ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
9 June 2009
Application Code
HSC09009
Application Type
To import into containment or manufacture in containment a
hazardous substance under Section 31 of the Hazardous
Substances and New Organisms Act 1996 (“the Act”)
Connovation Ltd
Applicant
Purpose of the Application
To manufacture in containment PAPP Paste for use on feral cats
in a field study (field).
Date Application Received
20 May 2009
Consideration Date
9 June 2009
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, PAPP 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:
PAPP Paste
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 containing PAPP [4-aminopropiophenone] as the
active ingredient. The applicant has previously had containment applications
approved for the testing of this paste against cats and other species. This application
is to allow for an additional field trial on feral cats.
3 Application process
3.1
The application was formally received on 20 May 2009.
3.2
3.3
Project Team:
Haydn Murdoch
Advisor (Hazardous Substances)
Patrick Gemmell
Senior Advisor, Kaupapa Kura Taiao
Noel McCardle
Senior Advisor (Hazardous Substances).
The applicant supplied the following documents:

the application; and

a confidential appendix, containing information regarding:
-
3.4
3.5
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;
draft label;
the proposed formulation of the paste;
the hazardous properties of the active ingredients and paste;
field trial protocol; and
information relating to Animal Ethics Committee approval.
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).
The applicant was provided with a copy of the proposed controls for PAPP Paste and
given the opportunity to comment on them.
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
ERMA New Zealand Decision: Application HSC09009
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overall trial will be supervised by the applicant’s Study Supervisor who is an
Approved Handler.
Manufacture
4.2.2
The PAPP Paste 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 PAPP Paste 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 Study Supervisor has an Approved Handler Certificate and will store
the substance 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 PAPP Paste 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.
Feral Cat Study
4.2.6
The field trials on feral cats will be conducted in accordance with the Feral
Cat Study Outline provided in section 5 of the Confidential Appendix to
the application.
4.2.7
A Central North Island site has been identified. An Animal Ethics
Application is in place for the trial and the study will be conducted in
compliance with the conditions of this approval.
4.2.8
The first step will be to undertake monitoring to get an estimate of cat
numbers and locations within the site. Monitoring of feral cat activity and
numbers will firstly be carried out using “submarine” bait stations (refer
Figure 1 in the application). Initially the feeders will be baited and the
wire mesh on either end will be left off to encourage cats to use them.
Tracking cards will be placed inside and once prints of cats are found in
the majority of feed stations and once “bait take” is frequent the wire mesh
will be placed on either end restricting access of non-target species.
ERMA New Zealand Decision: Application HSC09009
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4.2.9
The next stage will be the live capture of cats. Live traps will be set at the
same locations as the submarine bait stations; they will firstly be run for
three nights wired open to get cats used to entering them. On the fourth
night they will be set and run for five consecutive nights and checked each
morning. Traps will be standard live capture possum traps baited with
dried rabbit meat bait.
4.2.10
Cats caught in the traps will be weighed and injected intramuscularly with
Domitor (50-100µg/kg) and Ketamine (100mg/kg) to sedate the animals
and transmitter collars will be fitted. After securing the collars the cats will
be placed back in their cage under a blanket until they are fully revived
(c.10-30min) and then they will be released.
4.2.11
Once cats have acclimatised to the collars the next step will be pre feeding,
this will last approximately seven days. Pre-feeding will be undertaken
using the same “submarine” bait stations. Radio tracking equipment will be
used to locate cats during feeding visits to establish whether cats are still
alive and ensure the equipment is working properly. Once cats are visiting
the bait stations frequently then toxic baits will be deployed.
4.2.12
Approximately five baits will be placed in each bait station; baits will be
laid over five consecutive nights or until all collared cats are killed. Baits
will be checked, counted and removed each morning, bait condition will be
assessed and replaced each evening. The radio collars will have mortality
sensors and when cats are found collars will be removed and details
recorded.
4.2.13
Several bait stations will be monitored with camera traps to identify
whether bait take is by collared or non collared cats. Ink tracking cards
will be used at all tunnels to identify any non target species.
4.2.14
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 frozen if in meat ball) and sent back to
Connovation Ltd for disposal. Baits will be left out for a maximum of five
nights.
4.2.15
Domestic animals are excluded from the study area. The site is in a remote
location and has been chosen to minimise potential exposure to domestic
animals/pets. Dogs may present on the farmed area but will be under
control and excluded by use of the bait station design. An antidote,
methylene blue, is available which will be placed at the nearest veterinary
centre.
4.2.16
Secondary poisoning by dogs eating cats in the trial sites is very unlikely
as the active is rapidly excreted and does not accumulate in body tissue.
4.2.17
Baits will be placed at least 20 metres from any waterways. It is
considered feral cats and other potential scavenge ring predators unlikely
to take baits into water.
ERMA New Zealand Decision: Application HSC09009
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Disposal
4.2.18
Any unused or untaken toxic baits and unused PAPP Paste will be returned
to Connovation for disposal in accordance with local by-laws through
Transpacific Technical Services Limited.
4.2.19
Gloves and overalls will be put into a plastic bag and then washed
(separate to household laundry) and dried before re-use.
4.2.20
Disposal of dead cats will be by collection and burning. If local site
conditions do not allow incineration, then carcasses will be buried in a
landfill.
Hazardous properties
4.3
4.4
The applicant has examined the hazardous nature of the baits and considers them to
trigger the following hazard classifications:

