ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
5 August 2008
Application Code
HSC08014
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 into or manufacture in containment CatNap as a
potential vertebrate toxic agent to undertake field trials on stoats
(field trial).
Date Application Received
16 July 2008
Consideration Date
4 August 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 (HSC08014)
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 product has been referred to as CatNap. This application is
to allow testing on the stoat in a field trial. 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 16 July 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:
-
3.4
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 copy of the Animal Ethics Committee approval;
a copy of the proposed signage to be placed at the trial site;
Māori and other consultation;
trial methodology.
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
The Department of Conservation indicated their support of the CatNap field trials on
stoats.
3.6
The applicant was provided with a copy of the proposed controls for CatNap
(HSC08014) 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).
ERMA New Zealand Decision: Application HSC08014
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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.
4.2.3
At the Connovation laboratory, a pre-weighed amounts of CatNap paste
(32 -35 mg) will be placed into a very small plastic pottle with screw tops
(these containers are typically used for makeup/cosmetic samples). Each
pottle will contain sufficient paste to be added to each meat bait. Each
pottle will be uniquely numbered and placed into a larger labelled screw
top HDPE container before sending to the Study Supervisor.
Transportation
4.2.4
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.
4.2.5
The CatNap will be transported to Southland for the stoat field trials. 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
4.2.6
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.
Stoat Field Trials
4.2.7
The stoat field trials will be conducted in accordance with the Trial
Protocol provided in section 4 of the Confidential Appendix to the
application.
ERMA New Zealand Decision: Application HSC08014
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4.2.8
One field trial location in Waitutu, Southland has been identified. An
Animal Ethics Approval has been gained from the Lincoln University
Animal Ethics Committee and the trials will be conducted in compliance
with conditions of this approval. An application has also been made to the
ACVM Group for an extension to the Provisional Approval for CatNap.
4.2.9
Signage will be put in place prior to and during the trial, as a warning to
person’s who may be in that area.
4.2.10
Monitoring with tracking cards will be carried out prior and following the
toxic baiting to establish the change in animal numbers/tracking.
4.2.11
The trial will allow for the possibility of three full baiting sessions (460
baits); on the initial night and two more nights.
4.2.12
PAPP meat baits will be prepared immediately prior to laying the bait at
the field trial site. This will consist of 184 rabbit mince baits on the first
two baiting occasions and 92 on the last, each with 32 -35 mg of PAPP in a
36 - 40% paste (equivalent to 12.8mg of active per bait). Each mince bait
is ~ 5 g (~ teaspoon full) which is flattened then the pre-weighed CatNap
paste (in the small pottles container) is placed onto centre using tip of a
clean dry knife or similar, then the mince is to be carefully worked up from
the edges to cover over the paste. Baits will be put into small sealed plastic
containers ready for placement.
4.2.13
Bait stations containing meat bait will be placed in a grid over the site at
approximately 200 metre spacings. The baiting strategy will maximise the
exposure of stoats to the bait.
4.2.14
Domestic animals are unlikely to be present due to the location of the trial
site. Baits will be placed at least five metres from waterways. It is
considered stoats and other potential scavenging predators are unlikely to
take baits into water.
4.2.15
For the first two baiting sessions two meat/PAPP baits will be placed
inside each station and a single bait in each tunnel on the last session, with
a tracking card and left overnight. The following morning the tracking
cards and bait condition will be checked. If there is bait taken overnight
the station number will be recorded and bait(s) replaced. Any tracking
cards displaying heavy tracking will be removed and those with light
tracking can be marked to identify/discount pre-existing tracks on the
following day inspection.
4.2.16
All uneaten baits will be removed at the end of the trial and returned to
Connovation for disposal. All signage at entry points to the study area will
be removed at the completion of the trial.
ERMA New Zealand Decision: Application HSC08014
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Disposal
4.2.17
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). The small pottle containers will also be returned to
Connovation.
4.2.18
Gloves and overalls will be put into a plastic bag and then washed
(separate to household laundry) and dried before re-use.
4.2.19
Any dead stoats that are seen will be collected for examination or for
disposal by burying.
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)
 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.
ERMA New Zealand Decision: Application HSC08014
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4.8
The Project Team has considered the highly ecotoxic properties of the substance, the
quantities required for the trials (≤ 100 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:
 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.
4.11
The Project Team has considered the toxic properties of the substance, the quantities
required for the trials (≤ 100 g), 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 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
The Project Team notes that the applicant undertook consultation with the appropriate
iwi/Māori groups within the regions of the trial site and considers their efforts to be
consistent with ERMA New Zealand policy (details included in Section 6 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.
ERMA New Zealand Decision: Application HSC08014
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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 4
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
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.
ERMA New Zealand Decision: Application HSC08014
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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
(HSC08014) 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 August 2008
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
CatNap (HSC08014)
ERMA New Zealand Decision: Application HSC08014
HSC000335
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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 Protocol (provided in
section 4 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 100 g 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 Site
12.
The stoat field trials shall be carried out at Waitutu, Southland as identified in the
confidential section of the application (Section 4)
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 have signs, as
illustrated in attachment 3 of section 4 of the confidential appendix to the
application, positioned in the vicinity of the trial site in accordance with section 4.1
of the Trial Protocol.
Trial Conditions
14.
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.
15.
The field trials will use tunnel bait stations and tracking cards as identified in
section 5.1.1 of the application.
16.
The antidote, methylene blue, will be held at a hut at the trial site.
17.
Before the stoat field trials commence, notification of the Otautau Veterinary Clinic
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.
The location of the CatNap and toxic bait shall be recorded at each stage of the
lifecycle from manufacture to disposal.
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 HSC08014
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Emergency Management
19.
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
20.
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.
21.
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.
22.
Any dead stoats that are seen will be collected for examination and ultimately
disposed of by burying.
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
CatNap (in containment)
HSC08014
HSC000335
Haydn Murdoch
24.
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.
25.
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 HSC08014
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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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