ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
03 September 2007
Application Code
HSC07018
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
Purpose of the Application
Multi-species 1080 bait (paste, cereal based & loose grain): To seek
approval to manufacture for the development of formulation and
then testing of 1080 baits as vertebrate toxic agents for possums,
rats and mice.
Date Application Received
25 July 2007
Consideration Date
03 September 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,
multi-species 1080 paste bait, multi-species 1080 cereal based bait, and multi-species 1080
loose grain bait 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 identifier for the ERMA New
Zealand Hazardous Substances Register:
Multi-species 1080 paste bait
Multi-species 1080 cereal based bait
Multi-species 1080 loose grain bait
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.
3
Application process
3.1
The application was formally received on 25 July 2007.
3.2
Project Team:
Elizabeth Morgan
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 manufacturing site and methods;
- 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 application;
- trial protocol;
- Curriculum Vitae for the Person in Charge of the trials
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 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 the multi-species
1080 bait and given the opportunity to comment on them. The applicant had no concerns
with the controls.
ERMA New Zealand Decision: Application HSC07018
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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.
Purpose of the application
4.3
The applicant is seeking approval to develop and test multi-species 1080 baits containing
sodium fluroacetate (1080) for the control of possums, rats and mice. The applicant notes
that current 1080 baits sometimes kill rats and rarely kill mice, and that a multi-species
1080 bait for possums, rats and mice would be an improvement on current pest control
measures.
4.4
As part of the development of the multi-species 1080 baits the applicant intends to
conduct stability trials in the laboratory to identify the preferred bait formulation. Once the
preferred baits are identified, cage trials of these formulations will be carried out in a secure
animal testing facility (which is at a different location to the bait manufacturing facility).
The objective of these trials is to determine whether the baits are an effective and humane
method of killing the target pests.
4.5
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).
Lifecycle
4.6
The applicant has advised that the following measures will be undertaken throughout the
lifecycle of the multi-species 1080 baits in order to ensure that the substances are
contained in accordance with the requirements of the Act:
4.6.1
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 Research & Development
Director.
4.6.2
The experimental baits will be manufactured in a secure laboratory which is
located at the premises of Connovation Ltd. An approved handler is on site
at this facility. The applicant has advised that the active ingredient sodium
fluroacetate (1080), which has not been handled at the site previously, will be
stored under lock and key in accordance with the HSNO Regulations. Most
of the other raw materials are available on site and any new materials to be
brought on site are not considered to be hazardous. The applicant has
estimated that no more than 10kg of each of the paste, cereal, and loose-grain
ERMA New Zealand Decision: Application HSC07018
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baits will be required in order to complete the formulation development and
cage study. The applicant advises that the building has appropriate signage,
physical controls (locked access) and procedures in place to limit access to the
general public or unauthorised persons. Any bait retained for stability trials
will be stored securely.
4.6.3
Transportation of bait off-site to the animal test facility or laboratory
undertaking analysis of the active ingredient will be in Dangerous Goods
Management boxes in accordance with all Land Transport Rules and will be
dispatched from an Approved Handler at Connovation Ltd into the care of
another Approved Handler at the test facility. All relevant transport
documentation will be provided. Given that the applicant has indicated that
no more than 10kg of each of the experimental baits will be manufactured,
the Agency considers that no more than 30kg of the baits in total (i.e. 10kg
each of the paste, cereal based bait, and loose grain mix) will be transported
from the bait manufacturing site to the animal testing facility.
4.6.4
The applicant has indicated that prior to the commencement of the animal
trials, a sample of the baits will be sent to the Landcare Research Toxicology
Laboratory for analysis to quantify the active ingredient. This laboratory has
received accreditation by International Accreditation New Zealand (IANZ)
and also under the NZFSA laboratory approval scheme (LAS). Any bait left
over from this analysis will be returned to the applicant for disposal.
4.6.5
The efficacy studies will be conducted in a secure animal facility. The
applicant has indicated that this facility is purpose built for the testing of new
products and the test animals in this trial are to be housed in cages in an
indoor facility to limit access of non-target species and unauthorised persons.
The facility has restricted access and is kept locked when technicians and
researchers are not actively working in the facility. Procedures are in place to
ensure the experimental bait is stored, handled and used safely.
