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DECISION
21 April 2016
Summary
Substance Fabula
Application code APP202755
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 Adria New Zealand Limited
Purpose of the application To import Fabula, a herbicide containing 480 g/litre sulfentrazone in
the form of a suspension concentrate, to control a range of weeds in
pumpkin, buttercup squash and potatoes
Date application received 8 March 2016
Consideration date 21 April 2016
Considered by The Chief Executive1 of the Environmental Protection Authority (“the
EPA”)
Decision Approved with controls
Approval code HSR101129
Hazard classifications 6.3B, 6.4A, 6.8B, 6.9B (oral), 9.1A, 9.2A
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
1. Substance
1.1. Fabula is a suspension concentrate containing 480 g/L sulfentrazone as the active ingredient. It is
intended to be used by professional users to control a range of weeds in crops such as pumpkin,
buttercup squash, and potatoes.
1.2. The applicant intends to import Fabula into New Zealand fully formulated, packaged and labelled
ready for sale in 500 mL and 1 L HDPE containers.
2. Process and notification
Application receipt
2.1. The application was formally received on 8 March 2016 under section 28 of the Act.
Information available for consideration
2.2. The information available for the consideration comprises:
the application form,
confidential appendices to the application,
the EPA Kaupapa Kura Taiao Māori advice memorandum, and
the EPA science advice memorandum.
2.3. I consider that I have sufficient information to assess the application.
Public notification
2.4. Fabula contains an active ingredient that is used in similar ways in other approved substances.
Accordingly, this application was not publicly notified under section 53(2) of the Act because it was
unlikely that there would be significant public interest in the application.
Notification to government departments
2.5. In line with section 53(4) of the Act, the following government departments were notified of the
application on 9 March 2016: WorkSafe New Zealand, the Ministry for Primary Industries (Agricultural
Compounds and Veterinary Medicines Group), and the Department of Conservation. No comments
were received.
Legislative criteria for the application
2.6. The application was considered in accordance with section 29 of the Act, taking into account other
relevant sections of the Act, the Hazardous Substances Regulations and the Hazardous Substances
and New Organisms (Methodology) Order 1998.
3. Hazardous properties
3.1. The hazard classification of Fabula were determined based on the information provided by the
applicant and other available information.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
3.2. The classifications that I have applied to this substance are different to those submitted by the
applicant (Table 1). These differences have arisen due to new information on a component of the
formulation, and to a review of the interpretation of the mixture rules for this substance.
Table 1: Hazard classifications of Fabula
Hazard Applicant classification EPA classification
Acute toxicity (oral) 6.1D -
Skin irritancy 6.3B 6.3B
Eye irritancy 6.4A 6.4A
Contact sensitisation 6.5B -
Reproductive/ developmental toxicity 6.8B 6.8B
Target organ or systemic toxicity 6.9B (oral) 6.9B (oral)
Aquatic ecotoxicity 9.1A 9.1A
Soil ecotoxicity 9.2A 9.2A
4. Risk and benefit assessment
Prescribed controls
4.1. The hazard classifications of Fabula determine a set of prescribed controls as specified by the
Hazardous Substances Regulations under the Act.
4.2. These prescribed controls form the basis of the controls detailed in Appendix A and set the baseline
for how the substance should be managed throughout its lifecycle in New Zealand.
Risk assessment
4.3. The risk assessment takes into account the prescribed controls and other legislation such as the Land
Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994.
4.4. This assessment:
considers the risks posed by Fabula,
determines whether the risks are outweighed by the benefits, and
determines whether any variations or additions to the prescribed controls are required to
manage the risks of this substance, and identifies controls that are not applicable or necessary
that can therefore be deleted.
Assessment of risks to human health and the environment
4.5. I have evaluated the potential of Fabula to cause adverse effects to people and/or the environment
during every lifecycle stage of the substance. The identification and qualitative assessment of the risks
arising from the human health and environmental hazards associated with Fabula are set out in
Appendix B.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
4.6. In addition, I note that Fabula contains the same active ingredient as other herbicides that are already
approved. Based on the application rates, proposed use-pattern and the prescribed controls that are
triggered by the hazard classifications of Fabula, the risks to human health are not likely to be
significantly higher from the use of Fabula compared to these other approved substances.
