ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
30 November 2007
Application Code
HSR06133
Application Type
To import or manufacture for release any hazardous
substance under Section 28 of the Hazardous Substances
and New Organisms Act 1996 (“the Act”)
Applicant
Ministry of Agriculture and Forestry Biosecurity New
Zealand (“MAF BNZ”)
Date Application Received
20 December 2006
Submission Period
29 January 2007 to 13 March 2007
Consideration Date
12 October 2007
Considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
Campaign Ant Bait and Amdro Fire Ant Bait: to import
and release two insecticides containing hydramethylnon
for the control of exotic ant infestations.
1 Summary of decision
The application to import or manufacture Campaign Ant Bait (“Campaign”) and Amdro
Fire Ant Bait (“Amdro”) for release is approved with controls in accordance
with the relevant provisions of the Act, the HSNO Regulations and the HSNO
(Methodology) Order 1998 (“the Methodology”).
The substances have been given the following unique identifiers for the ERMA New
Zealand Hazardous Substances Register:
Campaign Ant Bait
Amdro Fire Ant Bait
2 Legislative criteria for application
The application was lodged pursuant to section 28. The decision was determined in
accordance with section 29, taking into account matters to be considered in that
section and additional matters specified under Part II of the Act. Unless
otherwise stated, references to section numbers in this decision refer to sections
of the Act.
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
The application was formally received on 20 December 2006.
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public notification
was made on 29 January 2007.
Various Government departments, Crown Entities and interested parties, including the
New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines (ACVM) Group), the Ministry of Health, and the Department of
Labour Work Place Group, which in the opinion of the Authority would be
likely to have an interest in the application, were notified of the receipt of the
application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and provided
with an opportunity to comment or make a public submission on the application.
The Department of Conservation (DoC) was also identified as having an interest,
and was notified about the application.
Submissions closed on 13 March 2007. A submission was received from Environment
Southland. Comments were also received from DoC. Both organisations were
in support of the application. Comments from the Ministry of Health were also
received regarding the proposed controls for the substances.
The applicant and submitters were also given the opportunity to comment on the ERMA
New Zealand Evaluation and Review Report (“the E&R Report”) and the
controls proposed therein. As a result, the applicant and the Ministry of Health
provided written comments on the E&R Report and these were placed before the
Committee before the consideration.
The Committee noted that Ms Bleakley submitted in opposition to the application for
modified reassessment of Engage Ant Bait and Distance Ant Bait (HRE07001),
and was heard at a hearing on 12 October 2007. Ms Bleakley wished to note her
objection extended to aerial application of Campaign and Amdro, but did not
make a submission during the submission period. The Committee took account
of this objection in its consideration of HSR06133.
No external experts were used in the consideration of this application (clause 17).
3.1
The Authority, with the applicant’s consent, extended the requirement to
consider this application 30 working days after the closing date for submissions.
This extension was made in accordance with section 58 (for further information)
and section 59 (for delays in producing the E&R report). In addition, a time
waiver was issued under section 59 as the circulation of the E&R report was
delayed by three working days.
The following members of the Authority considered the application (section 19(2)(b)):
Professor George Clark (Chair), Dr Deborah Read, Dr Kieran Elborough and Dr
Max Suckling.
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The information available to the Committee comprised:
 the application;
 the E&R Report, including a confidential appendix;
 submissions and comments received from government agencies;
 comments on the E&R Report from the applicant;
 comments on the E&R Report from the Ministry of Health;
 advice from the Agency on the above comments, and a correction regarding
the setting of acceptable daily exposure (ADE) and potential daily exposure
(PDE) values from those proposed in the E&R report;
 the consideration of HRE07001 (Engage Ant Bait and Distance Ant Bait).
4 Consideration
Purpose of the application
The purpose of the application is to import or manufacture and release two insecticides
containing hydramethylnon for the control of exotic ant infestations.
Sequence of the consideration
In accordance with clause 24, the approach to the consideration adopted by the
Committee was, for each substance, to:
 establish the hazard classifications for the substance and derive the default
controls that are prescribed under section 77 for each classification.
 identify potentially non-negligible risks, costs, and benefits.
 assess the potentially non-negligible risks and costs. Risks were assessed in
accordance with clause 12, and costs in accordance with clause 13. The
adequacy of the default controls, prescribed under section 77, was
considered alongside the assessment of risks and costs to determine whether
those controls should be varied and identify where additional controls need
to be applied, under section 77A, to mitigate any unacceptable risks.
 undertake a combined consideration of all the risks and costs and determine
whether the combined risks and costs are negligible or non-negligible.
