ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
19 December 2008
Application code:
HSR08013
Application type:
To import or manufacture any hazardous substance under
Section 28A(2)(b) of the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant:
Date application received:
Novartis New Zealand Ltd
To import or manufacture AHC-2102225 and NBSOA108 for
use in and as a veterinary medicine to treat and prevent
parasites in farm animals (low hazard)
4 December 2008
Consideration Date:
19 December 2008
Considered by:
Rob Forlong (Chief Executive, ERMA New Zealand)
Purpose of the application:
1 Summary of decision
1.1
The application to import AHC-2102225 and to manufacture or import
NBSOA108 for release is approved with the controls as set out in Appendix 1.
The approval has been given in accordance with the relevant provisions of the
Act, the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998
(“the Methodology”), based on the proposed substances being formulated so
that the substances have one or more hazardous properties and each hazardous
property has the least degree of hazard for that property1.
1.2
The proposed substances have been given the following unique identifiers for
the ERMA New Zealand Hazardous Substances Register:
AHC-21202225
NBSOA108
2 Legislative criteria for the application
1
2.1
Unless otherwise stated, references to section numbers in this decision refer to
sections of the Act. The application was lodged pursuant to section 28. The
decision was determined in accordance with section 28A(2)(b), taking into
account the requirements of that section and matters specified under Part II of
the Act.
2.2
Unless otherwise stated, references to clauses in this decision refer to clauses of
the Methodology. Consideration of the application followed the relevant
provisions of the Methodology.
See section 28(2)(b)
3 Application process
3.1
The purpose of this application is to gain approval to import AHC-2102225 to
manufacture a liquid drench formulation (NBSOA108) for use as a veterinary
medicine to treat and prevent parasites in farm animals.
3.2
The application was formally received on 4 December 2008.
3.3
As a result of a request for further information on the proposed controls, the
consideration of this application was postponed until 19 December 2008.2
3.4
The Agricultural Compounds & Veterinary Medicines Group (ACVMG) of the
New Zealand Food Safety Authority (NZFSA) and the Department of Labour
Workplace Group were advised of the application3.
3.4.1
3.5
No responses were received.
Evaluation of the application was undertaken by the ERMA New Zealand
project team which comprised the following staff members:
Jim Waters
Cora Drijver
Noel McCardle
3.6
Senior Advisor (Hazardous Substances)
Advisor (Hazardous Substances)
Senior Advisor (Hazardous Substances).
The application was considered by the Chief Executive of ERMA New Zealand
as provided for by a delegation from the Authority4.
4 Consideration
Sequence of the consideration
4.1
Novartis New Zealand Ltd seeks approval5 to import AHC-2102225 to
manufacture a liquid drench formulation (NBSOA108) for use as a veterinary
medicine to treat and prevent parasites in farm animals.
4.2
An application can be assessed by rapid assessment procedures6 if it can be
shown that the substances have one or more hazardous properties and each
hazardous property has the least degree of hazard for that property.
4.3
The approach adopted when considering this application was:
 to review the information provided;

to identify the composition and hazardous properties of the proposed
substances, AHC-2102225 and NBSOA108;
2
Section 58(3)
Clause 2(2)(e)
4
section 19(2)(d)
5
Under section 28
6
Under section 28A(2)(b)
3
Environmental Risk Management Authority Decision: Application HSR08013
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
4.4
to determine whether AHC-2102225 and NBSOA108 have one or more
hazardous properties and each hazardous property has the least degree of
hazard for that property.
And then:
 to consider whether there are any other effects that mean AHC-2102225
and NBSOA108 should not be approved under section 28A; and

to consider whether the controls that apply under the Act will prevent or
manage the adverse effects of AHC-2102225 and NBSOA108.
Information review
4.5
The project team has reviewed the information supplied by Novartis New
Zealand Ltd, and considers that the information constitutes an adequate and
appropriate basis for assessing the application7. They also consider that there are
no significant uncertainties (ie sufficient to influence decision making) in the
scientific and technical information relating to the risks of AHC-2102225 and
NBSOA1088 .
Identification of AHC-2102225 and NBSOA108
4.6
AHC-2102225 is a new active ingredient.
4.7
NBSOA108 is a liquid drench containing AHC-2102225 and standard
excipients.
Use of AHC-2102225 and NBSOA108
4.8
AHC-2102225 is a new active ingredient which will be imported and stored
until used to manufacture the veterinary medicine NBSOA108.
4.8
NBSOA108 is an anthelmintic drench formulation for use in farm animals to
treat and prevent parasitism.
Hazardous properties of AHC-2102225 and NBSOA108
4.9
As AHC-2102225 is a new active ingredient, the applicant supplied a
comprehensive data package relating to its potential hazardous properties. The
project team’s evaluation of the information is set out in Appendix 2.
4.10
The project team’s hazard classifications for AHC-2102225 and NBSOA108 are
set out in Tables 4.1 and 4.2.
