ERMA New Zealand
Evaluation and Review Report
Application for Approval to Import or
Manufacture Preventol A20 and Preventol A20CT30 for Release
Application Number: HSR08145
Prepared for the Environmental Risk Management
Authority
EXECUTIVE SUMMARY
Background information

Lanxess Deutschland GmbH is seeking approval to import Preventol A20 and
Preventol A20-CT30 for release.

Preventol A20 is a powder containing 500 g/kg tebuconazole and 500 g/kg
triadimefon. Preventol A20-CT30 is a liquid containing 162.75 g/litre tebuconazole
and 162.75 g/litre triadimefon.

Preventol A20 and Preventol A20-CT30 are manufacturing concentrates to be used
in the preparation of wood protection formulations.

Tebuconazole and triadimefon are present in a number of products currently
available in New Zealand.
Classification

The Agency and the applicant have independently classified Preventol A20 and
Preventol A20-CT30 based on the available information on Preventol A20 and
Preventol A20-CT30 and their components. The classifications are summarised in
the table below:
Preventol A20
Hazardous Property
Acute Toxicity (Oral)
Applicant’s Agency’s
Applicant’s Agency’s
Assessment Assessment Assessment Assessment
6.1D
6.1D
6.1D
6.1D
─
─
6.1E
6.1E
Eye Irritancy
6.4A
─
6.4A
6.4A
Skin Sensitisation
6.5B
6.5B
6.5B
6.5B
Reproductive/developmental
Toxicity
6.8A
6.8A
6.8A
6.8A
Target Organ Toxicity
6.9A
6.9A
6.9A
6.9A
Aquatic Ecotoxicity
9.1A
─
9.1A
─
9.1B
9.1B
9.2B
9.2B
9.3C
9.3C
9.3C
9.3C
Acute Toxicity (Dermal)
Soil Ecotoxicity
Ecotoxicity to Terrestrial
Vertebrates

Preventol A20-CT30
The difference between the Agency’s and the Applicant’s classifications is because
the applicant has classified Preventol A20 as a 6.4A eye irritant, whereas the
Agency has determined, from formulation test data, that this substance is not an eye
irritant.
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Risk Assessment

The Agency considers that the risk assessments indicate that the risks associated with
Preventol A20 and Preventol A20-CT30 are negligible with the proposed controls in
place.

The Agency has evaluated information supplied by the applicant about the benefits of
Preventol A20 and Preventol A20-CT30 and considers that benefits are likely to be
realised through the release of these substances.
Controls

The Agency has proposed that the default controls for Preventol A20 and Preventol
A20-CT30 be modified, such that:
- the Tolerable Exposure Limits (T1) control is deleted,
- no Workplace Exposure Standards (T2) or Environmental Exposure Limits
(E1) are set at the present time and any default values are deleted;
- the application rate (E2) control is deleted;
- the controls relating to keeping records of use (T3, E5) are deleted;
- the approved handler (E7, AH1) controls are deleted;
- further controls regarding stationary containment systems and pipework are
added; and
- a control which restricts the use of Preventol A20 and Preventol A20-CT30
to that of manufacturing concentrates is added.
Agency Conclusion

In conclusion, the Agency considers that there are negligible risks to human health
and to the environment and potential benefits associated with the release of
Preventol A20 and Preventol A20-CT30. Therefore, the Agency considers that it is
evident that the benefits of releasing Preventol A20 and Preventol A20-CT30
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
Application Details ............................................................................................................................ 5
Legislative Criteria for the Application ........................................................................................ 5
Application Process ........................................................................................................................... 5
Notification and Consultation ......................................................................................................... 6
Application Synopsis and Information Review........................................................................... 6
Hazardous Properties, Thresholds and Classification ................................................................ 9
Default Controls ................................................................................................................................. 9
Risk Assessment .............................................................................................................................. 10
Assessment of Beneficial Effects ................................................................................................. 14
Controls ............................................................................................................................................. 16
Overall Evaluation of Risks, Costs and Benefits ...................................................................... 19
Conclusion ........................................................................................................................................ 19
Appendix 1: Decision Path .................................................................................................................... 21
Appendix 2: Hazard Classification ...................................................................................................... 22
Appendix 3: Risk Assessment............................................................................................................... 22
Appendix 4: Discussion on Controls ................................................................................................... 34
Appendix 5: List of Proposed Controls for Preventol A20 and Preventol A20-CT30.............. 36
Appendix 6: Scales for Qualitative Risk Assessment ...................................................................... 48
Appendix 7: Government Departments, Crown Entities and Interested Parties Notified ........ 51
Appendix 8: Confidential Material ...................................................................................................... 53
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1 APPLICATION DETAILS
Application Code
HSR08145
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
Lanxess Deutschland GmbH
Date Application Received
1 May 2009
Submission Period
15 May 2009 – 29 June 2009
To be considered by
A Committee of the Authority (‘the Committee”)
Purpose of the Application
To import Preventol A20 and Preventol A20-CT30,
manufacturing concentrates with fungicidal properties
for use in the preparation of other mixtures.
2 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.
3 APPLICATION PROCESS
3.1
3.2
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)
Cora Drijver
Advisor (Hazardous Substances)
Tonderai Kaitano
Advisor (Hazardous Substances)
Patrick Gemmell
Senior Advisor (Kaupapa Kura Taiao).
The report was reviewed and signed out by:
Noel McCardle
Senior Advisor (Hazardous Substances).
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3.3
Timeline
Application formally received
1 May 2009
Application notified
15 May 2009
Submission closing date
29 June 2009.
4 NOTIFICATION AND CONSULTATION
4.1
The Minister for the Environment was advised of the application1 and given the
opportunity to “call-in” the application2. This action was not initiated.
4.2
The Department of Labour (Workplace Group) was identified as having a
specific interest in the application and was provided with a copy of the
application (excluding the confidential information but with the opportunity to
access this if necessary).
4.2.1
4.3
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.
4.3.1
4.4
No comments or submissions were received.
No comments or submissions were received.
The application was publicly notified on the ERMA New Zealand website on 15
May 2009 and subsequently advertised in The Dominion Post, the New Zealand
Herald, the Christchurch Press and the Otago Daily Times3.
4.4.1
No submissions were received.
5 APPLICATION SYNOPSIS AND INFORMATION
REVIEW
Information supplied by the applicant
5.1
The applicant supplied the following documents:

the application;

