ERMA New Zealand
Evaluation and Review Report
Application for Approval to Import or
Manufacture Moxidectin + Triclabendazole
Oral Drench for Release
Application Number: HSR07111
Prepared for the Environmental Risk Management
Authority
EXECUTIVE SUMMARY
Background information

Fort Dodge New Zealand Limited is seeking approval to import or manufacture
Moxidectin + Triclabendazole Oral Drench for release.

Moxidectin + Triclabendazole Oral Drench is a veterinary medicine containing 1 g/L
moxidectin and 50 g/L triclabendazole in the form of a liquid.

Moxidectin + Triclabendazole Oral Drench is proposed to be administered to sheep
for the control of liver fluke, gastrointestinal roundworms and lungworm.

Moxidectin + Triclabendazole Oral Drench is proposed to be administered with
drench equipment at a dose rate of 1 ml per 5 kg bodyweight.

Both moxidectin and triclabendazole are present in other veterinary medicines
currently available in New Zealand.
Key issues
The key issues for this application are:


The Agency and the applicant have classified Moxidectin + Triclabendazole Oral
Drench based on the composition of Moxidectin + Triclabendazole Oral Drench and
the properties of its components.
Hazardous Property
Applicant’s
Assessment
Agency’s
Assessment
Acute Toxicity (Oral)
6.1E
6.1E
Dermal Sensitisation
6.5B
6.5B
Target Organ Toxicity
6.9B
6.9B
Aquatic Ecotoxicity
9.1A
9.1A
Soil Ecotoxicity
9.2C
9.2C
Terrestrial Vertebrate Ecotoxicity
9.3C
9.3C
Terrestrial Invertebrate Ecotoxicity
9.4C
9.4C
The Agency has proposed that the default controls for Moxidectin + Triclabendazole
Oral Drench be modified, such that:
- the controls regarding application rates (E2), protection of terrestrial
invertebrates (E3), requirements for keeping records of use (E5), approved
handler (E7, AH1) and tracking (TR1) are deleted;
- no Tolerable Exposure Limits (T1), Workplace Exposure Standards (T2) or
Environmental Exposure Limits (E1) are set at the present time and any
default values deleted;
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- the trigger quantity for carriage on passenger service vehicles (T7) is
increased from 0.1 L to 1.0 L;
- further controls regarding stationary containment systems and pipework are
added; and
- a further control restricting the use of this substance to that of a veterinary
medicine is added.

A submission was received from Ancare New Zealand Limited expressing concern
that the constitution of Moxidectin + Triclabendazole Oral Drench may have a
toxic/hazardous consequence and expressing a desire to examine the consequences
of its release before the application is approved. Ancare New Zealand Limited
requested a hearing and sought postponement of this hearing until information on the
‘constitution of the substance’ was provided to them. As a result of the recent Court
of Appeal Ruling (Wyeth vs Ancare), Ancare New Zealand have withdrawn their
request for a hearing.

The Agency considers that the risk assessments indicate that the risks associated
with Moxidectin + Triclabendazole Oral Drench are negligible with the proposed
controls in place.

The Agency has evaluated information supplied by the applicant about the benefits
of Moxidectin + Triclabendazole Oral Drench and considers that significant benefits
are likely to be realised through the release of this substance.

In conclusion, the Agency considers that there are negligible risks to human health
and the environment and significant benefits associated with the release of
Moxidectin + Triclabendazole Oral Drench. Therefore, the Agency considers that it
is evident that the benefits of releasing Moxidectin + Triclabendazole Oral Drench
outweigh the costs and the application may be approved in accordance with
clause 26.
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TABLE OF CONTENTS
1
2
3
4
5
6
7
8
9
10
11
12
13
Application Details ............................................................................................................. 5
Legislative Criteria for the Application .............................................................................. 5
Purpose of the Evaluation and Review Report ................................................................... 5
Application Process ............................................................................................................ 6
Notification and Consultation ............................................................................................. 7
Application Synopsis and Information Review .................................................................. 8
Hazardous Properties, Thresholds and Classification ......................................................... 9
Default Controls ................................................................................................................ 10
Risk Assessment ............................................................................................................... 12
Assessment of Benefits (Benefical Effects) ...................................................................... 20
Controls ............................................................................................................................. 21
Overall Evaluation of Risks, Costs and Benefits .............................................................. 27
Conclusion ........................................................................................................................ 28
Appendix 1: Decision Path .......................................................................................................29
Appendix 2: Hazard Classification ...........................................................................................29
Appendix 3: Risk Assessment ..................................................................................................37
Appendix 4: Discussion on Controls ........................................................................................40
Appendix 5: List of Proposed Controls for Moxidectin + Triclabendazole Oral Drench ........47
Appendix 6: Scales for Qualitative Risk Assessment ...............................................................54
Appendix 7: Government Departments, Crown Entities and Interested Parties Notified ........58
Appendix 8: Confidential Material ...........................................................................................61
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1
APPLICATION DETAILS
Application Code
HSR07111
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
Fort Dodge New Zealand Limited
Date Application Received
21 November 2007
Submission Period
5 December 2007 to 13 February 2008
To be considered by
A Committee of the Authority (“the Committee”)
Purpose of the Application
To import Moxidectin and Triclabendazole Oral Drench,
a veterinary medicine for prevention of parasites in farm
animals.
2
3
LEGISLATIVE CRITERIA FOR THE
APPLICATION
2.1
The application was lodged pursuant to section 28.
2.2
This report takes into account matters to be considered in section 29; matters
specified under Part II of the Act; and the relevant provisions of the Hazardous
Substances and New Organisms (Methodology) Order 1998 (“the
Methodology”). Unless otherwise stated, references to section numbers in this
report refer to sections of the Act and clauses to clauses of the Methodology.
PURPOSE OF THE EVALUATION AND REVIEW
REPORT
3.1
The purpose of the Evaluation and Review Report (“the E&R Report”) is to
assist and support decision-making by the Environmental Risk Management
Authority (“the Authority”) by:

consolidating the information provided by the applicant and submitters,
and obtained from other sources, into a common format which enables
conflicts and similarities to be readily identified;

presenting the relevant information in a format and sequence which is
consistent with the decision-making requirements of the Act and of the
Methodology;
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4

evaluating the information (and assessments) provided to give an opinion
on its quality and credibility, to identify gaps and to analyse overlaps and
conflicts;

identifying key issues arising from the evaluation relevant to the
Authority’s consideration of applications;

where controls or conditions may be applied, providing technical advice
on the control or condition options available; and

advising the Authority on the classification of substances.
3.2
The advice contained in the E&R Report is given solely on the basis of an
objective and expert review of the application and the assessments of risks, costs
and benefits provided in relation to that application.
3.3
The Agency does not comment on the correctness of draft labels or safety data
sheets that might be supplied by the applicant.
3.4
The decision-making path and the steps involved in the decision path are
attached as Appendix 1.
APPLICATION PROCESS
4.1
4.2
4.3
Evaluation of the application was undertaken by the ERMA New Zealand
project team (“the Agency”) which comprised the following staff members:
Haydn Murdoch
Advisor (Hazardous Substances)
Jim Waters
Senior Advisor (Hazardous Substances)
Cora Drijver
Advisor (Hazardous Substances)
Zack Bishara
Advisor, Māori Unit.
The report was reviewed and signed out by:
Noel McCardle
Senior Advisor (Hazardous Substances)
Dr Peter Dawson
Principal Scientist (Hazardous Substances).
Timeline
Application formally
received
21 November 2007
Application notified
5 December 2007
Submission closing date
13 February 2008.
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5
NOTIFICATION AND CONSULTATION
5.1
The Minister for the Environment was advised of the application (section
53(4)(a)) and given the opportunity to “call-in” the application under section 68.
This action was not initiated.
5.2
The Ministry of Health, the Department of Labour (Workplace Group) and the
New Zealand Food Safety Authority (Agricultural Compounds and Veterinary
Medicines (ACVM) Group) were identified as having a specific interest in the
application and were provided with a copy of the application (excluding the
confidential information, but with the opportunity to access this if necessary).
5.2.1
5.3
Other Government departments, Crown agencies and other interested parties, as
listed in Appendix 7, were provided with a copy of the application summary and
given the opportunity to comment or to make a submission.
5.3.1
5.4
No comments or submissions were received.
No comments or submissions were received.
The application was publicly notified on the ERMA New Zealand website on
5 December 2007 and subsequently advertised in The Dominion Post, the New
Zealand Herald, the Christchurch Press and the Otago Daily Times (section 53).
5.4.1
A submission was received from Ancare New Zealand Limited
expressing concern that the constitution of Moxidectin +
Triclabendazole Oral Drench may have a toxic/hazardous consequence
and expressing a desire to examine the consequences of its release
before the application is approved. Ancare New Zealand Limited
requested a hearing and sought postponement of this hearing until
information on the ‘constitution of the substance’ was provided to
them.
5.4.2
This request coincides with a request under the Official Information
Act 1982 (OIA) for release of this information. While the request was
declined under section 9(2)(b)(ii) of the OIA in accordance with
section 57 of the Act, as the information was considered to be
commercially sensitive, the Agency sought submissions from the
requester and Fort Dodge New Zealand Limited on the possibility of a
limited disclosure of the requested information (in accordance with
section 59(3)(b)). Initial responses from both parties were received by
the deadline of 17 April. Additional legal advice was sought and the
Agency wrote to both parties to give them another opportunity to
present their case in writing, the deadline for this was 13 June 2008.
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5.4.3
6
The consideration of this application experienced further delays while
guidance material was prepared for the Authority relating to the
procedure for ordering a limited disclosure of the requested
information. Subsequently the judgement CA424/2007 Ancare New
Zealand Limited v Wyeth (NZ) Limited has been released. This
judgement states that the Authority does not have the power, under the
HSNO Act, to order a limited disclosure of information which had been
withheld under the OIA. As a consequence of this ruling, Ancare New
Zealand Limited has withdrawn their request to be heard in support of
their submission.
APPLICATION SYNOPSIS AND INFORMATION
REVIEW
Information supplied by the applicant
6.1
The applicant supplied the following documents:

