ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
18 December 2006
Application Code
HSC06033
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
Connovation Ltd
PO Box 58 613
Manakau City 2141
Auckland
Purpose of the Application
CatNap: to allow research and development of a new Vertebrate
Toxic Agent containing PAPP as a new Active Ingredient for feral
cat and mustelid control. The application will allow testing to be
undertaken to generate information (Field trial).
Date Application Received
12 December 2006
Consideration Date
15 December 2006
Considered by
Rob Forlong, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import into, or manufacture in, containment the hazardous substance,
CatNap, is approved with controls in accordance with the relevant provisions of the Act
and the HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA New Zealand
Hazardous Substances Register:
CatNap
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31. The decision was determined 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 and the provisions of Part III of the
Third Schedule of the Act. Unless otherwise stated, references to section numbers in this
decision refer to sections of the Act.
2.2
Consideration of the application followed the relevant provisions of the Methodology.
Unless otherwise stated, references to clauses in this decision refer to clauses of the
Methodology.
ERMA New Zealand Decision: Application HSC06033
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3
Application Process
3.1
The application was formally received on 12 December 2006.
3.2
Project Team:
David Hodge
Advisor (Hazardous Substances)
Nicola Reeves
Advisor (Hazardous Substances)
Linda Robinson
General Manager, Māori Unit
Report review and sign-out by:
Noel McCardle
Senior Advisor (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application;
 a confidential appendix;
 the Animal Ethics applications for testing PAPP on magpies, cats, mallards, stoats and
weka; and
 the CV for the trial Director.
3.4
The following government departments were advised of the receipt of the application (in
accordance with clause 2(2)(e)) and given the opportunity to comment:
 the Ministry of Health;
 the Department of Labour (Workplace Group);
 the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
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 comments provided were taken into account
in the setting of controls.
4
Consideration
Sequence of the Consideration
4.1
This application was considered by the Chief Executive of ERMA New Zealand under
delegated powers from the Authority (section 19(2)(e)).
4.2
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 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.
ERMA New Zealand Decision: Application HSC06033
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Purpose of the Application
4.3
The purpose of the application is to conduct further contained field trials on CatNap to
evaluate the efficacy and non-target toxicity of a new Vertebrate Toxic Agent containing
PAPP as a new active ingredient for feral cat and mustelid control.
4.4
As the purpose amounts to “research and development on any hazardous substance”, the
Project Team considers that the application qualifies for consideration under section
30(ba).
Life Cycle
4.5
CatNap® formulation will be manufactured at Connovation Ltd premises at 36B Sir
William Ave, East Tamaki, Manukau in small batches. Any active poison ingredient not
used in manufacture will be stored in a locked poisons store at Connovation Ltd.
Toxicants are contained by their Quality Assurance system during preparation of baits. The
formulation will be mixed and rolled into a ball (pellet) of the correct weight. Formulated
product will be packed into suitable containers and appropriate dangerous goods boxes
with labels and Dangerous Good Declarations for transportation to the testing facilities.
4.6
Animal studies will be conducted at the premises of Pest Tech, Leeston. Chemical Analysis
will be conducted at The Toxicology Laboratory, Landcare Research, Lincoln, Canterbury
The animal trials will be conducted in a secure animal facility. The aim of the project is to
acquire cage data on the efficacy and non-target toxicity of PAPP. Toxicity assessments
will follow the MAF, ACVM “Registration Standard and Guidelines for Efficacy of
Vertebrate Pesticides” (MAF, April 2000). The product will be applied to palatable meat
baits and presented to individual animals. Only small amounts of the product will be
carefully applied to bait. The means of administration of the product will be voluntary
ingestion with food. All animals will be carefully and closely monitored after ingestion of
bait or meat from poisoned animals. The animals are to be housed in pens and caged in an
indoor facility, which will limit access of non-target species (other than the “non-target
species included in the trials) and unauthorised persons. The facility has restricted access
and is maintained locked when technicians and researchers are not actively working in the
facility. The studies will be fully compliant with the Lincoln University Animal Ethics
Committee Conditions and directed by an experienced toxicologist.