a confidential appendix (including full formulation data).
1
section 53(4)(a)
section 68
3
section 53
2
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Information review
5.2
The confidential information on the composition of Preventol A20 and
Preventol A20-CT30 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.
5.3
The Agency considers that there are no significant uncertainties sufficient to
influence decision making in the scientific and technical information relating to
the potential adverse effects of Preventol A20 or Preventol A20-CT304.
Therefore, the Agency considers that the information constitutes an adequate
and appropriate basis for considering the application5.
Description and use of the substance
5.4
Preventol A20 is a powder containing 500 g/kg tebuconazole and 500 g/kg
triadimefon. Preventol A20-CT30 is a liquid containing 162.75 g/litre
tebuconazole and 162.75 g/litre triadimefon. Preventol A20 and Preventol A20CT30 are manufacturing concentrates to be used in the preparation of wood
protection formulations.
Lifecycle
Manufacture/Importation
5.5
Preventol A20 and Preventol A20-CT30 will be manufactured outside of New
Zealand and imported into New Zealand for use as manufacturing concentrates.
Import into New Zealand as sea freight is expected to be via Auckland port
although Lyttleton (Christchurch) is also possible.
5.6
While Preventol A20 and Preventol A20-CT30 will be manufactured overseas,
it is possible that the substances could be manufactured in New Zealand in the
future. Consequently, the risks associated with the manufacture of Preventol
A20 and Preventol A20-CT30 have also been evaluated, so that approval of
these substances will be applicable to both the import and manufacture of
Preventol A20 and Preventol A20-CT30.
Transport, storage and packaging
4
5
5.7
Preventol A20 will be packaged in 25 kg polyethylene bags in a cardboard box.
Preventol A20-CT30 will be packaged in 60 L (65 kg) high density
polyethylene jerry cans.
5.8
Each container will carry a product label identifying the substance, ingredients,
priority identifiers (hazard classifications), warning and first aid information,
manufacturer and contact details. In addition a Safety Data sheet will be
available.
clauses 29 and 30
clause 8
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5.9
Shipments (containers) of Preventol A20 and Preventol A20-CT30 will be
transported from the port by road then unpacked upon arrival at the storage
facility (Bayer warehouse or customer site) and stored in a secure fully bunded
site.
5.10
Transport to customers within New Zealand would be using road transport
operators approved to handle products classified as hazardous. Although it is
unlikely packaging would rupture or leak there is potential risk of a spillage in
the event of a traffic accident. Under such circumstances site management
would be assisted by the emergency services (police, fire) to contain the spill
and oversee the recovery of liquid and clean up.
5.11
An appropriate generic proper shipping name for the Preventol A20 is
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S
(contains tebuconazole, triadimefon), UN No 3077, Class 9, Packing Group III,
Hazchem code 3Z.
5.12
As Preventol A20-CT30 a liquid, this substance will be identified as an
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S
(contains tebuconazole, triadimefon), UN No 3082, Class 9, Packing Group III,
Hazchem code 3Z.
Use
5.13
Preventol A20 and Preventol A20-CT30 are manufacturing concentrates of two
fungicide actives to be used in the preparation of other substances (wood
protection products). These wood protection products are expected to require
separate approvals under the HSNO Act.
Disposal
5.14
The applicant advises that the normal method of disposal of the substances will
be via use as manufacturing concentrates.
5.15
The empty packaging would be disposed on as hazardous waste to an approved
landfill. Empty containers used for the liquid product will be rinsed with a
suitable solvent and the contaminated washings then recycled back into the
manufacturing system. Empty rinsed containers could be disposed on to an
approved incineration plant or to an approved landfill in accordance Regional
Council requirements. Controlled incineration with energy recovery is
considered overseas as the most environmentally acceptable means of disposal.
5.16
In all cases, the substances and their packaging will be disposed of in
accordance with the Hazardous Substances (Disposal) Regulations 2001 and the
Resource Management Act 1991.
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6 HAZARDOUS PROPERTIES, THRESHOLDS AND
CLASSIFICATION
6.1
The Agency has evaluated the information supplied by the applicant and also
referred to other data sources in assessing the hazardous properties of Preventol
A20 and Preventol A20-CT30. This assessment is attached as Appendix 2.
6.2
The applicant’s and the Agency’s classification of the hazard profiles of
Preventol A20 and Preventol A20-CT30 are listed in Table 6.1.
Table 6.1: Summary of applicant’s and Agency’s HSNO classification of Preventol
A20 and Preventol A20-CT30
Preventol A20
Hazardous Property
Acute Toxicity (Oral)
Preventol A20-CT30
Applicant’s Agency’s
Applicant’s Agency’s
Assessment Assessment Assessment Assessment
6.1D
6.1D
6.1D
6.1D
─
─
6.1E
6.1E
Eye Irritancy
6.4A
─
6.4A
6.4A
Skin Sensitisation
6.5B
6.5B
6.5B
6.5B
Reproductive/developmental
Toxicity
6.8A
6.8A
6.8A
6.8A
Target Organ Toxicity
6.9A
6.9A
6.9A
6.9A
Aquatic Ecotoxicity
9.1A
─
9.1A
─
9.1B
9.1B
9.2B
9.2B
9.3C
9.3C
9.3C
9.3C
Acute Toxicity (Dermal)
Soil Ecotoxicity
Ecotoxicity to Terrestrial
Vertebrates
6.3
The difference between the Agency’s and the Applicant’s classifications is
because the applicant has classified Preventol A20 as a 6.4A eye irritant,
whereas the Agency has determined, from formulation test data, that this
substance is not an eye irritant.
6.4
The risk assessment in Section 8 of this report is based on the Agency’s
classifications of Preventol A20 and Preventol A20-CT30.
7 DEFAULT CONTROLS
7.1
Based on the hazard classifications shown in Table 6.1, the set of associated
controls has been identified. These default controls are listed in Appendix 4.
7.2
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 Preventol A20 and
Preventol A20-CT30. Variations and additional controls for Preventol A20 and
Preventol A20-CT30 are considered in Section 10 of this report.
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8 RISK ASSESSMENT
Identification of potentially non-negligible risks and costs
8.1
Potentially non-negligible risks were identified for evaluation following clauses
9 and 11, which incorporate sections 5, 6 and 8.
8.2
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.
8.3
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 of the substances. The Agency has also identified potential sources of
risk and these, along with those identified by the applicant, are tabulated in
Table 8.1.
Table 8.1: Potential sources of risks associated with Preventol A20 and Preventol A20-CT30
Lifecycle Activity
Associated Source of Risk
Manufacture and
packing
An incident within the manufacturing facility resulting in spillage or
leakage and subsequent exposure of people or the environment to the
substances.
Import, transport and
storage
An incident during the import, transport or storage resulting in spillage
and subsequent exposure of people or the environment to the
substances.
Use
An incident during use of the substances in formulating wood
protection products.
Disposal of substances
or packaging
Disposal of the substances or packaging resulting in exposure of
people or the environment to the substances.
Assessment of potentially significant risks
6
8.4
In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has
assessed the potentially non-negligible risks of this substances 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.
8.5
The Agency notes that the evidence provided by the applicant and additional
evidence found by the Agency, relating to the hazardous properties of Preventol
A20 and Preventol A20-CT30, is largely scientific in nature6. 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.
clause 25(1)
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8.6
The analysis of risk takes into account the controls that derive from the HSNO
Regulations (in particular the default controls identified in Appendix 4) 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.
8.7
A qualitative assessment has been undertaken for all stages of the lifecycles. 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 3).
Assessment of the risks to the environment
8.8
The Agency has evaluated the potential of Preventol A20 and Preventol A20CT30 to cause adverse effects to the environment (non-target organisms) during
all stages of the substances’ lifecycles using qualitative risk assessment
methodologies.
8.9
The Agency has classified Preventol A20 as being very toxic in the aquatic
environment (9.1A) and harmful to terrestrial vertebrates (9.3C). The Agency
has classified Preventol A20-CT30 as being toxic in the aquatic environment
(9.1B), toxic in the soil environment (9.2B) and harmful to terrestrial vertebrates
(9.3C). Both tebuconazole and triadimefon are considered persistent in the
environment. Thus, a range of organisms in the environment may be adversely
affected if exposed to Preventol A20 or Preventol A20-CT30.
8.10
The risks of Preventol A20 and Preventol A20-CT30 to the environment (with
controls in place) at various stages of their lifecycles are summarised below in
Table 8.2 and discussed more fully in Appendix 3.
Table 8.2: Level of risk of Preventol A20 and Preventol A20-CT30 to the
environment.
Lifecycle Stage
Potential Adverse
Effect
Manufacture and
packing /Import,
transport, storage
/Use / Disposal of
substance or
packaging
Death or adverse
effects to aquatic
organisms
Death or adverse
effects to soil
organisms –
(Preventol A20CT30 only)
Death or adverse
effects to terrestrial
vertebrates
Likelihood of
Adverse
Effect
Occurring
Magnitude of
Adverse Effect
Highly
improbable
Moderate
Negligible
Highly
improbable
Moderate
Negligible
Highly
improbable
Minor
Negligible
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Level of
Risk
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Assessment of the risks to human health and safety
8.11
The Agency has evaluated the potential of Preventol A20 and Preventol A20CT30 to cause adverse effects to the health and safety of humans during all
stages of the substances’ lifecycles using qualitative risk assessment
methodologies.
8.12
The Agency has classified Preventol A20 as an acute oral toxicant (6.1D), a skin
sensitiser (6.5B), a reproductive/development toxicant (6.8A) and a target organ
toxicant (6.9A). The Agency has classified Preventol A20-CT30 as an acute
oral toxicant (6.1D), an acute dermal toxicant (6.1E), an eye irritant (6.4A), a
skin sensitiser (6.5B), a reproductive/development toxicant (6.8A) and a target
organ toxicant (6.9A).
8.13
The risks of Preventol A20 and Preventol A20-CT30 to human health and safety
(with controls in place) at various stages of their lifecycles are summarised
below in Table 8.3 and discussed more fully in Appendix 3.
Table 8.3: Level of risk of Preventol A20 and Preventol A20-CT30 to human
health and safety.
Lifecycle stage
Potential Adverse
Effect
Likelihood of
Adverse Effect
Occurring
Manufacture and
packing
Acute oral and
dermal (Preventol
A20-CT30 only)
toxicity
Highly
improbable
Moderate
Negligible
Eye irritancy
(Preventol A20CT30 only)
Highly
improbable
Minimal
Negligible
Skin sensitisation
Highly
improbable
Minor to
moderate
Negligible
Reproductive/
Developmental
toxicity
Target organ
toxicity
Highly
improbable
Moderate
Negligible
Acute oral and
dermal (Preventol
A20-CT30 only)
toxicity
Highly
improbable
Moderate
Negligible
Eye irritancy
(Preventol A20CT30 only)
Highly
improbable
Minimal
Negligible
Skin sensitisation
Highly
improbable
Minor to
moderate
Negligible
Acute oral and
dermal (Preventol
A20-CT30 only)
toxicity
Highly
improbable
Moderate
Negligible
Import, transport,
storage
Use
ERMA New Zealand Evaluation and Review Report: Application HSR08145
Magnitude
of Adverse
Effect
Level of
Risk
Page 12 of 53
Lifecycle stage
Disposal of
substance or
packaging
Potential Adverse
Effect
Likelihood of
Adverse Effect
Occurring
Magnitude
of Adverse
Effect
Level of
Risk
Eye irritancy
(Preventol A20CT30 only)
Highly
improbable
Minimal
Negligible
Skin sensitisation
Highly
improbable
Minor to
moderate
Negligible
Reproductive/
Developmental
toxicity
Target organ
toxicity
Highly
improbable
Moderate
Negligible
