ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
22 May 2007
Application Code
HSC07015
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
‘Baits containing diphacinone’ and ‘baits containing diphacinone
plus cholecalciferol’: to gain approval under the HSNO Act to
manufacture or import under containment anticoagulant
rodenticide baits for laboratory trials.
Date Application Received
27 April 2007
Consideration Date
22 May 2007
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 substances,
baits containing diphacinone and baits containing diphacinone plus cholecalciferol, is
approved with controls in accordance with the relevant provisions of the Act and the
HSNO (Methodology) Order 1998 (the Methodology).
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Baits containing diphacinone
Baits containing diphacinone plus cholecalciferol
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 HSC07015
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3
Application process
3.1
The application was formally received on 27 April 2007.
3.2
Project Team:
David Hodge
Advisor (Hazardous Substances)
Sekove Tinalevu
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances)
3.3
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing information regarding:
- the composition of the baits;
- the hazardous properties of the active ingredients and baits;
- Connovation Ltd;
- the draft labels;
- the Ethics Committee approval for testing;
- the animal testing facility; and
- the external analytical laboratory.
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; and
 the Department of Labour (Workplace Group).
3.5
No responses were received.
3.6
The applicant was provided with a copy of the proposed controls for baits containing
diphacinone and baits containing diphacinone plus cholecalciferol and given the
opportunity to comment on them. The applicant had no concerns with the 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.
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Purpose of the application
4.3
The purpose of the application is to conduct contained laboratory trials on baits containing
diphacinone and baits containing diphacinone plus cholecalciferol to evaluate the efficacy
of these anticoagulant rodenticides.
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
A small quantity of each of the baits will be manufactured at the Connovation Ltd
premises in Auckland.
4.6
The baits will then be transported by an approved dangerous goods courier to the test
laboratory at a secure animal research facility in Christchurch. This facility will have
restricted access and will be kept locked when technicians and researchers are not actively
working on-site. There will be no access by unauthorised personnel or non target
vertebrates.
4.7
The baits will then be tested for efficacy on rats in cages by voluntary ingestion. The test
procedures will be designed to meet the requirements of the NZFSA Standard for testing
vertebrate toxic agents. Additionally, the baits will undergo stability trials to confirm the
physical and chemical stability of the substances.
4.8
Excess bait and packaging will be returned to Connovation Ltd for disposal by a
commercially licensed waste management company. The dead rats will be placed into a
labelled plastic bag and frozen. These will then be disposed of by a commercially licensed
waste company.
Hazardous properties
4.9
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.
4.10
The applicant has examined the hazardous nature of baits and considers them to be acute
oral toxicants (6.1D), target organ toxicants (6.9B) and harmful to terrestrial vertebrates
(9.3C).
4.11
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 substances in New Zealand can be managed through the
application of controls.
ERMA New Zealand Decision: Application HSC07015
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Identification and evaluation of the significant risks of the substance in
containment
4.12
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
4.13
If released into the environment the substances have the potential to result in adverse
effects within the environment.
4.14
On the basis of the lifecycle of the substances, 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.
4.15
The project team considers that the contained manufacture and trialling of the baits 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.
4.16
The project team notes that small quantities of the substances will be used in the
laboratory trials.
4.17
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
4.18
The project team considers that adverse effects to human health and welfare may result
from exposure to the baits, given the level of detail and related uncertainty involved in
studies conducted for experimental substances such as these.
4.19
On the basis of the lifecycle of the substance outlined in paragraph 4.5-4.8, 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.
4.20
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
ERMA New Zealand Decision: Application HSC07015
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proposed by the applicant, the containment controls in Appendix 1 and controls in place
under other legislation.
Māori issues and concerns
4.21
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.
4.22
The applicant has classified the baits as acute oral toxicants (6.1D), target organ toxicants
(6.9B) and as harmful to terrestrial vertebrates (9.3C). Thus, there is the potential that these
substances could negatively impact Māori, the mauri of iwi, cultural tāonga and the
environment.
4.23
The project team has completed its assessment of the application, and has identified the
risks and the appropriate controls necessary to mitigate the substances’ potential physical,
toxic and eco-toxic properties after careful consideration of the following:
 storage of the baits;
 packaging, product labelling, handling and transportation procedures; and
 appropriately supervised containment-trial use
4.24
Based on this assessment, the project team is unaware of any impacts that the laboratory
trials of the baits could have on Māori culture, or, on our traditional relationships with
ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga. The project
team has no evidence to suggest that the controlled containment-trial use of the baits will
breach the principles of the Treaty of Waitangi and sees no requirement for the applicant
to consult with Māori regarding this application.
4.25
This assessment is made on the condition that the baits are handled, stored, transported,
used and disposed of, 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
the applicant 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 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 substances;
 inspection and monitoring requirements; and
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
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, 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).
6.2
Having considered the risks associated with the lifecycle of baits containing diphacinone
and baits containing diphacinone plus cholecalciferol, I am satisfied that the controls
imposed, including those in place under other legislation, will result in the substances 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.
6.5
The application to import into, or manufacture in, containment the hazardous substance
baits containing diphacinone and baits containing diphacinone plus cholecalciferol is thus
approved pursuant to section 32, with controls as set out in Appendix 1.
Libby Harrison
Date: 22 May 2007
Acting Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Baits containing diphacinone
Baits containing diphacinone plus cholecalciferol
ERMA New Zealand Decision: Application HSC07015
HSC000274
HSC000276
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Appendix 1: list of controls that apply to Baits containing
diphacinone and baits containing diphacinone plus cholecalciferol
General
1. The trials shall be undertaken in accordance with the information specified within the
confidential Appendix 1 of the application as well as that 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. Connovation Ltd may manufacture a maximum of 5kg of each bait product at the
Connovation Ltd premises in Auckland under this approval.
Packaging and Information
5. The substances 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 shipment of the substances and be held at the Animal Research
Facility for the duration of the application.
Storage
9. The baits shall be held in locked storage when not in use.
Transport
10. The substances 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
11. Personal Protective Equipment (e.g. glasses, gloves and protective clothing) shall be worn
when handling the substances (e.g. during handling, application and disposal).
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Trial Sites
12. The trials shall be carried out at the Animal Research facility in Christchurch as identified in
the confidential section of the application.
13. 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.
Trial Conditions
14. During use the baits 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 substances.
15. The location and movement of the baits shall be recorded at each stage of its lifecycle.
Emergency Management
16. Any accidental spillage of the substances shall be contained, and placed in an appropriate
container. These containers shall be returned to Connovation Ltd for disposal.
Disposal
17. 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.
18. 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.
19. All animal carcasses shall be disposed of by a commercial licensed waste company.
Notification and Inspection
20. 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 names
ERMA Application number
ERMA Approval numbers
ERMA Applications Advisor
Baits containing diphacinone
Baits containing diphacinone plus
cholecaliciferol
HSC07015
HSC00274, HSC00276
David Hodge
The Trial 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 1 of the application and approval controls.
1
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21. 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.
22. 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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