 consider (a) whether any of the non-negligible risks could be reduced by
varying the controls in accordance with sections 77 or 77A, and (b) the costeffectiveness of the application of controls in accordance with clause 35 and
sections 77 and 77A.
 assess the benefits associated with this application in accordance with
clauses 9, 11, 13 and 14 and section 6(e).
 taking into account the risk characteristics established under clause 33,
evaluate the risks, costs and benefits in accordance with clause 34 and
section 29 and determine whether the application should be approved or
declined.
 confirm and set the controls.
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Hazard classification
The Agency has classified Campaign as follows:
Hazardous Property
Reproductive/developmental toxicity
Aquatic ecotoxicity
Classification
6.8B
9.1A
The Agency has classified Amdro as follows:
Hazardous Property
Skin irritancy
Skin sensitisation
Reproductive/developmental
toxicity
Aquatic ecotoxicity
Classification
6.3B
6.5B
6.8B
9.1A
Default controls
In the E&R Report, the Agency assigned default controls for Campaign and Amdro based
on their hazardous properties as set out in the HSNO Regulations. The default
controls were used as a reference for evaluation of the application in the E&R
Report. The default controls are listed in section 8 of the E&R Report and have
not been reproduced here.
Setting of exposure limits and application rates
4.1
Control T1 relates to the requirement to limit public exposure to toxic
substances by the setting of Tolerable Exposure Limits (TELs). TELs are
designed to limit the extent to which the general public is exposed to a toxic
substance. A TEL represents the maximum concentration of a substance legally
allowable in a particular medium, and can be set as a guideline value or an
action level that should not be exceeded. TELs are established from potential
daily exposure (PDE) values, which are themselves established from acceptable
daily exposure (ADE) values.
4.2
The Class 6 (toxicity) classification of Amdro and Campaign that triggers the
need to consider setting an ADE (and consequently a TEL) is 6.8B. The
Committee considers that hydramethylnon fulfils the requirements for setting a
TEL set out in Regulations 11(1)(a), (b) and (c), and therefore notes that an ADE
is required to be set for this component. With regard to TELs, the Authority is
intending to review the setting of such values under section 77B. As this review
has not been completed, TELs are not set for hydramethylnon in Amdro or
Campaign at this time.
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4.3
The Committee has set ADE and PDE values for hydramethylnon. Under
control T1, the following PDE values are set1for this component:
ADE= 0.024 mg/kg bw/day
PDE food = 0.01 mg/kg bw/day
PDE drinking water = 0.01 mg/kg bw/day
PDE other = 0.002 mg/kg bw/day.
4.4
Control T2 relates to the requirement to limit worker exposure to toxic
substances by the setting of Workplace Exposure Standards (WESs). The
Committee notes that no WES values have been set by the Department of
Labour for any of the components of Amdro or Campaign. It is further noted
that the conditions of Regulation 29 (1)(c) (relating to the setting of WES
values) are not met as the Agency is not aware of industrial hygiene data
available, which is a requirement for setting a WES value for a component.
Consequently, WES values are not set for Campaign or Amdro at this time.
4.5
Control E1 relates to the requirements to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). An EEL is the maximum concentration of a substance in an
environmental medium that will present a negligible risk of adverse
environmental effects to organisms in non-target areas. The Authority is
intending to review the setting of EELs under section 77B. As this review has
not been completed, EELs are not set at this time for Campaign and Amdro.
The default EEL water values are deleted.
4.6
Control E2 relates to the requirement to set an application rate for a class 9
substance that is to be sprayed on an area of land (or air or water) and for which
an EEL has been set. Although no EEL has been set for Amdro or Campaign, the
Committee notes that the substances present a risk to the aquatic environment.
The Committee has therefore set a maximum application rate for Amdro and
Campaign in accordance with section 77A (refer Paragraphs 5.15-5.15.2).
Identification and assessment of risks and costs
Identification of potentially non-negligible risks and costs
4.7
In its E&R Report, the Agency identified potentially non-negligible risks in the
following areas:
1
The E&R report stated that exposure would occur primarily through food and drinking water, so the PDEs are
distributed as follows (E&R report, pp. 40, 75-79). The Committee (on the Agency’s advice) noted an omission
in the proposed PDE values in the E&R report, as the values were distributed between water and food only (PDE
drinking water = 50% PDE food = 50%). The Committee noted that exposure may occur through other surfaces
(non-food and non-drinking water surfaces) that the baits may be deposited onto, from which hand to mouth
ingestion of the substances may occur. Therefore, the Committee allocated the distribution of PDEs amongst
food, water, and ‘other’ (PDE drinking water = 45%, PDE food = 45%, PDE other = 10%) to derive the final
values.
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
The environment (native species and/or ecosystems) - Campaign and Amdro
are both classified as ecotoxic within aquatic environments (9.1A). While
Campaign and Amdro do not trigger a classification for ecotoxicity to
terrestrial vertebrates, the risk to birds has been considered given that
exposure to birds may occur and reports estimating toxicity to birds are
available.

