ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
Amended under Section 67A of the HSNO Act on 22 December 2008
14 August 2008
Application Code
HSR08024
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
Elanco Animal Health
Date Application Received
31 March 2008
Submission Period
21 April 2008 to 04 June 2008
Consideration Date
6 August 2008
To be considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
To import and manufacture NZCA4222 as an insecticide
tablet to treat and prevent ectoparasites on dogs.
(Category A).
1 Summary of decision
1.1
The application to import or manufacture NZCA4222 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”).
1.2
The substance has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
NZCA4222
2 Legislative criteria for application
2.1
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.
2.2
Consideration of the application followed the relevant provisions of the
Methodology. Unless otherwise stated, references to clauses in this decision
refer to clauses of the Methodology.
3 Application process
3.1
The application was formally received on 31 March 2008.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 21 April 2008.
3.3
Submissions closed on 4 June 2008.
3.4
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.
3.4.1
No submissions were received.
3.5
The Agency was commissioned to prepare an Evaluation and Review Report
(“the E&R Report”) to aid the Committee in its decision making process. The
E&R Report consists of the Agency’s review of the application and available
data regarding the substance and/or its constituent components. In the E&R
Report, the Agency proposed a suite of controls considered suitable to manage
the risks associated with the release of NZCA4222 and has assessed the
potential risks the substance may pose to the environment, human health, Māori,
community and to the market economy.
3.6
The ACVM Group, the Ministry of Health, the Department of Labour and the
applicant were given the opportunity to comment on the Agency’s Evaluation
and Review Report (“the E&R Report”) and the controls proposed therein. The
applicant indicated that they did not believe any of the controls to be
impracticable or inappropriate.
3.7
No external experts were used in the consideration of this application (clause
17).
3.8
Due to delays in completing the E&R Report, the Authority, with the applicant’s
consent, postponed the consideration of the application until 6 August 2008.
3.9
The following members of the Authority considered the application (section
19(2)(b)): Dr Deborah Read(Chair), Dr Kieran Elborough and Dr Shaun Ogilvie
.
3.10
The information available to the Committee comprised:
 the application; and
 the E&R Report including confidential appendices( with full
formulation data).
ERMA New Zealand Decision: Application HSR08024
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4 Consideration
Purpose of the application
4.1
The purpose of the application is to import or manufacture NZCA4222 as an
insecticide tablet to treat and prevent ectoparasites on dogs. NZCA4222 contains
an active ingredient that is contained in currently approved veterinary medicine
and pesticide formulations
4.2
The product is formulated as a tablet and is administered orally. The dose rate is
one tablet monthly.
Sequence of the consideration.
4.3
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:

establish the hazard classifications for the substances 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.

consider the adequacy of the default controls, prescribed under section 77,
and exposure limits alongside the assessment of risks and costs to
determine whether those controls or limits should be varied or set and
identify where additional controls need to be applied, under section 77A, to
mitigate any unacceptable risks.

vary and add controls in accordance with sections 77 and 77A.

undertake a combined consideration of all the risks and costs and
determine whether the combined risks and costs are negligible or nonnegligible. The combined risks and costs for this application were
determined to be negligible.

consider the cost-effectiveness of the application of controls in accordance
with clause 35 and sections 77 and 77A.

determine whether it was evident that the identified potential benefits
outweighed the costs.

confirm and set the controls.

approve or decline the application under section 29 and clause 26
Hazard classification
4.4
The Agency has classified NZCA4222 as follows:
Hazardous Property
NZCA4222
Target Organ Toxicity
6.9B
Aquatic Ecotoxicity
9.1A
Ecotoxicity to terrestrial invertebrates
9.4A
ERMA New Zealand Decision: Application HSR08024
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Default controls
4.5
In the E&R Report, the Agency assigned default controls for NZCA4222 based
on its 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.
Identification of the potentially non-negligible risks, costs and benefits
of the substance
4.6
In its evaluation of NZCA4222 the Agency identified potentially significant, and
therefore non-negligible, risks, costs and benefits associated with the substance.
Potentially non-negligible risks
4.7
The Agency considers that the risks associated with NZCA4222 that are
potentially non-negligible relate to the substance’s toxic and ecotoxic properties.
Potentially non-negligible costs
4.8
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.
Potentially non-negligible benefits
4.9
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.
4.10
The Committee considers that NZCA4222 will provide greater choice for
consumers when choosing flea control for dogs and contribute to an
improvement in public health through the control of ectoparasites on pets.
4.11
Overall, the Committee considers the benefits to be derived from the use of
NZCA4222 are potentially non-negligible.
Assessment of the potentially non-negligible risks and costs of the
substance
4.12
Taking into account the Agency’s assessment of the potentially non-negligible
risks and costs associated with NZCA4222 in New Zealand, the Committee
considers that the risks to the environment are negligible because:
4.12.1
The solid tablet formulation of NZCA4222 will limit the spread of
any spillage and assist in easy recovery of the spilt material during
any stage of the lifecycle.
ERMA New Zealand Decision: Application HSR08024
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4.12.2
4.13
Contamination of the environment with NZCA4222 as metabolised
or unmetabolised components in the treated animals excreta will be
minimised because:

It will be localised to the site of excretion;

Only small quantities will be involved ( small quantities will
be administered monthly); and

The substance is not classified as being ecotoxic to birds or
mammals.
Taking into account the Agency’s assessment of the potentially non-negligible
risks and costs associated with NZCA4222 in New Zealand, the Committee
considers that the risks to the health and safety are negligible because:
4.13.1
It is highly improbable that repeated or prolonged exposure will
occur as a consequence of an incident occurring where unprotected
people are present.
4.13.2
Workers likely to be in contact with large quantities of NZCA4222
will be required to use personal protective clothing and equipment.
4.13.3
Dog owners in the home are unlikely to wear protective clothing
while handling the substance but their contact will be brief and
infrequent (once monthly).
4.13.4
Disposal by dog owners will involve small quantities of packaging
and it will be easy to dispose of safely in accordance with label
recommendations.
4.14
Significant adverse impacts on the relationship of Maori to the environment, the
market economy and to society and the community are not anticipated with the
controlled use of NZCA4222.
4.15
There is no evidence to suggest that the controlled use of NZCA4222 will
provide significant risks to New Zealand’s international obligations.
5 Controls
5.1
A number of variations to the default controls for NZCA4222 were proposed in
the E&R Report in accordance with clause 35 and sections 77 and 77A. These
variations and the setting of exposure limits and applications rates are discussed
below.
5.2
Control T1 relates to the requirement to limit public exposure to toxic
substances by the setting of Tolerable Exposure Limits (TELs), which are
derived from Acceptable Daily Exposure (ADE) values. NZCA4222 does not
contain any components that meet the requirement of Regulation 11(1)(a).
Therefore, ADEs are not required to be set for any component of this substance,
and subsequently no TELs are set. The Committee determines that this control
is deleted.
ERMA New Zealand Decision: Application HSR08024
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5.3
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 Department of Labour WES values have been set for
components F and G and an overseas WES value has been set for component E.
However, the conditions of regulation 29(1)(a)1 are not met due to the physical
form of the substance as a tablet, therefore the substance is unlikely to become
airborne and disperse in air in the form of inspirable or respirable dusts, mists,
fumes, gases, or vapours under the temperature and pressure it will be used in.
Consequently, the Committee determines that this control is deleted.
5.4
Control E1 relates to the requirements to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). However, the use pattern for NZCA4222 means that it is extremely
unlikely that the substance will enter the environment in quantities sufficient to
present a risk to the environment. To be consistent with control modifications to
veterinary medicines at transfer, the Committee determines this control is
deleted.
5.5
Control E2 relates to restrictions on use of substances in application areas. The
Committee does not consider this control to be relevant to NZCA4222 as it is
intended for use as a veterinary medicine. As animals are not included within the
definition of application area (land, air, water) and to be consistent with
modifications to controls of veterinary medicines at transfer, the Committee
therefore considers that this control does not apply.
Proposed additional controls
5.6
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.
5.7
The Committee notes that the risk assessment has been based solely upon the
substance being used as a veterinary medicine but none of the specified (default)
controls limit how the substance may be used. Accordingly, the Committee
considers that the following control should be applied to NZCA4222 as it will be
more effective than the specified controls in terms of their effect on the
management, use and risks of the substance (section 77A(4)(a)):
“NZCA4222 shall only be used as a veterinary medicine”
Proposed modification of controls
5.8
1
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),
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001
ERMA New Zealand Decision: Application HSR08024
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controls may be substituted or deleted. Under section 77(5), where a substance
triggers more than one hazard classification, controls may be combined.
5.9
The following modifications are proposed to the default controls for
NZCA4222:
5.9.1
Controls T4 and E6 relate to the proper management of equipment used
to handle toxic and ecotoxic substances. To be consistent with
modifications to controls of veterinary medicines at transfer, the
Committee determines that these controls be deleted in accordance with
section 77(4)(a) as NZCA4222 is in solid form as a tablet and applied
directly to the animal, and consequently the risk of exposure to people
or the environment is not considered to be significant.
5.9.2
Control T5 specifies that personal protective clothing and equipment
must be employed when NZCA4222 is being handled. The Committee
determines that, as the substance is in tablet form, this control should be
varied (in accordance with variations made to the transferred veterinary
medicines) so as to apply during all stages of the lifecycle with the
exception of use. This variation is proposed in accordance with section
77(4)(b).
5.9.3
Control E3 relates to the protection of terrestrial invertebrates (e.g.