4.7. The use pattern of Fabula is such that there is potential for an environmental exposure to occur.
However, I note that similar products with a similar use pattern are already approved for use, and that
controls are applied to these products which mitigate these risks. I consider that any potential
ecological risks associated with the use of Fabula can be sufficiently mitigated by the application of
similar controls.
Assessment of risks to Māori and their relationship to the environment
Kupu arataki (context)
4.8. The potential effect of Fabula on the relationship of Māori to the environment has been assessed in
accordance with sections 5(b), 6(d) and 8 of the Act. Under these sections all persons exercising
functions, powers, and duties under the Act shall: recognise and provide for the maintenance and
enhancement of people and communities to provide for their cultural well-being, and take into account
the relationship of Māori and their culture and traditions with their ancestral lands, water, taonga and
the principles of the Treaty of Waitangi (Tiriti o Waitangi).
4.9. I note that Fabula triggers several hazardous properties that give rise to the potential for cultural risk
e.g. aquatic ecotoxicity and suspected reproductive or developmental toxicity. Cultural risk includes
any negative impacts to taonga species, the environment, and the general health and well-being of
individuals and the community. In addition, the introduction and use of hazardous substances has the
potential to inhibit the ability of Māori to fulfil their role as kaitiaki.
Taha hauora (human health)
4.10. I note that Fabula is classified as a skin and eye irritant, is harmful to human organs or systems and is
a suspected human reproductive or developmental toxicant. For these reasons, Fabula poses risks to
taha hauora, in particular the dimensions of taha tinana (physical health and well-being) and taha
wairua (spiritual health and well-being obtained through the maintenance of a balance with nature and
the protection of mauri (life principle, vital essence)).
4.11. If not adequately managed, I note that the potential for reproductive impairment may lead to impacts
on whakapapa, which is sacrosanct and which pervades Māori art forms and is fundamental to Māori
cosmogeny. Furthermore, the potential for Fabula to affect reproductive capability is of concern as this
has the potential to disrespect the connection between Māori and their mortal and spiritual origins.
Mahinga kai, rongoā me pūeru (food resources, medicine and textiles)
4.12. Fabula is classified as a soil ecotoxicant and therefore has the potential to cause adverse effects to
culturally significant plants used for food, medicine and weaving, such as pūhā and harakeke. I note
that such effects are only possible if taonga species are exposed to Fabula, for example through spray
drift onto adjoining land, and that the controls applied to Fabula will mitigate these risks.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Pūkohu wai (algae)
4.13. Fabula is ecotoxic in aquatic environments and therefore has the potential to cause adverse effects to
pūkohu wai (freshwater algae). These organisms are valuable to Māori due to their role in water
purification and as a food source for small organisms and fish, which are in turn prey species for
culturally significant food species. I consider that these risks are mitigated by the suite of controls
proposed for Fabula, which include prohibiting application into or onto water.
Ngā one (soil)
4.14. I note that Fabula is very ecotoxic to soil environments and is therefore of concern to Māori due to the
potential effects on Papatūānuku (earth mother), who is considered the source of all living things and
is integral to Māori creation stories and to whenua (land) and ngā one.
Ētahi atu mea (other matters)
4.15. The intended use of Fabula to control a range of weeds in pumpkin, buttercup squash and potatoes
will produce economic benefits for those growing or working with these crops, some of whom are
Māori.
Kupu whakatepe (conclusion)
4.16. Based on the information provided, including the use pattern and the suite of controls proposed for
Fabula, I consider that the potential risks to Māori culture or traditional relationships with the
environment will be adequately mitigated, and that there are potential benefits to Māori that arise from
the use of Fabula.
4.17. If Fabula is used in the prescribed manner, I consider that it is unlikely to breach the principles of the
Treaty of Waitangi, including the principle of active protection.
Assessment of risks to society, the community and the market economy
4.18 I have not identified any risks to society, communities or the market economy from the approval of
Fabula.
New Zealand’s international obligations
4.19 I have not identified any international obligations that may be impacted by the approval of Fabula.
The effects of the substance being unavailable
4.20 I have considered the likely effects of the substance being unavailable in accordance with section
29(1) of the Act. I consider that, should this substance not be available, it would lead to less consumer
choice.
