ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
16 August 2007
Application Code
HSC07003
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
SwineOff bait: To develop and test a bait containing potassium
cyanide for the control of feral pigs. (field trial)
Date Application Received
17 January 2007
Consideration Date
16 August 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 substance,
SwineOff Pig 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 substance has been given the following unique identifier for the ERMA New Zealand
Hazardous Substances Register:
SwineOff Pig 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.
ERMA New Zealand Decision: Application HSC07003
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3
Application process
3.1
The application was formally received on 17 January 2007.
3.2
On 19 January 2007 the Project Team requested further information from the applicant in
accordance with section 52. This information was received on 9 July 2007.
3.3
Project Team:
Bella Whittle
Advisor (Hazardous Substances)
Nicola Reeves
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit
Report review and sign-out by:
Beth Dye
Applications Manager (Hazardous Substances)
3.4
The applicant supplied the following documents:
 the application; and
 a confidential appendix, containing information regarding:
- 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;
- material safety data sheets for the components;
- a copy of the Animal Ethics Committee application;
- trial protocol;
- Curriculum Vitae for the Person in Charge of the trials
3.5
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).
3.6
No responses were received.
3.7
The applicant was provided with a copy of the proposed controls for Swine-Off Pig Bait
and given the opportunity to comment on them. The applicant had no concerns with the
controls.
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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 describes the purpose of this application as allowing for the development of
a cyanide bait as a vertebrate toxic agent for the control of feral pigs. The applicant
currently manufactures an approved potassium cyanide bait for possums, Cyanara
Ferapaste containing 50% w/w potassium cyanide1. It is proposed to modify this bait to
create SwineOff Pig Bait for use on pigs. The SwineOff bait will be a paste product,
coloured green, that will be encapsulated as a solid bait.
4.4
This application includes the formulation development and stability trials in a laboratory to
identify the preferred bait formulation, and the testing of the preferred bait to determine
the effectiveness and humaneness on killing feral pigs in a pen trial. The trial will be
housed in an indoor pen within a secure animal facility. If the pen trial confirms the
preferred bait as a humane and effective means of killing feral pigs a further application
will be lodged with ERMA for approval of pen field trials2.
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 advises that the substance will be dealt with throughout its lifecycle in the
following way:
1
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 at the premises of Connovation
Ltd. The (hazardous) raw materials are already available on site and any new
materials to be brought on site are not considered to be hazardous. The
Approval Code: HSR001607
The applicant advises that additionally an application would be made to the ACVM Group, New Zealand Food
Safety Authority for a provisional approval to carry out the pen trials to generate efficacy data to support the
approval of the trade name product.
2
ERMA New Zealand Decision: Application HSC07003
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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. The active ingredient, potassium cyanide, will be stored
under lock and key in accordance with the HSNO Regulations. An Approved
Handler with certification for the appropriate substance classifications is on
site. Only small quantities of bait will be prepared in a secure laboratory
contained within the secure building to finalise the bait formulation to be
used in the pen trial. Any bait stored or retained for stability trials will be
kept in a secure (locked) laboratory.
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. All relevant transport documentation will be
provided. The quantity of bait to be sent off site is small. It will be necessary
for the Approved Handler to transport the experimental baits to the location
of the pen and test animals. This location is secure (no public access, within
building, no other animals present).
4.6.4
The means of administration to the test animals will be by voluntary ingestion
by pre-conditioning with non-toxic bait (pre-feed). It is noted that the pen
study on feral pigs has undergone an Animal Ethics approval.
4.6.5
The trial will be conducted in containment within a secure animal facility. The
pen is housed indoors 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
Those people carrying out the trial will wear personal protective equipment
(overalls, gloves and face shield). A minimum of three people will be present:
two to conduct the trial and the third person as an observer in case a problem
arises and intervention is needed. A cyanide emergency kit will be available.
4.6.7
Prior to commencement of the animal testing trial, a sample of bait will be
sent to the Landcare Research Toxicology Laboratory for analysis of the
cyanide content. This facility also has procedures in place to manage
hazardous substances. Any bait leftover from the analysis requirement would
be returned to the applicant for disposal.
4.6.8
All experimental baits containing potassium cyanide 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).
4.6.9
As the test animals are expected to succumb to the toxic effects of the bait
quickly no other animal waste is anticipated. 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.
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4.6.10
The dead animals will be buried on-site in an approved offal pit after the trial.
Should a situation arise that this were not possible, then the dead animals will
be wrapped (and frozen if there were a delay) then disposed of by a
commercial waste management company by burying or burning at an
approved site.
Hazardous properties
4.7
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.