the application; and

a confidential appendix (including full formulation data).
Information review
6.2
Information on the full formulation of Moxidectin + Triclabendazole Oral
Drench has been withheld at the request of the applicant for reasons of
commercial sensitivity. The information is provided for the Committee in
Confidential Appendix 8.
6.3
The Agency considers that there are no significant uncertainties in the scientific
and technical information sufficient to influence decision making relating to the
potential adverse effects of Moxidectin + Triclabendazole Oral Drench (clauses
29 and 30). Therefore, the Agency considers that the information available
constitutes an adequate and appropriate basis for considering the application
(clause 8).
Description and use of the substance
6.4
Moxidectin + Triclabendazole Oral Drench is a veterinary medicine containing
1 g/L moxidectin and 50 g/L triclabendazole in the form of a liquid. The
substance is proposed to be orally administered to sheep for the control of liver
fluke, gastrointestinal roundworms and lungworm.
Lifecycle
Importation/manufacture and packing
6.5
The veterinary medicine Moxidectin + Triclabendazole Oral Drench (in HDPE
containers, 100mL to 21L in size) will be imported into NZ either by air or sea.
It will be stored at the airport or the wharf before being transported to nearby
warehouses.
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6.6
While Moxidectin + Triclabendazole Oral Drench will be manufactured
overseas, it is possible that the substance could be manufactured in New
Zealand in the future. Consequently, the risks associated with the manufacture
of Moxidectin + Triclabendazole Oral Drench in New Zealand have been
evaluated and the appropriate controls proposed, so that approval of this
substance will be applicable to both the import and manufacture of Moxidectin
+ Triclabendazole Oral Drench.
Transport and storage
6.7
After importation the substance will be transported (most likely by land
transport) to wholesalers, veterinary clinics, other distributors and end users.
Distributors (including wholesalers and veterinary clinics) will store the
substance until on-sold to the end user (e.g. farmers). Smaller amounts are
likely to be stored on farms.
6.8
Packaging and transportation of Moxidectin + Triclabendazole Oral Drench will
conform to international requirements for air/sea transportation with regards to
packaging and vessels etc., and with New Zealand domestic transportation
requirements. Package labelling will conform to the requirements of HSNO and
the NZFSA, supplying safety, handling, use and disposal information.
Use
6.9
Moxidectin + Triclabendazole Oral Drench will be used by veterinarians,
veterinary staff, farmers and farm workers as an anthelmintic formulation to
treat and prevent parasitism in farm animals.
6.10
The substance will be administered using standard drench equipment at a dose
rate of 1 ml per 5 kg bodyweight.
Disposal
7
6.11
The substance will primarily be disposed of through administration as a
veterinary medicine in accordance with recommended dose rates. In some
unique circumstances (e.g. product contamination), Moxidectin +
Triclabendazole Oral Drench may need to be disposed of by means other than
use. In this case, disposal will occur in accordance with the requirements of the
Hazardous Substances (Disposal) Regulations 2001 and the Resource
Management Act 1991.
6.12
Used packaging will be disposed of in accordance with the requirements of the
Hazardous Substances (Disposal) Regulations 2001 and the Resource
Management Act 1991.
HAZARDOUS PROPERTIES, THRESHOLDS AND
CLASSIFICATION
7.1
The Agency has evaluated the information supplied by the applicant and also
referred to other data sources in assessing the hazardous properties of
Moxidectin + Triclabendazole Oral Drench. This assessment is attached as
Appendix 2.
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7.2
The applicant’s and the Agency’s classification of the hazard profiles of
Moxidectin + Triclabendazole Oral Drench are listed below.
Table 7.1: Summary of applicant’s and Agency’s HSNO classification of
Moxidectin + Triclabendazole Oral Drench.
7.3
8
Hazardous Property
Applicant’s
Assessment
Agency’s
Assessment
Acute Toxicity (Oral)
6.1E
6.1E
Dermal Sensitisation
6.5B
6.5B
Target Organ Toxicity
6.9B
6.9B
Aquatic Ecotoxicity
9.1A
9.1A
Soil Ecotoxicity
9.2C
9.2C
Terrestrial Vertebrate Ecotoxicity
9.3C
9.3C
Terrestrial Invertebrate Ecotoxicity
9.4C
9.4C
The risk assessment in Section 9 of this report is based on the Agency’s
classifications of Moxidectin + Triclabendazole Oral Drench.
DEFAULT CONTROLS
8.1
Based on the hazard classifications as determined by the Agency, the set of
associated controls has been identified. These default controls, expressed as
control codes1, are listed in Table 8.1.
Table 8.1: List of default controls for Moxidectin + Triclabendazole Oral Drench.
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
E3
Controls relating to the protection of terrestrial invertebrates e.g. beneficial insects
E5
Requirements for keeping records of use
E6
Requirements for equipment used to handle substances
E7
Approved handler/security requirements for certain ecotoxic substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility,
comprehensibility, clarity and durability
I3
Priority identifiers for ecotoxic substances
1
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.
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I8
I9
I11
I16
I17
I18
I19
Priority identifiers for toxic substances
Secondary identifiers for all hazardous substances
Secondary identifiers for ecotoxic substances
Secondary identifiers for toxic substances
Use of generic names
Requirements for using concentration ranges
Additional information requirements, including situations where substances are in
multiple packaging
I21
General documentation requirements
I23
Specific documentation requirements for ecotoxic substances
I28
Specific documentation requirements for toxic substances
I29
Signage requirements
I30
Advertising corrosive and toxic substances
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
P15
Packaging requirements for ecotoxic substances
PG3
Packaging requirements equivalent to UN Packing Group III
PS4
Packaging requirements as specified in Schedule 4
Disposal Controls
D4
Disposal requirements for toxic or 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
Tracking Controls
TR1
General tracking requirements
Approved Handler Controls
AH1
Approved Handler requirements (including test certificate and qualification
requirements)
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.
8.2
The Authority is able to vary the default controls and impose controls under
sections 77 and 77A to produce a set of controls relevant to Moxidectin +
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Triclabendazole Oral Drench. Variations and additional controls for Moxidectin
+ Triclabendazole Oral Drench are considered in Section 11 of this report.
9
RISK ASSESSMENT
Identification of potentially non – negligible risks and costs
9.1
Potentially non-negligible risks were identified for evaluation following clauses
9 and 11, which incorporate sections 5, 6 and 8.
9.2
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”. Thus,
these have been assessed in an integrated fashion together with the risks of the
adverse effects in the following assessment.
9.3
The applicant has identified potential sources of risk to the environment and to
human health and safety through release, spillage or exposure throughout the
lifecycle. The Agency has also identified potential sources of risk and these,
along with those identified by the applicant, are tabulated in Table 9.1.
Table 9.1: Potential sources of risks associated with Moxidectin + Triclabendazole Oral
Drench.
Lifecycle Activity
Associated Source of Risk
Import, transport or
storage.
An incident during the import, transport or storage of Moxidectin +
Triclabendazole Oral Drench resulting in spillage and subsequent
exposure of people or the environment to the substance.
Use.
Application of Moxidectin + Triclabendazole Oral Drench resulting in
exposure of users or bystanders or the environment; or an incident
during use resulting in spillage and subsequent exposure of users or the
environment to the substance.
Disposal.
Disposal of Moxidectin + Triclabendazole Oral Drench or packaging
resulting in exposure of people or the environment to the substance.
Manufacture2.
An incident during the manufacture of Moxidectin + Triclabendazole
Oral Drench resulting in spillage and subsequent exposure of people or
the environment to the substance.
Assessment of potentially significant risks
9.4
In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has
assessed the potentially non-negligible risks of this substance in terms of risks to
the environment, to human health and safety, to the relationship of Māori to the
environment, to society and the community, to the market economy, and to New
Zealand’s international obligations.
2
While Moxidectin + Triclabendazole Oral Drench will be manufactured overseas, the risks associated with
the manufacture of the substance in New Zealand are also considered, so that this approval is applicable for
both the import and manufacture of Moxidectin + Triclabendazole Oral Drench.
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9.5
Pursuant to clause 25(1), the Agency notes that the evidence provided by the
applicant and additional evidence found by the Agency, relating to the
hazardous properties of Moxidectin + Triclabendazole Oral Drench, is largely
scientific in nature. However, as the evaluation of risks, costs and benefits has
been carried out on a qualitative basis, it is recognised that there is a degree of
uncertainty in the risk analysis.
9.6
The analysis of risk takes into account the controls that derive from the HSNO
Regulations (in particular the default controls identified in Table 8.1) and from
other legislation such as the Resource Management Act 1991 and the Health and
Safety in Employment Act 1992. That is, the analysis assumes controls are in
place.
9.7
A qualitative assessment has been undertaken for all stages of the lifecycle. In
these cases, the level of risk has been evaluated on the basis of the magnitude
and likelihood of adverse effects occurring to people or the environment (see
Appendix 6).
Assessment of the risks to the environment
9.8
The Agency has evaluated the potential of Moxidectin + Triclabendazole Oral
Drench to cause adverse effects to the environment (non-target organisms)
during all stages of the substance’s lifecycle using qualitative risk assessment
methodologies.
9.9
The Agency has classified Moxidectin + Triclabendazole Oral Drench as being
very toxic in the aquatic environment (9.1A), harmful to the soil environment
(9.2C), harmful to terrestrial vertebrates (9.3C) and harmful to terrestrial
invertebrates (9.4C).
9.10
The Agency considers the overall level of risk of Moxidectin + Triclabendazole
Oral Drench to the environment to be negligible with the controls in place for
all stages of the lifecycle. The risks of Moxidectin + Triclabendazole Oral
Drench to the environment (with controls in place) at various stages of its
lifecycle are summarised below in Table 9.2 and discussed more fully in the
following paragraphs.
Table 9.2: Level of risk of Moxidectin + Triclabendazole Oral Drench to the environment.
Lifecycle Stage
Importation, transport
and storage.
Use.
Potential Adverse Effect
Spillage resulting in death or
adverse effects to organisms
in the environment.
Spillage resulting in death or
adverse effects to organisms
in the environment.
Likelihood of
Adverse
Effect
Occurring
Magnitude of
Adverse
Effect
Level of Risk
Highly
improbable.
Moderate.
Negligible.
Highly
improbable.
Minimal.
Negligible.
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Lifecycle Stage
Disposal.
Manufacture
Potential Adverse Effect
Excreta containing
metabolised substance
resulting in death or adverse
effects to soil organisms.
Disposal resulting in death
or adverse effects to
organisms in the
environment.
Spillage resulting in death or
adverse effects to organisms
in the environment.
Likelihood of
Adverse
Effect
Occurring
Magnitude of
Adverse
Effect
Level of Risk
Improbable.
Minor.
Negligible.
Highly
improbable.
Minor.
Negligible.
Highly
improbable.
Minor.
Negligible.
Assessment of environmental risks - importation, transport and storage
9.11
The Agency has qualitatively assessed the risks to the environment of
Moxidectin + Triclabendazole Oral Drench during importation, transportation
and storage and considers the risks to be negligible.
9.12
This assessment is based on the following considerations:
9.12.1
The magnitude of adverse effects on the environment from a spillage
during importation, transport and storage are considered by the Agency
to be moderate, given that Moxidectin + Triclabendazole Oral Drench
is very toxic to aquatic organisms, harmful in the soil environment,
harmful to terrestrial vertebrates and invertebrates and any spill would
involve small quantities which would lead to localised effects only. The
Agency also considers such an event to be highly improbable given
adherence to the HSNO controls (e.g. packaging, identification and
emergency management) and the Land Transport Rule 45001, Civil
Aviation Act 1990 and Maritime Transport Act 1994 (as applicable).
Assessment of environmental risks - use
9.13
The Agency has qualitatively assessed the risks to the environment of
Moxidectin + Triclabendazole Oral Drench during use and considers the risk to
be negligible.
9.14
This assessment is based on the following consideration:
9.14.1
The Agency considers that it is highly improbable that spillage of
Moxidectin + Triclabendazole Oral Drench will occur given the HSNO
requirements for equipment used to handle Moxidectin +
Triclabendazole Oral Drench to retain and dispense the substance in the
manner intended (i.e. controls T4 and E6). The magnitude of any such
spillage effects on the environment would be minimal, as any spillage
would be very small in quantity.
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9.14.2
The Agency acknowledges that, in general, the risk of adverse effects
to the environment associated with the excreta of metabolised
veterinary medicines from treated animals is an area of uncertainty.
However, despite this uncertainty, the Agency considers that it is
improbable that excreta of metabolised Moxidectin + Triclabendazole
Oral Drench will have adverse effects on the environment, given the
small quantities administered to animals. The magnitude of adverse
effects is considered to be minor, given that the non-metabolised
substance is harmful to soil organisms.
Assessment of environmental risks - disposal
9.15
The Agency has qualitatively assessed the risks to the environment of disposal
of Moxidectin + Triclabendazole Oral Drench and considers the risks to be
negligible.
9.16
This assessment is based on the following considerations:
9.16.1
Moxidectin + Triclabendazole Oral Drench will generally be disposed
of by normal use as a veterinary medicine.
9.16.2
If Moxidectin + Triclabendazole Oral Drench is disposed of by means
other than use, this will be in accordance with the requirements of the
Hazardous Substances (Disposal) Regulations 2001 and the Resource
Management Act 1991. The Agency considers the likelihood of
adverse effects to the environment arising from disposal to be highly
improbable and the magnitude of such effects minor.
Assessment of environmental risks - manufacture
9.17
The Agency has also qualitatively assessed the risks of Moxidectin +
Triclabendazole Oral Drench to the environment during manufacture, should the
substance be manufactured in New Zealand in future, and considers the risks to
the environment to be negligible.
9.18
This assessment is based on the following considerations:
9.18.1
The Agency considers a spillage event during manufacture resulting in
exposure to the environment to be highly improbable given compliance
with Good Manufacturing Practice (GMP) and the HSNO controls. In
addition, the magnitude of a spillage and consequent adverse effects on
the environment are considered minor, given that the manufacturing
site will be required to provide secondary containment.
Assessment of the risks to human health and safety
9.19
The Agency has evaluated the potential of Moxidectin + Triclabendazole Oral
Drench to cause adverse effects to the health and safety of humans during all
stages of the substance’s lifecycle using qualitative risk assessment
methodologies.
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9.20
The Agency has classified Moxidectin + Triclabendazole Oral Drench as an
acute oral toxicant (6.1E), skin sensitiser (6.5B) and target organ toxicant
(6.9B).
9.21
In the Agency’s opinion, the chronic hazards normally require repeated
exposure to the substance for adverse effects to occur and are therefore most
relevant to end-users.
9.22
The Agency considers the overall level of risk of Moxidectin + Triclabendazole
Oral Drench to human health and safety to be negligible with the controls in
place. The risks of Moxidectin + Triclabendazole Oral Drench to human health
and safety (with controls in place) at various stages of the lifecycle are
summarised below in Table 9.3 and discussed more fully in the following
paragraphs.
Table 9.3: Level of risk of Moxidectin + Triclabendazole Oral Drench to human health
and safety.
Lifecycle stage
Potential Adverse
Effect
Importation, transport
or storage.
Acute oral toxicity.
Skin sensitisation.
Use.
Acute oral toxicity.
Skin sensitisation.
Target organ
toxicity.
Acute oral toxicity.
Disposal.
Skin sensitisation.
Manufacture.
Target organ
toxicity.
Acute oral toxicity.
Skin sensitisation.
Target organ
toxicity.
Likelihood of
Adverse Effect
Occurring
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Highly
improbable.
Magnitude of
Adverse
Effect
Level of
Risk
Moderate.
Negligible.
Minor –
moderate.
Moderate.
Negligible.
Minor –
moderate.
Major.
Negligible.
Moderate.
Negligible.
