ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
11 November 2007
Application Code
HRE07001
Application Type
To reassess any substance under section 63A 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
9 July 2007
Submission Period
20 July 2007 - 31 August 2007
Hearing Date
12 October 2007
Consideration Date
12 October 2007
Considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
To seek approval to the modification to the groundbased application control to allow aerial application of
the baits in addition to ground-based application.
1 Summary of decision
1.1
The application to reassess a specific aspect of the approvals for Engage Ant
Bait (“Engage”, approval code: HSR002439) and Distance Ant Bait (“Distance”,
approval code: HSR002438) is approved in accordance with the relevant
provisions of the Act, the HSNO Regulations and the HSNO (Methodology)
Order 1998 (“the Methodology”).
The substances were originally approved by the Authority in a decision dated 14
February 2006, and were subject to a control limiting their use to ground-based
methods. This control is now modified to allow aerial application of the baits in
addition to ground-based application. The Authority has also added and varied
other controls as a result of its consideration.
2 Legislative criteria for the application
The application was lodged by MAF BNZ pursuant to section 63A following grounds for
reassessment having been established under section 62 by the Authority in its
decision dated 29 May 2007. In that decision, the Authority established that
information showing a significant change of use of Engage and Distance has
become available (section 62(2)(c)). In addition, the potentially beneficial
effects of the use of Engage and Distance by aerial means were considered
relevant to the grounds for reassessment, in accordance with section 6.
Under section 63A, the Authority may, following a finding that there are grounds for the
reassessment of a hazardous substance, conduct a modified reassessment of the
substance where the Authority considers that the reassessment will involve only
a specific aspect of the approval and the proposed amendment is not a minor or
technical amendment to which section 67A applies.
By virtue of section 63A(2), the Authority, as a result of a modified reassessment under
section 63A, may vary the controls that attach to a hazardous substance but may
not revoke an approval given to the substance under the Act to import or
manufacture the substance.
Pursuant to section 63A(6), in deciding whether to approve or decline an application for a
modified reassessment, the Authority must take into account all the effects
associated with the reassessment proposal and the best international practices
and standards for the safe management of the substance.
This reassessment decision was determined in accordance with section 63A, taking into
account matters to be considered in that section and 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 also 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 9 July 2007.
3.1
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, the Department
of Labour Work Place Group, and the Department of Conservation, 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.
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public notification
was made on 20 July 2007.
Submissions closed on 31 August 2007. Submissions were received from Environment
Southland, Environment Bay of Plenty, and the Department of Conservation.
Comments by the Ministry of Health were also received. These submissions and
comments were all in support of the application.
A submission was also received from Ms Claire Bleakley of Featherston. Ms Bleakley
submitted in opposition to the application, and requested to be heard in support
of her submission. Accordingly, a public hearing was held at the Authority’s
offices in Wellington on Friday 12 October 2007.
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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, Ms Bleakley and the
Ministry of Health provided written comments on the E&R Report and these
were placed before the Committee at the hearing.
No external experts were used in the consideration of this application (clause 17).
A time waiver was issued under section 59 as the circulation of the E&R report was
delayed by four working days.
The following members of the Authority’s Hearings Committee considered the
application (section 19(2)(b)): Professor George Clark (Chair), Dr Deborah
Read, Dr Kieran Elborough and Dr Max Suckling.
The information available to the Committee comprised:
 the application;
 the E&R Report, including a confidential appendix;
 all submissions;
 comments on the E&R Report from the applicant;
 comments on the E&R Report from Ms Bleakley, and additional documents
in support of her submission;
 comments on the E&R Report from the Ministry of Health;
 advice from the Agency on the above comments.
4 Consideration
Purpose of the application
The purpose of the application is to seek modification to the ground-based application
control to allow aerial application of the baits in addition to ground-based
application.
Sequence of the consideration
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:
 identify the controls affected by the reassessment proposal;
 identify and 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;
 identify and assess the benefits associated with this application in accordance
with clauses 9, 11, 13 and 14 and section 6(e);
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