Benefit assessment
4.21 The applicant considers that the approval of Fabula will provide the following benefits:
Highly effective control of weeds in pumpkins, buttercup squash, and potatoes leading to
higher crop yields.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Low toxicity to humans and non-target species, and minimal environmental impact when used
as directed.
4.22 I am satisfied that the availability of Fabula will provide beneficial economic effects for some
businesses, with the potential for flow-on effects to local communities and the New Zealand economy
such as increased customer choice and greater competition.
5. Variation and cost-effectiveness of prescribed controls
Modification of controls under section 77 of the Act
5.1. Section 77 of the Act allows the EPA to substitute, add or delete prescribed controls under certain
conditions. No modifications to the prescribed controls for Fabula have been made under section 77 of
the Act.
Addition and variation of controls under section 77A of the Act
5.2. Section 77A of the Act allows the EPA to add, vary, substitute, combine or delete specified controls if
such changes are more effective or more cost-effective in terms of managing the use and risks of the
substance, or are more likely to achieve their purpose than the prescribed controls.
5.3. I have, therefore varied the prescribed controls as set out in Table 2, and added controls as set out in
Table 3.
Table 2: Justification for variations to the prescribed controls (see Appendix A for control variations)
Control(s) Justification
E1, E2 Limiting exposure to ecotoxic substances through the setting of EEL values, and
restrictions on use of substances in application areas.
An Environmental Exposure Limit (EEL) can be set to limit a hazardous substance from
entering the environment in quantities sufficient to present a risk to it. I have not set an EEL for
any component of Fabula at this time as I consider that, at present, setting a maximum
application rate is more likely to achieve the intended purpose of this control.
T1 Limiting exposure to toxic substances through the setting of TEL, ADE and PDE values
Acceptable Daily Exposure (ADE), Potential Daily Exposure (PDE) and Tolerable Exposure
Limit (TEL) values can be set to limit the amount of a hazardous substance in the environment
to a level below that which presents a risk to human health. I consider that it is not necessary
to set these limits at this time as the risks to human health are adequately managed by other
controls.
I16 Identification and information requirements
This control specifies the requirement for identifying the name and concentration of certain
toxic components on the product label and other documentation. Consistent with the guidance
provided by the Globally Harmonized System of Classification and Labelling of Chemicals
(GHS), this control has been varied to include the revised concentration cut-offs that trigger the
requirements for labelling the relevant components present in this substance. I have outlined
this control in full in Appendix A.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Control(s) Justification
Under these regulations, the name and concentration of the following component(s) need(s) to
be specified on the label and (M)SDS:
Labelling requirement (M)SDS requirement
Sulfentrazone – 6.8B, 6.9B Sulfentrazone – 6.8B, 6.9B
Ethylene glycol – 6.9B
EM12 Emergency management requirements
This control specifies the emergency management requirements for secondary containment of
liquid hazardous substances (or those likely to liquefy in a fire) and pooling substances.
However, this control does not allow for dispensation where it is unnecessary for any pipework
associated with the stationary container systems to have secondary containment. I have,
therefore, varied the emergency management controls to address this, as I consider that this
variation is more likely to achieve the intended purpose of the control.
I consider 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 secondary containment requirements can be reduced. I
consider that these reduced secondary containment measures are adequate to manage the
risks of a spillage of Fabula, as this substance does not ignite or explode. Therefore, the
proposed variation is more cost-effective in terms of managing the risks of the substance.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Table 3: Justification for addition of controls (see Appendix A for additional controls)
Control(s) Justification
Water
Application
method
Application
rate
I consider that the risk assessment requires additional restrictions on use and application of this
substance are necessary to mitigate the risk of adverse effects in the environment. Accordingly, I
consider that the application of controls addressing these potential risks will be more effective than the
prescribed controls with respect to their effects on the management, application and risks of this
substance. Consequently, the following additional controls are applied to Fabula to restrict the level of
risk to the environment:
This substance must not be applied into or onto water.
This substance must be applied using ground-based methods only.
This substance must not be applied at rates exceeding 470 mL of formulated product/ha per application
(equivalent to 225.6 g sulfentrazone/ha) and must not be applied to the same area more than once per
year.