4.7
Connovation Ltd, Auckland, Landcare Research, Lincoln and Pest Tech, Leeston all have
Standard Operation Procedures for the safe disposal of product. These include use of
approved hazardous waste disposal companies in each jurisdiction. Connovation use
Transpacific Services in Auckland.
Hazardous Properties
4.8
The Project Team notes that a containment application only requires sufficient
understanding of the hazardous properties to ensure that any risks can be managed by the
containment controls. The scope of the hazard information will often be limited for
containment applications, as the substance will be experimental and may not be
commercialised.
ERMA New Zealand Decision: Application HSC06033
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4.9
The applicant has examined the hazardous nature of CatNap and considers it to be acutely
toxic 6.1C, and ecotoxic to terrestrial vertebrates.
4.10
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 controls.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
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
4.12
If released into the environment the substance has the potential to result in adverse effects
within the environment.
4.13
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 substance;
 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
substance; or
 failure to follow correct disposal procedures.
4.14
The Project Team considers that the contained manufacture and trialling of CatNap will
not pose any significant risks to the environment. In its consideration, the Project Team
took several factors into account, including the containment regime proposed by the
applicant, the overall quantity of the substance involved, the controls set out in Appendix
1 and the requirements of other legislation.
4.15
The Project Team notes that limited quantities of the substance will be manufactured and
released into containment for trials.
4.16
The Project Team considers that, taking into account the hazardous properties of the
substance, the quantities involved, the containment controls in Appendix 1 and controls in
place under other legislation, there are no significant risks to the environment from this
trial.
Risks to Human Health and Welfare
4.17
The Project Team considers that adverse effects to human health and welfare may result
from exposure(s) to the substance, given the level of detail and related uncertainty involved
in studies conducted for experimental substances such as CatNap.
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4.18
On the basis of the lifecycle of the substance outlined in paragraph 4.5-4.7, adverse effects
could arise from:
 an accident during manufacture, storage, use or transportation, resulting in release of
the substance;
 failure to follow the correct operational procedures as set out in the controls and the
containment system, resulting in personnel exposure while contained, or bystander
exposure if released; or
 failure to follow correct disposal procedures.
4.19
The Project Team considers that there are no significant risks to human health and welfare,
given the properties of the substance, the quantities involved, the containment regime
proposed by the applicant, the containment controls in Appendix 1 and controls in place
under other legislation.
Māori Issues and Concerns
4.20
The Project Team has considered this application in accordance with clauses 9(b)(i) and
9(c)(iv) and sections 6(d) and 8. In addition, the Project Team used the framework
contained in the ERMA New Zealand user guide “Working with Māori under the HSNO
Act 1996” to assess this application.
4.21
CatNap triggers a number of hazard classifications giving rise to the potential for cultural
risk including the deterioration of the mauri of taonga fauna species, the environment and
the general health and well-being of individuals and the community. In addition, the
introduction and use of this substance has the potential to inhibit the ability of iwi/Māori
to fulfil their role as kaitiaki.
4.22
The applicant proposes to use Weka, considered a taonga species by many iwi, as a nontarget species. The applicant has discussed the proposal with Te Runanga o Ngai Tahu
receiving support for both the trial of the substance and the use of Weka as a non-target
test species. Kaupapa Kura Taiao also notes that the applicant will continue to work with
Ngai Tahu in relation to the collection and use of the Weka, and encourages the proactive
further development of this working relationship.
4.23
On considering all the available information, and having regarded the contained nature and
scope of the proposed trial, Kaupapa Kura Taiao considers that although CatNap is
expected to have a moderate impact on the native species being used in the trial (i.e.
Weka), the potential long term benefits to Māori culture or traditional relationships with
their ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga are
major. This assessment is made on the condition that the substance is handled, stored,
transported, used, and disposed of, in accordance with the explicitly stated HSNO
controls, and any controls stipulated in other applicable Acts.
4.24
In addition, there is no evidence to suggest that the controlled use of CatNap will breach
the principles of the Treaty of Waitangi. Subsequently, there is no requirement for the
applicant to consult further with Māori regarding this containment application.