Table 4.1: Hazard classification of AHC-2102225
Hazardous Property
Classification
Target organ toxicity*
6.9B
Aquatic ecotoxicity**
9.1D (biocidal action)
7
8
Clause 8
Clauses 29 and 30
Environmental Risk Management Authority Decision: Application HSR08013
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Table 4.2: Hazard classification of NBSOA108
Hazardous Property
Classification
Skin irritancy***
6.3B
Target organ toxicity*
6.9B
Aquatic ecotoxicity**
9.1D (biocidal action)
*The project team classified AHC-2102225 as a target organ systemic toxicant (6.9B)
and the component is present at a high enough concentration for this to apply also to
NBSOA108. This 6.9B classification is driven by the presence of adverse liver
findings (including biliary proliferation) seen on the dog toxicity studies.
**Based on the data available AHC-2102225 and NBSOA108 do not trigger any of the
thresholds for ecotoxicity. However, based on their biocidal activity the project team
has applied a 9.1D classification.
***Despite data provided on AHC-2102225 not triggering classification as an irritant,
formulation data does support classification of NBSOA108 as a skin irritant (6.3B).
Classification as a skin irritant is further supported by the results from the skin
sensitisation study on the formulation in which irritation at the site of application was
reported.
Meeting the criteria for rapid assessment under section 28A(2)(b)
4.11
Based on the information presented in Tables 4.1 and 4.2, the project team
considers that the criteria for rapid assessment9 have been met in that the
substances have been formulated with the hazardous properties having the least
degree of hazard for each property.
4.12
The project team considers that there are no other matters which would prevent
this application for AHC-2102225 and NBSOA108 from being rapidly assessed.
5 Controls and Risk Assessment
Default controls
9
5.1
Based on the hazard classifications determined for the proposed substances, a
set of associated default controls has been identified by the project team as
being applicable to AHC-2102225 and NBSOA108. These default controls,
expressed as control codes10, are listed in Tables 5.1 and 5.2.
5.2
Additional controls under section 77A are available to manage the risks
associated with AHC-2102225 and NBSOA108, which are not addressed by the
default controls. These are considered in paragraphs 5.21.1 to 5.21.5 below.
Under section 28A(2)(b)
Control codes are those assigned by ERMA NZ to enable easy cross reference with the regulations. A detailed
list of these codes is contained in the ERMA New Zealand User Guide to the Controls Regulations.
10
Environmental Risk Management Authority Decision: Application HSR08013
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Table 5.1: List of default controls for AHC-2102225
Toxicity Controls
T1
Limiting exposure to toxic substances through the setting of TELs
T2
Controlling exposure in places of work through the setting of WESs.
T4
Requirements for equipment used to handle substances
T5
Requirements for protective clothing and equipment
Ecotoxicity Controls
E1
Limiting exposure to ecotoxic substances through the setting of EELs
E2
Restrictions on use of substances in application areas
E6
Requirements for equipment used to handle substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility,
comprehensibility, clarity and durability
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I17
Use of generic names
I18
Requirements for using concentration ranges
I19
Additional information requirements, including situations where substances
are in multiple packaging
I21
General documentation requirements
I28
Specific documentation requirements for toxic substances
I29
Signage requirements
Packaging Controls
P1
General packaging requirements
P3
Criteria that allow substances to be packaged to a standard not meeting
Packing Group I, II or III criteria
PS4
Packaging requirements as specified in Schedule 4
Disposal Controls
D4
Disposal requirements for toxic and corrosive substances
D5
Disposal requirements for ecotoxic
D6
Disposal requirements for packages
D7
Information requirements for manufacturers, importers and suppliers, and
persons in charge
D8
Documentation requirements for manufacturers, importers and suppliers, and
persons in charge
Emergency Management Controls
EM1
Level 1 information requirements for suppliers and persons in charge
EM6
Information requirements for toxic substances
EM7
Information requirements for ecotoxic substances
EM8
Level 2 information requirements for suppliers and persons in charge
EM11 Level 3 emergency management requirements: duties of person in charge,
emergency response plans
EM13 Level 3 emergency management requirements: signage
Tank Wagon and Transportable Containers Controls
The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations
2004 prescribe a number of controls relating to tank wagons and transportable
containers.
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Table 5.2: List of default controls for NBSOA108
Toxicity Controls
T1
Limiting exposure to toxic substances through the setting of TELs
T2
Controlling exposure in places of work through the setting of WESs.
T4
Requirements for equipment used to handle substances
T5
Requirements for protective clothing and equipment
T7
Restrictions on the carriage of toxic or corrosive substances on passenger
service vehicles
Ecotoxicity Controls
E1
Limiting exposure to ecotoxic substances through the setting of EELs
E2
Restrictions on use of substances in application areas
E6
Requirements for equipment used to handle substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility,
comprehensibility, clarity and durability
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I17
Use of generic names
I18
Requirements for using concentration ranges
I19
Additional information requirements, including situations where substances
are in multiple packaging
I21
General documentation requirements
I28
Specific documentation requirements for toxic substances
I29
Signage requirements
Packaging Controls
P1
General packaging requirements
P3
Criteria that allow substances to be packaged to a standard not meeting
Packing Group I, II or III criteria
P13
Packaging requirements for toxic substances
PS4
Packaging requirements as specified in Schedule 4
Disposal Controls
D4
Disposal requirements for toxic and corrosive substances
D5
Disposal requirements for ecotoxic substances
D6
Disposal requirements for packages
D7
Information requirements for manufacturers, importers and suppliers, and
persons in charge
D8
Documentation requirements for manufacturers, importers and suppliers, and
persons in charge
Emergency Management Controls
EM1
Level 1 information requirements for suppliers and persons in charge
EM6
Information requirements for toxic substances
EM7
Information requirements for ecotoxic substances
EM8
Level 2 information requirements for suppliers and persons in charge
EM11 Level 3 emergency management requirements: duties of person in charge,
emergency response plans
EM12 Level 3 emergency management requirements: secondary containment
EM13 Level 3 emergency management requirements: signage
Tank Wagon and Transportable Containers Controls
The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations
Environmental Risk Management Authority Decision: Application HSR08013
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2004 prescribe a number of controls relating to tank wagons and transportable
containers.