Label The prohibition of application of this substance onto or into water, the restriction to ground-based
application and the maximum application rate are key requirements to mitigate the potential
environmental risks associated with the use of Fabula. I consider it important for these requirements to
be stated on the product label and safety data sheet to ensure they are clearly communicated to users
of the substance, and that this variation is more effective in terms of its effect on the management, use
and risks of the substance. Therefore I have conferred these requirements on Fabula as an additional
control under section 77A of the Act.
Schedule 8 Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)
Transfer Notice 2004
The prescribed controls do not address the risks associated with storage or use of substances within
stationary container systems (e.g. tanks). These risks include the potential failure of primary
containment resulting in a large spill of the substance into the environment. It is therefore necessary to
mitigate against the risk that this substance will be stored in bulk without consideration of the equipment
it is contained in, or the location of that equipment.
Accordingly, I have applied the requirements of Schedule 8 of the Hazardous Substances (Dangerous
Goods and Scheduled Toxic Substances) Transfer Notice 20042 (as amended) to this substance. I
consider that the application of controls addressing these risks are more effective than the specified
prescribed controls with respect to their effect on the management, use and risks of the substance and
therefore set them as a control (Sch 8) under section 77A of the Act, notwithstanding clause 1 of that
schedule.
Review of controls for cost-effectiveness
5.1 The proposed controls, provided they are complied with, are the most cost-effective means of
managing the identified potential risks associated with this substance. The applicant was provided an
opportunity to comment on the additional controls as set out in this decision and no concerns were
raised.
2 Available at http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
6. Risk and benefit assessment summary
6.1. I conclude that the residual level of risk of any potential adverse effects, after taking into account the
prescribed controls and any variations to these controls, is negligible.
6.2. I consider that there are non-negligible benefits associated with the use of Fabula.
7. Decision
7.1 Pursuant to section 29 of the Act, I have considered this application for approval made under section
28 of the Act. I have considered the effects of this substance throughout its lifecycle, the controls that
may be imposed on this substance and the likely effects of this substance being unavailable.
7.2 I have determined that the positive effects of this substance outweigh any adverse effects. Therefore,
the import or manufacture of Fabula is approved with controls as listed in Appendix A.
Mark Patchett Date: 21 April 2016
Acting Chief Executive, EPA
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Appendix A: Controls applying to Fabula
Please refer to the Hazardous Substances Regulations3 for the requirements prescribed for each control.
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T1 11 – 27 Limiting exposure to toxic substances
through the setting of TEL, ADE and
PDE values
No TEL, ADE or PDE values are set for
any component of this substance at this
time
T2 29, 30 Controlling exposure in places of work
through the setting of WES values
The EPA adopts as WES values for this
substance, and each component of this
substance, any applicable value specified
in WorkSafe New Zealand’s Workplace
Exposure Standards and Biological
Exposure Indices Document; 7th Edition;
February 20134
T4 7 Requirements for equipment used to
handle substances
T5 8 Requirements for protective clothing
and equipment
T7 10 Restrictions on the carriage of toxic or
corrosive substances on passenger
service vehicles
E1 32 – 45 Limiting exposure to ecotoxic
substances through the setting of EEL
values
No EEL values are set at this time
E2 46 – 48 Restrictions on use of substances in
application areas
See additional controls set under s77A
E5 5(2), 6 Requirements for keeping records of
use
E6 7 Requirements for equipment used to
handle substances
E7 9 Approved handler/security
requirements for certain ecotoxic
substances
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 6, 7, 32 – 35,
36(1) – (7)
Identification requirements, duties of
persons in charge, accessibility,
3 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
4 Or any subsequent version of this Standard approved or endorsed by the EPA.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Code Regulation Description Variation
comprehensibility, clarity and
durability
I3 9 Priority identifiers for ecotoxic
substances
I9 18 Secondary identifiers for all
hazardous substances
I11 20 Secondary identifiers for ecotoxic
substances
I16 25 Secondary identifiers for toxic
substances
The concentration cut-offs that trigger the
requirement for labelling of components
are set out in the following table:
HSNO Classification