Human health (public and occupational) - both Campaign and Amdro are
classified as reproductive/developmental toxicants (6.8B). Further, Amdro is
classified as being an irritant (6.3B) and sensitiser (6.5B) to human skin. In
addition to the hazards posed by the toxicity of the substances, the
Committee considers that public concern may arise during use of the
substances (particularly when used aerially), resulting in anxiety and stress.

Society and communities - public concern about application of the
substances may have effects on social wellbeing.

The relationship of Māori to the environment - the substances may pose a
risk to the mauri of native species and to the role of Māori as kaitiaki.
4.8
The Committee considers that the effects identified above due to the presence of
Campaign or Amdro throughout the lifecycle of the substances. The risk
assessment for each of these areas of risk is summarised below.
4.9
As a “cost” is defined in Regulation 2 of the Methodology as “the value of a
particular adverse effect expressed in monetary or non-monetary terms”, the
costs were assessed in an integrated fashion together with the risks in the
Agency’s assessment.
Assessment of risks to the environment
4.10
Risks to the environment were assessed as ranging from negligible to high. The
Committee notes that:
4.10.1
Campaign and Amdro pose negligible risks to the environment during
manufacture, importation, transport, storage and disposal, taking
controls into account. This assessment was made using qualitative
techniques.
4.10.2
Campaign and Amdro pose risks to the aquatic environment when used
aerially or by ground-based means. In quantitative modelling
undertaken for these substances, the level of concern was exceeded for
one species tested (diatom) indicating that the substances pose a high
acute risk when applied aerially or by ground-based methods. For other
species, and for chronic exposure to all species modelled, the risks
posed by Campaign and Amdro were assessed as low, or manageable
with controls.
4.10.3
Campaign and Amdro pose risks to non-target terrestrial invertebrates.
This risk has been assessed as low. Campaign and Amdro are not
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classified as toxic to terrestrial invertebrates. However, the Committee
notes the lack of available data on terrestrial invertebrates for Campaign
and Amdro and uncertainty regarding the level of specificity of the
substances to the target species (exotic ants). The Committee has based
its consideration on the assessment that Campaign and Amdro pose a
low risk to such species. This qualitative assessment took into account
the views of the Department of Conservation, which advised on the
likely nature of the application area, and potential for invertebrate
communities to repopulate from surrounding areas following treatment.
4.10.4
4.11
Campaign and Amdro pose a low risk to birds during use. Neither
substance bears a classification for toxicity to birds, and quantitative
field-dose estimates fell well below the level of concern, indicating that
the risk is low.
The Committee considered the type, severity and characteristics of the risks
associated with environmental exposure to Campaign and Amdro during use
(clause 33). The Committee notes:

the infrequent and time limited nature of exposure (application up to a
maximum of twice per annum);

the restriction of application of the substances to the application area while
noting that this could include native bush and waterways; and

the potential for adverse effects to be reversible following exposure due to
repopulation of affected species from surrounding areas.
4.12
The Committee adopted a cautious approach in its consideration. This approach
was due to assessment of risks as set out in the E&R Report. The Committee
also notes that the aerial application of the substances in rapid incursion
responses to eradicate a pest organism may differ from application in a pestmanagement situation, where a routine bait application may be required.
4.13
The Committee considers that the risks to the aquatic environment and to
terrestrial invertebrates should be mitigated as far as possible through controls.
The following controls are considered appropriate:
4.14

the requirement for the substances to be under the control of an approved
handler when applied in a wide dispersive manner or by a commercial
contractor (E7, AH1);

a maximum application rate of 2.5 kg/ha with twice per annum in any
particular application area;

a restriction to prevent users from applying Campaign or Amdro into or onto
water.
The Committee considers that existing and additional controls are sufficient to
manage the risks posed by Campaign and Amdro to the environment.
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Assessment of risks to human health
4.15
4.16
Campaign and Amdro are classified as reproductive/developmental toxicants.
Amdro is also classified as sensitising and irritating to skin. Risks to human
health due to exposure have been considered, including any effects resulting
from perception of risk. Risks to human health were assessed as ranging from
negligible to high. The Committee notes that:
4.15.1
During import, manufacture, transport, storage and disposal, the risks to
workers and the public are assessed as negligible to low, noting the
limited exposure and controls in place.
4.15.2
Risks to operators during use resulting in reproductive/developmental
toxicity are assessed as negligible, noting the use pattern, physical form
(granules), and controls in place.
4.15.3
The risk of toxic effects occurring to members of the public during use
(aerial or ground-based) are assessed as negligible to low. The
Committee notes that repeated exposure at sufficient levels to cause
reproductive effects would not arise from the use pattern of the
substances (negligible risk). However, skin sensitisation or irritation
could occur due to a single exposure. The occurrence of a skin
irritation or sensitisation effect is considered improbable given the
physical form of the substances and use pattern of the bait (low risk).
4.15.4
The application of substances, particularly by aerial means, may cause
concern to individuals or communities, resulting in anxiety and stress.
This effect is considered relevant to human health in relation to
wellbeing as defined by the World Health Organisation2, and also to
social wellbeing in accordance with section 5(b). The risk assessment
indicates that this risk could range from low to high. The Committee
considers that the level of effect would vary depending on the
application method (ground-based or aerial), local factors (for example
land use, population) and the success of communication before, during
and after the operation.
The Committee considered the type, severity and characteristics of the risks
associated with human exposure to Campaign and Amdro during use, with
particular attention to aerial application (clause 33). The Committee notes that:

use of the substances would usually be infrequent and time-limited, thereby
restricting potential exposure;
2
As defined by the World Health Organisation, Health is “a state of complete physical, mental and social
well-being and not merely the absence of disease or infirmity”. Preamble to the Constitution of the World
Health Organization as adopted by the International Health Conference, New York, 19 June - 22 July 1946;
signed on 22 July 1946 by the representatives of 61 States (Official Records of the World Health
Organization, no. 2, p. 100) and entered into force on 7 April 1948.
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
4.17
if no pre-operation consultation with the public occurs, exposure to the
substances could be involuntary and the risks would not be well known or
understood by those potentially exposed.
The Committee considers that risks to the public should be mitigated through the
use of controls. The public should have some level of awareness of the risks and
control over their exposure to ant bait, and risks associated with exposure should
be appropriately mitigated. The Committee has set the following controls
relevant to public health:

no person may apply Campaign and Amdro by aerial means unless that
person first obtains permission from the Authority under section 95A;

acceptable daily exposure (ADE) and potential daily exposure (PDE) values
(control T1). These allow for the setting of Maximum Residue Limits,
Maximum Acceptable Values, or Tolerable Exposure Limits if necessary in
future;

signage must be provided when Campaign and Amdro are used by groundbased application;

the requirement for the substances to be under the control of an approved
handler when applied in a wide dispersive manner or by a commercial
contractor. The approved handler control has been triggered due to the
ecotoxic properties of the substances, but is also relevant to public health.
Risks to the relationship of Māori to the environment
4.18
The Committee has considered this application in accordance with clauses
9(b)(i) and 9(c)(iv) and sections 6(d) and 8.
4.19
The Committee notes that:
4.20
4.19.1
The levels of biophysical adverse effect to native species are generally
considered negligible to low, with the exception of a high risk for one
indicator species (diatom) modelled. The high risk is considered
manageable with controls. The Committee notes that any adverse effect
to the mauri of those species is likely to be similar. This is also
balanced against consideration of the devastating impact invasive ant
species are likely to have on native species and ecosystems.
4.19.2
The level of adverse effect to the role of Māori as kaitiaki is assessed as
negligible. Although the use of any toxic substance in the environment
is considered generally by Māori to be inconsistent with tikanga and
mātauranga Māori, an incursion of such an invasive pest species would
place the intergenerational role of Māori as kaitiaki at significant risk.
The Committee also notes that the applicant indicated in its application that it
will consult all affected parties prior to each aerial operation, including relevant
iwi/Māori groups. The Committee has set the additional control that the
substance user obtain prior permission from the Authority under section 95A
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(refer to paragraphs 5.3-5.9). The Committee considers that those seeking
permission from the Authority for aerial application of Campaign and Amdro
should be required to demonstrate consultation with iwi/Māori groups to an
adequate standard. In this regard, the Committee notes the interpretation of
‘consultation’ in ERMA New Zealand guidance3, namely that the overall aim of
good consultation is to provide easily understood information about the
proposal; obtain the necessary information and understanding of Māori
perspectives and views as they relate to specific issues associated with the
proposal; and discuss, where issues are raised by Māori, ways of minimising,
mitigating or remedying any potential adverse effects and enhancing potential
benefits. The Committee would expect that those proposing to use the substance
(and therefore seeking permission to do so) will be required to demonstrate
consultation with Māori to at least this standard.
4.21
With the controls imposed in this decision and the planned use and management
of the substances (as outlined in the application), the Committee considers that
any potential adverse effects on the relationship of Māori to the environment
will be minimised to acceptable levels. In addition, the Committee
acknowledges the high level of potential adverse effects likely to occur to taonga
species should any of the target invasive ant species establish self sustaining
populations in the New Zealand environment.
4.22
Overall, the Committee considers a negligible to low impact from Campaign and
Amdro on the relationship of Māori and their culture and traditions with their
ancestral lands, water, sites, wāhi tapu, valued flora and fauna and other taonga.
This takes into account the potentially high risk to some aquatic species which
may be reduced with appropriate controls. In addition there is no evidence to
suggest that the controlled use of Campaign and Amdro will breach the
principles of the Treaty of Waitangi. This assessment is based on the
assumption that the substances will be handled, stored, transported, used, and
disposed of, in accordance with the controls set out in this decision and those
required by other legislation.
4.23
However, the Committee recommends that should inappropriate use, or an
accident, result in the contamination of waterways or the environment generally,
users should 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 remediate.
Risks to society and the community
4.24
3
The Committee considers that the aerial application of baits may give rise to
public concerns about risks to people’s health or to the environment. Therefore
there is the potential for adverse effects to individuals or groups within the
exposed community. Concern over health effects would be relevant to social
wellbeing. These effects were assessed in relation to human health and safety.
No additional risks relevant to society and the community were identified.
User Guide Working with Māori under the HSNO Act 1996: A Guide for Applicants (ER-UG-01-4 04/05)
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Risks to the market economy
4.25
The Committee does not anticipate any significant adverse impacts on the
market economy with the controlled use of Campaign and Amdro by aerial
means.
Risks to New Zealand’s international obligations
4.26
Risks to New Zealand’s international obligations are not anticipated with the
controlled use of Campaign and Amdro.
Identification and assessment of benefits
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular
positive effect expressed in monetary or non-monetary terms”. Benefits that
may arise from any of the matters set out in clauses 9 and 11 were considered in
terms of clause 13.
4.27
The Committee considered the benefits identified by the applicant in relation to
the substances being used as effective pesticides against the Red Imported Fire
Ant (RIFA), and potentially other invasive ant species. The Committee notes
that an efficacy report provided by the applicant notes the efficacy of the toxin in
controlling different ant species, including RIFA (Stanley, 2006). The
Committee considers that the availability of Campaign and Amdro will give
MAF BNZ the opportunity to apply appropriate treatments for a target species
(for example, RIFA) in a timely manner.
4.28
Based on the efficacy of the substances in preventing or managing the negative
effects of RIFA explained by the applicant, the Committee notes and agrees with
the Agency’s assessment of a high level of benefit for the following:
4.29

the environment, due to the prevention of RIFA predating on or competing
with native species;

human health, due to the prevention of RIFA stings, which may potentially
result in a severe allergic reaction in some individuals;

the relationship of Māori to the environment through avoidance of the
anticipated significant adverse effect on native species and consequently
the role of Māori as kaitiaki;

society and community, due to the protection of leisure and outdoor
pursuits that may be hampered by the presence of RIFA.