4.8
The applicant has examined the hazardous nature of baits and considers them to trigger
the following hazard classifications:











4.9
Acute toxicity, oral (6.1 B or 6.1C)
Acute toxicity, inhalation (6.1 C or 6.1D)
Skin irritancy (6.3B)
Eye irritancy (6.4A)
Contact sensitisation (6.5B)
Reproductive/Developmental toxicity (6.8B)
Target organ toxicity (6.9A or 6.9B)
Aquatic ecotoxicity (9.1A)
Soil ecotoxicity (9.2B)
Terrestrial vertebrate ecotoxicity (9.3B or 9.3C)
Terrestrial invertebrate ecotoxicity (9.4A).
The project team has reviewed the hazard information provided by the applicant and notes
that the potassium cyanide containing paste (Cyanara Ferapaste) has already been classified
as part of its approval under the HSNO Act. On this basis, the project team 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
4.10
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:
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Risks to the environment
4.11
The proposed substance is highly ecotoxic to a range of organisms. If released into the
environment the substance has the potential to result in adverse effects within the
environment.
4.12
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.
4.13
The project team has considered the highly ecotoxic properties of the substance, the
quantities required for the trials (≤1kg), the controls in Appendix 1 and requirements
under other legislation. It is noted that the applicant intends that the manufacture and
trialling of the baits will occur indoors at a suitably secure facility, so exposure to nontarget organisms will be minimal. Based on these considerations, the project team
considers that significant risks to the environment from this trial can be adequately
managed.
Risks to human health and welfare
4.14
The project team considers that adverse effects to human health and welfare may result
from exposure to the baits, given that the substance contains cyanide and therefore has
highly toxic properties.
4.15
On the basis of the lifecycle of the substance outlined in paragraph 4.6, 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.
4.16
The project team has considered the toxic properties of the substance, the quantities
required for the pen trial (≤1kg), 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 substance contains a highly acutely toxic
substance (cyanide). Provisions to avoid risk to human health include approved handler
requirements, personal protective equipment, and information requirements. The
substance will be handled (manufactured and trialled) within locked facilities, and when not
in use the baits will be secured. In addition, wherever the baits are being handled, an
emergency cyanide kit will be on hand in the case of any adverse effect to human health
resulting from the baits. Based on these considerations, the project team considers that
risks to human health and welfare can be adequately managed.
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
ERMA New Zealand Decision: Application HSC07003
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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 applicant and the project team noted that SwineOff Pig Bait triggers HSNO
thresholds of toxicity and ecotoxicity that may have a negative impact on Māori and the
mauri of iwi, cultural taonga of the environment.
4.19
The project team has identified the risks associated with SwineOff Pig Bait and the
appropriate controls necessary to mitigate the toxic and ecotoxic risks based on the
assessed hazard classifications and its proposed purpose and regulated use in a contained
field trial situation associated with this application. Careful consideration was given to the
following:
 storage of the baits;
 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
field 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.
4.21
This assessment is made on the condition that the substance is handled, blended, stored,
transported, used, and disposed of as outlined in the trial protocol (Appendix A, Section 6)
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 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.
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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).
6.2
Having considered the risks associated with the lifecycle of SwineOff Pig Bait, 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.
6.5
The application to import into, or manufacture in, containment the hazardous substance
baits containing SwineOff Pig Bait is thus approved pursuant to section 32, with controls
as set out in Appendix 1.
Rob Forlong
Date
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Code:
SwineOff Pig Bait
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HSC000282
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Appendix 1: list of controls that apply to SwineOff Pig Bait
General
1. The trials shall be undertaken in accordance with the Trial Protocol (provided in Appendix
A, section 6 to the application) and the information specified within 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 shall manufacture a maximum of 1kg of SwineOff Pig Bait 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 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 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.
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).
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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 (Appendix A, Section 6).
13. Access to the trial site shall be by permission of the Trial Director3 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.
15. A cyanide emergency kit shall be kept available while baits are being handled at the
manufacturing and trial facilities.
Trial Conditions
16. During use the baits 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 substance.
17. The location and movement of the bait 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 returned to Connovation Ltd for disposal.
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 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
substance in a manner to render the substance, as a whole, non-hazardous; or exporting the
substance from New Zealand.
21. The dead animals shall be buried on-site in an approved offal pit that meets any relevant
requirements in place under the Resource Management Act 1991 or disposed of by a
licensed commercial waste management company.
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.
3
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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
ERMA Applications Advisor
SwineOff Pig Bait
HSC07003
HSC000282
Bella Whittle
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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