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;
identify and assess best international practices and standards for the safe
management of hazardous substances;
evaluate overall risks, costs, and benefits to reach a conclusion; and
set the controls.
Identification of the controls affected by the reassessment proposal
The Authority has set controls for Engage and Distance under the original approvals to
import or manufacture the substances for release dated 14 February 2006. The
controls set out in those approvals are intended to manage the risks of the
substances throughout their lifecycles, and include provisions for packaging,
identification, disposal, emergency management as well as specific measures to
manage the ecotoxicity of the substances.
In addition to the default controls specified in the approvals, the use of Engage and
Distance was limited by a control set under section 77A(4)(a); that “Engage and
Distance may only be applied by ground-based methods.” The approval states
that this control would be “more effective at managing the risks associated with
application of the baits [than the default controls]”, and that the additional
control would have the effect of “limiting the risks to only those that have been
considered as part of the Agency’s risk assessment”. Further, the approval states
that “the applicant states in their application that if a large infestation were
discovered the success of these baits in reducing a part of a colony would
determine what action to take in order to obtain approval for aerial application of
the substances”.
It is this control which is the subject of this reassessment.
Identification and assessment of risks and costs
Identification of potentially non-negligible risks and costs
4.1
In its evaluation of Engage and Distance, the Agency identified potentially
significant, and therefore non-negligible, risks, and costs associated with the
change to the use pattern of the substances.
4.2
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”.
Accordingly, the costs were assessed in an integrated fashion together with the
risks in the Agency’s assessment.
4.3
The Agency and the applicant identified potential sources of risk that may arise
due to the proposed change in the application method for Engage and Distance
to allow aerial application of these substances. Given this change in use pattern,
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and taking the hazardous properties into account, the Agency has identified the
potential for the following adverse effects to occur:
4.4

The environment (native species and/or ecosystems) - due to the ecotoxicity
of the substances to aquatic organisms (9.1B-C) and terrestrial invertebrates
(9.4B). While neither Engage nor Distance trigger a classification for
ecotoxicity to terrestrial vertebrates, the substances may pose a risk to birds
given that exposure to birds may occur and reports estimating toxicity to
birds are available.

Human health (public and occupational) - Distance and Engage do not have
any toxicity classifications; however, public concern over the aerial
application of the substances, resulting in anxiety and stress, may pose
adverse effects to human health.

The relationship of Māori to the environment- by posing a risk to the mauri
of native species and to the role of Māori as kaitiaki.

Society and communities- primarily due to public concern about aerial
application of the substances.
The Committee considers that the effects identified above may arise if human or
environmental exposure to Engage or Distance occurs to humans or the
environment during aerial application. These risks are summarised below.
Risks to the environment
4.5
Risks to the environment were assessed as negligible to high. The Committee
noted that:
4.5.1
Distance poses a risk to the aquatic environment when used aerially or
by ground-based means. In quantitative modelling undertaken for this
substance, the level of concern was exceeded for one species (diatom)
indicating that the substance poses a high chronic risk when applied
aerially or by ground-based methods. For other species, and for acute
exposure to all species modelled, the risks posed by Distance were
assessed as low, or manageable with controls. Engage poses a low or
manageable risk to the aquatic environment when applied aerially or by
ground-based means.
4.5.2
The substances pose risks to non-target terrestrial invertebrates. Such
risks have been considered separately for bees, and other invertebrates.
Risks to bees were assessed as low, using qualitative and quantitative
assessment.
4.5.3
Distance and Engage pose a risk to other non-target terrestrial
invertebrate species. The Committee notes the lack of available data on
terrestrial invertebrates (excluding bees), and uncertainty regarding the
level of specificity of the substances to the target species (exotic ants).
The Committee has based its assessment on the assessment that Engage
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and Distance pose a medium 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.
4.5.4
4.6
Distance and Engage 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 Engage and Distance during use, with
particular attention to aerial application (clause 33). The Committee noted:

the infrequent and time limited nature of exposure (application up to a
maximum of twice per annum);

