ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
30 October 2003
Application Code
HSC03013
Application Type
To import or manufacture a hazardous substance in
containment under Section 31 of the Hazardous
Substances and New Organisms (HSNO) Act 1996
Applicant
Pest-Tech Ltd
Purpose of the Application
To assess the cost effectiveness of two new
anticoagulant baits for the control of possums in
replicated field trials, to obtain data on toxicant levels
used, residues in possums, cost-effectiveness of each
bait formulation, and regulatory toxicology.
Date Application Received
11 September 2003
Consideration Date
23 October 2003
Considered by
Bas Walker, Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to manufacture in containment the hazardous substances Enhanced
anticoagulant bait BC and Enhanced anticoagulant bait CC is approved with controls
in accordance with the relevant provisions of the Hazardous Substances and New
Organisms Act 1996 (the HSNO Act) and the HSNO (Methodology) Order 1998.
1.2
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Enhanced anticoagulant bait BC
Enhanced anticoagulant bait CC
1.3
For the purpose of this Decision, the substances will be referred to as: EabBC, and
EabCC respectively.
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 31 of the HSNO Act. The decision was
determined in accordance with section 32, taking into account additional matters to be
ERMA New Zealand Decision: Application HSC03013
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considered in that section and matters relevant to the purpose of the Act, as specified
under Part II of the HSNO Act and the provisions of Part III of the Third Schedule of
the HSNO Act. Unless otherwise stated, references to section numbers in this decision
refer to sections of the HSNO Act.
2.2
Consideration of the application followed the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (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 11 September 2003 and verified as having
sufficient information on 19 September 2003.
3.2
Project Team:
Khay Ooi
Applications Adviser (Hazardous Substances)
Sue Scobie
Senior Adviser (Hazardous Substances), Science
& Analysis
Senior Adviser (Toxicology), Science &
Analysis
Sue Thomas
Report review and sign-out by:
Donald Hannah
3.3
The applicant supplied the following documents:




3.4
The application
Confidential appendices, containing compositional information, a Management
Plan, and a Project Plan
A report on the development of the anticoagulant baits
Patent filing information
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:




3.5
Manager (Science and Analysis)
The Ministry of Health
The Department of Labour (Occupational Safety and Health)
The Department of Conservation
The New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines Group (ACVM Group)).
A response was received from ACVM Group, stating that as the application will be
considered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act,
any issues which may arise under the Acts administered by MAF/NZFSA will be
considered as part of that application. The ACVM Group noted, however, that there is a
potential for secondary residues to occur for Component B in the bait. This concern is
addressed later in this decision in relation to the potential for secondary poisoning.
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3.6
A response was received from the Ministry of Health, stating that they are aware of the
persistence of Component B, and that residues have been detected in the liver of sheep
128 days after oral administration, and the possibility of transfer of this compound
through the food chain to humans. The Ministry considered that with appropriate HSNO
controls, and given that the public does not have free access to the trial sites, they had
no further issues to raise at this time.
3.7
The applicant was provided with a copy of the proposed controls for EabBC and
EabCC, and given the opportunity to comment on these. No comments were made by
the applicant.
3.8
The ERMA New Zealand Senior Advisor (Māori Affairs) was advised of the
application. Her comments form the basis of paragraphs 4.26 - 4.27 and the second
sentence of control 24 of this Decision.
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) of the HSNO Act).
4.2
In accordance with section 32 of the Act, 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
substances 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 purpose of the application is to seek approval to manufacture in containment the
substances EabBC and EabCC for field testing to assess their efficacy, toxicant and
residue levels, in order to obtain information regarding development, and future
registration of these baits under the ACVM Act, and possible future approval for release
under the HSNO Act.
4.4
As the purpose amounts to “research and development on any hazardous substance”, I
consider that the application qualifies for consideration under section 30(ba) of the Act.
Hazard Properties
4.5
I note that a containment application only requires sufficient understanding of the
hazardous properties to ensure that any risks can be managed by the containment
controls.
4.6
The applicant has assessed the available information and has identified that the
hazardous properties of EabBC and EabCC are limited to toxic (acute oral toxicity) and
ecotoxic (terrestrial vertebrate toxicity) properties.
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4.7
I note however, that two active ingredients of the three have been classified and are
listed in the ERMA database as possessing an aquatic ecotoxicity property.
4.8
Sufficient information describing the hazards associated with the substances has been
provided to consider whether any risks can be managed by the containment controls.
