the
Toxicology Laboratory, Landcare Research, for analysis of the PAPP
content. Procedures will be in place to store and handle products securely.
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Weka Trials
4.2.6
The weka trials will be conducted in accordance with the Trial Protocol
provided in section 6 of the Confidential Appendix to the application.
4.2.7
Twenty weka (a mixture of adults and juveniles) will be captured and kept
in separate cages in a shed. The means of administration to the weka will
be by voluntary ingestion. The weka will be preconditioned with non toxic
raw minced meat, but it is not envisaged there would be a long delay
between capture and the cage trial.
4.2.8
The study outline will first be approved via an Animal Ethics Application
to the Lincoln University Animal Ethics Committee and conducted in
compliance with any conditions on that approval.
4.2.9
The cage study will be undertaken at a Department of Conservation
approved site on the Chatham Islands. The birds will be in cages in a shed
to limit access of non-target species and unauthorised persons to the
substance.
4.2.10
The weka will be provided with a single feed of minced meat dosed with
different concentrations of PAPP. The birds will be observed for 3 hours or
until fully recovered. Any weka showing any sign of distress will be
euthanased within this time and then individually frozen in labelled bags.
All weka will be euthanased on completion of the trial. Provision will also
be made for frozen weka carcasses from the trial to be sent to the Landcare
laboratory for residue analyses should this be required. The weka carcasses
will then be disposed of by incineration by a licensed commercial
contractor.
Feral Cat Trials
4.2.11
The feral cat trials will be conducted in accordance with the Trial Protocol
provided in section 8 of the Confidential Appendix to the application.
4.2.12
Two locations in Canterbury and a single Northland site have been
identified. An Animal Ethics Application from the Lincoln University
Animal Ethics Committee is required for trials and the trials will be
conducted in compliance with any conditions of that approval.
4.2.13
A pre-feeding regimen with non-toxic feed will be employed prior to
dispensing of the toxic meat bait containing the CatNap bait. Feed baits
will be placed in the field for up to five weeks before the toxic bait is
placed.
4.2.14
For these trials, the baiting will be undertaken using a “submarine” bait
station as illustrated in the application to minimise non-target
access/interference. The bait station design for this trial has been chosen to
prevent access by species other than cats, stoats or ferrets. Most dogs,
ERMA New Zealand Decision: Application HSC07046
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hedgehogs and domestic stock would be excluded. This bait station design
would also exclude meat eating birds such as the morepork and hawks.
4.2.15
Bait stations containing meat bait will be placed in a grid over the sites at
approximately 400 metre spacings. The baiting strategy will maximise the
exposure of feral cats to bait but will also take into account the
presence/population/location of other non-target species observed during
the pre-feeding part of the study. Therefore the precise size of the trial plot,
number of lines and bait stations will vary depending on the features of the
actual field site. The toxic baits will be placed in the field for five nights
and an assessment of mortality made. A second application of toxic bait
will be undertaken if required.
4.2.16
Baits will be checked, counted and removed each morning; bait condition
will be assessed and replaced each evening. Baits that are unusable will be
placed in air tight containers and sent back to Connovation Ltd. Baits will
be left out for a maximum of five nights.
4.2.17
All baits removed from the site will be placed in a sealed plastic container.
All untaken or unused CatNap bait will be returned to Connovation Ltd for
disposal.
4.2.18
Surviving feral cats in this trial will be trapped in cage traps and humanely
euthanased using standard veterinary practice. All the feral cats that are
tagged as part of this trial will be collected and disposed of by burning or
burying depending on the availability of facilities at or near the test sites.
4.2.19
Baits will be placed at least 20 metres from waterways. The applicant
considers feral cats and other potential scavengers or predators are unlikely
to take baits into water.
Disposal of Bait
4.2.20
Any unused or untaken toxic baits and unused CatNap paste will be
returned to Connovation for disposal in accordance with local by-laws
through Transpacific Technical Services Limited (formerly United
Environmental Ltd).
4.2.21
Wiped bait stations and cages from the weka trial will be washed down
with water.
4.2.22
Gloves and overalls will be put into a plastic bag and then washed
(separate to household laundry) and dried before re-use.
Hazardous properties
4.3
The applicant has examined the hazardous nature of the baits and considers them to
trigger the following hazard classifications:
 Acute oral toxicity (6.1B)
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 Terrestrial vertebrate ecotoxicity (9.3A)
4.4
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
4.5
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, human health and welfare and Māori
issues and concerns as set out below:
Risks to the environment
4.6
The proposed substance is highly ecotoxic to terrestrial vertebrates (especially
carnivores). If released into the environment the substance has the potential to
result in adverse effects on non-target species.
4.7
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.
4.8
The Project Team has considered the highly ecotoxic properties of the substance,
the quantities required for the trials (≤1kg), 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.
Risks to human health and welfare
4.9
The Project Team considers that adverse effects to human health and welfare may
result from exposure to the baits, given that the substance has highly toxic
properties.
4.10
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.