Acute oral and
dermal (Preventol
A20-CT30 only)
toxicity
Highly
improbable
Moderate
Negligible
Eye irritancy
(Preventol A20CT30 only)
Highly
improbable
Minimal
Negligible
Skin sensitisation
Highly
improbable
Minor to
moderate
Negligible
Reproductive/
Developmental
toxicity
Target organ
toxicity
Highly
improbable
Moderate
Negligible
Relationship of Māori to the Environment
8.14
The Agency has considered this application in accordance with the clauses
9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the framework
contained in the ERMA New Zealand user guide “Working with Māori under
the HSNO Act 1996” has been used to assess the effects of this application on
the relationship of Māori to the environment.
8.15
The Agency notes that Preventol A20 and Preventol A20-CT30 trigger 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.
8.16
In addition, the introduction and use of these substances 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 species, and potential risks to the mauri ora of human
health under prolonged exposure to these substances.
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8.17
On considering the information outlined here and elsewhere in this report, the
Agency considers a minimal impact from Preventol A20 and Preventol A20CT30 on the relationship of Māori and their culture and traditions with their
ancestral lands, water, sites, wāhi tapu, valued flora and fauna and other taonga
to be highly improbable. In addition there is no evidence to suggest that the
controlled use of Preventol A20 or Preventol A20-CT30 will breach the
principles of the Treaty of Waitangi.
8.18
The overall level of risk is therefore considered to be negligible assuming that
the substances 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.
8.19
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
8.20
There are not expected to be any significant adverse impacts on the social
environment with the controlled use of Preventol A20 or Preventol A20-CT30,
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
8.21
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.
8.22
The Agency notes that direct economic costs will be borne by the applicant and
users of the substances. The HSNO default controls intentionally do not manage
direct economic effects. These are for suppliers and users of the substances to
address.
New Zealand’s international obligations
8.23
The Agency does not anticipate that Preventol A20 and Preventol A20-CT30
will pose any risks to New Zealand’s international obligations.
9 ASSESSMENT OF BENEFICIAL EFFECTS
Potentially non-negligible benefits
9.1
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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9.2
9.3
The applicant claims that the approval of Preventol A20 and Preventol A20CT30 will provide the following benefits:
9.2.1
Preventol A20 and Preventol A20-CT30 are mixtures of two technical
active substances. They may be incorporated as active ingredients in
wood preservation products for surface applications (e.g. paints) or for
application in industrial wood preservative treating solutions (surface
and penetrating treatments). Both products can be impregnated into
timber as either water or solvent-based wood preservatives and
therefore will assist companies to more easily formulate their wood
preservatives containing a combination of the actives. By providing
mixtures of two actives, this avoids the formulators having to purchase
and mix up the actives separately.
9.2.2
Preventol A20 and Preventol A20-CT30 offer an alternative
combination of two active substances to products consisting of only
one active substance which are already on the market. The combination
of triadimefon and tebuconazole offers a well-balanced efficacy against
a broad range of wood rotting fungi (Basidiomycetes) with a low
concentration of the actives required. In wood preservation triadimefon
has a specific spectrum of activity against certain brown rot and white
rot fungi and complements the efficacy of tebuconazole.
The Agency considers that the economic and related benefits to be derived from
the use of Preventol A20 and Preventol A20-CT30 are potentially significant.
Likely effects of the substance being unavailable
9.4
In accordance with section 29, consideration has been given to the likely effects
of Preventol A20 and Preventol A20-CT30 being unavailable.
9.5
The Agency notes that there are a number of registered products containing
tebuconazole and triadimefon already available in New Zealand, but none that
contain both active ingredients in the same formulation.
9.6
The likely effects of Preventol A20 and Preventol A20-CT30 being unavailable
would thus be the removal of the option of a formulation containing both active
ingredients for those persons wishing to manufacture wood protection products.
Risk reduction implications
9.7
The applicant has not provided information on any significant risk reduction
implications for the import of Preventol A20 or Preventol A20-CT30 for
release.
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10 CONTROLS
Setting of exposure limits and application rates
10.1
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. The Agency considers
that under conditions of normal use there is no requirement to set an ADE for
Preventol A20 or Preventol A20-CT30 and accordingly no requirement to set
PDE or TEL values. (See Appendix 4).
10.2
Control T2 relates to the requirement to limit worker exposure to toxic
substances by the setting of Workplace Exposure Standards (WESs). No WES
values are proposed for any components of Preventol A20 or Preventol A20CT30 at this time (See Appendix 4).
10.3
Control E1 relates to the requirements to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). It is proposed that no EELs are set at this time for Preventol A20 or
Preventol A20-CT30 and the default values are deleted (see Appendix 4).
10.4
Control E2 relates to the requirement to set an application rate for a class 9
substance that is to be sprayed on an area of land (or air or water) and for which
an EEL has been set. As Preventol A20 and Preventol A20-CT30 are not
intended for use in this manner and no EEL has been set, the Agency considers
that this control may be deleted.
Proposed additions and modifications to controls
10.5
The Agency notes that the risk assessments for Preventol A20 and Preventol
A20-CT30 have been limited to the intention to use the substances to formulate
products. The Agency notes that none of the specified (default) controls limits
how the substances may be used. Accordingly, the Agency considers that the
following control should be applied to Preventol A20 and Preventol A20-CT30
as it will be more effective than the specified controls in terms of its effect on
the management, use and risks of the substances (section 77A(4)(a)):
10.5.1
10.6
7
The approval of this substance is limited to the importation or
manufacture of this substance for inclusion into formulated products.
The Agency notes that the specified controls for Preventol A20-CT30 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 substance7. The proposed controls are shown in Table 5.1 of Appendix 5.
section 77A(4)(a)
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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10.7
Control EM12 relates to the requirements for secondary containment of pooling
substances8. The EM12 secondary containment requirements have been
triggered for Preventol A20-CT30 as a result of its 9.1B 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 can be reduced. The
Agency considers that these reduced secondary containment measures are
adequate to manage the risks of a spillage of Preventol A20-CT30. Therefore,
the proposed additional control, which varies the EM12 control, is more costeffective in terms of managing the risks of the substance. The proposed controls
are shown in Table 5.1 of Appendix 5.
10.8
The Agency considers that the following controls should be varied under section
77(4)(a) for Preventol A20 and Preventol A20-CT30, as the adverse effects of
the substances are less than the adverse effects which would normally be
associated with substances of the same hazard classifications:
10.9
10.8.1
Control T3 relates to the requirement for keeping records of use of
highly toxic or corrosive substances if the application is in an area
where members of the public may be present, or where the substance is
likely to enter air or water and leave the place. This control is not
considered relevant because Preventol A20 and Preventol A20-CT30
are not applied in a widely dispersive manner. Thus, this control may
be deleted.
10.8.2
Control E5 (Preventol A20 only) 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. The Agency considers that this control may
be deleted, as Preventol A20 is intended for use within timber
treatment facilities and may not legally be applied outdoors for the
purposes of causing biocidal action.
The Agency considers that the following controls should be varied under section
77(4)(b) for Preventol A20, as the variations will not significantly increase the
adverse effects of the substance:
10.9.1
8
Controls E7 and AH1 relate to requirements for ecotoxic substances to
be under the control of an approved handler. The Agency considers that
for ecotoxic substances that are not intended to be used outdoors in a
widely dispersive manner (such as timber treatment chemicals) it is
unlikely there will be significant adverse environmental effects
resulting from their proposed use. The Agency therefore considers that
the approved handler controls for Preventol A20 can be deleted.
Regulations 35 – 41 of the Hazardous Substances (Emergency Management) Regulations 2001
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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10.9.2
10.10
Control TR1 relates to the requirements for a substance to be tracked.
The Agency notes that the tracking control was triggered solely by
virtue of the ecotoxicity of the substance. Consequently, the Agency
considers that tracking the substance would be unduly onerous, as the
key risks can be managed through other controls such as packaging,
labelling and emergency management requirements. Thus, this control
may be deleted for Preventol A20.
The Agency considers that the following controls may be combined9 for
Preventol A20 and Preventol A20-CT30 as they relate to the same requirements:
10.10.1 Controls T4 and E6 which relate to requirements for equipment used to
handle hazardous substances.
10.10.2 Controls P13 and P15 which relate to requirements for packaging
hazardous substances.
10.10.3 Controls D4 and D5 which relate to requirements for disposal of
Preventol A20 and Preventol A20-CT30.
Control precedents
10.11
The Agency considered the Authority’s approvals given to manufacturing
concentrates and timber treatment substances under Part 5 of the Act as well as
those transferred to the Act under the Hazardous Substances (Timber
Preservatives, Antisapstains and Antifouling Paints) Transfer Notice 2004 (as
amended) and the Hazardous Substances (Chemicals) Transfer Notice 2006.
Summary of controls
10.12
The Agency considers that the customised controls listed in Appendix 5 should
apply to Preventol A20 and Preventol A20-CT30.
Environmental user charges
9
10.13
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.
10.14
The Agency considers that use of controls is the most effective means of
managing the risks throughout the lifecycles of Preventol A20 and Preventol
A20-CT30. The imposition of an environmental user charge instead of, or in
combination with controls, is therefore not required at this time.
section 77(5)
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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11 OVERALL EVALUATION OF RISKS, COSTS AND
BENEFITS
11.1
The Agency considers the risks of Preventol A20 and Preventol A20-CT30 to
human health and the environment to be negligible.
11.2
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.
11.3
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 substances is negligible.
11.4
The Agency considers that there are benefits associated with the release of
Preventol A20 and Preventol A20-CT30 as are specified in Section 9 of this
report.
11.5
Thus, the Agency considers that it is evident that the benefits of releasing
Preventol A20 and Preventol A20-CT30 outweigh the costs.
12 CONCLUSION
12.1
Lanxess Deutschland GmbH has applied for approval to import for release in
New Zealand the substances identified as Preventol A20 and Preventol A20CT30.
12.2
The Agency considers Preventol A20 triggers the following hazard
classifications:
12.3