Life Cycle
4.9
Pest-Tech Ltd plans to manufacture up to 60 kg of each formulation of bait pellet. The
substances will be manufactured at a lockable building at a secure site used for
manufacture of prototype baits. Bait pellets are manufactured by mixing the components
with a filler (such as a cereal that is palatable to the target species) in a mixer in order to
homogenise the components, and forming the homogenate into 1-2 g pellets using an
orbital pelleter. Manufactured bait pellets will be stored in a locked store room at the
same facility until required for field testing.
4.10
Bait pellets will be transported to the trial sites by the Trial Director, using private
transport, in 1 kg lots in plastic bags placed inside plastic buckets. Trial sites are pine
plantations (in Selwyn in mid-Canterbury) of 30-50 hectares in size, surrounded by
cleared pasture land acting as buffer zones. At the trial site, 1 kg of pellets will be
placed in each weatherproof bait station. Bait stations have been designed to prevent
access by non-target species. The bait will be kept in the stations for two months. Each
bait station will be examined once a week for measurement and recording of the amount
of bait consumed. At the end of the trial, all uneaten bait will be recovered from the
stations, and disposed off by a contracted hazardous waste disposal company.
Appropriate disposal procedures for surplus bait, used containers, and target species
samples are detailed in the Management Plan supplied by the applicant.
Identification and Evaluation of the Significant Risks of the Substance in
Containment
4.11
In accordance with sections 5, 6, and 8 and clauses 9 and 11, I considered the potential
risks of escape from containment under the headings of environmental, human health
and welfare and Māori issues and concerns.
4.12
In the application, the applicant identified and assessed potential risks, and detailed
proposals for, and impacts of, risk management. I have taken this into account in my
consideration of the risks.
Risks to the Environment
4.13
If released into waterways, the substances may have adverse effects on aquatic
vertebrates.
4.14
On the basis of the lifecycle of the substances outlined in paragraph 4.9 - 4.10, effects
on aquatic organisms could arise from:
 An accident during manufacture, storage, use or transportation, resulting in release
of the substances into waterways
 Failure to follow correct use and disposal procedures as outlined in the Management
Plan.
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
Carcasses of target or poisoned non-target species ending up in waterways.
4.15
The applicant has shown in the Management Plan that the likelihood of these effects
occurring is very low, as the baits will be manufactured and stored in secure
environments, adequately sealed and packaged in small quantities for transport, and the
plantations where trial sites are located are situated away from catchment areas. The bait
stations are designed to reduce the potential for non-target vertebrate species from
accessing the bait.
4.16
If the substances do not remain contained, they may have adverse effects on terrestrial
vertebrates when ingested. On the basis of the lifecycle of the substances outlined in
paragraph 4.9 - 4.10, effects on terrestrial vertebrates could arise from:
 An accident during manufacture, storage, use or transportation, resulting in release
of the substances such that they become accessible to terrestrial vertebrates
 Primary poisoning of non-target species through direct feeding of toxic bait
 Secondary effects arising from residues in dead carcasses that might be scavenged
by non-target vertebrate species
 Secondary effects arising from invertebrate species acting as ‘vectors’ of the
substances
 Failure to follow correct disposal procedures as outlined in the Management Plan.
4.17
The applicant states in the Management Plan that EabBC and EabCC are less attractive
to birds than similar commercially available toxic baits, and are of a similar degradation
profile. This is supported through supplied literature indicating that the cereal base is
less palatable than previous cereal bases (cereal No. 7 bait). From experiments, the
applicant states that the ‘discard’ profile from possums feeding on the bait indicates that
very little bait will be available outside of the bait stations.
4.18
Anticoagulant poisons do not kill immediately, and there is the potential for the target
pest, or other non-target species, to wander away from the bait stations after consuming
bait. The applicant has stated that the range is restricted in situations involving
anticoagulant toxicity because of its debilitating effect in the latter stages of
anticoagulant poisoning, and that it is unlikely that possums will be far from their nest
sites, which are usually in windrows. The average mean length of home range of healthy
possums in pine forests is 200-300m, though some studies have placed home ranges in
the range of 0.7-2 hectares. The applicant has supplied references which indicate that
the home range depends on the nutritional status of the animal (well-nourished possums
roam less), and the availability of food. The pine plantations serving as trial sites are
40-50 ha in size. The possibility of affected possums ranging outside of the trial site will
depend on where the bait stations are sited.
4.19
The applicant has cited studies in which large-scale possum control operations have had
little measurable impact on invertebrate populations. However, bait may also be eaten
by non-target vertebrates or insects, which, while not themselves affected by the
substances, might in turn preyed upon by birds (or other non-target vertebrates), thus
acting as ‘vectors’. The applicant states that the bait contains an ingredient which is
likely an effective deterrent to insects such as wetas, beetles, weevils, springtails and
ants and has provided literature to support this statement.