4.6.6
All persons involved in preparing the baits or undertaking the efficacy trials
will wear personal protective equipment (overalls, gloves and face shield).
4.6.7
All unused experimental baits from the formulation trials, analytical work or
animal test facility will be disposed of by the applicant through an approved
waste management company (TransPacific Technical Services Ltd). Dead test
animals will be frozen and then disposed of through a waste management
company either by burying in an approved landfill or burning in a specialised
facility approved by local authorities.
4.6.8
The applicant predicts that the test animals will succumb to the toxic effects
of the bait quickly, and therefore that the amount of other animal waste will
be limited. However if there are any other residues that might be
contaminated then this would also be collected in a container, labelled, and
disposed of through the waste management company.
ERMA New Zealand Decision: Application HSC07018
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Hazardous properties
4.7
The project team notes that in seeking approval to use or manufacture a hazardous
substance in containment, applicants must provide an indication of the test substance’s
hazardous properties so that the containment plan and controls can be tailored to address
any risks associated with these hazards. The project team recognises that in some cases, for
example in the development of experimental substances, the scope of this information may
be limited.
4.8
In considering the hazardous properties of the experimental baits, the applicant has taken
into account the Agency’s classification of the active ingredient sodium fluroacetate. The
applicant considers that the active ingredient will confer the following hazardous
properties to the bait formulations:





4.9
6.1B (acutely toxic)
6.8A (human reproductive/developmental toxicant)
6.9A (toxic to human target organs/systems)
9.1D (harmful in the aquatic environment)
9.3A (very ecotoxic to terrestrial vertebrates)
The applicant considers that, as the active ingredient is the only component in each of the
three formulation types to trigger a hazard classification, and the same proportion of active
ingredient will be present in each of three bait types (paste, cereal and loose grain baits) the
hazard classification will be the same for each.
Identification and evaluation of the significant risks of the substance in
containment
4.10
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
4.11
The hazard classification presented by the applicant indicates that the baits will be highly
ecotoxic to terrestrial vertebrates and may cause harm to organisms in the aquatic
environment.
4.12
Taking into account the lifecycle proposed by the applicant, the project team considers
that adverse environmental effects could arise due to:
 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, resulting in release of the baits or
contaminated waste material.
4.13
The project team considers that given the limited quantities of bait involved in the trials
(≤10 kg of each of the three bait types) and the conditions of the trial (i.e. development
and testing of the baits will be carried out in a secure, purpose-built facility by
ERMA New Zealand Decision: Application HSC07018
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appropriately trained and qualified staff) the risks to the environment are minimal and can
be adequately managed by the controls specified in Appendix 1.
Risks to human health and welfare
4.14
The project team considers that, because the baits contain a highly toxic active ingredient,
adverse effects to human health and welfare may result from exposure to the baits.
4.15
On the basis of the lifecycle of the substance outlined in paragraph 4.6, adverse effects
could arise as a result of:
 an accident during storage, use or transportation, resulting in release of the baits and
subsequent human exposure;
 failure to follow the correct operational procedures as proposed by the applicant in
their application and as required by the controls ain Appendix 1, resulting in the
exposure of personnel; or
 failure to follow correct disposal procedures, resulting in exposure of personnel
responsible for disposal or of individual coming into contact with the substance as a
result of incorrect disposal.
4.16
The project team has considered the toxic properties of the substances, the quantities
required for the trials, the containment regime proposed by the applicant, the controls in
Appendix 1, and requirements under other legislation. The applicant has given specific
consideration to the fact that the active ingredient is highly toxic. Provisions to avoid risk
to human health include approved handler requirements, personal protective equipment,
and information requirements. The substances will be handled (manufactured and
trialled) within locked facilities, and when not in use the baits will be secured. The project
team considers that these measures, combined with the controls in appendix 1, will
minimise the likelihood of human exposure and limit the consequences of any exposure
should such an event occur.
Māori issues and concerns
4.17
ERMA New Zealand has considered this application in accordance with the HSNO
Methodology Order 1998 clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8 of the HSNO
Act 1996. 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.