Cut-off for label % (I16)
6.5A, 6.5B, 6.6A, 6.7A
0.1
6.6B 1
6.7B 1
6.8A, 6.8C 0.3
6.8B 3
6.9A, 6.9B 10
I17 26 Use of generic names
I18 27 Requirements for using concentration
ranges
I19 29 – 31 Additional information requirements,
including situations where substances
are in multiple packaging
I21 37 – 39,
47 – 50
General documentation requirements
I23 41 Specific documentation requirements
for ecotoxic substances
I28 46 Specific documentation requirements
for toxic substances
I29 51, 52 Signage requirements
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
P1 5, 6, 7(1), 8 General packaging requirements
P3 9 Criteria that allow substances to be
packaged to a standard not meeting
Packing Group I, II or III criteria
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Code Regulation Description Variation
P13 19 Packaging requirements for toxic
substances
P15 21 Packaging requirements for ecotoxic
substances
PG3 Schedule 3 Packaging requirements equivalent to
UN Packing Group III
PS4 Schedule 4 Packaging requirements as specified
in Schedule 4
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 8 Disposal requirements for toxic and
corrosive substances
D5 9 Disposal requirements for ecotoxic
substances
D6 10 Disposal requirements for packages
D7 11, 12 Information requirements for
manufacturers, importers and
suppliers, and persons in charge
D8 13, 14 Documentation requirements for
manufacturers, importers and
suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 6, 7, 9 – 11 Level 1 information requirements for
suppliers and persons in charge
EM6 8(e) Information requirements for toxic
substances
EM7 8(f) Information requirements for ecotoxic
substances
EM8 12 – 16, 18 –
20
Level 2 information requirements for
suppliers and persons in charge
EM11 25 – 34 Level 3 emergency management
requirements: duties of person in
charge, emergency response plans
EM12 35 – 41 Level 3 emergency management
requirements: secondary containment
The following subclauses are 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
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Code Regulation Description Variation
that is installed and operated so as to
manage any loss of containment in the
pipework it—
(a) is not to be taken into account in
determining whether a place is
required to have a secondary
containment system; and
(b) is not required to be located in a
secondary containment system.
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary
container; and
(ii) is used to transfer a
hazardous substance into or
out of the stationary
container; and
(b) includes a process pipeline or a
transfer line.
The following subclauses are added at the
end of regulation 37:
(2) If pooling substances which do not
have class 1 to 5 hazard classifications
are held in a place above ground in
containers each of which has a
capacity of 60 litres or less—
(a) if the place’s total pooling
potential is less than 20,000
litres, the secondary containment
system must have a capacity of
at least 25% of that total pooling
potential:
(b) if the place’s total pooling
potential is 20,000 litres or more,
the secondary containment
system must have a capacity of
the greater of—
(i) 5% of the total pooling
potential; or
(ii) 5,000 litres.
(3) Pooling substances to which
subclause (2) applies must be
segregated where appropriate to
ensure that leakage of one substance
may not adversely affect the container
of another substance.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Code Regulation Description Variation
The following subclauses are added at the
end of regulation 38:
(2) If pooling substances which do not
have class 1 to 5 hazard classifications
are held in a place above ground in
containers 1 or more of which have a
capacity of more than 60 litres but
none of which have a capacity of more
than 450 litres—
(a) if the place’s total pooling
potential is less than 20,000
litres, the secondary containment
system must have a capacity of
either 25% of that total pooling
potential or 110% of the capacity
of the largest container,
whichever is the greater:
(b) if the place’s total pooling
potential is 20,000 litres or more,
the secondary containment
system must have a capacity of
the greater of—
(i) 5% of the total pooling
potential; or
(ii) 5,000 litres
(3) Pooling substances to which subclause
(2) applies must be segregated where
appropriate to ensure that the leakage
of one substance may not adversely
affect the container of another
substance.
EM13 42 Level 3 emergency management
requirements: signage
Hazardous Substances and New Organisms (Personnel Qualifications) Regulations 2001
Code Regulation Description Variation
AH 1 4 – 6 Approved Handler requirements
(including test certificate and
qualification requirements)
Hazardous Substances (Tracking) Regulations 2001
Code Regulation Description Variation
TR1 4(1), 5, 6 General tracking requirements
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank
Wagon
4 – 43, as
applicable
Controls relating to tank wagons
and transportable containers
Additional controls
Code Section of
the Act Control
Water 77A This substance must not be applied into or onto water.