Assessment of the adverse effects
5.3
The project team has evaluated the potential of AHC-2102225 and NBSOA108
to cause adverse effects to human health and the environment (non-target
organisms) during all stages of the substance’s lifecycle.
Assessment of risks to human health
5.4
5.5
5.6
AHC-2102225
The project team considers that the chronic hazard posed by AHC-2102225,
target organ toxicity, normally requires repeated exposures to the substance to
result in adverse effects. As exposures during import, transport, storage and
disposal are improbable and will be isolated events, the project team considers
that this hazard poses negligible risk to human health.
Similarly, the project team considers that with Department of Labour and
HSNO requirements in place and with adherence to the ACVM Standard for
Good Manufacturing Practice (GMP), the risks to workers involved in using
AHC-2102225 to formulate veterinary medicines are negligible.
NBSOA108- Risks to operators
Due to the use of the substance as an oral drench in farm animals, the project
team did not undertake any quantitative assessment of risks to operator health as
no suitable models are available for this work.
5.7
The project team notes that the substance is a moderate skin irritant and target
organ toxicant. The risk to operators from these toxic properties are considered
negligible, as equipment (a drench gun) will be used to dispense the substance
to farm animals without the need for measuring or dilution, and this will reduce
the likelihood of skin contact. The users will be experienced with use of this
type of product so excessive exposure to the substance is highly improbable.
5.8
The project team concludes the risk to operators is negligible.
5.9
NBSOA108- Risks to public health
The application is for the manufacture of the substance in New Zealand, so the
project team qualitatively reviewed the risks and concluded that good
manufacturing processes and compliance with Health and Safety in
Employment legislation will adequately protect workers during the manufacture
of NBSOA108.
5.10
There is very little potential for exposure of the general public from NBSOA108
(other than via food residues which will be considered as part of the registration
of this substance under the Agricultural Compounds and Veterinary Medicines
(ACVM) Act 1997) as the product is used only on farms and administered
directly to farm animals, without dilution using a drench gun.
5.11
The project team, therefore, concludes that the risk to members of the public
from the use of the substance is negligible.
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Assessment of risks to the environment
5.12
5.13
5.14
5.15
AHC-2102225
Taking into account the low ecotoxicity of the substance, the HSNO controls
and the requirements of other relevant legislation, the project team considers
that the substance pose a negligible risk to the environment.
NBSOA108- Risks during manufacture
It is expected that any waste generated during the manufacture of NBSOA108
will be disposed of responsibly in accordance with GMP under which the
manufacturing facility operates. Exposure of the environment to NBSOA108 as
a consequence of its manufacture is therefore highly improbable.
NBSOA108- Risks during and following use
The applicant provided a Phase II assessment because NBSOA108 is an
endoparasiticide used on farm animals. Predicted environmental concentration
(PEC) soil, water and dung were calculated using default values stated in ‘
Guideline on environmental impact assessment for veterinary medicinal
products’ of European Medicines Agency (EMEA).
The project team reviewed the assessment (see Appendix 3) and concluded that
NBSOA108 does not pose a risk for aquatic organisms, terrestrial plants and
earthworms but does pose a risk for dung fly and dung beetle. However, the risk
assessment is a worst case situation and the concentration of the substance in the
excretions will be lower 48 hours after dosing. Furthermore, no significant acute
effects on hatching and development were observed on the dung fly. There is no
data of the dung beetle on hatching and development. Although there are some
uncertainties about the long term effects the Agency considers the risks for dung
organisms in the field as acceptable at this stage.
Relationship of Māori to the Environment
5.16
The project team notes that the hazard classifications triggered by AHC2102225 and NBSOA108 give rise to the potential for cultural risk including the
deterioration of the mauri of taonga flora and fauna species, the environment
and the general health and well-being of individuals and the community. In
addition, the introduction and use of this substance has the potential to inhibit
the ability of iwi/Māori to fulfil their role as kaitiaki.
5.17
On considering the information available, the project team considers a minimal
impact from AHC-2102225 and NBSOA108 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 to be highly improbable. In addition
there is no evidence to suggest that the controlled use of AHC-2102225 and
NBSOA108 will breach the principles of the Treaty of Waitangi.
5.18
The overall level of risk is therefore considered to be negligible given that the
substance is handled, stored, transported, used, and disposed of, in accordance
Environmental Risk Management Authority Decision: Application HSR08013
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with the explicitly stated default and additional controls proposed in this report,
and any other controls required by other legislation.