Acute oral toxicity (6.1B)

Terrestrial vertebrate ecotoxicity (9.3A).
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
ERMA New Zealand Decision: Application HSC09009
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
4.8
failure to follow correct disposal procedures.
The Project Team has considered the highly ecotoxic properties of the substance, the
quantities required for the trials (< 500 g), 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:
4.11

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.
The Project Team has considered the toxic properties of the substance, the quantities
required for the trials (< 500 g), the containment regime proposed by the applicant,
the controls in Appendix 1 of this decision and requirements under other legislation.
The applicant has given specific consideration to the fact that PAPP Paste 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 PAPP 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.
4.14
Taking into account the containment measures proposed and the proposed location of
the trials, 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.
ERMA New Zealand Decision: Application HSC09009
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4.15
This assessment is made on the condition that the substance is handled, blended,
stored, transported, used, and disposed of as outlined in the Feral Cat Study Outline
(Section 5 of the Confidential Appendix to the application) and in accordance with the
explicitly stated HSNO controls, and any controls stipulated in other applicable Acts.
4.16
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
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/trial site;

to exclude unauthorised people from the facility/trial site;

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 PAPP Paste, I am satisfied
that the controls imposed, including those in place under other legislation, will result
in the substance being adequately contained.
ERMA New Zealand Decision: Application HSC09009
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6.3
The application to manufacture in containment the hazardous substance PAPP 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: 9 June 2009
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
PAPP Paste
ERMA New Zealand Decision: Application HSC09009
HSC100000
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APPENDIX 1: LIST OF CONTROLS THAT APPLY TO
PAPP BAIT
General
1.
The trials shall be undertaken in accordance with the Feral Cat Study Outline
(provided in section 5 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 500 g of PAPP Paste 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 PAPP Paste 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 substance 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 feral cat study shall be carried out at the Central North Island location
identified in the confidential section of the application.
13.
Access to the trial sites shall be by permission of the Study Supervisor1 or
researcher nominated by the Study Supervisor. The trial site 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
14.
During use the substance 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.
15.
The field trials will use “submarine” bait stations and tracking cards as identified in
section 3.4.4 of the application.
16.
The antidote, methylene blue, will be held at the veterinary clinic closest to the trial
site.
17.
Before the feral cat study commences, notification of the veterinary clinic is
required advising them of:
18.

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.
Before the feral cat study commences, notification of occupiers of land within 1 km
of the trial site is required advising them of:

where and when trials are taking place;

steps to be taken to prevent domestic animals/pets accessing the trial site;

signs/symptoms of poisoning with PAPP; and
1
The Study Supervisor 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 HSC09009
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
19.
which vet clinic has 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.
The location of the PAPP Paste 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 cats will be collected for examination and ultimately disposed of by
incineration or burying in a landfill.
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
PAPP Paste
HSC09009
HSC100000
Haydn Murdoch
25.
If for any reason a breach of containment occurs, the Study Supervisor 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.
ERMA New Zealand Decision: Application HSC09009
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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.
ERMA New Zealand Decision: Application HSC09009
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