the restriction of application of the substance 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.
4.7
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; and the concerns
raised by a submitter, Ms Bleakley, on the ecotoxic properties of the substances,
and uncertainties on effects on non-target species and ecosystems. Within the
material presented to the Committee at the hearing, Ms Bleakley commented
that no new information had been presented regarding the adverse effects of the
substances on the environment. Further, Ms Bleakley submitted that aerial
application should only be considered for use in an emergency, rather than twice
yearly as proposed by the applicant. Ms Bleakley also conveyed a range of
concerns around the potential risks of the aerial application of both Engage and
Distance to New Zealand’s native species.
4.8
The Committee noted the potential adverse effects of the substances on nontarget species. However, the issues raised by Ms Bleakley regarding the effects
of the substance were not considered sufficient to influence decision making, as
the reassessment primarily concerned the change in use pattern (from ground to
aerial), and not the intrinsic hazardous properties of the substances.
4.9
The Committee noted that the aerial application of the substances in rapid
incursion responses to eradicate a pest organism may differ from application in a
pest-management situation, where a routine bait application may be required.
4.10
The Committee considered 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:
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
for Distance, the addition of the approved handler control for ground-based
and aerial application;

for Engage, the addition of the approved handler control during aerial
application only;

a maximum application rate of 2 kg/ha with a maximum of two applications
per annum in any particular application area;

that Distance should not be applied into or onto water.
4.11
While the risk to bees from use of either substance is assessed as low, Engage is
assessed as presenting a level of risk to bees, and the Committee considers it
appropriate that beekeepers are required to be notified of applications using this
substance.
4.12
The Committee considers that existing and additional controls are sufficient to
manage the risks posed by Engage and Distance to the environment.
Risks to human health
4.13
Neither Engage nor Distance has been assigned any toxic property
classifications. However, the risks to human health from exposure have been
considered, including any effects resulting from perception of risk. On this
basis, risks to human health are considered negligible to high. The Committee
noted that:
4.13.1
Operators and the general public may be exposed to the substances on a
short term basis when the baits are loaded and applied during an aerial
operation. Neither Engage or Distance have been assigned any toxic
property classifications, and the risk assessment indicates that the
substances pose a negligible direct risk to human health and safety due
to the occurrence of any toxic effect during aerial application.
4.13.2
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 Organisation1, 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
1
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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land use, population) and the success of communication before, during
and after the operation.
4.14
4.15
The Committee considered the type, severity and characteristics of the risks
associated with human exposure to Engage and Distance during use, with
particular attention to aerial application (clause 33). The Committee noted that:

use of the substances would usually be infrequent and time-limited, thereby
restricting potential exposure;

if no pre-operation consultation with the public occurred, exposure to the
substances could be involuntary and the risks would not be well known or
understood by those potentially exposed.
The Committee considered that the public should have some level of awareness
of the risks and control over their exposure to ant bait. The Committee proposes
an additional control to prevent any person applying Engage or Distance by
aerial means unless that person first obtains permission from the Authority under
section 95A.
Risks to the relationship of Māori to the environment
4.16
The Committee has considered this application in accordance with clauses
9(b)(i) and 9(c)(iv) and sections 6(d) and 8.
4.17
The Committee noted that:
4.18
2
4.17.1
Given that elsewhere in the Agency’s assessment the levels of
biophysical adverse effect to native species are considered low to
medium, 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.
4.17.2
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
(refer to paragraphs 5.4-5.7). The Committee considers that those seeking
permission from the Authority for aerial application of Engage and Distance
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 guidance2, namely that the overall aim of
User Guide Working with Māori under the HSNO Act 1996: A Guide for Applicants (ER-UG-01-4 04/05)
ERMA New Zealand Decision: Application HRE07001
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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.
4.19
With the controls imposed in this decision and the planned use and management
of the substance (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.
4.20
Overall, the Committee considers a low to medium impact from Engage and
Distance 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 from
Distance, which may be reduced with appropriate controls. In addition there is
no evidence to suggest that the controlled use of Engage or Distance will breach
the principles of the Treaty of Waitangi. This assessment is based on the
assumption that the substance 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.
4.21
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
4.22
The Committee considers that the aerial application of baits may give rise to
public concerns about risks to people’s health. 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.
Risks to the market economy
4.23
The Committee does not anticipate any significant adverse impacts on the social
or economic environment with the controlled use of Engage or Distance by
aerial means.
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Risks to New Zealand’s international obligations
4.24
Risks to New Zealand’s international obligations are not anticipated with the
controlled use of Engage or Distance Ant Baits. The alignment of the proposed
use pattern of the substances with international best practice is considered
below.
Identification and assessment of benefits
4.25
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.
4.26
The Committee considered the benefits identified by the applicant in relation to
the substances being used as an effective pesticide against the Red Imported Fire
Ant (RIFA), and potentially other invasive ant species.
4.27
The applicant asserted that few other baits are available to treat RIFA, and that
aerial application is the most effective method of applying Engage and Distance.
In addition, the applicant asserted that aerial application of the baits is required
for follow up treatments as part of a three year programme to eradicate RIFA in
Whirinaki, where the applicant advised that the terrain makes ground-based
treatment unfeasible. The Committee also noted the applicant’s proposed
approach of alternating treatments with different active ingredients to provide
the greatest efficacy in controlling the target species (for example, an insect
growth regulator such as Distance or Engage in spring, followed by a
hydramethylnon product in autumn). Thus assessment of benefits was based on
the ability of Engage and Distance to be aerially applied to control or eradicate
RIFA, which will give MAF BNZ the opportunity to apply other appropriate
treatments for a target species 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 noted and agreed
with the Agency’s assessment of a high level of benefit for the following:

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;
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4.29

society and community, due to the protection of leisure and outdoor
pursuits that may be hampered by the presence of RIFA; and

the market economy, through prevention of the high economic cost
expected should RIFA establish in New Zealand.
The Committee noted 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
4.30
The Committee considers that the benefits (assessed as high) of allowing
Engage and Distance 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
5.1
Under section 77A, the Authority may impose as controls any obligations and
restrictions as the Authority thinks fit. Under section 77A(4), 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.
5.2
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.
5.3
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.
5.4
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 Engage and Distance, particularly when applied aerially. The
Committee considers that users of Engage and Distance should take all
reasonable efforts toward genuine consultation with the iwi and/or hapū group/s
in the region of the proposed operation.
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5.5
The applicant commented on the proposal to set a control requiring the user of
the substance 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.
5.6
The Committee noted the concerns raised by the applicant.
5.7
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. 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)):
5.7.1
5.8
No person may aerially apply Engage and Distance unless that person
first obtains a permission from the Authority under section 95A of the
Hazardous Substances and New Organisms Act 1996.
The Committee noted 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. Initially, the Authority will have the power to issue a
permission, and the question of a delegation is a matter which the Authority will
consider at a future date.
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5.9
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 Engage and Distance when applied
by ground-based methods (section 77A(4)(a)):
5.9.1
Any person applying Engage or Distance 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 the
NZS 8409:2004.
5.10
The Committee also notes that the risk assessment for Engage and Distance was
made on the assumption that the substances will be used by trained operators,
and at a maximum application rate of 2 kg/ha per annum in any particular
application area. Therefore, to ensure that aerial operations are carried out to a
consistent standard, the Committee requires that when aerially applied, the
substances should be used by an approved handler, and that a maximum
application rate should be set for this application method. The Committee
considers that, for Engage, in respect of potential public concerns, these controls
should apply during use when the substance is used aerially as this is when the
greatest exposure to the substance could occur to the public. For Distance, with
further regard to environmental concerns, these controls should apply during
aerial and ground-based application.
5.11
In addition, on the basis of the environmental risk assessment of the substances,
the approved handler control is necessary to manage the risk posed by Distance
(but not Engage) to the aquatic environment. This risk would be present when
applied aerially or by ground-based methods. The Committee has set the
approved handler control for Distance, but has modified it so as to apply only
during use, as this is when the substance poses the greatest risk to the aquatic
environment. The Committee considers that the proposed additional control will
be more effective than the current controls on the approval to manage the use
and risks of the substance. The approved handler control will be equally
effective for managing the environmental risks of the substance if modified to
apply only when applied in a wide dispersive manner or when the substance is
used by a commercial contractor during use. At other stages of the lifecycle, the
approved handler control is not considered necessary.
5.12
Also on the basis of the environmental risk assessment, the Committee considers
Distance should not be applied into or onto water. The Committee noted a
proposal by the Agency in the E&R Report that neither Engage nor Distance
ERMA New Zealand Decision: Application HRE07001
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should be applied into or onto water, but that when aerially applied, this control
would only be applicable to water-bodies over 3 metres. In its consideration, the
Committee considered that this control may present practical problems for
treatment of more difficult bush or unmanaged areas, and may not be effective in
managing the risk. With regard to this control, the Committee noted that