the market economy, through prevention of the high economic cost
expected should RIFA establish in New Zealand.
The Committee notes the potential for anxiety and stress to be caused to
members of the public if RIFA are not eradicated. In preventing such an effect,
the substances may be beneficial to human health and society and communities.
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4.30
The Committee notes that the substances may also be effective against other ant
species, but that insufficient information was available to determine the scope of
such effects.
Overall evaluation of risks, costs and benefits
4.31
The Committee considers that the benefits (assessed as high) of allowing
Campaign and Amdro to be aerially applied in New Zealand outweigh the risks
and costs (assessed as negligible to high), in consideration of the controls in
place to manage non-negligible risks.
5 CONTROLS
The applicant was given an opportunity to comment on the proposed controls as set out in
the E&R Report (clause 35(b)). Comments received by the applicant and the
Ministry of Health were taken into account during the consideration of the
application.
Additional controls under section 77A
Under section 77A, the Authority may impose as controls any obligations and restrictions
that it thinks fit. Before imposing a control under this section, the Authority
must be satisfied that, against any other specified controls that apply to the
substance:
(a) the proposed control is more effective in terms of its effect on the
management, use and risks of the substance; or
(b) the proposed control is more cost-effective in terms of its effect on the
management, use and risks of the substance; or
(c) the proposed control is more likely to achieve its purpose.
5.1
The Committee notes that the application of ant baits by aerial means may cause
adverse public perceptions, and associated anxiety and stress of residents and
land users in the area. The Committee notes that MAF BNZ intends to consult
and communicate with affected parties; however, other users may not. Further,
the Committee considers that there are factors that may be important at a local
level (for example: land use, population density) that would influence the level
of public exposure, and therefore the level of concern anticipated.
5.2
If there is no local consultation with people or communities, their exposure to
the substances would be involuntary, and the associated risks and their
management would not be well enough known and understood. If kept
adequately consulted and informed, the public can better control their level of
exposure to the substances, and have a greater level of awareness of the level of
risk.
5.3
Further, the Committee notes the issues raised in the Agency’s assessment
regarding the role of iwi/Māori as kaitiaki, and the need to ensure best practice
consultation with iwi/Māori whose land or other interests might be affected by
the use of Campaign and Amdro, particularly when applied aerially. The
Committee considers that users of Campaign and Amdro should take all
ERMA New Zealand Decision: Application HSR06133
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reasonable efforts toward genuine consultation with the iwi and/or hapū group/s
in the region of the proposed operation.
5.4
The applicant commented on the proposal to set a control requiring the user of
the substances to seek prior permission from the Authority under section 95A.
The applicant viewed this control as presenting a barrier to its ability to respond
quickly to incursions of exotic ants, and noted that mitigating factors (for the
risks of the substances) were already in existence. The applicant commented
that:

an additional step (seeking permission) prior to a rapid aerial response,
could result in delays. Further, the implications, process and criteria
required to successfully seek permission are as yet unknown, as the
process by which approval is sought has not yet been determined by the
Authority. The applicant considered that this could result in delays to
response actions, and at worst, a failed incursion response. As the
substances are required for an aerial treatment in late 2007, the applicant
sees a risk that permission would not be granted in time;

if the Authority delegates its permission granting power, a permission may
be granted by a stakeholder agency that is not principally responsible for
the eradication. The applicant considered it to be the Authority’s
responsibility to decide whether aerial use should be permitted at the time
it considers this application;