Minor –
moderate.
Major.
Negligible.
Moderate.
Negligible.
Minor –
moderate.
Major.
Negligible.
Negligible.
Negligible.
Negligible.
Negligible.
Assessment of risks to human health - importation, storage and transport
9.23
The Agency has qualitatively assessed the risk of Moxidectin + Triclabendazole
Oral Drench to human health and safety during importation, transportation and
storage and considers the risks to be negligible.
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9.24
This assessment is based on the following considerations:
9.24.1
Workers and bystanders could only be exposed to the substance during
importation, transport and storage in isolated incidents where spillage
occurs.
9.24.2
In these circumstances, the Agency considers it highly improbable that
workers or bystanders will ingest sufficient Moxidectin +
Triclabendazole Oral Drench to result in a moderate adverse effect.
9.24.3
The Agency also considers that it is highly improbable that a spillage
of Moxidectin + Triclabendazole Oral Drench will occur during
importation, transport and storage and workers or bystanders will suffer
skin sensitisation, given adherence to the HSNO controls (e.g.
packaging, identification and emergency management). The magnitude
of skin sensitisation is considered minor to moderate depending on the
sensitivity of the exposed individual.
9.24.4
The Agency considers the risk of target organ toxicity from Moxidectin
+ Triclabendazole Oral Drench during importation, transport or storage
to be sufficiently remote that it is not necessary to address, given that
exposure could only occur in isolated spillage incidents.
Assessment of risks to human health - use
9.25
The Agency has qualitatively assessed the risks of Moxidectin +
Triclabendazole Oral Drench to human health and safety during use and
considers the risks to be negligible.
9.26
This assessment is based on the following considerations:
9.26.1
The Agency considers that it is highly unlikely that users or bystanders
could inadvertently ingest sufficient Moxidectin + Triclabendazole
Oral Drench to result in an acute moderate effect, given the HSNO
requirements for personal protective equipment (PPE) and provision of
hazard and precautionary information on the product label.
9.26.2
The Agency considers that it is highly improbable that users or
bystanders will suffer skin sensitisation from Moxidectin +
Triclabendazole Oral Drench during use, given requirements for PPE
and provision of hazard and precautionary information on the product
label. The magnitude of skin sensitisation is considered minor to
moderate depending on the sensitivity of the exposed individual.
9.26.3
The Agency considers it is highly improbable that users could be
repeatedly exposed to Moxidectin + Triclabendazole Oral Drench, to
such an extent that target organ toxicity effects occur given
requirements for PPE and provision of hazard and precautionary
information on the product label. However, as the magnitude of this
effect is considered major, the level of risk is assessed as low.
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9.26.4
However, the Agency anticipates that farmers, veterinarians and farm
workers, who will be the main users of Moxidectin + Triclabendazole
Oral Drench, have the knowledge, experience, and the skills to handle a
veterinary product as intended. Therefore, the Agency considers that
the chronic hazards associated with the voluntary use of Moxidectin +
Triclabendazole Oral Drench will be sufficiently managed by the users
of the substance to reduce the level of risk of chronic effects to human
health and safety during use to negligible.
Assessment of risks to human health - disposal
9.27
The Agency has qualitatively assessed the risk to human health and safety
during disposal of Moxidectin + Triclabendazole Oral Drench, and considers the
risks to the health and safety of people to be negligible.
9.28
This assessment is based on the following considerations:
9.28.1
If Moxidectin + Triclabendazole Oral Drench is disposed of by means
other than use, this will be in accordance with the requirements of the
Hazardous Substances (Disposal) Regulations 2001 and the Resource
Management Act 1991.
9.28.2
The Agency considers that it is highly unlikely that users or bystanders
could inadvertently ingest sufficient Moxidectin + Triclabendazole
Oral Drench during disposal to result in a moderate effect, given that
Moxidectin + Triclabendazole Oral Drench will generally be disposed
of by use.
9.28.3
The Agency considers that it is highly improbable that workers will
suffer skin sensitisation from Moxidectin + Triclabendazole Oral
Drench during disposal, given that Moxidectin + Triclabendazole Oral
Drench will generally be disposed of by use. The magnitude of skin
sensitisation is considered minor to moderate.
9.28.4
The Agency considers it is highly improbable that users could be
repeatedly exposed to Moxidectin + Triclabendazole Oral Drench
during disposal to such an extent that target organ toxicity effects
occur. However, as the magnitude of this effect is considered major,
the level of risk is assessed as low.
9.28.5
However, the Agency anticipates that the main users of Moxidectin +
Triclabendazole Oral Drench (i.e. farmers, veterinarians or people
following their instructions) will have the knowledge, experience and
the skills to dispose of a veterinary product as intended. Therefore, the
Agency considers that the chronic hazards associated with Moxidectin
+ Triclabendazole Oral Drench will be sufficiently managed by the
users to reduce the overall level of risk to human health and safety
during disposal to negligible.
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Assessment of risks to human health - manufacture
9.29
The Agency has qualitatively assessed the risk of Moxidectin + Triclabendazole
Oral Drench to human health and safety during manufacture, should the
substance be manufactured in future, and considers the risks to be negligible.
9.30
This assessment is based on the following considerations:
9.30.1
The Agency considers that, while Moxidectin + Triclabendazole Oral
Drench has the potential to cause a major adverse effect through its oral
toxicity, workers handling the substance will be aware of the hazards
and the measures that need to be undertaken to ensure their own safety
and will not ingest sufficient Moxidectin + Triclabendazole Oral
Drench to result in a major adverse effect. Even a moderate effect is
highly improbable.
9.30.2
The Agency considers that it is highly improbable that workers will
receive skin sensitisation from Moxidectin + Triclabendazole Oral
Drench, given requirements for PPE, compliance with the HSNO
information provisions (e.g. labels and SDS) and compliance with
Good Manufacturing Practice (GMP). The magnitude of
respiratory/skin sensitisation is considered minor to moderate.
9.30.3
The Agency considers that it is highly improbable that workers will
receive repeated exposure to Moxidectin + Triclabendazole Oral
Drench at levels required to cause target organ toxicity effects, given
requirements for PPE, compliance with the HSNO information
provisions (e.g. labels and SDS) and compliance with Good
Manufacturing Practice (GMP). While target organ toxicity effects are
considered major, the Agency considers that the voluntary risk will be
sufficiently managed by workers involved in the manufacture of the
substance to reduce the level of risk to human health during
manufacture of the substance to negligible.
Relationship of Māori to the Environment
9.31
The Agency considered the potential Māori cultural effects in accordance with
clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the Agency used
the assessment framework contained in the ERMA New Zealand User Guide
“Working with Māori under the HSNO Act 1996” in assessing this application.
9.32
The Agency notes that Moxidectin + Triclabendazole Oral Drench triggers a
number of hazardous properties giving 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,
particularly in relation to the guardianship of waterways given the highly
ecotoxic nature of the substance to aquatic environments.
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9.33
On considering the information outlined here and elsewhere in this report, the
Agency considers a minimal impact from Moxidectin + Triclabendazole Oral
Drench 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 very unlikely. In addition there is no evidence to suggest that the
controlled use of Moxidectin + Triclabendazole Oral Drench will breach the
principles of the Treaty of Waitangi.
9.34
The overall level of risk is therefore considered to be negligible assuming that
the substance will be handled, stored, transported, used, and disposed of, in
accordance with the explicitly stated default and additional controls proposed in
this report, and any other controls required by other legislation.
9.35
However, the Agency 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.
Assessment of the risks to society and the community
9.36
There are not expected to be any significant adverse impacts on the social
environment with the controlled use of Moxidectin + Triclabendazole Oral
Drench, apart from the health effects and environmental effects already
discussed. Consequently, the Agency considers that this aspect of potential risk
need not be considered further.
Assessment of the risks to the market economy
9.37
Taking into account the level of risk to the environment and to human welfare,
no sources of additional risk have been identified that could result in an adverse
economic impact on a community.
9.38
The Agency notes that direct economic costs will be borne by the applicant and
users of the substance. The HSNO default controls intentionally do not manage
direct economic effects. These are for suppliers and users of the substance to
address.
New Zealand’s international obligations
9.39
The Agency does not anticipate that Moxidectin + Triclabendazole Oral Drench
will pose any risks to New Zealand’s international obligations.
10 ASSESSMENT OF BENEFICIAL EFFECTS
Potentially non-negligible benefits
10.1
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.
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10.2
The applicant has claimed that the availability of Moxidectin + Triclabendazole
Oral Drench will increase farm productivity which will increase community
resources we can be used to improve human health and the environment.
10.3
The Agency considers that the economic and related benefits to be derived from
the use of Moxidectin + Triclabendazole Oral Drench are potentially significant.
Likely effects of the substance being unavailable
10.4
In accordance with section 29, consideration has been given to the likely effects
of Moxidectin + Triclabendazole Oral Drench being unavailable.
10.5
The Agency notes that there are other products with the same active ingredients
available in the NZ market.
10.6
The likely effects of Moxidectin + Triclabendazole Oral Drench being
unavailable would be a reduction in choice for the consumer, a reduction in
sales for Fort Dodge New Zealand Limited and a reduction in employment
opportunities in the company.
Risk reduction implications
10.7
The applicant did not provide any information on the risk reduction implications
of the import or manufacture of Moxidectin + Triclabendazole Oral Drench for
release. The Agency does not consider that there are any risk reduction
implications for the approval of Moxidectin + Triclabendazole Oral Drench.
11 CONTROLS
Setting of exposure limits and application rates
11.1
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. For Moxidectin +
Triclabendazole Oral Drench, the Agency considers that moxidectin and
triclabendazole fulfill the requirements of Regulation 11(1)(a), (b) and (c), and
therefore notes that an ADE is required to be set for these components. Given
the specific use of Moxidectin + Triclabendazole Oral Drench, the Agency
considers that the principal source of exposure of the general public to the
substance is via food residues, an exposure route managed by the NZFSA
through the setting of MRLs. The Agency notes that MRLs have been set for
moxidectin and triclabendazole. The MRLs are likely to be relevant to the use
of Moxidectin + Triclabendazole Oral Drench.
11.2
The Agency notes that ADEs of 0.002 mg/kg bw/day and 0.003 mg/kg bw/day
have already been set for moxidectin and triclabendazole, respectively, in a
previous Part V application (application number HSR03005). The following
PDE values for triclabendazole and moxidectin, respectively were also set in
that application:
PDEfood = 0.0014 mg/kg bw/day (moxidectin)
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PDEdrinking water = 0.0004 mg/kg bw/day (moxidectin)
PDEfood = 0.0021 mg/kg bw/day (triclabendazole)
PDEdrinking water = 0.0006 mg/kg bw/day (triclabendazole).
11.3
The Agency proposes that these values are set for triclabendazole and
moxidectin in Moxidectin + Triclabendazole Oral Drench. The Agency is
intending to review the setting of ADEs, PDEs and TELS under section 77B of
the Act and until this review is complete, the Agency proposes not to set any
TELs for moxidectin or triclabendazole.
11.4
Control T2 relates to the requirement to limit worker exposure to toxic
substances by the setting of Workplace Exposure Standards (WESs). The
Agency notes that a Department of Labour WES value has been set for
component F, but considers that this value should not be applied to Moxidectin
+ Triclabendazole Oral Drench due to the low concentration of component F in
the product. No other Department of Labour WES/overseas WES values have
been set for any other components of Moxidectin + Triclabendazole Oral
Drench. In addition, the conditions of Regulation 29(1)(a) are not met as
Moxidectin + Triclabendazole Oral Drench would not become airborne and
disperse in the air during use. Therefore, no WES values are proposed for any
components of Moxidectin + Triclabendazole Oral Drench at this time.
11.5
Control E1 relates to the requirements to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). Following the enactment of the Hazardous Substances and New
Organisms (Approvals and Enforcement) Act 2005, the Authority is intending to
review the setting of EELs under section 77B. Until this review is complete, it is
proposed that no EELs are set at this time for Moxidectin + Triclabendazole
Oral Drench and the default values are deleted.
11.6
Control E2 relates to the requirement to set an application rate for a class 9
substance that is applied to an area of land (or air or water). As Moxidectin +
Triclabendazole Oral Drench is not intended for use in this manner, the Agency
considers this control may be deleted under section 77(4)(a), as the adverse
effects of the substance are less than the adverse effects which would normally
be associated with substances of the same hazard classifications.
Proposed additional controls
11.7
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.
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11.8
The Agency 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 limits how the substance may be used. Accordingly, the Agency
considers that the following control should be applied to Moxidectin +
Triclabendazole Oral Drench 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)):
11.8.1
11.9
3
“Moxidectin + Triclabendazole Oral Drench shall only be used as a
veterinary medicine”
The Agency notes that the specified controls do not address the risks associated
with stationary container systems, nor do they allow for dispensation where it is
unnecessary for any associated pipework to have secondary containment.
Accordingly, the Agency considers that the application of controls addressing
these risks will be more effective than the specified (default) controls in terms of
their effect on the management, use and risks of the substance (section
77A(4)(a)). Such controls were applied to veterinary medicines on transfer to
the HSNO regime. The Agency considers that these controls are similarly
appropriate for the management of the risks associated with Moxidectin +
Triclabendazole Oral Drench and proposes that the following controls should be
applied to the substance:
11.9.1
"The 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,
are proposed for this substance, notwithstanding clause 1(1) of that
schedule.”
11.9.2
The Agency considers that the following subclauses should be added
after subclause (3) of regulation 36 of the Hazardous Substances
(Emergency Management) Regulations 20013:
‘(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.
(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
These sub-clauses were applied to veterinary medicines on transfer to the Act.
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(b) includes a process pipeline or a transfer line.”
11.10
Under section 77A(3)(b) a proposed additional control may vary another
specified control if this variation is more cost-effective in terms of its effect on
the risks of the substance (section 77A(4)(b)).
11.10.1 Control EM12 relates to the requirements for secondary containment of
pooling substances (Regulations 35 – 41 of the Hazardous Substances
(Emergency Management) Regulations 2001). The EM12 secondary
containment requirements have been triggered for Moxidectin +
Triclabendazole Oral Drench as a result of its 9.1A classification. The
Agency considers that the risks associated with the containment of
substances which are not class 1 to 5 substances (i.e. do not ignite or
explode) are different to those associated with class 1 to 5 substances.
Consequently the Agency considers that the secondary containment
requirements of regulations 37 and 38 can be reduced. The Agency
considers that the reduced secondary containment measures specified
below are adequate to manage the risks of a spillage of Moxidectin +
Triclabendazole Oral Drench. Therefore, the proposed additional
control, which varies the EM12 control, is more cost-effective in terms
of managing the risks of the substance.
11.10.2 Accordingly, the Agency considers that:

the following subclauses should be added after subclause (1) of
regulation 37 of the Hazardous Substances (Emergency
Management) Regulations 20014:
(2) If pooling substances that 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.
and
4
These sub-clauses were applied to veterinary medicines on transfer to the Act.
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
the following subclauses should be added after subclause (1) of
regulation 38 of the Hazardous Substances (Emergency
Management) Regulations 20015:
(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.
Proposed modification of controls
11.11
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.
11.12
The Agency considers that the following controls should be varied under section
77(4)(a) for Moxidectin + Triclabendazole Oral Drench, as the adverse effects
of the substance are less than the adverse effects which would normally be
associated with substances of the same hazard classifications:
11.12.1 Control E3 relates to the requirement to protect bees. As Moxidectin +
Triclabendazole Oral Drench is intended for oral administration to farm
animals, the Agency considers this control may be deleted as provided
by section 77 (4)(a).
11.12.2 Control E5 relates to the requirement for keeping records of use when
an ecotoxic substance is used for the purposes of causing biocidal
action and 3 kg or more of the substance is applied within 24 hours in
an area where the substance is likely to enter air or water and leave the
place. Moxidectin + Triclabendazole Oral Drench is intended for oral
5
These sub-clauses were applied to veterinary medicines on transfer to the Act.
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administration to farm animals. Therefore, the Agency considers this
control can be deleted as provided by section 77 (4)(a).
11.13
The Agency considers that the following controls should be varied under section
77(4)(b) for Moxidectin + Triclabendazole Oral Drench, as the variations will
not significantly increase the adverse effects of the substance:
11.13.1 Control T7 relates to restrictions on the carriage of hazardous
substances on passenger service vehicles. The Agency notes that the
trigger quantity for this control was varied for the sensitisation hazard
for veterinary medicines transferred to the Act under the Hazardous
Substances (Veterinary Medicines) Transfer Notice 2005.
Consequently, the Agency considers that the quantity of Moxidectin +
Triclabendazole Oral Drench triggering these requirements should
likewise be varied from 0.1 L to 1 L as provided by section 77 (4)(b).
11.13.2 Control E7 relates requirements for ecotoxic substances to be under the
control of an approved handler. The approved handler requirements
have been triggered for Moxidectin + Triclabendazole Oral Drench as a
result of its 9.1A classification. The outcome of the ecological risk
assessment (refer Appendix 3) indicates that it is unlikely there will be
any adverse environmental effects from the proposed use of this
substance. The Agency, therefore, considers that the approved handler
controls can be deleted as provided by section 77 (4)(b).
11.13.3 Control TR1 relates to the requirements for a substance to be tracked
and is triggered for Moxidectin + Triclabendazole Oral Drench only by
virtue of its ecotoxicity. Consequently, the Agency considers that
tracking the substance would be unduly onerous can be managed
through other controls such as packaging, labelling and emergency
management requirements. Thus, this control may be deleted as
provided by section 77 (4)(b).
11.14
Control I16 (Regulation 25 of the Hazardous Substances (Identification)
Regulations 2001) includes a requirement to identify certain toxic components
on product labels. In March 2006, consistent with the guidance provided by
Global Harmonised System (GHS), the Hazardous Substances Standing
Committee (HSSC) agreed that regulation 25(e) may be varied such that the
concentration cut-offs that apply to a component with a hazard classification of
6.5, 6.6, 6.7, 6.8 or 6.9, for the purpose of triggering this requirement, are as
follows:
HSNO Classification of Component
Concentration Cut-off for Label (%)
6.5A, 6.5B
0.16
6.6A, 6.7A
0.1
6.6B, 6.7B
1
6
Identification of sensitising components may be required below the 0.1% level if a lower value has been
used for classification.
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11.15
6.8A, 6.8C
0.3
6.8B
3
6.9A, 6.9B
10
The Agency considers that the following controls may be combined under
section 77(5) for Moxidectin + Triclabendazole Oral Drench as they relate to the
same requirements:
11.15.1 Controls T4 and E6 which relate to requirements for equipment used to
handle hazardous substances.
11.15.2 Controls P13 and P15 which relate to requirements for the packaging
of Moxidectin + Triclabendazole Oral Drench.
11.15.3 Controls D4 and D5 which relate to requirements for disposal of
Moxidectin + Triclabendazole Oral Drench.
Control precedents
11.16
The Agency considered the Authority’s approvals given to veterinary medicines
under Part V of the Act as well as those transferred to the Act under the
Hazardous Substances (Veterinary Medicines) Transfer Notice 2005 (as
amended).
Summary of controls
11.17
The Agency considers that the customised controls listed in Appendix 5 should
apply to Moxidectin + Triclabendazole Oral Drench.
Environmental User Charges
11.18
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.
11.19
The Agency considers that use of controls is the most effective means of
managing the risks throughout the lifecycle of Moxidectin + Triclabendazole
Oral Drench. The imposition of an environmental user charge instead of, or in
combination with controls, is therefore not required at this time.
12 OVERALL EVALUATION OF RISKS, COSTS AND
BENEFITS
12.1
The Agency notes that the qualitative risk assessment shows that:
12.1.1
Risks posed to the environment by Moxidectin + Triclabendazole Oral
Drench throughout the lifecycle of the substance are negligible.
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12.1.2
Risks posed by the substances to human health and safety by
Moxidectin + Triclabendazole Oral Drench throughout the lifecycle of
the substance are negligible.
12.2
The Agency does not consider there to be significant risks to Māori cultural
wellbeing, society and the community, the market economy, or to New
Zealand’s international obligations.
12.3
The Agency has taken the type and severity of the risks, and the characteristics
of such risks into account, and considers that the overall level of risk posed by
the substance is negligible.
12.4
The Agency considers that there are significant benefits associated with the
release of Moxidectin + Triclabendazole Oral Drench as are specified in
Section 10 of this report.
12.5
Thus, the Agency considers that it is evident that the benefits of releasing
Moxidectin + Triclabendazole Oral Drench outweigh the costs.
13 CONCLUSION
13.1
Fort Dodge New Zealand Limited has applied for approval to import or
manufacture for release in New Zealand the substance identified as Moxidectin
+ Triclabendazole Oral Drench.
13.2
The Agency considers Moxidectin + Triclabendazole Oral Drench triggers the
following hazard classifications:

6.1E Acute oral toxicity

6.5B Skin sensitisation

6.9B Target organ toxicity

9.1A Aquatic ecotoxicity

9.2C Soil ecotoxicity

9.3C Terrestrial vertebrate ecotoxicity

9.4C Terrestrial invertebrate ecotoxicity.
13.3
The Agency considers that there are negligible risks to the environment and
human health and significant benefits associated with the release of Moxidectin
+ Triclabendazole Oral Drench. Therefore, the Agency considers that it is
evident that the benefits of releasing Moxidectin + Triclabendazole Oral Drench
outweigh the costs and the application may be approved in accordance with
clause 26.
13.4
The Agency considers the controls listed in Appendix 5 should apply to
Moxidectin + Triclabendazole Oral Drench.
ERMA New Zealand Evaluation and Review Report: Application HSR07111
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APPENDIX 1: DECISION PATH
Decision path for applications to import or manufacture a
hazardous substance
Context
This decision path describes the decision-making process for applications to import or
manufacture a hazardous substance. These applications are made under section 28 of the
HSNO Act, and determined under section 29 of the Act.
Introduction
The purpose of the decision path is to provide the Authority with guidance so that all
relevant matters in the HSNO Act and the Methodology have been addressed. It does not
attempt to direct the weighting that the Authority may decide to make on individual aspects
of an application.
In this document ‘section’ refers to sections of the HSNO Act, and ‘clause’ refers to clauses
of the ERMA New Zealand Methodology.
The decision path has two parts –