6.1D Acute oral toxicity

6.5B Skin sensitisation

6.8A Reproductive/developmental toxicity

6.9A Target organ systemic toxicity

9.1A Aquatic ecotoxicity

9.3C Terrestrial vertebrate ecotoxicity.
The Agency considers Preventol A20-CT30 triggers the following hazard
classifications:

6.1D Acute oral toxicity

6.1E Acute dermal toxicity

6.4A Eye irritancy

6.5B Skin sensitisation

6.8A Reproductive/developmental toxicity

6.9A Target organ systemic toxicity

9.1B Aquatic ecotoxicity
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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
9.2B Soil ecotoxicity

9.3C Terrestrial vertebrate ecotoxicity.
12.4
The Agency considers that there are negligible risks to the environment and
human health and benefits associated with the release of Preventol A20 and
Preventol A20-CT30. Therefore, the Agency considers that it is evident that the
benefits of releasing Preventol A20 and Preventol A20-CT30 outweigh the costs
and the application may be approved in accordance with clause 26.
12.5
The Agency considers the controls listed in Appendix 5 should apply to
Preventol A20 and Preventol A20-CT30.
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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APPENDIX 1: DECISION PATH
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))
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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APPENDIX 2: HAZARD CLASSIFICATION
Classification of Preventol A20 and Preventol A20-CT30
Data from effects testing of the formulation were not provided for all endpoints of
Preventol A20 and Preventol A20-CT30. Where no data were available, classification
was estimated using mixture rules based on information on the components. A
summary of the physical, toxicity and ecotoxicity hazard classifications associated
with Preventol A20 and Preventol A20-CT30 and its components is provided in Table
A2.1 to A2.3. Formulation test data are detailed in these tables where applicable. The
relevant sections of the User Guide to Thresholds and Classifications under the HSNO
Act (ERMA 2008a) that describe the mixture rules are listed in Table A2.4.
Data quality – overall evaluation
The Agency has adopted the Klimisch et al (1997) data reliability scoring system for
evaluating data used in the hazard classification and risk assessment of chemicals
(section 1.2.4 in ERMA 2008a). The data used by The Agency to classify Preventol
A20 and Preventol A20-CT30 are predominantly the classifications which have been
officially gazetted during the transfer process and are publicly available through the
HSNO Chemical Classification Information Database (CCID) (ERMA 2008b). Where
additional data has been provided by the applicant, The Agency has assigned
Klimisch data reliability scores to that information and these are included in tables
A2.5 and A2.6. Generally these data are high quality by current international
standards. The available ecotoxicity data can be considered of high quality by current
international standards.
The Agency acknowledges that there are frequently data gaps in the hazard
classification for chemicals which have been in use internationally for a long time.
International programmes such as the OECD High Production Volume programme
(OECD 1990) and REACH (EU 2006) are progressively working towards filling these
data gaps. As new information becomes available, and resources permit, The Agency
will endeavour to update the HSNO classifications for those substances.
The effect of the quality of data on the overall evaluation of the effects of Preventol
A20 and Preventol A20-CT30 was not significant because the substances are raw
materials to be used to manufacture products for timber treatment use. Due to this
intended non dispersive use, exposure to the environment is not very likely.
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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Table A2.1: Summary of the physical hazard classifications of Preventol A20.
Endpoint
Class 1
Class 2
Component
NA#
NA#
Preventol A20
Tebuconazole
NA
NA
Triadimefon
NA
NA
ND = no data/insufficient data/inconclusive data
NA = not applicable
#
Classification based on data from components
Class 3
Class 4
Class 5
Class 8.1
NA#
NA
NA
ND#
ND
ND
ND#
NA
ND
ND#
ND
ND
Table A2.2: Summary of the toxicity hazard classifications of Preventol A20.
Endpoint
6.1
6.1
6.1
Component
(oral)
(dermal)
(inhalation)
Preventol A20
6.1D*
No*
ND#
Tebuconazole
6.1D
No
No
Triadimefon
6.1D
ND
ND
ND = no data/insufficient data/inconclusive data
#
Classification based on data from components / mixture rules
*Based on formulation test data
6.3
6.4
6.5A
6.5B
6.6
6.7
6.8A/B
6.8C
6.9
No*
No
No
No*
No
No
ND#
ND
ND
6.5B#
No
6.5B
No#
No
No
ND#
ND
No
6.8A#
ND
6.8A
ND#
ND
ND
6.9A#
6.9B
6.9A
Table A2.3: Summary of the ecotoxicity hazard classifications of Preventol A20.
Endpoint
9.1
9.1
9.1
BioRapidly
9.2
Soil
9.3
9.4
Component
(fish)
(crustacean)
(algae)
Accumulative$
Degradable^
persistence^
Preventol A20
9.1B#
9.1B#
9.1A#
No#
No#
No#
Yes#
9.3C*
ND#
Tebuconazole
9.1B
9.1B
9.1A
No
No
No
Yes
9.3C
ND
Triadimefon
9.1C
9.1C
9.1B
No
No
No
Yes
9.3B
No
ND = no data/insufficient data/inconclusive data
*Formulation test data provided
#
Classification based on data from components / mixture rules
$
in the case of the weighted sum of components that are bioaccumulative being >25%, then it can be said that the mixture contains toxic components that are
bioaccumulative
^ in the case of the weighted sum of components that are not rapidly degradable being >25%, then it can be said that the mixture contains toxic components that are not
rapidly degradable
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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Table A2.4: Summary of the physical hazard classifications of Preventol A20-CT30.
Endpoint
Class 1
Class 2
Component
NA#
NA#
Preventol A20-CT30
Tebuconazole
NA
NA
Triadimefon
NA
NA
A
NA
NA
ND = no data/insufficient data/inconclusive data
NA = not applicable
#
Classification based on data from components
Class 3
Class 4
Class 5
Class 8.1
NA#
NA
NA
NA
NA#
ND
ND
NA
ND#
NA
ND
ND
ND#
ND
ND
ND
Table A2.5: Summary of the toxicity hazard classifications of Preventol A20-CT30.
Endpoint
6.1
6.1
6.1
Component
(oral)
(dermal) (inhalation)
Preventol A20-CT30
6.1D#
6.1E#
ND#
Tebuconazole
6.1D
No
No
Triadimefon
6.1D
ND
ND
A
6.1D
6.1D
No
ND = no data/insufficient data/inconclusive data
#
Classification based on data from components / mixture rules
6.3
6.4
6.5A
6.5B
6.6
6.7
6.8A/B
6.8C
6.9
No#
No
No
No
6.4A#
No
No
6.4A
ND#
ND
ND
ND
6.5B#
No
6.5B
6.5B
No#
No
No
No
ND#
ND
No
No
6.8A#
ND
6.8A
No
ND#
ND
ND
ND
6.9A#
6.9B
6.9A
ND
Table A2.6: Summary of the ecotoxicity hazard classifications of Preventol A20-CT30.
Endpoint
9.1
9.1
9.1
BioRapidly
9.2
Soil
9.3
9.4
Component
(fish)
(crustacean)
(algae)
Accumulative$
Degradable^
persistence^
Preventol A20-CT30
9.1C#
9.1C#
9.1B#
No#
No#
9.2B#
No#
9.3C#
ND#
Tebuconazole
9.1B
9.1B
9.1A
No
No
No
Yes
9.3C
ND
Triadimefon
9.1C
9.1C
9.1B
No
No
No
Yes
9.3B
No
A
9.1D
9.1D
ND
No
Yes
9.2B
No
9.3C
ND
ND = no data/insufficient data/inconclusive data
#
Classification based on data from components / mixture rules
$
in the case of the weighted sum of components that are bioaccumulative being >25%, then it can be said that the mixture contains toxic components that are
bioaccumulative
^ in the case of the weighted sum of components that are not rapidly degradable being >25%, then it can be said that the mixture contains toxic components that are not