mitigating factors are believed to exist for the risks identified. The
applicant specifically noted the Agency’s risk assessment, the provisions
for consultation with Ministry of Health Officials and groups affected by
an incursion response and the presence of dedicated health advisers on the
MAF BNZ staff.
5.5
The Committee notes the concerns raised by the applicant.
5.6
On the basis of the considerations above, and noting the support of the Ministry
of Health for the approach, the Committee has decided to set a control requiring
that a permission under section 95A be sought from the Authority (or a delegate)
prior to use of the substances in order to determine what conditions should apply
to their use having regard to local circumstances or interests. Accordingly, the
following control is set under section 77A(2)(a), on the basis that it will be more
effective than the specified (default) controls in the management, use and risks
of the substances (section 77A(4)(a)):
5.6.1
5.7
No person may aerially apply Campaign or Amdro unless that person
first obtains a permission from the Authority under section 95A of the
Hazardous Substances and New Organisms Act 1996.
The Committee notes that the possible delegation of the power to grant
permissions to another agency is yet to be considered. Therefore, the specific
process and criteria required by the permissions issuing agency is outside the
scope of this decision.
ERMA New Zealand Decision: Application HSR06133
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5.8
The Committee notes that where ground-based treatment occurs in areas where
the public may be exposed, the requirement to obtain a permission from the
Authority will not apply, as this requirement relates to aerial application of the
bait only. However, the Committee notes that public exposure may occur and
pose risks (albeit low), when used by ground-based methods. The Committee
notes that it is best practice to notify the public where pesticides are applied in
places where the public ordinarily have access, as this will allow members of the
public to minimise their exposure to the substances in such areas. Relevant
guidelines for providing signage are set out in the Code of Practice, NZS
8409:2004 Management of Agrichemicals. Therefore, the Committee considers
that the following additional control should be imposed, as it will be more
effective in the management, use and risks of Campaign and Amdro when
applied by ground-based methods (section 77A(4)(a)):
5.8.1
Any person applying Campaign or Amdro by ground-based means in a
place in which the public ordinarily have access must ensure that signs
are erected in accordance with section 5.3.1 and Appendix M3 of NZS
8409:2004.
5.9
The Committee notes that Campaign and Amdro are classified as 9.1A
substances (highly ecotoxic in the aquatic environment). The risk quotient
derived from the environmental exposure modelling exceeds the level of concern
for acute risk, indicating that the substances may cause adverse environmental
effects when used. The Committee therefore considers it appropriate to set a
maximum application rate for Campaign and Amdro. Also, to avoid aquatic
exposure, the Committee has prohibited the use of Campaign and Amdro into or
onto water. The Committee notes that the possibility for this control to present
practical difficulties for aerial applicators. However, the Committee notes that
the applicant’s stated intention in their application to avoid contamination of
waterbodies, and therefore considers it possible for appropriate measures to be
made to avoid applying the substances into or onto water.
5.10
Further, the Committee notes DOC’s comments in support of restrictions on the
use of the baits to prevent application to waterbodies in order to protect aquatic
environments. DOC advised that it “recognises that, with adequate on site
calibration, bait can be aerially applied up to a safe buffer distance to the
margins of waterbodies.” And that “ground based methods are appropriate in
areas immediately adjacent to the water’s edge”. DOC’s views are considered
relevant and consistent with the additional control proposals relating to the
environmental risks.
5.11
The Ministry of Health also commented on the control restricting the use of
Campaign or Amdro into or onto water as proposed in the E&R Report. Noting
that this control is intended to address the environmental risks, the Ministry
noted that there was no equivalent control intended to protect public health, and
suggested adding a similar provision, that Campaign and Amdro shall not be
applied onto or into water.
5.12
The Committee notes the comments of the Ministry of Health regarding this
control. While the risks to human health posed by exposure to the substances
ERMA New Zealand Decision: Application HSR06133
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were assessed as negligible, the Committee has set the control that the
substances must not be applied into or onto water. Further, under control T1,
Acceptable Daily Exposure and Potential Daily Exposure values have been set.
If necessary these values can be used to derive Maximum Acceptable Values for
drinking water. The permissions control (under section 95A) will also allow for
consideration of local concerns relating to drinking water.
5.13
The Committee considers that the following controls will be more effective than
the specified (default) controls to manage the use and risks of Campaign and
Amdro to the aquatic environment (section 77A(4)(a)):
5.13.1
Campaign and Amdro shall not be applied into or onto water.
5.13.2
Campaign and Amdro shall be applied at a maximum rate of 2.5 kg/ha,
twice per annum in any particular application area.
Modification of controls
5.14
Under section 77, the default controls triggered for the substances may be
varied. Under section 77(3), controls may be substituted or added. Under section
77(4), controls may be substituted or deleted. Under section 77(5), where a
substance triggers more than one hazard classification, controls may be
combined.
5.15
Control T7 relates to restrictions on the carriage of hazardous substances on
passenger service vehicles. The Committee notes that the trigger quantity for
this control was varied for the sensitisation hazard for pesticides transferred to
the Act under the Hazardous Substances (Pesticides) Transfer Notice 2005.
Consequently, the quantity of Amdro triggering these requirements is varied
from 0.5 kg to 3 kg.
5.16
The Committee notes that the approved handler (E7, AH1) controls are triggered
for Campaign and Amdro due to the substances’ ecotoxicity to the aquatic
environment. However, the Committee considers that these controls should be
varied for Amdro or Campaign to apply only during use, as this is when the
substances are assessed as posing the greatest risk to the aquatic environment.
The Committee considers that the proposed modification will be equally
effective in managing the use and risks as if it had not been modified. Thus,
under section 77(4)(a), the following control is substituted for Regulation 9(1)
of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001:
5.16.1
5.17
(1). Campaign and Amdro must be under the personal control of an
approved handler when either substance is (a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.
Controls I16 and I21 relate to requirements to identify certain toxic components
on labels and in accompanying documentation. Under these controls, the name
and concentration of the certain components need to be specified on the label
and documentation for Campaign and Amdro. The Agency proposed not to vary
ERMA New Zealand Decision: Application HSR06133
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I164, which would require Component C (Amdro) and hydramethylnon
Campaign and Amdro) to be identified on the substance label (these components
trigger 6.5 and 6.8 classifications respectively), to allow an additional means to
access information about the substances.
5.18
5.19
The applicant commented on the proposed control to require Component C of
Amdro to be identified on the substance label. The applicant commented that:

Either new labels will have to be produced prior to import of the products,
or new labels will have to be prepared in New Zealand and stuck onto the
packaging upon arrival; and that

Confidential ingredients (Component C of Amdro) must be disclosed [on
the label] by the manufacturers.
The Committee notes the concerns of the applicant, and considers that, due to
the very low concentration of Component C in Amdro, and the requirement for
operators to wear personal protective equipment, it would be acceptable for
Component C not to be included on the label. However, the Committee
considered that the active ingredient, hydramethylnon, should be included on the
label. The identification and labelling requirements for Campaign and Amdro
are therefore as follows:
Labelling requirement
Hydramethylnon (Amdro and
Campaign Ant Bait, 6.8B)
5.20
Documentation requirement
Component C (Amdro only,
6.5B)
Hydramethylnon (Amdro and
Campaign Ant Bait, 6.8B)
The Committee has combined the following controls under section 77(5) for
Campaign and Amdro as they relate to the same requirements:
5.20.1
Controls T4 and E6 which relate to requirements for equipment used to
handle hazardous substances.
5.20.2
Controls D4 and D5 which relate to requirements for disposal of
Campaign and Amdro.
5.20.3
Controls P13 and P15 which relate to packaging requirements for
Campaign and Amdro.
4
Under Authority Policy (March 2006), regulation 25(e) may be varied such that the concentration cut-offs
that apply to a component with a hazard classification of 6.5, 6.6, 6.7, 6.8 or 6.9 are higher for labelling
requirements than for documentation.
ERMA New Zealand Decision: Application HSR06133
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Control precedents
5.21
The Committee notes that Campaign and Amdro are similar to the approved
product Maxforce Fire Ant Killer granular bait, having the same hazard profile
and active ingredient. Maxforce Fire Ant Killer and “Bait containing 10 g/kg
hydramethylnon” are covered under approval code HSR000693.
5.22
The Committee notes that, when initially approved, Maxforce Fire Ant Killer the
potential for widespread aerial use was not explicitly assessed. Therefore, the
Committee considers that the additional controls and varied controls set in this
decision should nevertheless apply to Campaign and Amdro. In addition, the
Committee considers that Maxforce Fire Ant Killer should be considered for
reassessment to ensure consistency with the relevant controls for this use pattern.
5.23
The Committee also considered the Authority’s approvals given to pesticides
under Part V of the Act as well as those transferred to the Act, for example,
under the Hazardous Substances (Pesticides) Transfer Notice 2004 (as
amended). The Committee noted the specific relevance of the following other
precedents:

Sodium Fluoroacetate (1080) and formulated substances containing 1080
(Approval code: HSR002771) in the consideration of controls and best
practice for aerially applied pesticides;