Flowchart (a logic diagram showing the process prescribed in the Methodology and the
HSNO Act to be followed in making a decision), and
Explanatory notes (discussion of each step of the process).
Of necessity the words in the boxes in the flowchart are brief, and key words are used to
summarise the activity required. The explanatory notes provide a more comprehensive
description of each of the numbered items in the flowchart, and describe the processes that
should be followed to achieve the described outcome.
For proper interpretation of the decision path it is important to work through the
flowchart in conjunction with the explanatory notes.
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FIGURE 1 FLOWCHART
Decision path for applications to import or manufacture a hazardous substance,
application made under section 28 of the Act and determined under section 29.
For proper interpretation of the decision path it is important to work through the flowchart in
conjunction with the explanatory notes
1
Review the content of the
application and all relevant
information
2
Is this information sufficient
to proceed?
No
3
Seek additional
information
4
Sufficient?
Yes
No
5
Identify the composition of the substance,
classify the hazardous properties of the
substance, and determine default controls
Yes
6
Identify all risks, costs and benefits that are
potentially non-negligible
Decline
(section 29(1)(c))
7
Assess each risk assuming controls in place.
Add, substitute or delete controls in
accordance with clause 35 and sections77,
77A, 77B
8
Undertake combined consideration of all risks
and costs, cognisant of proposed controls
9
Are all risks with controls in place
negligible?
Clause 27
No
12
Establish position on risk averseness
and appropriate level of caution
Clause 26 Yes
10
Review controls for cost-effectiveness in
accordance with clause 35 and sections 77,
77A, 77B
11
Is it evident that benefits outweigh
costs?
Yes
Yes
16
Confirm and set controls
13
Review controls for cost-effectiveness
in accordance with clause 35 and
sections 77, 77A, 77B
No
14
Assess benefits
15
Taking into account controls,
do positive effects outweigh adverse
effects?
No
Approve
Decline
(section 29(1)(a))
(section 29(1)(b))
Figure 1 EXPLANATORY NOTES
Item 1:
Review the content of the application and all relevant information
Review the application, the E&R Report, and information received from experts
and that provided in submissions (where relevant) in terms of section 28(2) of the
Act and clauses 8, 15, 16 and 20 of the Methodology.
Item 2:
Is this information sufficient to proceed?
Review the information and determine whether or not there is sufficient
information available to make a decision.
The Methodology (clause 8) states that the information used by the Authority in
evaluating applications shall be that which is appropriate and relevant to the
application. While the Authority will consider all relevant information, its
principal interest is in information which is significant to the proper consideration
of the application; ie information which is “necessary and sufficient” for decisionmaking.
Item 3:
(if no) Seek additional information
If there is not sufficient information then additional information may need to be
sought from the applicant, the Agency or other parties/experts under section 58 of
the Act (clause 23 of the Methodology).
Item 4
Sufficient?
When additional information has been sought, has this been provided, and is there
now sufficient information available to make a decision?
If the Authority is not satisfied that it has sufficient information for consideration,
then the application must be declined under section 29(1)(c).
Item 5:
(If ‘yes’ from item 2 or from item 4) Identify the composition of the substance,
classify the hazardous properties, and determine default controls
Identify the composition of the substance, and establish the hazard classifications
for the identified substance.
Determine the default controls for the specified hazardous properties using the
regulations ‘toolbox’.
Item 6:
Identify all risks, costs and benefits that are potentially non-negligible7
Costs and benefits are defined in the Methodology as the value of particular effects
(clause 2). However, in most cases these ‘values’ are not certain and have a
likelihood attached to them. Thus costs and risks are generally linked and may be
addressed together. If not, they will be addressed separately. Examples of costs
7
Relevant effects are marginal effects, or the changes that will occur as a result of the substance
being available. Financial costs associated with preparing and submitting an application are not
marginal effects and are not effects of the substance(s) and are therefore not taken into account in
weighing up adverse and positive effects. These latter types of costs are sometimes called ‘sunk’
costs since they are incurred whether or not the application is successful.
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that might not be obviously linked to risks are direct financial costs that cannot be
considered as ‘sunk’ costs (see footnote 1). Where such costs arise and they have
a market economic effect they will be assessed in the same way as risks, but their
likelihood of occurrence will be more certain (see also item 11).
Identification is a two step process that scopes the range of possible effects (risks,
costs and benefits).
Step 1:
Identify all possible risks and costs (adverse effects) and benefits
(positive effects) associated with the approval of the substance(s),
and based on the range of areas of impact described in clause 9 of
the Methodology and sections 5 and 6 of the Act8. Consider the
effects of the substance through its lifecycle (clause 11) and include
the likely effects of the substance being unavailable (sections
29(1)(a)(iii) and 29(1)(b)(iii)).
Relevant costs and benefits are those that relate to New Zealand and
those that would arise as a consequence of approving the application
(clause 14).
Consider short term and long term effects.
Identify situations where risks and costs occur in one area of impact
or affect one sector and benefits accrue to another area or sector; that
is, situations where risks and costs do not have corresponding
benefits.
Step 2:
Document those risks, costs and benefits that can be readily
concluded to be negligible9, and eliminate them from further
consideration.
Note that where there are costs that are not associated with risks
some of them may be eliminated at this scoping stage on the basis
that the financial cost represented is very small and there is no
overall effect on the market economy.
Item 7:
Assess each risk assuming controls in place. Add, substitute or delete controls
in accordance with clause 35 and sections 77, 77A and 77B of the Act.
The assessment of potentially non-negligible risks and costs should be carried out
in accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the
Methodology. The assessment is carried out with the default controls in place.
Assess each potentially non-negligible risk and cost estimating the magnitude of
the effect if it should occur and the likelihood of it occurring. Where there are
8
Effects on the natural environment, effects on human health and safety, effects on Maori culture
and traditions, effects on society and community, effects on the market economy.
9
Negligible effects are defined in the Annotated Methodology as “Risks which are of such little
significant in terms of their likelihood and effect that they do not require active management
and/or after the application of risk management can be justified by very small levels of benefits.
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non-negligible financial costs that are not associated with risks then the probability
of occurrence (likelihood) may be close to 1. Relevant information provided in
submissions should be taken into account.
The distribution of risks and costs should be considered, including geographical
distribution and distribution over groups in the community, as well as distribution
over time. This information should be retained with the assessed level of risk/cost.
This assessment includes consideration of how cautious the Authority will be in
the face of uncertainty (section 7). Where there is uncertainty, it may be necessary
to estimate scenarios for lower and upper bounds for the adverse effect as a means
of identifying the range of uncertainty (clause 32). It is also important to bear in
mind the materiality of the uncertainty and how significant the uncertainty is for
the decision (clause 29(a)).
Consider the Authority’s approach to risk (clause 33 of the Methodology) or how
risk averse the Authority should be in giving weight to the residual risk, where
residual risk is the risk remaining after the imposition of controls.
See ERMA New Zealand report ‘Approach to Risk’ for further guidance10.
Where it is clear that residual risks are non-negligible and where appropriate
controls are available, add substitute or delete controls in accordance with sections
77 and 77A of the Act to reduce the residual risk to a tolerable level. If the
substance has toxic or ecotoxic properties, consider setting exposure limits under
section 77B. While clause 35 is relevant here, in terms of considering the costs
and benefits of changing the controls, it has more prominence in items 10 and 13
If changes are made to the controls at this stage then the approach to uncertainty
and the approach to risk must be revisited.
Item 8:
Undertake combined consideration of all risks and costs, cognisant of
proposed controls
Once the risks and costs have been assessed individually, if appropriate consider
all risks and costs together as a ‘basket’ of risks/costs. This may involve
combining groups of risks and costs as indicated in clause 34(a) of the
Methodology where this is feasible and appropriate, or using other techniques as
indicated in clause 34(b). The purpose of this step is to consider the interactions
between different effects and determine whether these may change the level of
individual risks.
Item 9:
Are all risks with controls in place negligible?
Looking at individual risks in the context of the ‘basket’ of risks, consider whether
all of the residual risks are negligible.
10
http://www.ermanz.govt.nz/resources/publications/pdfs/ER-OP-03-02.pdf
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Item
10:
9
Are all risks with controls in place
negligible?
Clause 26 Yes
(from item 9 - if ‘yes’) Review controls for cost-effectiveness in accordance
with clause 35 and sections 77, 77A and 77B
Where all risks are negligible the decision must be made under clause 26 of the
Methodology.
Consider the practicality and cost-effectiveness of the proposed individual controls
and exposure limits (clause 35). Where relevant and appropriate, add, substitute or
delete controls whilst taking into account the view of the applicant, and the costeffectiveness of the full package of controls.
Item
11:
Is it evident that benefits outweigh costs?
Risks have already been determined to be negligible (item 9). In the unusual
circumstance where there are non-negligible costs that are not associated with risks
they have been assessed in item 7.
Costs are made up of two components: internal costs or those that accrue to the
applicant, and external costs or those that accrue to the wider community.
Consider whether there are any non-negligible external costs that are not
associated with risks.
If there are no external non-negligible costs then external benefits outweigh
external costs. The fact that the application has been submitted is deemed to
demonstrate existence of internal or private net benefit, and therefore total benefits
outweigh total costs11. As indicated above, where risks are deemed to be
negligible, and the only identifiable costs resulting from approving an application
are shown to accrue to the applicant, then a cost-benefit analysis will not be
required. The act of an application being lodged will be deemed by the Authority
to indicate that the applicant believes the benefits to be greater than the costs.
However, if this is not the case and there are external non-negligible costs then all
benefits need to be assessed (via item 14).
11Technical
Guide ‘Risks, Costs and Benefits’ page 6 - Note that, where risks are negligible and the
costs accrue only to the applicant, no explicit cost benefit analysis is required. In effect, the Authority
takes the act of making an application as evidence that the benefits outweigh the costs”. See also
Protocol Series 1 ‘General requirements for the Identification and Assessment of Risks, Costs, and
Benefits’.
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Item
12:
9
Are all risks with controls in place
negligible?
Clause 27
No
(from item 9 - if ‘no’) Establish Authority’s position on risk averseness and
appropriate level of caution
Although ‘risk averseness’ (approach to risk, clause 33) is considered as a part of
the assessment of individual risks, it is good practice to consolidate the view on
this if several risks are non-negligible. This consolidation also applies to the
consideration of the approach to uncertainty (section 7)
Item
13:
Review controls for cost-effectiveness in accordance with clause 35 and
sections 77, 77A and 77B
This constitutes a decision made under clause 27 of the Methodology (taken in
sequence from items 9 and 12).
Consider whether any of the non-negligible risks can be reduced by varying the
controls in accordance with sections 77 and 77A of the Act, or whether there are
available more cost-effective controls that achieve the same level of effectiveness
(section 77A(4)(b) and clause 35(a)).
Where relevant and appropriate, add, substitute or delete controls whilst taking
into account the views of the applicant (clause 35(b)), and making sure that the
total benefits that result from doing so continue to outweigh the total risks and
costs that result.
As for item 7, if the substance has toxic or ecotoxic properties, consider exposure
limits under section 77B.
Item
14:
(if ‘no’ from item 11 or in sequence from item 13) Assess benefits
Assess benefits or positive effects in terms of clause 13 of the Methodology.
Since benefits are not certain, they are assessed in the same way as risks. Thus the
assessment involves estimating the magnitude of the effect if it should occur and
the likelihood of it occurring. This assessment also includes consideration of the
Authority’s approach to uncertainty or how cautious the Authority will be in the
face of uncertainty (section 7). Where there is uncertainty, it may be necessary to
estimate scenarios for lower and upper bounds for the positive effect.
An understanding of the distributional implications of a proposal is an important
part of any consideration of costs and benefits, and the distribution of benefits
should be considered in the same way as for the distribution of risks and costs.
The Authority will in particular look to identify those situations where the
beneficiaries of an application are different from those who bear the costs12. This
is important not only for reasons related to fairness but also in forming a view of
just how robust any claim of an overall net benefit might be. It is much more
This principle derives from Protocol Series 1, and is restated in the Technical Guide ‘Risks,
Costs and Benefits’.
12
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difficult to sustain a claim of an overall net benefit if those who enjoy the benefits
are different to those who will bear the costs. Thus where benefits accrue to one
area or sector and risks and costs are borne by another area or sector then the
Authority may choose to be more risk averse and to place a higher weight on the