Application
method This substance must be applied using ground-based methods only.
Application
rate
The maximum application rate of this substance is 470 mL of formulated product/ha
(equivalent to 225.6 g of sulfentrazone/ha).
This substance must not be applied to the same area more than once per calendar
year.
Label The following statements, or words to the same effect, must be included on the
product label and safety data sheet (including the relevant definitions):
This substance must not be applied into or onto water.
The application of this substance is limited to ground-based application
methods only.
This substance must not be applied at rates exceeding 470 mL of
formulated product/ha per application (equivalent to 225.6 g
sulfentrazone/ha) and must not be applied to the same area more than
once per year.
Stationary
Container
Systems
Schedule 8 Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004
This schedule prescribes the controls for stationary container systems. The
requirements of this schedule are detailed in the consolidated version of the
Hazardous Substances (Dangerous Goods and Schedule Toxic Substances)
Transfer Notice 2004, available from http://www.epa.govt.nz/Publications/Transfer-
Notice-35-2004.pdf
The following clause replaces Clause 1 of Schedule 8 of the Hazardous Substances
(Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004:
This Schedule applies to every stationary container system that contains, or is
intended to contain the substance.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Definitions
Unless defined below, terms used in the controls have the same meaning as defined in the Act or regulations
made under the Act.
Term Definition
a.i Active ingredient - the biologically active chemical in a pesticide product
Ground-based
methods
Ground-based methods of applying pesticides include, but are not limited to, application by ground
boom, airblast or knapsack, and do not include aerial application methods.
Water
Where ‘water’ means water in all its physical forms, whether flowing or not, and whether over or
under ground, but does not include water in any form while in a pipe, tank or cistern or water used in
the dilution of the substance prior to application.
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Appendix B: Risk assessment
To facilitate the risk assessment, I have identified the most common potential sources of risk to human
health and the environment through release, spillage or exposure throughout the life cycle of the substance.
These are shown in Table B1. The process by which the risk assessment of hazardous substances is
undertaken is specified in the Methodology5. Guidance on risk assessment is provided on the EPA website6.
Table B1: Potential sources of risks associated with hazardous substances
Life cycle stage Associated source of risk
Manufacture* / Import An incident during the manufacture or importation of the substance resulting in a spill and
subsequent exposure of people or the environment to the substance.
Packing An incident during the packing of the substance resulting in a spill and subsequent
exposure of people or the environment to the substance.
Transport or storage An incident during the transport or storage of the substance resulting in a spill and
subsequent exposure of people or the environment to the substance.
Use Application of the substance resulting in exposure of users or bystanders or the
environment; or an incident during use resulting in a spill and subsequent exposure of
users or the environment to the substance.
Disposal Disposal of the substance or packaging resulting in exposure of people or the
environment to the substance.
* Although the applicant intends to import (not manufacture) Fabula, it is possible that this substance could be manufactured in New
Zealand in the future. Consequently, the risks associated with the manufacture of Fabula have also been evaluated
A summary of the qualitative risk assessment is given in Tables B2 and B3 below.
5 http://www.legislation.co.nz/regulation/public/1998/0217/latest/DLM254556.html?src=qs
6 http://www.epa.govt.nz/Publications/ER-TG-05-02_03_09_Decision_Making.pdf
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Table B2: Qualitative risk assessment of biological hazards to human health
Life cycle Biological hazard Likelihood Magnitude Level of
risk
according
to matrix
Comments Residual
level of
risk
Manufacture
and packaging
Skin and eye irritancy
Very unlikely
Minimal
Negligible
The applicant does not currently intend to manufacture Fabula in
New Zealand. However, I note that should this occur,
manufacturing and packaging in New Zealand will be required to
meet the HSNO requirements for equipment, emergency
management and Personal Protective Equipment (PPE). The need
for compliance with HSNO information provisions for the constituent
components (e.g. labels, Safety Data Sheets) and WorkSafe New
Zealand’s Health and Safety requirements will also apply.
This means that workers handling this substance will need to be
aware of its hazards and the measures that need to be undertaken
to ensure their own safety. Provided that these measures are
taken, the level of risk is negligible.