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4.11
The Project Team has considered the toxic properties of the substance, the
quantities required for the trials (≤1kg), the containment regime proposed by the
applicant, the controls in Appendix 1of this decision and requirements under other
legislation. The applicant has given specific consideration to the fact that CatNap
contains a highly toxic substance. Provisions to avoid risk to human health include
approved handler requirements, personal protective equipment, and information
requirements. Based on these considerations, the Project Team considers that risks
to human health and welfare can be adequately managed.
Māori issues and concerns
4.12
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”.
4.13
The applicant and the Project Team noted that CatNap triggers HSNO thresholds
for toxicity and ecotoxicity 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.
4.14
The Project Team notes that the applicant undertook consultation with the
appropriate iwi/Māori groups within the regions of the trial sites and considers their
efforts to be consistent with ERMA New Zealand policy (details included in
Section 10 of the Confidential Appendix to the application).
4.15
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.
4.16
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 (Section
6 and 8 of 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 Connovation
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.
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;
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5.2

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(ba),
namely research and development on any hazardous substance.
6.2
Having considered the risks associated with the lifecycle of CatNap, 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 CatNap 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: 5 March 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
CatNap (in containment)
ERMA New Zealand Decision: Application HSC07046
HSC000319
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Amendment May 2008
On Page 10 of the original decision control 13 read as follows:
“The feral cat field trials shall be carried out at the two Canterbury sites and one Northland site
as identified in the confidential section of the application (Appendix A- Section 8)”
It was amended under Section 67A of the HSNO Act so that page 11 now reads
“The feral cat field trials shall be carried out at the two Canterbury sites (as identified in the
applicant’s email of 28 April 2008) and one Northland site as identified in the confidential
section of the application (Appendix A- Section 8)”
Rob Forlong
Chief Executive
ERMA New Zealand
ERMA New Zealand Decision: Application HSC07046
Date
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
CATNAP
General
1.
The trials shall be undertaken in accordance with the Trial Protocols (provided in
sections 6 and 8 of the Confidential Appendix to the application) and the
information specified within section 4 of 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.
Connovation Ltd shall manufacture a maximum of 1kg of CatNap at the
Connovation Ltd premises in Auckland under this approval.
Packaging and Information
5.
The substance shall be securely packed in suitable containers that comply with the
Hazardous Substances (Packaging) Regulations 2001.
6.
Packages shall be labelled in accordance with the Hazardous Substances
(Identification) Regulations 2001.
7.
The labels must also set out instructions that any of the bait remaining after the
trials must be returned in its original container to Connovation Ltd.
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 Sites
12.
The weka cage trials shall be carried out in the Chatham Islands as identified in the
confidential section of the application (Appendix A - Section 6).
13.
The feral cat field trials shall be carried out at the two Canterbury sites (as
identified in the applicants e-mail of 28 April 2008) and one Northland site as
identified in the confidential section of the application (Appendix A - Section 8)
14.
Access to the trial sites shall be by permission of the Study Director1 or researcher
nominated by the Study Director. The trial sites shall be signed indicating that
unauthorised access is not permitted, that the site is subject to a trial, and that trial
animals and other animals should not be removed.
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.
The feral cat field trials will use ‘submarine’ bait stations as illustrated in section
3.4.5 of the application.
17.
Before the feral cat field trials commence, notification of veterinary clinics within
the vicinity of each trial site is required advising them of:
 where and when trials are taking place;
 signs/symptoms of poisoning with PAPP; and
 treatment of PAPP poisoning, including the use of methylene blue as an effective
antidote.
18.
Before the feral cat field trials commence, notification of occupiers of land within 1
km of the trial sites is required advising them of:
 where and when trials are taking place;
1
The Study Director is the individual appointed by the applicant to be responsible for the overall conduct of the
trial in accordance with information provided in Appendix A of the application and the approval controls.
ERMA New Zealand Decision: Application HSC07046
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 steps to be taken to prevent domestic animals/pets accessing the trial sites;
 signs/symptoms of poisoning with PAPP; and
 which vet clinics have been briefed on the trial and how quickly they need to get
an animal treated and the use of methylene blue as an effective antidote.
19.
The location of the CatNap and toxic bait shall be recorded at each stage of the
lifecycle from manufacture to disposal.
Emergency Management
20.
Any accidental spillage of the substance shall be contained, and placed in an
appropriate container. These containers shall be returned to Connovation Ltd for
disposal.
Disposal
21.
Any surplus substance remaining at the end of the trials shall be returned to
Connovation Ltd where it shall be securely stored in a laboratory complying with
the requirements set out in the Hazardous Substances (Exempt Laboratories)
Regulations 2001 for the purpose of further analysis or until disposed of.
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.
Dead feral cats will be disposed of by incineration, or burying in a landfill,
depending on the availability of facilities near or at the trial sites. Dead weka shall
be disposed of by incineration by a licensed commercial contractor.
Notification and Inspection
24.
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
CatNap (in containment)
HSC07046
HSC000319
Haydn Murdoch
25.
If for any reason a breach of containment occurs, the Study 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.
26.
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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