risks and costs.
As for risks and costs, the assessment is carried out with the default controls in
place.
Item
15:
Taking into account controls, do positive effects outweigh adverse effects?
In weighing up positive and adverse effects, consider clause 34 of the
Methodology. Where possible combine groups of risks, costs and benefits or use
other techniques such as dominant risks and ranking of risks. The weighing up
process takes into account controls proposed in items 5, 7, 10 and/or 13.
Where this item is taken in sequence from items 12, 13 and 14 (i.e. risks are not
negligible) it constitutes a decision made under clause 27 of the Methodology.
Where this item is taken in sequence from items 9, 10, 11 and 14 (i.e. risks are
negligible, and there are external non-negligible costs) it constitutes a decision
made under clause 26 of the Methodology.
Item
16:
11
Is it evident that benefits outweigh
costs?
Yes
Yes
15
Taking into account controls,
do positive effects outweigh adverse
effects?
(if ‘yes’ from items 11 or 15) Confirm and set controls
Controls have been considered at the earlier stages of the process (items 5, 7, 10
and/or 13). The final step in the decision-making process brings together all the
proposed controls, and reviews them for overlaps, gaps and inconsistencies. Once
these have been resolved the controls are confirmed.
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APPENDIX 2: HAZARD CLASSIFICATION
Data from effects testing of the formulation were not provided for any hazard
endpoint for Moxidectin + Triclabendazole Oral Drench so classification was
estimated using information on the effects of the components and mixture rules. A
summary of the physical, toxicity and ecotoxicity hazard classification associated
with Moxidectin + Triclabendazole Oral Drench and its components is provided in
Tables A2.1 to A2.3. The relevant sections of the HSNO Thresholds and
classifications user guide that describe the mixture rules are listed in Table A2.4.
Physical Hazards
The Agency has reviewed the available information on Moxidectin + Triclabendazole
Oral Drench and its components and considers that Moxidectin + Triclabendazole
Oral Drench does not trigger the thresholds for explosiveness, flammability,
oxidising capacity or metal corrosivity.
Table A2.1: Summary of the physical hazard classifications of Moxidectin+
Triclabendazole Oral Drench
Endpoint
Component
Class 1
Class 2
Class 3
Class 4
Class 5
Moxidectin+
Triclabendazole
Oral Drench
No
No
No
No
No
Class
8.1
No
NA
No
No
No
No
No
ND
ND
No
ND
NA
NA
ND
NA
ND
No
ND
No
ND
ND
No
ND
No
ND
ND
ND
ND
No
A
NA
NA
B
No
No
C
ND
NA
D
No
NA
E
NA
NA
F
NA
NA
G
No
NA
ND = no data/insufficient data/inconclusive data
N/A = not applicable
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Table A2.2: Summary of the toxicity hazard classifications of Moxidectin+ Triclabendazole Oral Drench
Endpoint
6.1
6.1
6.1
6.3
6.4
6.5A
6.5B
6.6
6.7
6.8A/B
6.8C
6.9
Component
(oral)
(dermal)
(inhalation)
Moxidectin+
Triclabendazole
Oral Drench
A
6.1B
ND
6.1D
6.3B
6.4A
ND
No
No
No
6.8B*
6.8C*
6.9A
B
6.1C
No
No
No
No
ND
6.5B
No
No
No
No
6.9B
C
No
ND
ND
ND
ND
ND
ND
No
No
No
ND
No
D
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
ND
E
6.1D
6.1D
No
No
6.4A
ND
6.5B
No
No
No
ND
ND
F
6.1D
ND
ND
No
No
ND
6.5B
No
ND
No
6.8C*
6.9B
G
No
ND
No
No
No
ND
No
No
No
No
ND
No
ND = no data/insufficient data/inconclusive data
* The Agency notes that the density of the formulation is greater than 1 g/L, so the concentration on a % weight/weight basis for components triggering 6.8B/C is less than
0.1%. Therefore the formulation is not classified for 6.8 reproductive/developmental toxicity.
Table A2.3: Summary of the ecotoxicity hazard classifications of Moxidectin+ Triclabendazole Oral Drench
Endpoint
9.1 (fish)
9.1
9.1
Component
(crustacean)
(algae)
Moxidectin+
9.1A overall
Triclabendazole Oral
Drench
A
9.1A
9.1A
ND
B
ND
ND
ND
C
No
ND
ND
D
ND
ND
ND
E
9.1D
9.1D
ND
F
ND
9.1D
9.1D
G
ND
ND
ND
ND = no data/insufficient data/inconclusive data
* in case of ND the Agency assumes bioaccumulation and persistence
ERMA New Zealand Evaluation and Review Report: Application HSR07111
BioAccumulative*
Yes
Aquatic
persistence*
Yes
Yes
ND
ND
ND
No
Yes
ND
ND
ND
ND
ND
No
Yes
ND
Page 38 of 61
9.2
9.3
9.4
9.2C
Soil
persistence*
Yes
9.3C
9.4C
9.2A
ND
ND
ND
9.2B
ND
ND
Yes
ND
ND
ND
No
No
ND
9.3A
9.3B
No
ND
9.3C
9.3C
No
9.4A
ND
ND
ND
ND
ND
ND
Table A2.4: Location of mixture rules within the HSNO Thresholds and Classifications
User Guide.
Hazard
User Guide to HSNO
Thresholds and Classifications
Reference
Subclass 6.1 Acute Toxicity
Part VI, Page 19
Subclass 6.3/8.2 Skin Irritancy/Corrosivity
Part VI, Page 32
Subclass 6.4/8.3 Eye Irritancy/Corrosivity
Part VI, Page 32
Subclass 6.5 Contact and Respiratory Sensitisation Part VI, Page 51
Subclass 6.6 Mutagenicity
Part VI, Page 61
Subclass 6.7 Carcinogenicity
Part VI, Page 73
Subclass 6.8 Reproductive Developmental
Part VI, Page 86
Toxicity
Subclass 6.9 Target Organ Systemic Toxicity
Part VI, Page 98
Subclass 9.1 Aquatic Ecotoxicity
Part VII, Page 25-26
Subclass 9.2 Soil Ecotoxicity
Part VII, Page 41-43
Subclass 9.3 Terrestrial Vertebrate Ecotoxicity
Part VII, Page 55-56
Subclass 9.4 Terrestrial Invertebrate Ecotoxicity
Part VII, Page 68-70
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APPENDIX 3: RISK ASSESSMENT
Human health risk assessment
Operator exposure assessment
The Agency has not undertaken a quantitative assessment of risks to operator health as no
models for applications of this type are available.
The Agency notes that dosing equipment is used for products of this type, and this is likely to
greatly reduce the likelihood of exposure of the operator. Nevertheless, there is the possibility
of skin contact, and to address this risk there will be a recommendation for use of personal
protective equipment.
Public health exposure and risk assessment
Direct exposure of the general public to the substance is very unlikely as it will be used only
in commercial stock operations.
Environmental exposure and risk assessment
With respect to ecotoxicity, Moxidectin + Triclabendazole Oral Drench triggers 9.1A, 9.2C,
9.3C and 9.4C classifications.
No quantitative modelling has been performed. 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 and following use
The product will be applied without dilution as an oral drench. Due to this application
method the environmental exposure and the effects on the environment will be limited.
Exposure of the environment to components of Moxidectin + Triclabendazole Oral Drench
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. However, since no data have been
provided to quantify the concentration of contaminants in soil/dung, any risks from these
exposures cannot be evaluated.
Therefore, there is some uncertainty in the assessment of the environmental risks resulting
from the use of this product. Nevertheless, it is noted that there are two other products
containing the same active ingredients at similar concentrations currently on the market in
New Zealand it is therefore considered the use of Moxidectin + Triclabendazole Oral Drench
is unlikely to pose a significantly different risk than the use of existing products.
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APPENDIX 4: DISCUSSION ON CONTROLS
Those controls which require calculations, derivations or extended discussion are considered
in the following sections.
Toxicity Controls
Setting of TELs (Control Code T1)
Tolerable Exposure Limits (TELs) are designed to limit the extent to which the general public
is exposed to hazardous (toxic) substances. A TEL represents the maximum concentration of
a substance legally allowable in a particular medium, and can be set as either a guideline
value or an action level that should not be exceeded. For the purposes of setting TELs, an
environmental medium is defined as air, water, soil or a surface that a hazardous substance
may be deposited onto.
TELs are established from PDE (potential daily exposure) values, which are themselves
established from ADE (acceptable daily exposure) values or reference doses (RfD) which are
similar to ADE but are used to protect against a specific toxic effect of concern.
Human exposure may also occur through food or drinking water. Exposure through food is
managed via the establishment of Maximum Residue Limits (MRLs) as set by the Minister of
Food Safety on the advice of the New Zealand Food Safety Authority (NZFSA). Exposure
through drinking water is managed via the establishment of Maximum Acceptable Values
(MAVs) as set by the Ministry of Health. MRLs and MAVs are also established from ADE
values.
Setting of PDEs
If an ADE or RfD value is set for a substance, or component of a substance, a PDE value for
each relevant exposure route must also be set. A PDE is an amount of substance (mg/kg
bodyweight/day), calculated in accordance with Regulation 23, that estimates the relative
likelihood of particular exposures. A PDE for any single exposure route is a fraction of the
ADE or RfD, and the sum of all PDE values from all possible exposures must be less than or
equal to the ADE or RfD.
The main routes of exposure considered are ingestion (food, water, air, soil), inhalation (air)
and skin contact (surface deposition, water, soil).
Setting of ADEs
An ADE is an amount of a hazardous substance (mg/kg bodyweight/day), that, given a
lifetime of daily exposure, would be unlikely to result in adverse human health effects. An
RfD (reference dose) is a similar measure that can be used to protect against a specific toxic
effect of concern.
Regulation 11(1) of the Hazardous Substances (Classes 6, 8 and 9) Controls Regulations 2001
determines when an ADE/RfD is required to be set:
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(1)
This regulation applies to a class 6 substance if(a)
it is likely to be present in(i) 1 or more environmental media; or
(ii) food; or
(iii) other matter that might be ingested; AND
(b)
it is a substance to which a person is likely to be exposed on 1 or more
occasions during the lifetime of the person; AND
(c)
exposure to the substance is likely to result in an appreciable toxic
effect.
If all three requirements of regulation 11(1) are met, then an ADE/RfD should be set for the
relevant component(s), and PDE and TEL values subsequently established for each relevant
exposure route.
The toxicity (Class 6) classifications of Moxidectin + Triclabendazole Oral Drench that
trigger the need to consider setting a TEL are 6.1E and 6.9B.
For Moxidectin + Triclabendazole Oral Drench, the Agency considers that moxidectin and
triclabendazole fulfill the requirements of Regulation 11(1)(a), (b) and (c), and therefore notes
that an ADE is required to be set for these components. Given the specific use of Moxidectin
+ Triclabendazole Oral Drench, the Agency considers that the principal source of exposure of
the general public to the substance is via food residues, an exposure route managed by the
NZFSA through the setting of MRLs. The Agency notes that MRLs have been set for
moxidectin and triclabendazole. The MRLs are likely to be relevant to the use of Moxidectin
+ Triclabendazole Oral Drench.
The Agency notes that ADEs of 0.002 mg/kg bw/day and 0.003 mg/kg bw/day have already
been set for moxidectin and triclabendazole, respectively, in a previous Part V application
(application number HSR03005). The following PDE values for triclabendazole and
moxidectin, respectively, were also set in that application:
PDEfood = 0.0014 mg/kg bw/day (moxidectin)
PDEdrinking water = 0.0004 mg/kg bw/day (moxidectin)
PDEfood = 0.0021 mg/kg bw/day (triclabendazole)
PDEdrinking water = 0.0006 mg/kg bw/day (triclabendazole)
The Agency proposes that these values are set for triclabendazole and moxidectin in
Moxidectin + Triclabendazole Oral Drench.
The Agency is intending to review the setting of ADEs, PDEs and TELS under section 77B of
the Act and until this review is complete, the Agency proposes not to set any TELs for
moxidectin or triclabendazole.
Setting of WES (Control Code T2)
Workplace exposure standards (WES) are designed to protect persons in the workplace from
the adverse effects of toxic substances. A WES is an airborne concentration of a substance
(expressed as mg substance/m3 of air, or ppm in air), which must not be exceeded in a
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workplace and only applies to places of work to which the public does not have access
(Regulation 29(2), Hazardous substances (Classes 6, 8, and 9 Controls) Regulations 2001).
Regulation 29(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations
2001 determines when a WES is required to be set. If all three of the requirements of this
regulation are met then a WES is required to be set.
Regulation 29 states:
(1) This regulation and regulation 30 apply to a class 6 substance if,(a) under the temperature and pressure the substance is to be used in, it can become
airborne and disperse in air in the form of inspirable or respirable dust, mists,
fumes, gases or vapours; AND
(b) human exposure to the substance is primarily through the inhalation or dermal
exposure routes; AND
(c) the toxicological and industrial hygiene data available for the substance is
sufficient to enable a standard to be set.
When setting WES, the Authority must either, adopt a value already proposed by the
Department of Labour or already set under HSNO, adopt a value set in another jurisdiction or
derive a value by taking into account the matters described in Regulation 30(2) of the
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations.
The Agency typically adopts WES values listed in the Workplace Exposure Standards
(Effective from 2002) document (refer to the link below).
http://www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf
The Agency notes that a Department of Labour WES value has been set for component F, but
considers that this value should not be applied to Moxidectin + Triclabendazole Oral Drench
due to the low concentration of component F in the product. No other Department of Labour
WES/overseas WES values have been set for any other components of Moxidectin +
Triclabendazole Oral Drench. This indicates that the conditions of Regulation 29(1)(c) are
not met as the Agency is not aware of industrial hygiene data for Moxidectin +
Triclabendazole Oral Drench that would enable a WES to be set for any of the constituent
components. In addition, the conditions of Regulation 29(1)(a) are not met as Moxidectin +
Triclabendazole Oral Drench would not become airborne and disperse in the air during use.
Therefore, no WES values are proposed for any components of Moxidectin + Triclabendazole
Oral Drench at this time.
Ecotoxicity Controls
Setting of EELs (Control code E1)
Regulation 33 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
specify that an environmental exposure limit (EEL) may be set for a class 9 substance for one
or more environmental media if organisms that live in that environment may be exposed to the
substance. An EEL is the (maximum) concentration of a substance in an environmental
medium that will present a negligible risk of adverse environmental effects to organisms
(excluding humans) in non-target areas.
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As specified by regulation 32, a default EEL of 0.1 µg/L water is set for any class 9.1
substance, and 1 µg/kg soil (dry weight) for any class 9.2 substance.
For the purposes of setting EELs, an environmental medium is defined as water, soil or
sediment where these are in the natural environment, or a surface onto which a hazardous
substance may be deposited.
An EEL can be established by one of three means:

Applying the default EELs specified in regulation 32

Adopting an established EEL as provided by regulation 35(a)

Calculating an EEL from an assessment of available ecotoxicological data as
provided by regulation 35(b).
The Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005
added a new section (s77B) to the HSNO Act, which, amongst other things provided the
Authority with the ability to set EELs as guideline values, rather than the previous pass/fail
values.
However, until the Agency has developed formal policy on the implementation of s77B, it
proposes not to set EELs for any components of Moxidectin + Triclabendazole Oral Drench at
this time. It is also proposed that the default EEL water and soil value(s) be deleted until the
policy has been established.
Approved Handler Controls- Highly ecotoxic substances (AH1, E7)
Approved handler requirements have been triggered for Moxidectin + Triclabendazole Oral
Drench as a result of its 9.1A classification. The outcome of the ecological risk assessment
indicates that it is unlikely there will be any adverse environmental effects from the proposed
use of this substance. The Agency therefore considers that the approved handler controls can
be deleted as provided by section 77 (4)(b).
This approach is consistent with the Authority’s policy on approved handler and tracking
controls for class 9 substances (January 2006).
Tracking control- Highly ecotoxic substances (TR1)
Tracking requirements have been triggered for Moxidectin + Triclabendazole Oral Drench as
a result of its 9.1A classification. However, for substance where the tracking control has been
triggered solely as a result of ecotoxicity, it is considered that any risk that may arise during
its life-cycle are adequately managed by other controls such as packaging, labeling and
emergency management requirements. The Agency therefore considers the tracking control
can be deleted as provided by section 77(4)(b).
This approach is consistent with the Authority’s policy on approved handler and tracking
controls for class 9 substances (January 2006).
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Setting of Application Rate (Control Code E2)
These regulations relate to the requirement to set an application rate for a class 9 substance
that is to be sprayed or applied to an area of land (or air or water) and for which an EEL has
been set.
Moxidectin + Triclabendazole Oral Drench is not designed to be used in this manner, nor
have any EELs been set. Consequently, the Agency considers this control is not relevant to
Moxidectin + Triclabendazole Oral Drench.
Identification controls
Identification of Toxic Components on Labels/Documentation (SDS)
The Hazardous Substances (Identification) Regulations 2001 specify that certain toxic and/or
corrosive components are required to be specified on the product label and on SDS
documentation.
Identification of toxic components on labels
Regulations 25(e) and 25(f) require that certain toxic components are required to be specified
on the product label.
Regulation 25(e) states:
...a toxic substance must be identified by...
'information identifying, by its common or chemical name, every ingredient, that would,
independently of any other ingredient, give the substance a hazard classification of 6.1A,
6.1B, 6.1C, 6.5, 6.6, 6.7, 6.8 or 6.9, and the concentration of that ingredient in the substance."
Regulation 25(f) states:
...a toxic substance must be identified by...
"information identifying (other than an ingredient referred to in paragraph (E)) that would,
independently of any other ingredient, give the substance a hazard classification of 6.1D, and
the concentration of the ingredient that would contribute the most to that classification."
Identification of toxic components on SDS
Regulation 39(5) of the Hazardous Substances (Identification) Regulations 2001, states that
certain corrosive and toxic components are required to be specified on documentation.
Regulations 39(5) states:
"The requirements of regulation 19(f) or (as the case requires) regulation 25(e) apply to all
documentation; but any ingredient required by that provision to be identified (other than an
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ingredient to which regulation 26 applies) must also be identified by any Chemical Abstract
Services number allocated to it."
Concentration cut-offs for component identification
Consistent with the guidance provided by GHS, the Hazardous Substances Standing
Committee (HSSC) agreed that the concentration cut-offs triggering the requirement for
identification of components on labels and documentation are:
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
Moxidectin + Triclabendazole Oral Drench - Components requiring identification
Under these regulations, as determined by the HSSC (March 2006), the name and
concentration of the following components need to be specified on the label and
documentation:
Label
Triclabendazole
Component E
Documentation
Triclabendazole
Component E
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APPENDIX 5: LIST OF PROPOSED CONTROLS FOR
MOXIDECTIN + TRICLABENDAZOLE ORAL
DRENCH
Table A5.1: Controls for Moxidectin + Triclabendazole Oral Drench – codes,
regulations and variations.
Control Regulation Topic
Variations
14
Code13
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
T1
11-27
Limiting exposure to toxic
substances.
The following ADE and PDEs are
set for moxidectin:
ADE = 0.002 mg/kg bw/day
PDEfood = 0.0014 mg/kg bw/day
PDEdrinking water = 0.0004 mg/kg
bw/day
The following ADE and PDEs are
set for triclabendazole:
ADEs of 0.003 mg/kg bw/day
PDEfood = 0.0021 mg/kg bw/day
PDEdrinking water = 0.0006 mg/kg
bw/day
No TEL values are set for Moxidectin
+ Triclabendazole Oral Drench at this
time.
T2
29, 30
Controlling exposure in places of
work
No WES values are set at this time.
T4/E6
7
Requirements for equipment used to
handle hazardous substances.
Controls T4 and E6 are combined.
T5
8
Requirements for protective clothing
and equipment.
T7
10
Restrictions on the carriage of
hazardous substances on passenger
service vehicles.
The trigger level for this control is
varied from 0.1 L to 1 L.
E1
32-45
Limiting exposure to ecotoxic
substances.
No EEL values are set for Moxidectin
+ Triclabendazole Oral Drench at this
time and the default EELs are deleted.
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.
14 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.
13
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Control Regulation Topic
14
Code13
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35,
36 (1)-(7)
Variations
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
I8
14
Priority identifiers for toxic
substances
I9
18
Secondary identifiers for all
hazardous substances.
I11
20
Secondary identifiers for ecotoxic
substances.
I16
25
Secondary identifiers for toxic
substances.
I17
26
Use of Generic Names.
I18
27
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
0.115
6.6A, 6.7A
0.1
6.6B, 6.7B
1
6.8A, 6.8C
0.3
6.8B
3
6.9A, 6.9B
10
For more information about this
variation see paragraph 11.14 of the
main document.
I19
29-31
Alternative information in certain
cases.
Regulation 29 – Substances in fixed
bulk containers or bulk transport
15
Identification of sensitising components may be required below the 0.1% level if a lower value has been
used for classification.
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Control
Code13
Regulation
Topic
Variations
14
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.
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.
I30
53
Advertising corrosive and toxic
substances.
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements.
Regulation 5 – Ability to retain
contents.
Regulation 6 – Packaging markings.
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Control
Code13
Regulation
Topic
Variations
14
Regulation 7(1) – Requirements
when packing hazardous substance.
Regulation 8 – Compatibility.
P3
9
P13
P15
19
21
PG3
Schedule 3
PS4
Schedule 4
Regulation 9A and 9B – Large
Packaging.
Packaging requirements for
substances packed in limited
quantities.
Packaging requirements for
Moxidectin + Triclabendazole Oral
Drench.
Packaging requirements equivalent
to UN Packing Group III
Controls P13 and P15 are combined
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
D5
8
9
D6
D7
D8
10
11, 12
13, 14
EM1
6, 7, 9-11
EM6
8(e)
EM7
8(f)
EM8
EM11
12-16, 1820
25-34
EM12
35-41
Disposal requirements for
Moxidectin + Triclabendazole Oral
Drench.
Controls D4 and D5 are combined
Disposal requirements for packages.
Disposal information requirements.
Disposal documentation
requirements.
Hazardous Substances (Emergency Management) Regulations 2001
Level 1 emergency management
information: General requirements.
Information requirements for toxic
substances.
Information requirements for
ecotoxic substances.
Level 2 emergency management
documentation requirements.
Level 3 emergency management
requirements – emergency response
plans.
Level 3 emergency management
requirements – secondary
containment.
ERMA New Zealand Evaluation and Review Report: Application HSR07111
The following subclauses shall be
added after subclause (3) of
regulation 36:
(4) For the purposes of this
regulation, and regulations
37 to 40, where this
substance is contained in
pipework that is installed and
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Control
Code13
Regulation
Topic
Variations
14
(5)
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.
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 shall be
added after subclause (1) of
regulation 37:
(2) If pooling substances that 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)
ERMA New Zealand Evaluation and Review Report: Application HSR07111
5% of the total
pooling potential; or
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Control
Code13
Regulation
Topic
Variations
14
(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.
The following subclauses shall be
added after subclause (1) of
regulation 38:
(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.
EM13
42
Level 3 emergency management
requirements – signage.
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Control Regulation Topic
Variations
14
Code13
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
The 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, apply to this substance,
notwithstanding clause 1(1) of that schedule.
Moxidectin + Triclabendazole Oral Drench shall only be used as a veterinary medicine.
Addition of subclauses after subclause (3) of Regulation 36, subclause (1) of Regulation 37 and
subclause (1) of Regulation 38 of the Hazardous Substances (Emergency Management Controls)
Regulations, refer control EM12.
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APPENDIX 6: SCALES FOR QUALITATIVE RISK
ASSESSMENT
Qualitative descriptors are indicative only and they are primarily intended to be used to rank
risks and benefits for the purposes of balancing risks and costs against benefits, and so that
risks can be prioritised for management. The ‘descriptor’ words should not be seen in any
absolute senses – they are simply a means of differentiating levels of significance.
Assessing risks, costs and benefits qualitatively
This section describes how the Agency staff and the Authority address the qualitative
assessment of risks, costs and benefits.
Risks and benefits are assessed by estimating the magnitude and nature of the possible
effects and the likelihood of their occurrence. For each effect, the combination of
these two components determines the level of the risk associated with that effect,
which is a two dimensional concept.
Because of a lack of data, risks are often presented as singular results. In reality, they
are better represented by ‘families’ of data which link probability with different levels
of outcome (magnitude).
Describing the magnitude of effect
The magnitude of effect is described in terms of the element that might be affected.
The qualitative descriptors for magnitude of effect are surrogate measures that should
be used to gauge the end effect or the ‘what if’ element.
Tables A6.1 and A6.2 contain generic descriptors for magnitude of adverse and
beneficial effect. These descriptors are examples only, and their generic nature means
that it may be difficult to use them in some particular circumstances. They are
included here to illustrate how qualitative tables may be used to represent levels of
adverse and beneficial effect.
The sample qualitative descriptors for effects on the market economy listed in the
ERMA New Zealand technical guide to decision making16 include representative
numbers. These ‘economic’ descriptors were developed prior to the publication of the
technical guide on identification and assessment of effects on the market economy,17
which refines the approach that ERMA New Zealand applies to identifying and
assessing economic effects. These numbers do not align well with the qualitative
descriptors in the other categories (effects on the environment, effects on human
health, and effects on society and communities), as they relate more to an event than
an effect. In particular the numbers are unclear about how they take account of time
16 ERMA New Zealand. 2004. Decision Making: A Technical Guide to Identifying, Assessing and Evaluating Risks,
Costs and Benefits, ER-TG-05-01. Wellington: Environmental Risk Management Authority.
17 ERMA New Zealand. 2005. Assessment of Economic Risks, Costs and Benefits: Consideration of Impacts on the
Market Economy, ER-TG-06-01. Wellington: Environmental Risk Management Authority.
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(are they annual, or over the life of the activity) and they do not have a local, regional
or national context.
ERMA New Zealand has adopted a revised set of qualitative descriptors for the
magnitude of effect on the market economy, as shown below.
Table A6.1: Magnitude of adverse effect (risks and costs).
Descriptor Examples of descriptions: ADVERSE
Minimal
Mild reversible short term adverse health effects to individuals in highly localised area
Highly localised and contained environmental impact, affecting a few (less than ten) individuals
members of communities of flora or fauna, no discernible ecosystem impact
Local/regional short-term adverse economic effects on small organisations (businesses,
individuals), temporary job losses
No social disruption
Minor
Mild reversible short term adverse health effects to identified and isolated groups
Localised and contained reversible environmental impact, some local plant or animal communities
temporarily damaged, no discernible ecosystem impact or species damage
Regional adverse economic effects on small organisations (businesses, individuals) lasting less
than six months, temporary job losses
Potential social disruption (community placed on alert)
Moderate
Minor irreversible health effects to individuals and/or reversible medium term adverse health
effects to larger (but surrounding) community (requiring hospitalisation)
Measurable long term damage to local plant and animal communities, but no obvious spread
beyond defined boundaries, medium term individual ecosystem damage, no species damage
Medium term (one to five years) regional adverse economic effects with some national
implications, medium term job losses
Some social disruption (e.g. people delayed)
Major
Significant irreversible adverse health effects affecting individuals and requiring hospitalisation
and/or reversible adverse health effects reaching beyond the immediate community
Long term/irreversible damage to localised ecosystem but no species loss
Measurable adverse effect on GDP, some long term (more than five years) job losses
Social disruption to surrounding community, including some evacuations
Massive
Significant irreversible adverse health effects reaching beyond the immediate community and/or
deaths
Extensive irreversible ecosystem damage, including species loss
Significant on-going adverse effect on GDP, long term job losses on a national basis
Major social disruption with entire surrounding area evacuated and impacts on wider community
Table A6.2: Magnitude of beneficial effect (benefits).
Descriptor Examples of descriptions: BENEFICIAL
Minimal
Mild short term positive health effects to individuals in highly localised area
Highly localised and contained environmental impact, affecting a few (less than ten) individuals
members of communities of flora or fauna, no discernible ecosystem impact
Local/regional short-term beneficial economic effects on small organisations (businesses,
individuals), temporary job creation
No social effect
Minor
Mild short term beneficial health effects to identified and isolated groups
Localised and contained beneficial environmental impact, no discernible ecosystem impact
Regional beneficial economic effects on small organisations (businesses, individuals) lasting less
than six months, temporary job creation
Minor localised community benefit
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Descriptor Examples of descriptions: BENEFICIAL
Moderate
Minor health benefits to individuals and/or medium term health impacts on larger (but
surrounding) community and health status groups
Measurable benefit to localised plant and animal communities expected to pertain to medium
term.
Medium term (one to five years) regional beneficial economic effects with some national
implications, medium term job creation
Local community and some individuals beyond immediate community receive social benefit.
Major
Significant beneficial health effects to localised community and specific groups in wider
community
Long term benefit to localised ecosystem(s)
Measurable beneficial effect on GDP, some long term (more than five years) job creation
Substantial social benefit to surrounding community, and individuals in wider community.
Massive
Significant long term beneficial health effects to the wider community
Long term, wide spread benefits to species and/or ecosystems
Significant on-going effect beneficial on GDP, long term job creation on a national basis
Major social benefit affecting wider community
Determining the likelihood of the end effect
Likelihood in this context applies to the composite likelihood of the end effect, and
not either to the initiating event, or any one of the intermediary events. It includes:

the concept of an initiating event (triggering the hazard), and

the exposure pathway that links the source (hazard) and the area of impact
(public health, environment, economy, or community).
Thus, the likelihood is the likelihood of the specified adverse effect18 resulting from
that initiating event. It will be a combination of the likelihood of the initiating event
and several intermediary likelihoods19. The best way to determine the likelihood is to
specify and analyse the complete pathway from source to impact.
Likelihood may be expressed as a frequency or a probability. While frequency is
often expressed as a number of events within a given time period, it may also be
expressed as the number of events per head of (exposed) population. As a probability,
the likelihood is dimensionless and refers to the number of events of interest divided
by the total number of events (range 0–1). (See Table A6.3.)
Table A6.3: Likelihood.
Descriptor
Description
1
Highly improbable
Almost certainly not occurring but cannot be totally ruled out
2
Improbable
(remote)
Only occurring in very exceptional circumstances.
3
Very unlikely
Considered only to occur in very unusual circumstances
4
Unlikely
Could occur, but is not expected to occur under normal operating conditions.
18 The specified effect refers to scenarios established in order to establish the representative risk, and may be
as specific as x people suffering adverse health effects, or y% of a bird population being adversely affected. The
risks included in the analysis may be those related to a single scenario, or may be defined as a combination of
several scenarios.
19 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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Descriptor
Description
(occasional)
5
Likely
A good chance that it may occur under normal operating conditions.
6
Very likely
Expected to occur if all conditions met
7
Extremely likely
Almost certain
Using magnitude and likelihood to construct the level of risk and benefit
Using the magnitude and likelihood tables a matrix representing a level of effect can
be constructed (Table A6.4).
Table A6.4: Level of risk.
Magnitude of effect
Likelihood
Minimal
Minor
Moderate
Major
Massive
Highly improbable
A
A
B
C
D
Improbable
A
B
C
D
E
Very unlikely
B
C
D
E
E
Unlikely
C
D
E
E
F
Likely
D
E
E
F
F
Very likely
E
E
F
F
F
Extremely likely
E
F
F
F
F
The Agency considers that, for this substance, the level of risk/benefit can be assigned
as follows in Table A6.5.
Table A6.5: Assignment of level of risk/benefit.
Code
Level of risk/benefit
A&B
Negligible
C
Low
D
Medium
E
High
F
Extreme
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APPENDIX 7: GOVERNMENT DEPARTMENTS,
CROWN ENTITIES AND INTERESTED PARTIES
NOTIFIED
Aakland Chemicals (1997) Limited
AgBio Research Limited
Agcarm Incorporated
AgResearch Limited
Agronica New Zealand Limited
Ancare New Zealand Limited
ARPPA
BASF New Zealand
Bayer New Zealand Limited
BOC Limited
Bomac Laboratories Limited
Caltex New Zealand Limited
Central Hawkes Bay District Council
Chancery Green
Chemagro New Zealand Limited
Chemsafety Limited
Crown Public Health
Department of Internal Affairs
Donaghys Industries Limited
Dow AgroSciences (NZ) Ltd.
DuPont (New Zealand) Limited
Environment Southland
Environment Waikato
Far North District Council
Federated Farmers of New Zealand (Incorporated)
Fish & Game Council of New Zealand
Fish & Game Council Otago
Fish & Game Eastern Region
Fish & Game Nelson/Marlborough
Fort Dodge Australia Pty Limited
Franklin District Council
GE Free (Wairarapa)
General Cable New Zealand Limited
Greater Wellington - The Regional Council
Green Party of Aotearoa New Zealand
Horizons Regional Council
Horticulture and Food Research Institute (HortResearch Auckland)
Horticulture News
HQ Joint Forces New Zealand
Human Rights Commission
Hunt Agencies Limited
Intervet Limited
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Jordens Nurseries
Kaipara District Council
Kawerau District Council
Landcare Research New Zealand Limited
Landcorp Farming Limited
Lowndes Associates
Mackenzie District Council
MAF Biosecurity New Zealand (MAFBNZ)
Makhteshim-Agan (Australia) Pty Limited
Makhteshim-Agan (New Zealand)
Marlborough District Council
Massey University
Matamata-Piako District Council
Merial New Zealand Limited
Minister of Conservation
Ministry of Health
Ministry of Pacific Island Affairs
Ministry of Research, Science & Technology (MoRST)
Muaupoko Co-operative Society
Napier Health Centre - Public Health Unit
National Aquarium of New Zealand
National Institute of Water & Atmospheric Research Limited (NIWA)
New Plymouth District Council
New Zealand Chemical Industry Council Inc
New Zealand Customs Service
New Zealand Institute for Crop & Food Research Limited
New Zealand Meatworkers Union
New Zealand Press Association
New Zealand Society of Gunsmiths Inc
New Zealand Veterinary Association Inc
New Zealand Bee Industry Group - Federated Farmers
Ngati Kahungunu Iwi Incorporated
Northern Chemical Workers Union
Northland Health
Northland Regional Council
Novartis Animal Health
Nufarm New Zealand Limited
Nursery & Garden Industry Association of NZ Inc
Otago District Health Board
Pacific Growers Supplies Limited
Pesticide Action Network Aotearoa NZ
PharmVet Solutions
Rangitikei District Council
Reckitt Benckiser
Royal Forest and Bird Protection Society of New Zealand Inc.
Rural & Associated Contractors Federation of NZ
South Taranaki District Council
Spraywatchers Group
Sustainability Council
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Syngenta Crop Protection Limited
Tairawhiti District Health
Taranaki Regional Council
Tasman District Council
Te Pataka Matauranga Charitable Trust
Technical Strategy Group Limited
Television New Zealand
Thames Coromandel District Council
The Green Party of Aotearoa New Zealand Inc
The National Beekeepers Association of New Zealand
Timaru District Council
TMP Consultancy
Union Chemicals Limited
University of Auckland
University of Otago
University of Waikato
Veg Gro Supplies Limited
ViaLactia Biosciences (NZ) Limited
Victoria University of Wellington
Virbac Laboratories New Zealand Limited
Wairoa District Council
Yates Australia
Zelam Limited
12 Private Individuals
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APPENDIX 8: CONFIDENTIAL MATERIAL
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