5.19
However, the project team notes that should inappropriate use, or accident,
result in the contamination of waterways or the environment generally, that
users 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.
Modification of controls and setting of exposure limits
5.20
The project team has reviewed the effectiveness of the default controls for
AHC-2102225 and NBSOA108 in managing the identified risks and costs
associated with the substances. Consequently a number of variations of the
default controls and additional controls are considered appropriate. The
variations, additions and the setting of exposure limits and applications rates are
discussed below.
Controls relating to the setting of exposure limits and application rates
5.20.1
The controls relating to the setting of exposure limits may be varied as
follows:
Controls
T1
T2
E1
E2
Comment
The Authority is intending to review the setting of ADEs, PDEs
and TELs under section 77B. Accordingly, the project team
proposes that TELs are not set for any components of
NBSOA108 at this time.
The project team considers that an ADE of 0.03 mg/kg bw/day
should be adopted for AHC-2102225. Based on this value, the
project team proposes that PDEfood = 0.02 mg/kg bw/day and
PDEdrinking water = 0.006 mg/kg bw/day should be set for AHC2102225.
The project team notes that no WES values have been set by the
Department of Labour for any component of NBSOA108. It is
further noted that the conditions of Regulation 29(1)(c)11 are not
met as there is insufficient industrial hygiene data available to
enable a WES to be set for any constituent components.
Therefore no WES values are proposed for NBSOA108 at this
time.
The Authority is intending to review the setting of EELs under
section 77B. Until this review is complete, the project team
proposes that EELs are not set for any component NBSOA108 at
this time. It is also proposed that the default EELwater value be
deleted.
As NBSOA108 will not be used in a wide dispersive manner, the
requirement to set an application rate may be deleted.
Identification controls
11
Hazardous Substances (Classes 6,8,& 9 controls) Regulations 2001
Environmental Risk Management Authority Decision: Application HSR08013
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5.21
Consistent with the guidance provided by GHS, the project team considers that
the concentration cut-offs triggering the requirement for identification of
components on labels and documentation should be modified as follows:
HSNO
Cut-off for label (% w/w)
Classification
6.9B
10
Cut-off for SDS (% w/w)
1
Additional controls
5.21.1
The project team notes that the risk assessment of NBSOA108 has been
based solely on the substance being used as a veterinary medicine, but
none of the specified (default) controls limit how the substance may be
used. Accordingly, the project team considers that the following
control should be applied to NBSOA108 under section 77A as it will
be more effective than the specified controls in terms of their effect on
the management, use and risks of the substance:
NBSOA108 shall only be used as a veterinary medicine
5.21.2
As no information on the process for manufacturing AHC-2102225 has
been provided and thus the risks associated with such a process are
unknown, the project team considers that this approval should be
restricted to the importation of the substance. Accordingly, the project
team is proposing that the following control should be applied to AHC2102225 under section 77A as being the most effective way to control
the uncertainties surrounding the manufacturing process:
AHC-2102225 may only be imported and may not be manufactured in
New Zealand.
5.21.3
The project team considers that controls relating to the specification
and prohibition on use12, should apply to AHC-2102225. These
controls have been included in the controls table, Table A1.1 in
Appendix 1.
5.21.4
The following additional controls are proposed for NBSOA108 to
address risks relating to stationary containers and secondary
containment:
Sch 8
Controls relating to stationary container systems as set out in
Schedule 8 of the Hazardous Substances (Dangerous Goods and
Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to
the New Zealand Gazette, 26 March 2004, No. 35, page 767), as
amended.
12
Consistent with Schedule 3 of the Hazardous Substances (Chemicals) Transfer Notice (New Zealand Gazette
Issue No. 72, 28 June 2006)
Environmental Risk Management Authority Decision: Application HSR08013
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EM12
Pipework: subclauses are added after subclause (3) of regulation
3613. See Table A1.2 in Appendix 1
Secondary containment: subclauses are added after subclause (3) of
regulation 3713. See Table A1.2 in Appendix 1.
Secondary containment: subclauses are added after subclause (3) of
regulation 3813. See Table A1.2 in Appendix 1.
Combined controls
5.21.5
The following controls may be combined as follows:
Controls
T4/E6
D4/D5
Comment
Both relate to requirements for equipment used to handle AHC2102225 and NBSOA108.
Both relate to disposal requirements for AHC-2102225 and
NBSOA108
5.22
The additions and modifications to the default controls for AHC-2102225 and
NBSOA108, as above, have been incorporated into the list of controls detailed
in Tables A1.1 and A1.2 in Appendix 1.
6 Environmental user charges
6.1
The project team considers that use of controls on AHC-2102225 and
NBSOA108 is 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. Accordingly, no
report has been made to the Minister for the Environment.
7 Decision
13
7.1
Pursuant to section 28A, I have considered this application to import or
manufacture hazardous substances for release made under section 28.
7.2
Having considered the composition, hazardous properties, and proposed use of
AHC-2102225 and NBSOA108, I am satisfied that the proposed substances
meets the criteria for rapid assessment under section 28A(2)(b) in that they have
one or more hazardous properties and each hazardous property has the least
degree of hazard for that property.