the risk assessment indicated that Distance is more ecotoxic than Engage.
Risk quotients based on quantitative exposure modelling indicate that
Engage is considered to pose a low risk to the aquatic environment,
whereas Distance poses a high chronic risk.
5.13
The applicant has proposed a buffer zone for use of Distance around waterways,
which could be established through prior mapping of the application area. The
applicant did not propose such a restriction for Engage.
5.14
The Committee considered both the Agency’s risk assessment and the
applicant’s proposal. The Committee noted that the control restricting the use of
Distance and Engage into or onto water could lead to a situation where ‘pockets’
of land could remain untreated, a situation which could compromise an incursion
response. The Committee considers that (the more ecotoxic) Distance should be
prohibited from being applied into or onto water. However, on the same
analysis, Engage would not be subject to such a restriction. This proposal would
allow the applicant to achieve uniform coverage of the application area with ant
bait while allowing the predominant environmental risk (namely of adverse
effects to aquatic organisms) associated with the aquatic ecotoxicity of Distance
to be minimised.
5.15
The Ministry of Health commented on the control restricting the use of Engage
or Distance 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 Engage and Distance shall not be applied onto or
into water.
5.16
The Committee noted the comments of the Ministry of Health regarding this
control. However, the Committee considered that the direct health risks through
drinking water exposure are negligible and that issues associated with adverse
public perception of risks should be addressed through consultation at the
appropriate local level by way of the permissions process.
5.17
Under section 77A(4)(a), the following additional controls are set for Distance:
5.17.1
Distance shall not be applied onto or into water.
5.17.2
Distance shall be applied at a maximum rate of 2 kg/ha, no more than
twice per annum in any particular application area (aerial or groundbased methods).
5.17.3
Distance must be under the personal control of an approved handler
when the substance is –
(a) applied in a wide dispersive manner; or
ERMA New Zealand Decision: Application HRE07001
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(b)
5.17.4
used by a commercial contractor.
Regulations 4 and 5 of the Hazardous Substances and New Organisms
(Personnel Qualifications) Regulations 2001 apply to Distance.
5.18
Under section 77A(4)(a), the Committee considers that these controls will be
more effective than the existing controls in the management, use and risks of
Distance with respect to the environment.
5.19
Under section 77A(4)(a), the following additional controls are set for Engage:
5.19.1
Engage shall be applied at a maximum rate of 2 kg/ha, no more than
twice per annum in any particular application area when aerially
applied.
5.19.2
Engage must be under the personal control of an approved handler
when aerially applied.
5.19.3
Regulations 4 and 5 of the Hazardous Substances and New Organisms
(Personnel Qualifications) Regulations 2001 apply to Engage when
aerially applied.
5.20
Under section 77A(4)(a), the Committee considers that these controls will be
more effective than the existing controls in the management, use and risks of
Engage with respect to the environment.
5.21
The Committee also notes the potential risk to invertebrates. The addition of the
approved handler control and a maximum application rate will also ensure that
the risks to invertebrates are restricted as far as possible, considering the
dispersive use pattern. However, in consideration of the welfare and safety of
bees, the Committee considers that, where Engage is used aerially, the user of
the substance should contact any beekeepers in the vicinity and inform them of
their intentions. This could be done by contacting beekeepers on the Apiary
Register (available to MAF BNZ) or by way of notification to the National
Beekeepers Association. The Committee recommends that the Authority (or its
delegates) take appropriate account of this when considering applications for
permission under section 95A for the aerial application of Engage.
Modification of controls
5.22
Under section 77, the default controls triggered for the substance 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.
5.23
The Committee notes that Engage and Distance ant baits have an additional
control on their original approvals, restricting their use to ground-based
methods. This control, which is the subject of this reassessment application,
states: “Engage Ant Bait and Distance Ant Bait may only applied by groundbased methods”. Therefore, on the basis of the risk assessment, and having
regard to the additional controls imposed, the Committee deletes this control in
ERMA New Zealand Decision: Application HRE07001
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accordance with section 77(4)(b). It is apparent from the risk assessment that
this deletion would not significantly increase any adverse effects of the use of
the substances and the Committee wishes to enable (retain) the benefits
associated with aerial application.
Consistency of controls with international best practice
5.24
Under section 63A(6)(a), the Authority is required to consider the best
international practices and standards for the safe management of the hazardous
substance.
5.25
The Committee considered information provided about the use of Engage and
Distance in the United States and Australia where these (or comparable)
substances have been used to control or suppress RIFA.
International practice in relation to aerial use
5.26
The Committee notes that Engage and Distance (or comparable products) are
used aerially in both Australia and the United States. The Committee considers
that the general approval of aerial use of Engage and Distance (the subject of the
reassessment proposal) is consistent with international practice in the USA and
Australia, where this is seen as an effective method to control or eradicate RIFA.
The Agency notes that in Australia and the USA, consideration is given to local
concerns that may arise. This includes the appropriate choice of application
method when used in public and residential areas, and the avoidance of areas
such as vegetable gardens. The Committee considers that the proposal to require
the substance user to seek permission under section 95A when the substance is
applied aerially will allow such considerations to be taken into account at a local
level.
International practice in relation to environmental risks
5.27
The Committee notes that the Australian Pesticides and Veterinary Medicines
Authority (APVMA), in issuing permits for the substances applied a buffer zone
when the substances are aerially used around waterways. The Committee has set
controls based on the environmental risk assessment of the substance. While the
proposal of a buffer-zone was considered for Distance, the Committee considers
that the environmental risk assessment did not warrant the control. However,
the Committee has set controls to minimise off-target adverse effects within the
aquatic environment, including preventing the user of Distance from applying
the substance into or onto water. The substances must be under the control of an
approved handler and at a maximum application rate (2 kg/ha), controls which
apply to Distance for ground-based and aerial application, and Engage for aerial
application only.
International practice in relation to public health concerns
5.28
The Committee notes that information provided about ant bait treatments
overseas, particularly in Australia, that the views of the affected community are
highly relevant in pest control or response operations involving ant bait. The
Committee considers that, when applied aerially, the control requiring the
ERMA New Zealand Decision: Application HRE07001
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substance user to seek permission under section 95A will ensure that appropriate
consultation and notification is carried out according to local conditions. This
will include consultation with iwi/Māori groups. The Committee notes that the
approved handler control will apply to Distance (for ground-based and aerial
application) and Engage (for aerial application).
5.29
The Agency considers that the controls set are consistent with international best
practice in the management of Engage and Distance, where used for eradication
of RIFA in Australia and the USA.
Control precedents
5.30
The Agency 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 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;