beneficial insects). As NZCA4222 is in solid form as a tablet and is
applied directly to the animal, the Committee considers the risk of
exposure to the environment is not significant and proposes that this
control not be applied to NZCA4222. This is consistent with
modifications to controls of veterinary medicines at transfer.
5.9.4
Control E5 relates to the requirements for keeping records of use of
very ecotoxic substances if 3 kg or more is applied within 24 hours in a
place where the substance is likely to enter air or water and leave the
place. The Committee considers that the oral administration of
NZCA4222 is not consistent with these requirements and therefore
determines that control E5 is deleted in accordance with section
77(4)(a).
5.9.5
Controls I3 and I11 relate to requirements for priority and secondary
identifiers for ecotoxic substances. Control EM7 describes the
information which must be provided with ecotoxic substances when
held in certain quantities. The Committee considers that these controls
should be deleted in accordance with section 77(4)(a) as the substance
is administered directly to the animal as a tablet and environmental
exposure is very unlikely to occur.
5.9.6
Controls D4 and D5 may be combined in accordance with section 77(5)
as they both relate to requirements for disposal of NZCA4222.
5.9.7
Approved handler requirements (control E7 and AH1) have been
triggered for NZCA4222 as a result of its 9.1A and 9.4A classifications.
The outcome of the ecological risk assessment (refer Appendix 3 and
ERMA New Zealand Decision: Application HSR08024
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Section 9 of the E&R Report) indicates that it is unlikely there will be
any adverse environmental effects from the proposed use of this
substance. The Committee therefore determines that the approved
handler controls is deleted as provided by section 77(4)(b).
5.10
5.9.8
Tracking requirements (control TR1) have been triggered for
NZCA4222 as a result of its 9.1A and 9.4A classifications. However,
for substances where the tracking control has been triggered solely as a
result of ecotoxicity, it is considered that any risk that may arise during
its lifecycle are adequately managed by other controls such as
packaging, labeling and emergency management requirements. The
Committee therefore determines that the tracking control can be deleted
as provided by section 77(4)(b).
5.9.9
Control I16 relates to the requirements for secondary identifiers for
toxic substances (Regulation 25 of the Hazardous Substances
(Identification) Regulations 2001). The applicant wished to modify this
control so that target organ information was not required on labeling.
The Committee considers that NZCA4222 is packaged in quantities
small enough that a human would have to have repeated access to
multiple packets over a long period of time to suffer chronic effects.
The Committee therefore determines that Clauses 25(a) to 25(d) of the
Hazardous Substances (Identification Regulations 2001) are deleted in
accordance with section 67A (under the category of minor in effect as
there is no increase in residual risk).
Control I16 (Regulation 25 of the Hazardous Substances (Identification)
Regulations 2001) includes a requirement to identify certain toxic components
on product labels. The Committee, consistent with the guidance provided by the
Global Harmonised System (GHS), considers that regulation 25(e) should 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, for the purpose of triggering this
requirement, should be as follows:
HSNO Classification
6.5A, 6.5B, 6.6A, 6.7A
6.6B
6.7B
6.8A, 6.8C
6.8B
6.9A, 6.9B
Cut-off for label (%
w/w)
0.1
1
1
0.3
3
10
Cut-off for SDS (% w/w)
0.1
1
0.1
0.1
0.1
1
5.11
The applicant was given an opportunity to comment on the proposed controls as
set out in the E&R Report (clause 35(b)).
5.12
In response, the applicant indicated that they did not believe any of the controls
to be impracticable or inappropriate.
ERMA New Zealand Decision: Application HSR08024
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6 Overall evaluation of risks and costs
6.1
On the basis of the risk assessment, and taking into account the controls
imposed, including the additional controls set under section 77A, the Committee
considers that NZCA4222 poses negligible risks to the environment and to
human health.
7 Review of controls for cost-effectiveness
7.1
The Committee considers that the proposed controls are the most cost-effective
means of managing the identified potential risks and costs associated with this
application in accordance with clause 35(a) and sections 77 and 77A.
7.2
The applicant was given an opportunity to comment on the proposed controls as
set out in the E&R Report (clause 35(b)). The applicant’s comments were taken
into account during the consideration of the application
8 Comparison of risks, cost and benefits
8.1
As the Committee considers that the risks to the environment and human health
are negligible with the controls in place, clause 26 applies and the Committee
may approve the manufacture or import for release of NZCA4222 if it is evident
that the benefits associated with the substances outweigh the costs.
8.2
As there are potentially non-negligible benefits associated with the import or
manufacture of NZCA4222, the Committee is satisfied that it is evident that the
benefits associated with the substances outweigh the costs
9 Recommendations
9.1
The Committee recommends that, should inappropriate or accidental use,
transport or disposal of NZCA4222 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.
10 Environmental User Charges
10.1