7.3
I am satisfied with the hazard classifications identified by the project team in
Tables 4.1 and 4.2 and accordingly confer them on the proposed substances.
7.4
As the risks posed by AHC-2102225 and NBSOA108 are negligible, I consider
that applying the HSNO default controls to AHC-2102225 and NBSOA108,
with the additions and amendments proposed under paragraphs 5.20 to 5.22 will
ensure adequate management of any adverse effects of AHC-2102225 and
NBSOA108.
Hazardous Substances (Emergency Management) Regulations 2001
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7.5
7.6
In this consideration, I have also applied the following criteria in the
Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;

clause 12 – risk assessment;

clause 21 – the decision accords with the requirements of the Act and
regulations;

clause 24 – the use of recognised risk identification, assessment,
evaluation and management techniques;

clause 25 – the evaluation of risks; and

clause 35 – the costs and benefits of varying the default controls.
The application for importation of AHC-2102225 and the importation or
manufacture of NBSOA108 is thus approved with controls as detailed in
Appendix 1.
Signed
Rob Forlong
Chief Executive, ERMA New Zealand
Date 19 December 2008
AHC-2102225
ERMA New Zealand Approval Code:
HSR008001
NBSOA108
ERMA New Zealand Approval Code:
HSR008002
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Appendix 1: Controls applying to AHC-2102225 and
NBSOA108
The controls imposed on AHC-2102225 and NBSOA108 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 AHC-2102225 – codes, regulations and variations
Control Regulation
15
Code14
Topic
Variations
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Toxic Property
Controls
Limiting exposure to toxic substances
No TEL values are set for AHCT1
11 – 27
through the setting of TELs
2102225 at this time.
The following values are set for
AHC-2102225:
ADE - 0.03 mg/kg bw/day
PDEfood - 0.02 mg/kg bw/day
PDEdrinking water - 0.006 mg/kg
bw/day.
T2
29, 30
Controlling exposure in places of work No WES values are set for
AHC-2102225 at this time.
Requirements for equipment used to
Controls T4 and E6 are
T4, E6
7
handle substances
combined.
T5
8
Requirements for protective clothing
and equipment
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
Limiting exposure to ecotoxic
No EEL values are set for AHCE1
32 – 45
substances through the setting of EELs 2102225 at this time and the
default EEL values are deleted.
Hazardous Substances (Identification) Regulations 2001
6, 7, 32-35, General identification requirements
I1
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
14
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.
15
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.
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Control
Code14
Regulation
15
Topic
Variations
of information
I9
18
I11
20
I16
25
I17
I18
I19
26
27
29-31
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
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
Regulation 49 – Documentation
requirements for vehicles
Regulation 50 – Documentation to be
supplied on request
I28
46
Specific documentation requirements
for toxic substances
I29
51, 52
Signage requirements
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
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Control
Code14
Regulation
15
Topic
Variations
packing hazardous substance
Regulation 8 – Compatibility
Regulation 9A and 9B – Large Packaging
Packaging requirements for substances
packed in limited quantities
This schedule describes the minimum
PS4
Schedule 4
packaging requirements that must be
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
Disposal requirements for toxic and
Controls D4 and D5 are
D4, D5
8, 9
ecotoxic substances
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
Level 1 emergency management
EM1
6, 7, 9-11
information: General requirements
8(e)
Information requirements for toxic
EM6
substances
Information requirements for ecotoxic
EM7
8(f)
substances
12-16, 18Level 2 emergency management
EM8
20
documentation requirements
Level 3 emergency management
EM11
25-34
requirements: duties of person in
charge, emergency response plans
Level 3 emergency management
EM13
42
requirements: signage
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43
The Hazardous Substances (Tank Wagons and Transportable Containers)
where applicable
Regulations 2004 prescribe a number of controls relating to tank wagons
and transportable containers and must be complied with as relevant.
Additional controls set under s77A
AHC-2102225 may only be imported and may not be manufactured in New Zealand
(1) Prohibition on use of AHC-210225
P3
9
(1) No person may use AHC-2102225 for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or product.
(2) Despite subclause (1)(a), research and development using AHC-2102225 does not
include investigation or experimentation in which the substance is discharged, laid or
applied in or to the outdoor environment.
(2)
Specification of AHC-2102225
(1)
Any person who -
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Control
Code14
Regulation
15
Topic
Variations
(a) imports into New Zealand AHC-2102225, which that person has not previously
imported; or
(b) had previously imported AHC-2102225, but has since changed the source of
manufacture for that hazardous substance, must provide to the Authority in writing
the information required by subclauses (3) and (4).
(2) The information required by subclause (1) must be provided –
(a) prior to the substance being imported; and
(b) in the case of AHC-2102225 to which subclause (1)(b) applies –
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the
previous source of manufacture, if such information has not previously been
provided to the Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of AHC-2102225 (as appropriate);
(b) the specification of AHC-2102225 (as appropriate) including –
the manufacturer’s specifications including purity of the hazardous
substance, isomeric ratio where applicable, maximum impurity content and
evidence to support these, including details of analytical methods used.