rapidly degradable
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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Table A2.4: Location of mixture rules within the User Guide to the Thresholds and
Classifications in the HSNO Act (V2.0. March 2008) (ERMA 2008a).
Hazard
User Guide to HSNO
Thresholds and
Classifications Reference
Subclass 6.1 Acute Toxicity
Part V, Chapter 10, Page 12
Subclass 6.3/8.2 Skin Irritancy/Corrosivity
Part V, Chapter 11, Page 7
Subclass 6.4/8.3 Eye Irritancy/Corrosivity
Part V, Chapter 12, Page 9
Subclass 6.5 Contact and Respiratory Sensitisation
Part V, Chapter 13, Page 8
Subclass 6.6 Mutagenicity
Part V, Chapter 14, Page 5
Subclass 6.7 Carcinogenicity
Part V, Chapter 15, Page 8
Subclass 6.8 Reproductive Developmental Toxicity
Part V, Chapter 16, Page 11
Subclass 6.9 Target Organ Systemic Toxicity
Part V, Chapter 17, Page 10
Subclass 9.1 Aquatic Ecotoxicity
Part VI, Chapter 19, Page 18
Subclass 9.2 Soil Ecotoxicity
Part VI, Chapter 20, Page 8
Subclass 9.3 Terrestrial Vertebrate Ecotoxicity
Part VI, Chapter 21, Page 7
Subclass 9.4 Terrestrial Invertebrate Ecotoxicity
Part VI, Chapter 22, Page 5
References
ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications. ERMA
New Zealand, Wellington.
ERMA New Zealand (2008b) HSNO Chemical Classification Information Database (CCID)
http://www.ermanz.govt.nz/hs/compliance/chemicals.html
European Union (2006) Regulation (EC) No 1907/2006 of the European Parliament and of
the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. http://reach.jrc.it/
Klimisch, HJ, Andreae, E, Tillman, U (1997). A systematic approach for evaluating the
quality of experimental and ecotoxicological data. Regulatory Toxicology and Pharmacology
25: 1–5.
OECD (1990) Manual for Investigation of HPV Chemicals.
http://www.oecd.org/document/21/0,3343,en_2649_34379_1939669_1_1_1_1,00.html
Retrieved 23 January 2008.
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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Table A2.5: Summary of toxicity data on Preventol A20.
ACUTE TOXICITY
Acute oral toxicity
Acute dermal toxicity
SPECIES: Rat
SPECIES: Rats
STRAIN: Sprague-Dawley derived albino
STRAIN: Sprague-Dawley derived albino
TEST SUBSTANCE: Preventol A20 containing
46.79% tebuconazole and 49.57% triadimefon
TEST SUBSTANCE: Preventol A20 containing
46.79% tebuconazole and 49.57% triadimefon
DOSE LEVELS: 175, 550, 1750, 5000 mg/kg bw
NUMBER OF ANIMALS: 8 females
DOSE LEVELS: 5000 mg/kg bw moistened with
distilled water and applied to the skin or animals
for 24 hours.
ENDPOINT: LD50
NO/SEX/GROUP: 5
VALUE: 1030 mg/kg bw at the 95% confidence
interval.
ENDPOINT: LD50
VALUE: >5000 mg/kg
RESULTS:
Limit test (5000 mg/kg)
 Performed in one animal which died within
four days of dosing.
 Red intestines observed at necropsy.
175 mg/kg dose level (one animal):
 The animal survived and gained weight.
 No signs of toxicity seen either in life or at
necropsy.
550 mg/kg dose level (three animals):
 All animals survived, gained weight. No
signs of toxicity were observed in-life or at
autopsy.
1750 mg/kg dose level (three animals):
 All animals died within five days of dosing.
 Signs observed include hypoactivity,
hunched posture, reduced fecal volume and
or facial staining.
 Red intestines and/or red lungs observed at
necropsy.
RESULTS:
All animals survived and gained body weight.
There were no signs of toxicity or abnormal
behavior. No gross abnormalities were noted for
any of the animals at necropsy.
TEST GUIDELINES:
US EPA Health Effects Test Guidelines, OPPTS
870.1200 (1998).
REFERENCE SOURCE:
Moore, G. (2008). Acute Dermal Toxicity Study
in Rats – Limit Test: Preventol A20. Eurofins
Product Safety Laboratories, 2394 US Highway
130, Dayton, NJ 08810. Laboratory Study
Number 24738.
RELIABILITY (KLIMISCH SCORE): 1
GLP: Yes
TEST GUIDELINES:
US EPA Health Effects Test Guidelines, OPPTS
870.1100 (2002).
REFERENCE SOURCE:
Moore, G. (2008). Acute Oral Toxicity Up and
Down Procedure: Preventol A20. Eurofins
Product Safety Laboratories, 2394 US Highway
130, Dayton, NJ 08810. Laboratory Study
Number 24737.
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RELIABILITY (KLIMISCH SCORE): 1
Conclusion on classification:
Conclusion on classification:
The test substance is classified 6.1D oral
The test substance does not trigger classification
toxicant based on the LD50 value of 550< LD50
as an acute dermal toxicant.
<1750 mg/kg bw.
IRRITATION STUDIES
Eye irritation
SPECIES: Rabbit
STRAIN: New Zealand White
TEST SUBSTANCE: Preventol A20 containing 46.79% tebuconazole and 49.57% triadimefon
ADMINISTRATION ROUTE: Single instillation of 0.1ml of test substance into the conjunctival sac of
the right eye.
RESULTS:
Mean Draize scores:
 Cornea opacity = 7/9 = 0.78
 Iritis = 7/9 = 0.78
 Conjunctival redness = 16/9 = 1.78
 Conjunctival chemosis = 7/9 = 0.78
 Conjunctival discharge = 10/9 = 1.11
GLP: Yes
TEST GUIDELINES:
US EPA Health Effects Test Guidelines, OPPTS 870.2400 (1998).
REFERENCE SOURCE:
Moore, G. (2008). Primary Eye Irritation Study in Rabbits. Eurofins Product Safety Laboratories,
2394 US Highway 130, Dayton, NJ 08810. Laboratory Study Number 24739.
RELIABILITY (KLIMISCH SCORE): 1
Conclusion on classification:
The test substance does not trigger classification as an eye irritant.
Skin irritation
SPECIES: Rabbit
STRAIN: New Zealand White
TEST SUBSTANCE: Preventol A20 containing 46.79% tebuconazole and 49.57% triadimefon
ADMINISTRATION ROUTE: Test substance moistened with distilled water and 0.77 g of this paste
was placed on a 1-inch x 1 inch, 4-ply gauze pad and applied to one 6 cm2 site for four hours.
RESULTS:
 No oedema was observed at any treated site;
 One site exhibited very slight erythema within one hour of patch removal;
 All animals were free of dermal irritation by 24 hours.
TEST GUIDELINES:
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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US EPA Health Effects Test Guidelines, OPPTS 870.2500 (1998).
REFERENCE SOURCE:
Moore, G. (2008). Primary Skin Irritation Study in Rabbits. Eurofins Product Safety Laboratories,
2394 US Highway 130, Dayton, NJ 08810. Laboratory Study Number 24740.
RELIABILITY (KLIMISCH SCORE): 1
Conclusion on classification:
The test substance does not trigger classification as a skin irritant.
Table A2.6: Summary of ecotoxicity toxicity data for Preventol A20.
Test species
Mammals
Rat
Test resultsa, b
Test type &
duration
Acute Oral
Test methodc
[reference number]
550 < LD50 < 1750 mg/kg bw
OPPTS 870.1100 (2002).
GLP
Moore, G. (2008). Acute Oral
Toxicity Up and Down Procedure:
Preventol A20. Eurofins Product
Safety Laboratories, 2394 US
Highway 130, Dayton, NJ 08810.
Laboratory Study Number 24737.
Klimisch score: 1
Conclusion: Preventol A20 triggers 9.3C
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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APPENDIX 3: RISK ASSESSMENT
Introduction
Qualitative assessments have been undertaken all other 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 for a description of the scales
used for qualitative assessment).
Environmental exposure and risk assessment
Likelihood of adverse environmental effects
Taking into account the controls in place at each stage of the lifecycle of Preventol A20 and
Preventol A20-CT30, and the use pattern proposed by the applicant, the Agency considers
that it is highly improbable that an exposure event resulting in adverse effects to any nontarget organism will occur at any stage of the lifecycle.
This assessment is based in the following considerations:

The manufacture and packing of Preventol A20 and Preventol A20-CT30 would be
carried out at a specialised facility, which would be compliant with the HSNO controls
on equipment, secondary containment and emergency management. The facility would
also be subject to the requirements of the Resource Management Act 1991.

Importation and transportation of Preventol A20 and Preventol A20-CT30 will be
carried out in accordance with the relevant legislation including the Land Transport
Rule 45001, the Civil Aviation Act 1990, and the Maritime Transport Act 1994 (as
applicable).

The Agency also considers that Preventol A20-CT30 will be stored and used within
stationary container systems (tanks or vessels), using appropriate equipment. The
stationary containers (both tanks and process containers) are required to meet specific
requirements. This would be demonstrated, as relevant, by compliance with the
Pressure Equipment, Cranes, and Passenger Ropeways Regulations 1999
(administered by the Department of Labour), or Schedule 8 of the Hazardous
Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004
(as amended).

The use of the substances as manufacturing concentrates in the formulating of wood
protection products will be carried out at specialised facilities which will be required
to be compliant with the HSNO controls on equipment, packaging, identification,
secondary containment, disposal and emergency management. The facilities will also
be subject to the requirements of the Resource Management Act 1991.
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
The Agency considers that there will be few occasions which require the disposal of
Preventol A20 and Preventol A20-CT30, because the substances will be used up in
formulating wood protection products. Should a reason for disposal of the substances
arise (for example, product contamination or where un-used product has expired)
disposal will be managed in accordance with the Hazardous Substances (Disposal)
Regulations 2001. Disposal of equipment and packaging will also be undertaken in
accordance with these regulations.
Magnitude of potential adverse environmental effects
The Agency considers that, in light of the substances’ 9.1, 9.2 (Preventol A20-CT30 only) and
9.3 hazard classifications, Preventol A20 and Preventol A20-CT30 have the potential to
adversely affect organisms in the aquatic or terrestrial environments, should they be exposed
to the substances at any stage during the lifecycles of the substances. The Agency considers
that the magnitude of these adverse effects will vary depending on the types of organisms
exposed, as discussed below.

The Agency has classified Preventol A20 as being very ecotoxic in the aquatic
environment (9.1A) and Preventol A20-CT30 as being toxic in the aquatic
environment (9.1B). Given that exposure to relatively limited quantities of the
substance could result in death or adverse effects to aquatic organisms, and that these
effects may extend beyond the immediate exposure period (based on persistence of the
active ingredients in the aquatic environment), the Agency considers that the
magnitude of the adverse effects which may result to aquatic organisms exposed to the
substances would be moderate.

The Agency has classified Preventol A20-CT30 as being toxic to the soil environment
(9.2B). Given that exposure to relatively limited quantities of the substance could
result in death or adverse effects to soil organisms, and that these effects may extend
beyond the immediate exposure period (based on the persistence of the active
ingredients in soil), the Agency considers that the magnitude of the adverse effects
which may result to soil organisms exposed to the substance would be moderate.

The Agency has classified Preventol A20 and Preventol A20-CT30 as being harmful
to terrestrial vertebrates (9.3C). This classification takes into account both
mammalian and avian acute oral toxicity data for the substances. The Agency
considers that the magnitude of such effects would be minor, as the impact would be
localised damage to individual animals.
Human health risk assessment
Assessment of risks to human health - manufacture and packing
The Agency has qualitatively assessed the risks of Preventol A20 and Preventol A20-CT30 to
human health and safety during manufacture and packing and considers the risks to be
negligible.
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This assessment is based on the following considerations:

The Agency considers that, while Preventol A20 and Preventol A20-CT30 have the
potential to cause a major adverse effect through their acute toxicity, workers handling
the substances will be aware of the hazards and the measures (including the
requirement for personal protective equipment (PPE)) that need to be undertaken to
ensure their own safety and will not ingest, absorb or inhale sufficient Preventol A20
or Preventol A20-CT30 to result in a major adverse effect. Even a moderate effect is
highly improbable.