4.25
Kaupapa Kura Taiao also considers that should inappropriate use, or accident, result in the
contamination of waterways or the environment generally, Connovation Ltd should notify
the appropriate authorities including the relevant iwi authorities in that region. This action
ERMA New Zealand Decision: Application HSC06033
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should include advising them of the contamination and the measures taken to contain and
remediate.
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 substances or
contamination by hazardous substances;
 to exclude organisms from a facility;
 to exclude unauthorized people from the facility;
 to prevent unintended release of the substances by experimenters working with the
substance;
 to control the effects of any accidental release of the substance;
 inspection and monitoring requirements; and
 qualifications required of the person responsible for implementing the controls.
5.2
The Project Team is satisfied that, with adherence to the controls listed in Appendix 1 and
those controls in place under other legislation, CatNap 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).
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
In accordance with clause 36(2)(b), I record that, in reaching this conclusion, I have
applied the criteria specified in section 32.
6.4
I have also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substances;
 clause 21 – the decision accords with the requirements of the Act and regulations;
 clause 22 – the evaluation of risks – relevant considerations;
 clause 24 – the use of recognised risk identification, assessment, evaluation and
management techniques.
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6.5
The application to import into, or manufacture in, containment the hazardous substance
CatNap is thus approved pursuant to section 32, with controls as set out in Appendix 1.
Rob Forlong
Date: 18 December 2006
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSC06033
HSC000255
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Appendix 1: List of Controls that apply to CatNap
General
1. The trials shall be undertaken in accordance with the information on the proposed
containment system provided under section four 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. CatNap shall only be manufactured at Connovation Ltd premises in Manukau.
5. The maximum total quantity of CatNap that shall be manufactured under this approval is
2 kg.
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. The label must also set out instructions that any of the substance remaining after the trial
must be returned in its original container to Connovation Ltd.
9. A Safety Data Sheet, compliant with the Hazardous Substance (Identification) Regulations
2001, shall accompany each shipment of the substance and be held at each trial site for the
duration of the trial.
Storage
10. When not in use, CatNap shall be held in locked storage throughout its lifecycle.
Transport
11. The substance shall be transported in compliance with any relevant requirements of the
Land Transport Rule: Dangerous Goods 2005, the Civil Aviation Act 1990 or the Maritime
Transport Act 1994.
General Handling of the Substance
12. Personal Protective Equipment (PPE), for example, safety glasses, gloves and protective
clothing shall be worn when handling the substance, for example during handling,
application and disposal.
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Trial Sites
13. The trials shall be carried out at the premises of Pest Tech in Leeston. Chemical Analysis will
be conducted at The Toxicology Laboratory, Landcare Research, Lincoln, Canterbury.
Trial Conditions
14. During use the substance shall be under the control of experimental staff, who are 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
study protocol and the controls in place in order to adequately manage the substance.
15. Access to the trial site shall be by permission of the Trial Director1 or nominated researcher.
The trial site shall be signed indicating that unauthorized access is not permitted, that the site
is subject to a trial, and that the trial animals should not be removed.
16. The trials shall be conducted indoors and managed so as to prevent non-target vertebrates
from coming into contact with the substance throughout the trials.
17. The location and movement of CatNap shall be recorded at each stage of its lifecycle.
Emergency Management
18. Any accidental spillage of the substance shall be contained, and placed in an appropriate
container. These containers shall be incinerated or returned to Connovation Ltd for
incineration.
Disposal
19. 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.
20. Any surplus substance shall ultimately be treated in a manner to render the substance, as a
whole, non-hazardous or be exported from New Zealand. Disposal shall be carried out in a
manner compliant with the Hazardous Substances (Disposal) Regulations 2001.
21. All animal carcases shall be incinerated after autopsy.
Notification and Inspection
22. 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
CatNap
HSC06033
HSC000255
1
The Trial Director is the individual appointed by the applicant to be responsible for the overall conduct of
the trial in accordance with the Management Plan and approval controls.
ERMA New Zealand Decision: Application HSC06033
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ERMA Applications Advisor
David Hodge
23. 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.
24. The Authority or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time. 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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