ERMA New Zealand Decision: Application HSC03013
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4.20
The bait stations have been designed, and are sited, to reduce the possibility for
opportunistic feeding by non-target vertebrate species such as rodents and hedgehogs.
The applicant has indicated that the risks of secondary poisoning are substantially lower
than for 1080 or phosphorus due to less bait being eaten. The Project Team notes that
the dual action of the formulations may result in lower residue levels for individual
anticoagulants following one feed, however the issue of when a toxic dose is reached
remains unanswered, and no direct data have been supplied to support the applicants’
statement.
4.21
The applicant also points to the ecological differences between North Island and South
Island pine plantations, in which there is little under-story in the latter for supporting
terrestrial vertebrates such as mice. The applicant has supplied supporting literature that
indicates that when bait stations are positioned at least 0.7 metres above ground, the
accessibility to ground-dwelling birds is reduced.
4.22
I consider that, taking into account the properties of the substances, the quantities
involved, the proposed containment regime, the proposed containment controls in
Appendix 1, and controls in place under other legislation (such as the Land Transport
Rule for Dangerous Goods), there are no significant risks to the environment.
Risks to Human Health and Welfare
4.23
Ingestion of the substances has the potential to result in adverse effects on human
health. Ingestion may occur through tertiary means, for example, by eating the meat of
game animals that may have eaten bait, or insects that have eaten bait, or scavenged
carcasses of animals that might have been killed by the bait. It is possible that inhalation
of the substances may result in adverse effects on human health.
4.24
On the basis of the lifecycle of the substances outlined in paragraphs 4.9 - 4.10, adverse
effects on human health and welfare could arise from:
 An accident, resulting in exposure, during manufacture, storage, use or
transportation;
 Exposure to anticoagulant residues in feral game animals.
 Failure to adhere to the Management Plan, including the disposal procedures.
4.25
I consider that, taking into account the properties of the substances, the quantities
involved, the proposed containment regime, and controls in place under other legislation
(such as the Land Transport Rule for Dangerous Goods), there are no significant risks to
human health and welfare.
Māori issues and concerns
4.26
I have considered the potential Māori cultural effects of this application in accordance
with sections 6(d) and 8 of the HSNO Act 1996, and the assessment framework
contained in the ERMA New Zealand User Guide “Working with Māori under the
HSNO Act 1996”.
4.27
On the basis of the information provided by the ERMA New Zealand Senior Advisor
(Māori Affairs), I consider that the substances are unlikely to have an impact on the
relationship of Māori and their culture and traditions with their ancestral lands, water,
ERMA New Zealand Decision: Application HSC03013
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sites, waahi tapu, valued flora and fauna and other taonga. This is on the condition that
the substances are used in accordance with the proposed containment regime, including
the controls as detailed in Appendix 1.
5
Containment and Controls
5.1
I have evaluated the adequacy of the containment arrangements of the applicant and the
controls listed in Appendix 1, and note 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
substances.
 To control the effects of any accidental release of the substances.
 Inspection and monitoring requirements.
 Qualifications required of the person responsible for implementing the controls.
5.2
I am satisfied that with adherence to the controls listed in Appendix 1 and those controls
in place under other legislation (such as the Land Transport Rule for Dangerous Goods),
the substances can be adequately contained.
6
Decision
6.1
I have considered this application under section 31 to manufacture in containment
hazardous substances, 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 the substances Enhanced
anticoagulant bait BC and Enhanced anticoagulant bait CC, 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) of the Methodology I record that, in reaching this
conclusion, I have applied the criteria specified in section 32 of the Act.
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 containment the hazardous substances Enhanced
anticoagulant bait BC and Enhanced anticoagulant bait CC is thus approved pursuant to
section 31 of the Act, with controls as set out in Appendix 1.
Bas Walker
Date
30 October 2003
Chief Executive of ERMA New Zealand
ERMA New Zealand Approval Codes:
Enhanced anticoagulant bait BC
Enhanced anticoagulant bait CC
HSC000071
HSC000072
ERMA New Zealand Decision: Application HSC03013
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Appendix 1: List of controls that apply to the
hazardous substances Enhanced anticoagulant bait
BC and Enhanced anticoagulant bait CC
1.
The trials shall be undertaken in accordance with the information contained in the
application. Modifications of the Project Plan or Management Plan may be approved in
writing by ERMA New Zealand providing that they comply with the following controls.
2.
Notwithstanding the requirements of control 1 above, the trials shall comply with the
following controls.
3.