Where AHC-2102225 is produced at more than one manufacturing site, this
information must be provided for each site separately;
(c) the identity of any impurity, its origin, and the nature of its relationship to the
active component when the impurity is present at a concentration of 10g/kg or
more;
(d) the identity of any impurity that is known to be of toxicological concern, its origin,
and the nature of its relationship to the active component when the impurity is
present at a concentration of less than 10g/kg.
(4) Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
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Table A1.2: Controls for NBSOA108 – codes, regulations and variations
Control Regulation
17
Code16
Topic
Variations
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Toxic Property
Controls
Limiting exposure to toxic substances
No TEL values are set for
T1
11 – 27
through the setting of TELs
NBSOA108 at this time.
The following values are set for
AHC-2102225:
ADE - 0.003 mg/kg bw/day
PDEfood - 0.002 mg/kg bw/day
PDEdrinking water - 0.0006 mg/kg
bw/day.
T2
29, 30
Controlling exposure in places of work No WES values are set for
NBSOA108 at this time.
Requirements for equipment used to
Controls T4 and E6 are
T4, E6
7
handle substances
combined.
T5
8
Requirements for protective clothing
and equipment
Restrictions on the carriage of toxic or
T7
10
corrosive substances on passenger
service vehicles
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
Limiting exposure to ecotoxic
No EEL values are set for
E1
32 – 45
substances through the setting of EELs NBSOA108 at this time and
the default EEL values are
deleted.
Hazardous Substances (Identification) Regulations 2001
6, 7, 32-35, General identification requirements
I1
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
16
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.
17
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.
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I9
18
I11
20
I16
25
I17
I18
26
27
I19
29-31
Secondary identifiers for all hazardous
substances
Secondary identifiers for ecotoxic
substances
Secondary identifiers for toxic
substances
Use of Generic Names
Use of Concentration Ranges
Reg 25(e) applies at the
following cut-off level:
HSNO
Classification
6.9B
Cut-off (%
w/w)
10
Alternative information in certain
cases
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
Reg 39(5) applies at the
following cut-off level:
HSNO
Cut-off (%
Classification w/w)
6.9B
1
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
I28
46
Specific documentation requirements
for toxic substances
I29
51, 52
Signage requirements
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
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Regulation 8 – Compatibility
Regulation 9A and 9B – Large Packaging
Packaging requirements for substances
packed in limited quantities
19
Packaging requirements for toxic
P13
substances
This schedule describes the minimum
PS4
Schedule 4
packaging requirements that must be
complied with for this substance.
Hazardous Substances (Disposal) Regulations 2001
Disposal requirements for toxic and
Controls D4 and D5 are
D4, D5
8, 9
ecotoxic substances
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
Level 1 emergency management
EM1
6, 7, 9-11
information: General requirements
8(e)
Information requirements for toxic
EM6
substances
Information requirements for ecotoxic
EM7
8(f)
substances
12-16, 18Level 2 emergency management
EM8
20
documentation requirements
Level 3 emergency management
EM11
25-34
requirements: duties of person in
charge, emergency response plans
EM12
35-41
Level 3 emergency management
The following subclauses are
requirements – secondary containment added after subclause (3) of
regulation 3618 (control EM12):
(4) For the purposes of this
regulation, and regulations
37 to 40, where this
substance is contained in
pipework that is installed
and operated so as to
manage any loss of
containment in the
pipework it—
(a) is not to be taken into
account in determining
whether a place is
required to have a
secondary containment
system; and
(b) is not required to be
located in a secondary
containment system.
P3
18
9
Hazardous Substances (Emergency Management) Regulations 2001
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(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a
stationary
container; and
(ii) is used to transfer
a hazardous
substance into or
out of the
stationary
container; and
(b)
includes a process
pipeline or a transfer line.
The following subclauses are
added after subclause (3) of
regulation 3719 (control EM12):
(2) If pooling substances which
do not have class 1 to 5
hazard classifications are
held in a place above
ground in containers each
of which has a capacity of
60 litres or less—
(a if the place’s total
pooling potential is
less than 20,000 litres,
the secondary
containment system
must have a capacity
of at least 25% of that
total pooling potential:
(b) if the place’s total
pooling potential is
20,000 litres or more,
the secondary
containment system
must have a capacity
of the greater of—
(i) 5% of the total
pooling potential;
or
(ii) 5,000 litres.
(3) Pooling substances to which
subclause (2) applies must
be segregated where
appropriate to ensure that
leakage of one substance
may not adversely affect the
container of another
substance.
19
Hazardous Substances (Emergency Management) Regulations 2001
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The following subclauses are
added after subclause (3) of
regulation 381 (control EM12):
(2) If pooling substances which
do not have class 1 to 5
hazard classifications are
held in a place above
ground in containers 1 or
more of which have a
capacity of more than 60
litres but none of which
have a capacity of more
than 450 litres—
(a) if the place’s total
pooling potential is
less than 20,000 litres,
the secondary
containment system
must have a capacity
of either 25% of that
total pooling potential
or 110% of the
capacity of the largest
container, whichever is
the greater:
(b) if the place’s total
pooling potential is
20,000 litres or more,
the secondary
containment system
must have a capacity
of the greater of—
(i) 5% of the total
pooling potential;
or
(ii) 5,000 litres
(3) Pooling substances to
which subclause (2) applies
must be segregated where
appropriate to ensure that
the leakage of one substance
may not adversely affect the
container of another
substance.