S-methoprene IGR 1.8 granules (Approval code: HSR001691), for
consideration of the setting of the requirement that the substance user seek
permission from the Authority when aerially applying an s-methoprene
substance (noting that Engage contains s-methoprene).
Environmental user charges
5.31
Section 96 provides that the Authority may identify and report to the Minister
where it considers that a reduction in the likely occurrence of adverse effects
similar to that achieved by the controls attached to any substance could be
achieved by any environmental user charge, or a combination of an
environmental user charge and controls.
5.32
The Committee considered that use of controls is the most effective means of
managing the risks due to aerial use of Engage and Distance. The imposition of
an environmental user charge instead of, or in combination with controls, is
therefore not required at this time.
ERMA New Zealand Decision: Application HRE07001
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6 Conclusion
6.1
MAF BNZ has applied to modify the approval for Engage and Distance to
permit aerial application of the baits in addition to ground-based application.
6.2
The Committee considered the risks, costs and benefits associated with the
reassessment proposal in relation to the environment, human health, relationship
of Māori to the environment, society and community and economy. In
accordance with clause 27, the Committee considered that the benefits of
modifying the approval of Engage and Distance outweigh the risks and costs.
6.3
Accordingly, the Committee considers the approval should be amended to
include the additional controls. Along with the existing controls, new and varied
controls are listed in Appendix 1.
7 Decision
The Committee determines that:
7.1.1
The application meets the criteria for consideration under section 63A.
7.1.2
Having considered all the effects associated with the reassessment
proposal and best international practices and standards for the safe
management of hazardous substances, that the controls on Engage and
Distance should be varied so as to allow aerial application under the
specific controls of this approval. Additional and varied controls also
apply.
7.1.3
The controls listed in Appendix 1 shall apply to both Engage and
Distance.
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has taken into account the criteria of section 63(6).
It has also applied the following criteria in the Methodology:











clause 9 – equivalent of sections 5, 6 and 8;
clause 11 – characteristics of substance;
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
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
clause 35 – the costs and benefits of varying the default controls.
Professor George Clark
Chair
Date
ERMA New Zealand Approval Codes:
Engage Ant Bait
HRE000003
Distance Ant Bait
HRE000002
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APPENDIX 1: CONTROLS FOR ENGAGE AND
DISTANCE ANT BAIT
Note: Please refer to the regulations for the requirements prescribed for each control and the
modifications listed as set out in section 5 of this document.
Table A1.1: Controls for Engage and Distance– codes, regulations and variations.
Control Regulation4 Topic
Variations
Code3
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
E6
7
Requirements for equipment used to
handle hazardous substances
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
General identification requirements
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
Priority identifiers for ecotoxic
substances
I9
18
Secondary identifiers for all
hazardous substances
I11
20
I19
29-31
Secondary identifiers for ecotoxic
substances
Alternative information in certain
cases
Regulation 29 – Substances in fixed
bulk containers or bulk transport
containers
Regulation 30 – Substances in
multiple packaging
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.
4 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.
3
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Control
Code3
Regulation4
Topic
Variations
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
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I23
41
Specific documentation requirements
for ecotoxic 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 substance
Regulation 8 – Compatibility
Regulation 9A and 9B – Large
Packaging.
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Control
Code3
P3
Regulation4
Topic
9
Packaging requirements for
substances packed in limited
quantities.
P15*
21
Packaging requirements for ecotoxic
substances.
PG3*
Schedule 3
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 when a
substance is packaged in limited
quantities.
Variations
Hazardous Substances (Disposal) Regulations 2001
D5
9
Disposal requirements for Engage
and Distance
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
EM7
8(f)
EM8
EM11
12-16, 1820
25-34
EM13
42
Level 1 emergency management
information: General requirements
Information requirements for
ecotoxic substances
Level 2 emergency management
documentation requirements
Level 3 emergency management
requirements – emergency response
plans
Level 3 emergency management
requirements – signage
Hazardous Substances (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
Added for Distance (when applied by
aerial or ground-based means); and
for Engage (when aerially applied).
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
where applicable
The Hazardous Substances (Tank 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 Engage and Distance unless that person first obtains a
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Control
Code3
Regulation4
Topic
Variations
permission from the Authority under section 95A of the Hazardous Substances and New
Organisms Act 1996.
Any person applying Engage or Distance 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 the NZS 8409:2004.
Distance shall not be applied onto or into water.
Distance shall be applied at a maximum rate of 2 kg/ha, no more than twice per annum in any
particular application area (aerial or ground-based methods).
Distance must be under the personal control of an approved handler when the substance is –
(a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.
Regulations 4 and 5 of the Hazardous Substances and New Organisms (Personnel
Qualifications) Regulations 2001 apply to Distance.
Engage shall be applied at a maximum rate of 2 kg/ha, no more than twice per annum in any
particular application area when aerially applied.
Engage must be under the personal control of an approved handler when aerially applied.
Regulations 4 and 5 of the Hazardous Substances and New Organisms (Personnel
Qualifications) Regulations 2001 apply to Engage when aerially applied
* DENOTES DISTANCE ONLY- CONTROL DOES NOT APPLY TO ENGAGE
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