The trial area is defined as the trial site (pine plantation) and the buffer zone (100m)
surrounding the trial site.
4.
The substances shall be transported and stored in suitable containers that comply with
the Hazardous Substances (Packaging) Regulations 2001, and shall be labelled in
accordance with the Hazardous Substances (Identification) Regulations 2001. A Safety
Data Sheet shall accompany each shipment.
5.
The substances shall be transported in accordance with good practice. This may require
compliance with the Land Transport Rule: Dangerous Goods 1999.
6.
The substances shall be manufactured and stored in secure facilities in accordance with
good practice. This would generally be achieved by compliance with local by-laws or
regional plans or requirements established by the various local or regional councils.
Access to the toxic bait manufacturing facility shall be limited to personnel authorised
by the Trial Director1.
7.
Bait shall be weighed out into trial sized amounts, bagged, packed and labelled before
being transported to the trial site. Only sufficient bait for each trial run shall be taken to
the trial site.
8.
Personnel handling the baits shall wear rubber gloves.
9.
Bait stations shall be positioned no lower than 0.7 metres above the ground, and no less
than 50 metres from the perimeter of the trial site.
10. Equipment used for manufacturing the baits shall be triple rinsed after use, and the
rinsate disposed of by a properly approved hazardous waste disposal company.
11. Plastic bags used to transport the baits, once empty, shall be disposed of at an
appropriate waste disposal facility (which may include incineration or a landfill),
subject to the facility’s waste acceptance policy.
12. Surplus and uneaten bait remaining at the end of the trials shall be collected, and
disposed of by a properly approved hazardous waste disposal company, as described in
1
The Trial Director is the individual responsible for the overall conduct of the trial, including manufacture of
the baits, in accordance with the Management Plan and approved controls.
ERMA New Zealand Decision: Application HSC03013
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the management plan. (Note that once the trials are complete the substances do not have
an approval to be present in New Zealand except in an exempt laboratory).
13. Any spillage of the baits shall be collected, prevented from entering waterways, placed
into sealed containers and disposed of at an appropriate waste disposal facility (which
may include a landfill), subject to the facility’s waste acceptance policy.
14. To minimise the effects of any accidental release of the substances or unintended
exposure, container labels shall carry appropriate safety precautions and relevant first
aid measures for immediate action pending medical attention.
15. Should accidental release and exposure occur, normal precautions shall be followed, as
detailed in the Safety Data Sheet.
16. The trial sites shall be chosen so as to prevent any of the substances entering any surface
water or groundwater system.
17. No person is to access the trial sites for the duration of the trial, and for a period of at
least 21 days beyond the end of the trial, except the Trial Director, and any person
inspecting the site under control 23. The trial site boundaries shall be clearly marked
and distinctly visible from outside the trial site throughout the life of the trials. The trial
sites shall be fenced, and the primary access points shall be signed indicating that
unauthorized access, livestock and dogs are not allowed, that the site is subject to a trial.
A buffer zone of at least 100 metres shall established around each trial site.
18. Bait stations shall be inspected weekly, and any carcasses found shall be collected and
safely disposed of, to reduce the possibility of secondary poisoning.
19. In order to ensure adequate containment of the substances to the trial sites, the buffer
zones of the trial sites shall be inspected weekly, and any vertebrate carcasses found
shall be collected and safely disposed of. This is to reduce the possibility of secondary
poisoning as a result of ranging by affected target or vertebrate non-target species.
20. Notwithstanding 17 above, buffer zone inspection shall continue for at least three weeks
after the ending of the trial at a trial site.
21. The trial shall be terminated immediately if there is evidence of secondary poisoning
outside the buffer zone, e.g. reports of dogs being poisoned are received.
22. A record shall be kept of all use of the substances by the Trial Director. This record
shall cover all matters referred to in Regulation 6 of the Hazardous Substances (Class 6,
8 and 9 Controls) Regulations.
23. Occupational Safety & Health, Head Office [Attn. HSNO Project Manager (OSH) or
equivalent position] and ERMA New Zealand shall be informed in writing of the
location, start, and completion of the trials. The OSH project manager shall be
informed at least three working days prior to application at specific sites.
24. If, for any reason, a breach of containment occurs, the Trial Director shall notify OSH
and ERMA New Zealand within 24 hours of the breach being detected. It is suggested
ERMA New Zealand Decision: Application HSC03013
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that if a breach in containment results in contamination of a waterway, or adverse
effects to native species, the relevant iwi authorities be advised.
25. The Authority, or its authorised agent or properly authorised enforcement officers, may
inspect the facilities and trial sites at any reasonable time.
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