The Agency considers that it is highly improbable that workers will suffer eye
irritancy from Preventol A20-CT30, given requirements for PPE, and compliance with
HSNO information provisions (e.g. labels, advertising, Safety Data Sheets (SDS)).
Furthermore, the magnitude of eye irritancy is considered minimal, given the
temporary nature of effects.

The Agency considers that it is highly improbable that workers will receive skin
sensitisation from Preventol A20 or Preventol A20-CT30, given requirements for PPE
and compliance with the HSNO information provisions (e.g. labels, advertising and
SDS). The magnitude of skin sensitisation is considered minor to moderate based on
the sensitivity of the exposed parties.

The Agency considers that it is highly improbable that workers will receive repeated
exposure to Preventol A20 or Preventol A20-CT30 at levels required to result in
reproductive/developmental toxicity or target organ toxicity effects, given
requirements for PPE, compliance with the HSNO information provisions (e.g. labels
and SDS). The chronic hazards associated with Preventol A20 and Preventol A20CT30 will be sufficiently managed by workers involved in the manufacture of the
substances to reduce the level of risk of a moderate effect to human health during
manufacture to negligible.

The Agency has not assessed risks to bystanders for this lifecycle phase, noting that
members of the public are generally excluded from manufacturing facilities.
Assessment of risks to human health - importation, transport and storage
The Agency has qualitatively assessed the risk of Preventol A20 and Preventol A20-CT30 to
human health and safety during importation, transportation, storage and disposal and
considers the risks to be negligible.
This assessment is based on the following considerations:

Workers and bystanders could only be exposed to the substances during transport and
storage in isolated incidents where spillage occurs.

In these circumstances, the Agency considers it highly improbable that workers or
bystanders will ingest or absorb sufficient Preventol A20 or Preventol A20-CT30 to
result in a moderate adverse effect.
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
The Agency considers that it is highly improbable that a spillage of Preventol A20CT30 will occur during importation, transport or storage and workers or bystanders
will suffer eye irritancy, 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). Furthermore, the
magnitude of eye irritancy is considered minimal, given the temporary nature of
effects.

The Agency considers that it is highly improbable that a spillage of Preventol A20 or
Preventol A20-CT30 will occur during importation, transport or storage and workers
or bystanders will suffer skin sensitisation, 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). The magnitude of skin sensitisation is considered minor to moderate
based on the sensitivity of the exposed parties.

The Agency considers that the risk of reproductive/developmental toxicity or target
organ toxicity from repeated exposure to Preventol A20 or Preventol A20-CT30
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
Preventol A20 and Preventol A20-CT30 will be used at timber treatment facilities in the
formulation of wood protection products.
The Agency notes that this lifecycle phase will be subject to HSNO controls including those
relating to equipment, identification, emergency management and personnel protective
equipment. In addition the operation will be subject to requirements of the Health and Safety
in Employment Act 1992 and the Agency assumes that, during its use as a timber preservative
or antisapstain, the substances will be used and managed in accordance with the Best Practice
Guideline for the Safe Use of Timber Preservatives and Antisapstain Chemicals. This
Guideline provides guidance on meeting requirements under the Act, the Resource
Management Act 1991 and the Health and Safety in Employment Act 1992.
Taking these controls into account, the Agency considers that:

it is highly improbable that workers will ingest or absorb sufficient Preventol A20 or
Preventol A20-CT30 to result in a moderate adverse effect.

it is highly improbable that workers will suffer eye irritancy. Furthermore, the
magnitude of eye irritancy is considered minimal, given the temporary nature of
effects.

it is highly improbable that workers will suffer skin sensitisation. The magnitude of
skin sensitisation is considered minor to moderate based on the sensitivity of the
exposed parties.
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The Agency considers that it is highly improbable that workers in manufacturing facilities
will receive repeated exposure to Preventol A20 or Preventol A20-CT30 during use as
manufacturing concentrates, at levels required to cause reproductive/developmental toxicity
or target organ toxicity effects, given requirements for PPE, compliance with the HSNO
information provisions (e.g. labels and SDS). The chronic hazards associated with Preventol
A20 and Preventol A20-CT30 will be sufficiently managed by workers involved in the use of
the substances as manufacturing concentrates to reduce the level of risk of a moderate effect
to human health during use to negligible.
The Agency has not assessed risks to bystanders for this lifecycle phase, noting that members
of the public are generally excluded from manufacturing facilities.
Assessment of risks to human health - disposal of substance and packaging
The Agency notes that the substances are most likely to be disposed of by use in formulating
wood protection products.
The Agency assumes that disposal of the substances and their packaging will be compliant
with the Hazardous Substances (Disposal) Regulations 2001 and RMA requirements. In
addition, the Best Practice Guideline for the Safe Use of Timber Preservatives and
Antisapstain Chemicals sets out best practice for disposal of timber treatment chemicals and
contaminated product. The Agency notes that quantities requiring disposal will be low as the
substances will be largely used for use in formulating timber treatment chemicals, so public
exposure is expected to be minimal.
Taking these controls into account, the Agency considers that:

the risks associated with acute toxicity are negligible as it is highly improbable that
workers will be exposed to Preventol A20 or Preventol A20-CT30 as a result of
disposal and the magnitude of such an effect is moderate;

the risks associated with eye irritancy are negligible as it is highly improbable that
workers will be exposed to Preventol A20-CT30 as a result of disposal and the
magnitude of such an effect is minimal;

the risks associated with skin sensitisation are negligible as it is highly improbable
that workers will be exposed to Preventol A20 or Preventol A20-CT30 as a result of
disposal and the magnitude of such an effect is minor to moderate based on the
sensitivity of the exposed parties;