The Committee considers that the application of controls to NZCA4222 will
provide an effective means of managing risks associated with this substance. At
this time no consideration has been given to whether or not environmental
charges should be applied to this substance as an alternative or additional means
of achieving effective risk management.
11 Decision
11.1
The Committee determines that NZCA4222 should be classified as follows:
• 6.9B target organ toxicity
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•
•
9.1A aquatic toxicity
9.4A terrestrial invertebrate ecotoxicity.
11.2
Pursuant to section 29 and clause 26, the Committee is satisfied that the positive
effects (benefits) of the substance outweigh the adverse effects (risks and costs).
11.3
The application for importation or manufacture and release of the hazardous
substance NZCA4222, is thus approved with controls as listed in Appendix 1.
11.4
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 26.
11.5
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
 clause 35 – the costs and benefits of varying the default controls.
signed
Date: 14 August 2008
Chair Dr Deborah Read
ERMA NZ Approval Code:
HSR007957
ERMA New Zealand Decision: Application HSR08024
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Amendment December 2008
Control I16 applies Regulation 25 of the Hazardous Substances (Identification) Regulations
2001 to a substance. This control relates to secondary identifiers for toxic substances and
required the applicant to have target organ information on labelling.
Control I16 has been modified for NZCA4222 so that target organ information on labelling is
not required. Paragraph 5.9.9 has been added to the decision and reads as follows:
Control I16 relates to the requirements for secondary identifiers for toxic substances
(Regulation 25 of the Hazardous Substances (Identification) Regulations 2001). The
applicant wished to modify this control so that target organ information was not
required on labeling. The Committee considers that NZCA4222 is packaged in
quantities small enough that a human would have to have repeated access to multiple
packets over a long period of time to suffer chronic effects. The Committee therefore
determines that Clauses 25(a) to 25(d) of the Hazardous Substances (Identification
Regulations 2001) are deleted in accordance with section 67A (under the category of
minor in effect as there is no increase in residual risk).
This change has been completed under section 67A as the change is considered minor in
effect as there is no increase in residual risk.
Dr Deborah Read
ERMA New Zealand
ERMA New Zealand Decision: Application HSR08024
Date: 22 December 2008
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APPENDIX 1: CONTROLS FOR NZCA4222
Note: The control explanations as listed below have been provided as guidance only and do
not have legal standing. Please refer to the regulations for the requirements prescribed for
each control and the modifications listed set out in section 5 of this document.
Table A5.1: Controls for NZCA4222– codes, regulations and variations
Control
Regulation3
Topic
Variations
2
Code
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T5
8
Requirements for protective clothing and The requirements of control T5 are varied
equipment
so as to apply during all stages of the
lifecycle with the exception of use.
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
I9
18
I16
25
I17
I18
26
27
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
Secondary identifiers for all hazardous
substances
Secondary identifiers for toxic
substances
Use of Generic Names
Use of Concentration Ranges
Revised cut-offs for component
labelling required by Regulation
25(e).
HSNO
Classification of
Component
Concentratio
n Cut-off for
Label (%)
6.5A, 6.5B
0.14
6.6A, 6.7A
0.1
6.6B, 6.7B
1
6.7B
1
6.8A, 6.8C
0.3
6.8B
3
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.
3
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 .
4
Identification of sensitising components may be required below the 0.1% level if a lower value has been
used for classification.
2
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Control
Code2
Regulation3
Topic
Variations
6.9A, 6.9B
I19
29-31
10
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk
containers or bulk transport containers
Regulation 30 – Substances in multiple
packaging
I21
37-39, 47-50
Regulation 31 – Alternative information
when substances are imported
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
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 substance
Regulation 8 – Compatibility
Regulation 9A and 9B – Large
Packaging
P3
9
Packaging requirements for substances
packed in limited quantities
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Control
Code2
P15
PG3
Regulation3
Topic
Variations
21
Schedule 3
Packaging requirements for NZCA4222
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
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for NZCA4222
Controls D4 and D5 are combined
D5
9
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
EM8
12-16, 18-20
Level 2 emergency management
documentation requirements
EM11
25-34
Level 3 emergency management
requirements – emergency response
plans
EM13
42
Level 3 emergency management
requirements – signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43 where The Hazardous Substances (Tank Wagons and Transportable Containers) Regulations
applicable
2004 prescribe a number of controls relating to tank wagons and transportable
containers and must be complied with as relevant.
Section 77A Additional Controls
NZCA4222 shall only be used as a veterinary medicine
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