Negligible
Reproductive or
developmental toxicity
Very unlikely
Moderate Low While the qualitative descriptors indicate a low level of risk driven
by the major chronic effects of Fabula, I note that if Fabula is
manufactured and packaged in New Zealand, this will be required
to meet the HSNO requirements for equipment, PPE, emergency
management and provision of information, as well as WorkSafe
New Zealand’s Health and Safety regulations. These requirements
will make the likelihood of exposure that would lead to an adverse
effect highly improbable, such that the level of risk for these
adverse effects is negligible.
Negligible
Target organ or system
toxicity
Very unlikely
Major Low Negligible
Importation,
transport,
storage
Skin and eye irritancy
Highly
improbable
Minimal
Negligible
Workers and bystanders will only be exposed to the substance
during this stage of the life cycle in isolated incidents if spillage
occurs, therefore only risks from acute exposure are considered for
these life cycle phases. Compliance with HSNO controls (e.g.
packaging, labels, SDS) and adherence to the Land Transport Rule
45001, Civil Aviation Act 1990 and Maritime Transport Act 1994, as
Negligible
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
applicable, is required and will minimise the likelihood of a spill and
accordingly mitigate the risk of these adverse effects.
Use
(application)
Skin and eye irritancy Unlikely Minimal Negligible The substance will be labelled to identify its potential risks,
minimising the opportunity for it to cause adverse effects. HSNO
requirements for PPE, packaging, identification and emergency
management must be complied with. In conjunction with the
requirement for this substance to be under the control of an
approved handler (due to its ecotoxicity) these controls will mitigate
risks to human health. I also note that bystanders are not expected
to come into contact with the substance as it is intended for
commercial use.
Negligible
Reproductive or
developmental toxicity
Very unlikely Moderate Low Negligible
Target organ or system
toxicity
Very unlikely Major Low Negligible
Disposal
Skin and eye irritancy Very unlikely Minimal Negligible The applicant intends for this substance to be used completely (i.e.
until the container is emptied), or alternately for excess product to
be returned to the supplier. Empty containers will be triple rinsed,
with the rinsate added to the spray tank, before the containers are
returned to an AgRecovery site for disposal. Disposal of the
substance and its used containers in New Zealand, if required,
must be in accordance with the requirements of the Hazardous
Substances (Disposal) Regulations 2001. Compliance with these
will reduce the opportunity for individuals to be exposed.
Negligible
Reproductive or
developmental toxicity
Highly
improbable
Moderate Negligible Negligible
Target organ or system
toxicity
Highly
improbable
Major Low Negligible
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Decision on application for approval to import or manufacture Fabula for release (APP202755)
Table B3: Qualitative assessment of biological hazards to the environment
Life cycle Biological hazard Likelihood Magnitude Level of
risk
according
to Matrix
Comment Residual
level of
risk
Manufacture,
importation,
transport and
storage
Death or adverse effects to
aquatic or terrestrial
organisms
Highly
improbable
Minor Negligible Provided that the exercise of this approval is in compliance with the
HSNO controls (and the Land Transport Rule 45001, Civil Aviation Act
1990 and Maritime Transport Act 1994 (as applicable)), the likelihood
of a spill leading to adverse effects is considered to be highly
improbable.
Negligible
Use
(application)
Death or adverse effects to
aquatic organisms
Unlikely Minor Low I consider that the use of appropriate statements on labels and Safety
Data Sheets prohibiting the application of this substance onto or into
water, the requirement for ground-based application only, the
maximum application rate and compliance with the approved handler
requirements will adequately manage the risks to the aquatic
environment.
Negligible
Death or adverse effects to
terrestrial organisms (e.g.
soil bacteria, plants)
Likely Minor Low I note that there is potential for localised environmental impact to occur
in that soil organisms within the application site may be affected by the
application of Fabula. I consider that the maximum application rate,
compliance with the approved handler requirements, and the
requirement for these to be listed on the product documentation will
adequately minimise risks to the soil environment.
Negligible
Disposal Death or adverse effects to
aquatic or terrestrial
organisms
Highly
improbable
Minor Negligible Users will, in most cases, utilise all of this substance by its intended
use as a herbicide. All cases of disposal are required to be in
accordance with the requirements of the Hazardous Substances
(Disposal) Regulations 2001.
Negligible
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Decision on application for approval to import or manufacture Fabula for release (APP202755)