the risks associated with reproductive/developmental toxicity and target organ toxicity
are negligible as, while the magnitude of the effects that may occur is moderate, it is
highly improbable that workers or bystanders will suffer repeated exposures of
Preventol A20 or Preventol A20-CT30 during disposal.
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APPENDIX 4: DISCUSSION ON CONTROLS
Based on the hazard classification as shown in Table 6.1, the set of associated controls has
been identified. These default controls, expressed as control codes10, are listed in Table A4.1
and Table A4.2.
Table A4.1: List of default controls for Preventol A20
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.
T3
Requirements for keeping records of use
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
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
I8
Priority identifiers for toxic substances
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I17
Use of generic names
I18
Requirements for using concentration ranges
I19
Additional information requirements, including situations where substances are in
multiple packaging
I20
Durability of information for class 6.1 substances
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
10
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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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
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.
Table A4.2: List of default controls for Preventol A20-CT30
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.
T3
Requirements for keeping records of use
T4
Requirements for equipment used to handle substances
T5
Requirements for protective clothing and equipment
T7
Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles
Ecotoxicity Controls
E1
Limiting exposure to ecotoxic substances through the setting of EELs
E2
Restrictions on use of substances in application areas
E6
Requirements for equipment used to handle substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility, comprehensibility,
clarity and durability
I3
Priority identifiers for ecotoxic substances
I8
Priority identifiers for toxic substances
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I17
Use of generic names
I18
Requirements for using concentration ranges
I19
Additional information requirements, including situations where substances are in
multiple packaging
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I20
Durability of information for class 6.1 substances
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
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.
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.
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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:
(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.
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The toxicity (Class 6) classifications of Preventol A20 and Preventol A20-CT30 that trigger
the need to consider setting a TEL are 6.1D, 6.5B, 6.8A and 6.9A; and 6.1D, 6.1E, 6.4A,
6.5B, 6.8A, 6.9A respectively.
The Agency notes that based on the proposed use pattern, both Preventol A20 and Preventol
A20-CT30 are unlikely to become present in the environment and pose a risk to the general
public. The issue of occupational exposure is addressed in the section on Workplace
Exposure Standards (WES) below.
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
workplace and only applies to places of work (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 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 2001.
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 no Department of Labour or HSNO WES values have been set for any
of the components of Preventol A20 and Preventol A20-CT30. Also, no values have been
found to have been set by any relevant overseas body that the Agency monitors. This
indicates that the conditions of Regulation 29(1)(c) are not met as the Agency is not aware of
industrial hygiene data for Preventol A20 and Preventol A20-CT30 that would enable a WES
to be set for any of the constituent components. Therefore no WES values are proposed for
any components of Preventol A20 and Preventol A20-CT30 at this time.
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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.
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 Preventol A20 and Preventol A20-CT30 at
this time. It is also proposed that the default EEL water and soil values be deleted until the
policy has been established.
Approved Handler Controls- Highly ecotoxic substances (AH1, E7)
Approved handler requirements have been triggered for Preventol A20 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).
This approach is consistent with the Authority’s policy on approved handler and tracking
controls for class 9 substances (November 2003).
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Tracking control- Highly ecotoxic substances (TR1)
Tracking requirements have been triggered for Preventol A20 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 emergence
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 (November 2003).
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.
Preventol A20 and Preventol A20-CT30 are not imported to be used in this manner, nor have
any EELs been set. Consequently, ERMA New Zealand considers this control is not relevant
to them.
Identification controls
Identification of Toxic Components on Labels/Documentation (SDS)
The Hazardous Substances (Identification) Regulations 2001 specify that certain toxic
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...
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"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 toxic components are required to be specified on documentation.
Regulations 39(5) states:
"The requirements of regulation 25(e) apply to all documentation; but any ingredient
required by that provision to be identified (other than an 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
Preventol A20 and Preventol A20-CT30 - 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:
Preventol A20
Label
Documentation
Tebuconazole, triadimefon Tebuconazole, triadimefon
Preventol A20-CT30
Label
Tebuconazole,
triadimefon, component A
Documentation
Tebuconazole, triadimefon,
component A
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APPENDIX 5: LIST OF PROPOSED CONTROLS FOR
PREVENTOL A20 AND PREVENTOL A20-CT30
Table A5.1: Proposed controls for Preventol A20 and Preventol A20-CT30 – codes,
regulations and variations.
Control Regulation Topic
Variations
12
Code11
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
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 toxic or corrosive
substance on passenger
service vehicles
E1
32-45
I1
6, 7, 32-35,
36 (1)-(7)
Limiting exposure to ecotoxic No EEL values are set at this time and the
substances
default EELs are deleted.
Hazardous Substances (Identification) Regulations 2001
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
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.
12 These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for definitions
and exemptions.
11
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Control
Code11
Regulation
Topic
Variations
12
hazardous substances
I11
20
Secondary identifiers for
ecotoxic substances
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of Generic Names
I18
I19
27
29-31
Use of Concentration Ranges
Alternative information in
certain cases
Regulation 29 – Substances
in fixed bulk containers or
bulk transport containers
Regulation 30 – Substances
in multiple packaging
Regulation 31 – Alternative
information when substances
are imported
I20
36(8)
I21
37-39, 4750
Durability of information for
class 6.1 substances
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
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Control
Code11
Regulation
Topic
Variations
12
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
Regulation 7(1) –
Requirements when packing
hazardous substance
Regulation 8 – Compatibility
P3
9
Regulation 9A and 9B – Large
Packaging
Packaging requirements for
substances packed in limited
quantities
P13
P15
19
21
Packaging requirements for
Preventol A20 and Preventol
A20-CT30
PG3
Schedule 3
The tests in Schedule 3
correlate to the packaging
requirements of UN Packing
Group III (UN PGIII).
PS4
Schedule 4
This schedule describes the
minimum packaging
requirements that must be
complied with when a
substance is packaged in
limited quantities
Controls P13 and P15 are combined.
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Control Regulation Topic
12
Code11
Hazardous Substances (Disposal) Regulations 2001
Variations
D4
D5
8
9
Disposal requirements for
Preventol A20 and Preventol
A20-CT30
Controls D4 and D5 are combined
D6
10
Disposal requirements for
packages
D7
11, 12
Disposal information
requirements
D8
13, 14
Disposal documentation
requirements
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency
management information:
General requirements
EM6
8(e)
Information requirements for
toxic substances
EM7
8(f)
Information requirements for
ecotoxic substances
EM8
12-16, 1820
Level 2 emergency
management documentation
requirements
EM11
25-34
Level 3 emergency
management requirements –
emergency response plans
EM12
(Prevent
ol A20CT30
only)
35-41
Level 3 emergency
management requirements –
secondary containment
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 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
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Control
Code11
Regulation
Topic
Variations
12
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)
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.
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)
ERMA New Zealand Evaluation and Review Report: Application HSR08145
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
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Control
Code11
Regulation
Topic
Variations
12
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
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 77 and 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, shall apply to Preventol A20CT30, notwithstanding clause 1(1) of that schedule.
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) Regulations
2001, refer control EM12.
The approval for these substances is limited to the importation or manufacture of these substances for
inclusion into formulated products.
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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 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.
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)
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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
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
Massive
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
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 effect13 resulting from that
initiating event. It will be a combination of the likelihood of the initiating event and several
13 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.
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intermediary likelihoods14. 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: Using magnitude and likelihood to construct the level of risk and benefit
Descriptor
Description
Highly improbable
Almost certainly not occurring but cannot be totally ruled out
Very unlikely
Unlikely (occasional)
Considered only to occur in very unusual circumstances
Could occur, but is not expected to occur under normal operating conditions.
Likely
A good chance that it may occur under normal operating conditions.
Highly likely
Almost certain, or expected to occur if all conditions met
Using the magnitude and likelihood tables a matrix representing a level of effect can be
constructed.
Determining the level or risk/benefit
In the example shown in Table 6.4, four levels of risk/benefit are allocated: A (negligible), B
(low), C (medium), and D (high). These terms have been used to avoid confusion with the
descriptions used for likelihood and magnitude, and to emphasise that the matrix is a tool to
help decide which risks/benefits require further analysis to determine their significance in the
decision making process.
For negative effects, the levels are used to show how risks can be reduced by the application
of additional controls. Where the table is used for positive effects it may also be possible for
controls to be applied to ensure that a particular level of benefit is achieved, but this is not a
common approach. The purpose of developing the tables for both risk and benefit is so that
the risks and benefits can be compared.
Table A6.4: Level of risk.
Magnitude of effect
Likelihood
Highly improbable
Minimal
A
Minor
A
Moderate
A
Major
B
Massive
B
Very unlikely
A
A
B
B
C
Unlikely
A
B
B
C
C
Likely
B
B
C
C
D
Highly likely
B
C
C
D
D
14 Qualitative event tree analysis may be a useful way of ensuring that all aspects are included.
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APPENDIX 7: GOVERNMENT DEPARTMENTS,
CROWN ENTITIES AND INTERESTED PARTIES
NOTIFIED
Agcarm Incorporated
AgResearch Limited
Agriquality Ltd
Arch Chemicals Inc
BALDWINS
BASF New Zealand Limited
Carter Holt Harvey
Certified Builders Association of New Zealand
Chancery Green
Chemsafety Limited
Crown Public Health
Department of Building and Housing
DuPont (New Zealand) Limited
Engineering, Printing & Manufacturing Union
Far North District Council
Green Party of Aotearoa New Zealand
Hawkes Bay Regional Council
Haz-Subs Solutions Limited
IMCD New Zealand Limited
Kaipara District Council
Lowndes Associates
Master Builders
Napier Health Centre - Public Health Unit
New Zealand Chemical Industry Council Inc
New Zealand Customs Service
New Zealand Press Association
New Zealand Society of Gunsmiths Inc
New Zealand Timber Industry Federation
Northland Health
Osmose
Pacific Building Steel Group
Pesticide Action Network Aotearoa New Zealand
Physicians and Scientists for Global Responsibility (PSGR)
Placemakers
Rangitikei District Council
Red Stag Timber
Selleys Pty Ltd (ORICA)
South Taranaki District Council
Sustainability Council of New Zealand
Syngenta Crop Protection Limited
Taranaki Regional Council
Tasman District Council
Technical Strategy Group Limited
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Television New Zealand
The National Beekeepers Association of New Zealand
TimTech Chemicals
TMP Consultancy
Zelam Limited
2 Private Individuals
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APPENDIX 8: CONFIDENTIAL MATERIAL
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