Aquathol K and Aquathol Super-K (Approval code: HSR000946), for the
consideration of the conditions required to be considered by the permission
granting body under section 95A.
6 RECOMMENDATIONS
The Committee recommends that, should inappropriate or accidental use, transport or
disposal of Campaign and Amdro result in the contamination of waterways, the
appropriate authorities, including the relevant iwi authorities in the region,
should be notified. This action should include advising them of the
contamination and the measures taken in response.
7 ENVIRONMENTAL USER CHARGES
The Committee considers that the application of controls to Campaign and Amdro will
provide an effective means of managing risks associated with these substances.
At this time no consideration has been given to whether or not environmental
charges should be applied to these substances as an alternative or additional
means of achieving effective risk management.
8 Decision
The Committee determines that:
8.1.1
Campaign triggers the following hazard classifications:
ERMA New Zealand Decision: Application HSR06133
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Hazardous Property
Reproductive/developmental toxicity
Aquatic ecotoxicity
8.1.2
Classification
6.8B
9.1A
Amdro triggers the following hazard classifications:
Hazardous Property
Skin irritancy
Skin sensitisation
Reproductive/developmental
toxicity
Aquatic ecotoxicity
Classification
6.3B
6.5B
6.8B
9.1A
8.1.3
pursuant to section 29 and clause 27, the positive effects (benefits) of
the substances outweigh the adverse effects (risks and costs).
8.1.4
the application for importation or manufacture and release of the
hazardous substances, Campaign and Amdro, is thus approved with
controls as listed in Appendix 1.
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has applied the balancing tests in section 29 and clause 27.
It has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of the substances;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand
 clause 21 – the decision accords with the requirements and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
 clause 24 – the use of recognised risk identification, assessment,
evaluation and management techniques;
 clause 25 – the evaluation of risks;
 clause 33 – risk characteristics;
 clause 34 – the aggregation and comparison of risks, costs and benefits;
and
 clause 35 – the costs and benefits of varying the default controls.
Professor George Clark
Chair
Date: 30 November 2007
ERMA New Zealand Approval Codes:
ERMA New Zealand Decision: Application HSR06133
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Campaign Ant Bait
HSR007881
Amdro Fire Ant Bait
HSR007882
ERMA New Zealand Decision: Application HSR06133
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APPENDIX 1: CONTROLS APPLYING TO CAMPAIGN
AND AMDRO
The controls imposed on Campaign and Amdro are as follows. The regulations cited should
be referred to for definitions and exemptions. The ERMA New Zealand publication User
Guide to Control Regulations provides useful guidance on the controls.
Table A1.1: Controls for Campaign and Amdro – codes, regulations and variations
Control
Code5
Regulation6 Topic
Variations
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property
Controls
T1
11-27
Limiting exposure to toxic substances The following ADE and PDEs
are set for hydramethylnon:
ADE= 0.024 mg/kg bw/day
PDE food = 0.01 mg/kg bw/day
PDE drinking water = 0.01
mg/kg bw/day
PDE other = 0.002 mg/kg
bw/day
T2
29, 30
Controlling exposure in places of
work
T4
7
Requirements for equipment used to
Controls T4 and E6 are
E6
handle hazardous substances
combined.
T5
8
Requirements for protective clothing
and equipment
T7*
10
Restrictions on the carriage of
The trigger level for T7 is 3kg
hazardous substances on passenger
service vehicles
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
E1
32-45
Limiting exposure to ecotoxic
substances
E2
46-48
Restrictions on use within application Maximum application rate set
area
(refer “Section 77A Additional
Controls)
E5
5(2), 6
Requirements for keeping records of
use
E7
9
Approved handler requirements
The following control is
substituted for Regulation 9(1):
(1). Campaign and Amdro must
be under the personal control of
an approved handler when
either substances are (a) applied in a wide
dispersive manner; or
5
Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links
the hazard classification categories to the regulatory controls triggered by each category. It is available from the ERMA New Zealand
website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.
6
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for
definitions and exemptions. The accompanying explanation is intended for guidance only.
ERMA New Zealand Decision: Application HSR06133
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Control
Code5
Regulation6
Topic
Variations
(b) used by a commercial
contractor.
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35, General identification requirements
36 (1)-(7)
Regulation 6 – Identification duties of
suppliers
Regulation 7 – Identification duties of
persons in charge
Regulations 32 and 33 – Accessibility of
information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and Durability
of information
I3
9
I9
18
I11
20
I16
25
I17
I18
I19
26
27
29-31
Priority identifiers for ecotoxic
substances
Secondary identifiers for all
hazardous substances
Secondary identifiers for ecotoxic
substances
Secondary identifiers for toxic
substances
Use of Generic Names
Use of Concentration Ranges
Alternative information in certain
cases
Variations: Component C of
Amdro is not required to be
identified on the label.
Hydramethylnon must be
identified on the label.
Regulation 29 – Substances in fixed bulk
containers or bulk transport containers
Regulation 30 – Substances in multiple
packaging
Regulation 31 – Alternative information
when substances are imported
I21
37-39, 4750
Documentation required in places of
work
Regulation 37 – Documentation duties of
suppliers
Regulation 38 – Documentation duties of
persons in charge of places of work
Regulation 39 – General content
requirements for documentation
Regulation 47 – Information not included
in approval
Regulation 48 – Location and
presentation requirements for
documentation
ERMA New Zealand Decision: Application HSR06133
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Control
Code5
Regulation6
Topic
Variations
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I23
41
Specific documentation requirements
for ecotoxic substances
I28
46
Specific documentation requirements
for toxic substances
I29
51-52
Duties of persons in charge of places
with respect to signage
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8 General packaging requirements
Regulation 5 – Ability to retain contents
Regulation 6 – Packaging markings
Regulation 7(1) – Requirements when
packing hazardous substances
Regulation 8 – Compatibility
Regulation 9A and 9B – Large Packaging
P3
9
Packaging requirements for
substances packed in limited
quantities
P13*
19
Packaging requirements for
Controls P13 and P15 are
P15
21
Campaign and Amdro
combined
PG3
Schedule 3
This schedule describes the
(minimum) packaging requirements
that must be complied with for these
substances when packaged in
quantities of more than 5 L. The tests
in Schedule 3 correlate to the
packaging requirements of UN
Packing Group III (UN PGIII).
PS4
Schedule 4
This schedule describes the minimum
packaging requirements that must be
complied with for these substances
when packaged in quantities equal to
or less than 5L.
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for Campaign
Controls D4 and D5 are
D5
9
and Amdro
combined
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation requirements
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management
information: General requirements
EM6*
8(e)
Information requirements for toxic
substances
ERMA New Zealand Decision: Application HSR06133
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Control
Code5
EM7
Regulation6
8(f)
Topic
Variations
Information requirements for ecotoxic
substances
EM8
12-16, 18Level 2 emergency management
20
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency response
plans
EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
The Hazardous Substances (Tank
where applicable
Wagons and Transportable
Containers) Regulations 2004
prescribe a number of controls
relating to tank wagons and
transportable containers and must be
complied with as relevant.
Section 77A Additional Controls
No person may aerially apply Campaign or Amdro unless that person first obtains a
permission from the Authority under section 95A of the Hazardous Substances and New
Organisms Act 1996.
Any person applying Campaign or Amdro by ground-based means in a place in which the
public ordinarily have access must ensure that signs are erected in accordance with section
5.3.1 and Appendix M3 of NZS 8409:2004 Management of Agrichemicals.
Campaign and Amdro shall not be applied onto or into water.
Campaign and Amdro shall be applied at a maximum rate of 2.5kg/ha, twice per annum in
any particular application area.
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