Level 3 emergency management
requirements: signage
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
EM13
42
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complied with as relevant.
Additional controls set under s77A
Controls relating to stationary container systems as set out in Schedule 8 of the Hazardous
Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement
to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended shall apply to this
substance, notwithstanding clause 1(1) of that schedule.
NBSOA108 shall only be used as a veterinary medicine.
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Appendix 2: Hazard Classification
Identity of AHC-2102225
The identity of the active ingredient AHC-2102225 is shown in the confidential appendix 4.
The active ingredient is a new veterinary medicine active ingredient to New Zealand. The
project team has provided a summary of the physicochemical, toxicity, ecotoxicity and
environmental fate data in Tables A4.1 to A4.11 (see confidential appendix 4).
Classification of NBSOA108
Formulation data were provided for the acute oral, dermal, skin irritation, eye irritation and
skin sensitization. For all other endpoints, classification was estimated using mixture rules
based on information on the components. Details of the key substance components and the
methods used to derive the classifications are presented in Table A2.1. The relevant sections
of the User Guide to the Thresholds and Classifications in the Act (ERMA 2008a) that
describes the mixture rules are listed in Table A2.2.
Data quality – overall evaluation
The project team has adopted the Klimisch et al (2001) data reliability scoring system for
evaluating data used in the hazard classification and risk assessment of the active ingredient
and NBSOA108 (section 1.2.4 in ERMA 2008a). Scores for individual studies, as evaluated
by the project team, are included in the data assessment tables A4.1 to A4.11 (see
confidential appendix 4). In general, data provided for the active ingredient and NBSOA108
were of high quality.
The project team acknowledges that there are frequently data gaps in the hazard classification
for chemicals which have been in use internationally for a long time. International
programmes such as the OECD High Production Volume programme (OECD 1990) and
REACH (EU 2006) are progressively working towards filling these data gaps. As new
information becomes available, and resources permit, the project team will endeavour to
update the HSNO classifications for those substances.
References
ERMA New Zealand 2008a. User Guide to HSNO Thresholds and Classifications. ERMA
New Zealand, Wellington.
European Union 2006. Regulation (EC) No 1907/2006 of the European Parliament and of the
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. http://reach.jrc.it/
Environmental Risk Management Authority Decision: Application HSR08013
Page 23 of 29
Klimisch, HJ, Andreae, E, Tillman, U 1997. A systematic approach for evaluating the quality
of experimental and ecotoxicological data. Regulatory Toxicology and Pharmacology 25: 1–
5.
OECD 1990. Manual for Investigation of HPV Chemicals.
http://www.oecd.org/document/21/0,3343,en_2649_34379_1939669_1_1_1_1,00.html
Retrieved 23 January 2008.
Table A2.0: Physical and chemical properties of NBSOA108
Test
Appearance
Odour
Density at 20°C
Surface tension
pH
Dynamic viscosity
Flash point
Auto flammability
Explosive
properties
NBSOA108
Liquid, solution
>180 oC
-
Method
-20
Reference
MSDS product
-
MSDS product
Table A2.1: Summary of the tox and ecotox hazard classifications of NBSOA108.
Hazardous Property
6.1 oral
6.1 dermal
6.1 inhalation
6.3/8.2 Skin
irritation/corrosion
6.4/8.2 Eye
irritation/corrosion
6.5 Respiratory
sensitization
6.5 contact
sensitisation
6.6 Mutagenicity
6.7 carcinogenicity
6.8 Reproductive
developmental toxicity
6.9 Target organ
systemic toxicity
9.1 Aquatic ecotoxicity
Aquatic Persistence
Bioaccumulative
9.2 Soil ecotoxicity
Soil Persistence
9.3 Terrestrial
vertebrate ecotoxicity
9.4 Terrestrial
invertebrate ecotoxicity
20
Project team
Classification
No
No
6.3B
Classification Method
Formulation data
Component(s) driving
classification
N/A
N/A
N/A
N/A
No
N/A
-
N/A
No
N/A
No
No
N/A
N/A
N/A
6.9B
Mixture rules
9.1D
ND
ND
Yes
-
Biocidal activity
Active ingredient
Active ingredient
ND
A dash in the tables means that no information is available to the project team.
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Table A2.2: Location of mixture rules within the HSNO Thresholds and Classifications
User Guide (V2.0. March 2008).