4.18
The Agency notes that the active agent of the multi-species 1080 baits triggers a number of
hazardous properties in the bait formulations giving rise to the potential for cultural risk
including the deterioration of the mauri of taonga flora and fauna species, the environment
and the general health and well-being of individuals and the community. In addition, the
introduction and use of these substances has the potential to inhibit the ability of
iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of
waterways given the substances’ potential to cause harm to organisms in the aquatic
environments.
4.19
The project team has considered the risks associated with the development and use of the
multi-species 1080 baits in the manner proposed by the applicant, and has identified the
appropriate controls necessary to mitigate these risks. Careful consideration was given to
the following:
ERMA New Zealand Decision: Application HSC07018
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


storage of the substance;
packaging, product labelling, handling and transportation procedures; and
appropriately supervised containment trial use.
4.20
Based on this assessment, the project team is unaware of any impacts that the contained
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.
4.21
This assessment is made on the condition that the substances are handled, blended, stored,
transported, used, and disposed of in the manner described by the applicant and in
accordance with the HSNO controls applied to the substance in this document (refer to
Appendix 1) 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 Limited 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
 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 Connovation’s multi-species
1080 baits, 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.
ERMA New Zealand Decision: Application HSC07018
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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 substances
multi-species 1080 paste bait, multi-species 1080 cereal based bait, and multi-species 1080
loose grain bait is thus approved pursuant to section 32, with controls as set out in
Appendix 1.
Rob Forlong
Date 04 September 2007
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
Multi-species 1080 paste bait
Multi-species 1080 cereal based bait
Multi-species 1080 loose grain bait
ERMA New Zealand Decision: Application HSC07018
HSC000286
HSC000284
HSC000285
Page 8 of 11
Appendix 1: list of controls that apply to the substances
General
1. The trials shall be undertaken in accordance with the trial procedures outlined in section 5 of
the confidential appendix submitted by the applicant, and the information specified within
section four of the application which addresses 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 10 kg of each of the multi-species 1080
paste bait, multi-species 1080 cereal based bait, and multi-species 1080 loose grain bait 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 shall also set out instructions that any of the substances 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 substances and be held at the animal research
facility for the duration of the application.
Storage
9. The substances 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 and 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 manufacture, bait analysis, use and disposal).
ERMA New Zealand Decision: Application HSC07018
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Trial Sites
12. The trials shall be carried out indoors at the animal research facility as identified in the
confidential section of the application (refer to applicant’s confidential appendix, Section 5).
13. Access to the trial site shall be by permission of the Trial Director1 or researcher nominated
by the Trial Director. 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.
14. The trial site should be locked when technicians and researchers are not actively working in
the facility.
Trial Conditions
15. During use the substances shall be under the control or supervision of an Approved Handler
with certification for the appropriate substance classifications. 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
study protocol and the controls in place in order to adequately manage the substances.
16. The location and movement of the bait shall be recorded at each stage of its lifecycle.
17. Trials must be managed so as to prevent non-target organisms from coming into contact
with the substance, throughout the trials.
Emergency Management
18. 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
19. Any surplus substances remaining at the end of the trials shall be returned to Connovation
Ltd where they shall be securely stored in a laboratory complying with the requirements set
out in the Hazardous Substances (Exempt Laboratories) Regulations 2001 until disposed of
in an approved manner.
20. Any surplus substances shall be disposed of by an approved hazardous waste disposal
company. Disposal shall be carried out in a manner compliant with the Hazardous
Substances (Disposal) Regulations 2001. Ultimately, this would involve treating the
substances in a manner to render them, as a whole, non-hazardous.
21. The dead animals and any other animal waste from the trials shall be disposed of by a
licensed commercial waste management company, and will either be buried in an approved
landfill or burned in an incinerator approved by local authorities.
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 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
ERMA New Zealand Decision: Application HSC07018
Page 10 of 11
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
Multi-species 1080 baits
HSC07018
HSC000286, HSC000284, HSC000285
Elizabeth Morgan
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 reflecting the
trial procedure/protocol (as referred to in Control 1) notwithstanding its confidential nature,
shall be available for inspection by any enforcement officer, upon request.
ERMA New Zealand Decision: Application HSC07018
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