Hazard
User Guide to HSNO
Thresholds and
Classifications Reference
Subclass 6.1 Acute Toxicity
Part V, Chapter 10, Page 12
Subclass 6.3/8.2 Skin Irritancy/Corrosivity
Part V, Chapter 11, Page 7
Subclass 6.4/8.3 Eye Irritancy/Corrosivity
Part V, Chapter 12, Page 9
Subclass 6.5 Contact and Respiratory Sensitisation
Part V, Chapter 13, Page 8
Subclass 6.6 Mutagenicity
Part V, Chapter 14, Page 5
Subclass 6.7 Carcinogenicity
Part V, Chapter 15, Page 8
Subclass 6.8 Reproductive Developmental Toxicity
Part V, Chapter 16, Page 11
Subclass 6.9 Target Organ Systemic Toxicity
Part V, Chapter 17, Page 10
Subclass 9.1 Aquatic Ecotoxicity
Part VI, Chapter 19, Page 18
Subclass 9.2 Soil Ecotoxicity
Part VI, Chapter 20, Page 8
Subclass 9.3 Terrestrial Vertebrate Ecotoxicity
Part VI, Chapter 21, Page 7
Subclass 9.4 Terrestrial Invertebrate Ecotoxicity
Part VI, Chapter 22, Page 5
Biological Hazards: Class 6 Toxicity
Information is provided in the confidential appendix 4.
Class 9 Ecotoxicity and environmental fate
Information is provided in the confidential appendix 4.
References
Name, Date. Company Reference Number.
Logie, A. 1987. WICB Ltd. Study number: 9507998F
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Appendix 3: Environmental Risk Assessment
Environmental exposure and risk assessment
For the risk assessment the EMEA Guideline on environmental impact assessment for
veterinary medicinal products Phase I and Phase II is used.
A quantitative risk assessment has been performed for exposure following use. A qualitative
assessment of the risks to the environment has been carried out in the main body of the E&R
Report and is also addressed below. Effects on the treated animal are not covered by this
assessment.
Environmental exposure during manufacture
It is expected that any waste generated during the manufacture of NBSOA108 will be
disposed of responsibly in accordance with GMP under which the manufacturing facility
operates. Exposure of the environment to NBSOA108 as a consequence of its manufacture is
therefore unlikely.
Environmental exposure during and following use
The product will be applied without dilution as an oral drench. Exposure of the environment
to components of NBSOA108 may occur through spillage of the product during application.
Excretion by the animal of either metabolised or unmetabolised components may lead to the
exposure of invertebrates, birds or small mammals to contaminants in soil/dung.
The applicant provided a Phase II assessment because NBSOA108 is an endoparasiticide
used on sheep. PEC soil, water and dung were calculated using default values stated in ‘
Guideline on environmental impact assessment for veterinary medicinal products’ of
European medicines Agency (EMEA). The project team reviewed the assessment and the
outcomes of the risk assessment are in the table below.
PECsoil initial = 4 µg/kg soil
PECsurface wate initial = 0.001 mg/L
PECdung refined= 15 mg/kg
species
Terrestrial
plants
Earthworm
Dung fly
(active
ingredient)
Dung fly
(metabolite)
Dung beetle
effect
EC50 >100
mg/kg
NOEC >2.4
mg/kg
NOEC>
1000 mg/kg
AF
100
PEC
0.004
PNEC
1
RQ
0.004
10
0.004
0.24
0.017
100
15
10
1.5
EC 50 =
1035.6
mg/kg
LC50 =1991
100
15
10.356
1.4
100
15
19.91
0.75
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(active
ingredient)
Dung beetle
(metabolite)
Fish
Daphnia
Algae
mg/kg
LC50 =940
mg/kg
NOEC>100
mg/L
NOEC>100
mg/L
EC50,
NOEC>100
mg/L
100
15
9.4
1.6
1000
0.001
0.1
0.04
1000
0.001
0.1
0.04
100
0.001
1
0.004
AF= assessment factor according Environmental impact assessments for veterinary medicinal
products- Phase II, final guidance 2006
PEC= predicted environmental concentration
PNEC=predicted no effect concentration
RQ= risk quotient
Conclusion
Based on the RQ < 1 NBSOA108 does not pose a risk for aquatic organisms, terrestrial plants
and earthworms. Based on the RQ there is a risk for dung fly and dung beetle. However, the
risk assessment is a worst case situation and the concentration of the substance in the
excretions will be lower 48 hours after dosing.
Furthermore, no significant acute effects on hatching and development were observed on the
dung fly. There is no data of the dung beetle on hatching and development. Although there
are some uncertainties about the long term effects the Agency considers the risks for dung
organisms in the field as acceptable at this stage
References
EMEA 2007. Guideline on environmental impact assessment for veterinary medicinal
products
EPPO 2001. Guideline on the test methods for evaluating the side-effects of plant protection
products. No PP 1/170(3)
ERMA New Zealand 2008a. User Guide to HSNO Thresholds and Classifications. ERMA
New Zealand, Wellington.
European Commission, Guidance Document on terrestrial ecotoxicology under Council
Directive 91/414/EEC, SANCO/ 10329/2002 rev. 2 final, 17 October 2002.
http://ec.europa.eu/food/plant/protection/evaluation/guidance/wrkdoc09_en.pdf
Novartis, 2007: MSDS of NBSOA108
Urban DJ, Cook, NJ 1986. Hazard Evaluation Division Standard Evaluation Procedure:
Ecological Risk Assessment. EPA 540/9-85-001. United States Environmental Protection
Agency Office of Pesticide Programs, Washington DC, USA.
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VICH 2000. Environmental impact assessment (EIAs) for veterinary medicinal products
(VMPs) - Phase I
VICH 2004. Environmental impact assessment (EIAs) for veterinary medicinal products
(VMPs)- Phase II
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Appendix 4: Confidential Information
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