ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
14 January 2008
Application Code
HSR07052
Application Type
To import or manufacture for release any hazardous
substance under the Hazardous Substances and New
Organisms Act 1996 (“the Act”)
Applicant
Bayer New Zealand Limited
Date Application Received
24 April 2007
Submission Period
08 May 2007 to 20 June 2007
Consideration Date
12 December 2007
Considered by
A Committee of the Authority
Purpose of the Application
To import for release Gaucho Clear, containing 600 g/L
imidacloprid, an insecticide for the treatment of seeds of
forage brassicas, grass seeds, cereals, maize, sweetcorn,
potatoes, pumpkins and winter squash.
1 Summary of decision
1.1
The application to import or manufacture Gaucho Clear for release is approved
with controls in accordance with the relevant provisions of the Act, the HSNO
Regulations and the HSNO (Methodology) Order 1998 (“the Methodology”).
1.2
The substance has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Gaucho Clear
2 Legislative criteria for application
2.1
The application was lodged pursuant to section 28. The decision was determined
in accordance with section 29, taking into account matters to be considered in
that section and additional matters specified under Part II of the Act. Unless
otherwise stated, references to section numbers in this decision refer to sections
of the Act.
2.2
Consideration of the application followed the relevant provisions of the
Methodology. Unless otherwise stated, references to clauses in this decision
refer to clauses of the Methodology.
3 Application process
3.1
The application was formally received on 24 April 2007.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 8 May 2007.
3.3
Submissions closed on 20 June 2007.
3.4
Various Government departments, Crown Entities and interested parties,
including the New Zealand Food Safety Authority (Agricultural Compounds and
Veterinary Medicines (ACVM) Group), the Ministry of Health and the
Department of Labour Work Place Group, which in the opinion of the Authority
would be likely to have an interest in the application, were notified of the receipt
of the application (sections 53(4) and 58(1)(c), and clauses 2(2)(e) and 5) and
provided with an opportunity to comment or make a public submission on the
application.
3.5
No submissions or comments were received.
3.6
The ACVM Group, the Ministry of Health, the Department of Labour and the
applicant were given the opportunity to comment on the Agency’s Evaluation
and Review Report (“the E&R Report”) and the controls proposed therein. The
applicant indicated that they did not believe any of the controls to be
impracticable or inappropriate.
3.7
No external experts were used in the consideration of this application (clause
17).
3.8
Due to delays in completing the E&R Report, the Authority, with the applicant’s
consent, waived the requirement to consider this application 30 working days
after the closing date for submissions for 86 days.
3.9
The following members of the Authority considered the application (section
19(2)(b)): Professor George Clark (chair), Dr Deborah Read, Dr Manuka
Henare.
3.10
The information available to the Committee comprised:
 the application; and
 the E&R Report including confidential appendices.
4 Consideration
Purpose of the application
4.1
The purpose of the application is to import or manufacture Gaucho Clear. This
substance contains 600 g/L imidacloprid and is an insecticide for the treatment
of seeds of forage brassicas, grass, cereals, maize, sweetcorn, potatoes,
pumpkins and winter squash.
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Sequence of the consideration
4.2
In accordance with clause 24, the approach to the consideration adopted by the
Committee was to:
 establish the hazard classifications for the substance and derive the default
controls that are prescribed under section 77 for each classification.
 identify potentially non-negligible risks, costs, and benefits.
 assess the potentially non-negligible risks and costs. Risks were assessed in
accordance with clause 12, and costs in accordance with clause 13. The
adequacy of the default controls, prescribed under section 77, was
considered alongside the assessment of risks and costs to determine whether
those controls should be varied and identify where additional controls need
to be applied, under section 77A, to mitigate any unacceptable risks.
 undertake a combined consideration of all the risks and costs and determine
whether the combined risks and costs are negligible or non-negligible.
 consider (a) whether any of the non-negligible risks could be reduced by
varying the controls in accordance with sections 77 or 77A, and (b) the costeffectiveness of the application of controls in accordance with clause 35 and
sections 77 and 77A.
 assess the benefits associated with this application in accordance with
clauses 9, 11, 13 and 14 and section 6(e).
 taking into account the risk characteristics established under clause 33,
evaluate the risks, costs and benefits in accordance with clause 34 and
section 29 and determine whether the application should be approved or
declined.
 confirm and set the controls.
Hazard classification
4.3
The Agency has classified Gaucho Clear as follows:
Hazardous Property
Classification
Acute Toxicity (Oral)
6.1C
Skin Irritancy
6.3A
Eye Irritancy
6.4A
Dermal Sensitisation
6.5B
Target Organ Toxicity
6.9B
Aquatic Ecotoxicity
9.1A
Soil Ecotoxicity
9.2A
Terrestrial Vertebrate Ecotoxicity
9.3A
Terrestrial Invertebrate Ecotoxicity
9.4A
Default controls
4.4
In the E&R Report, the Agency assigned default controls for Gaucho Clear
based on its hazardous properties as set out in the HSNO Regulations. The
default controls were used as a reference for evaluation of the application in the
E&R Report. The default controls are listed in section 8 of the E&R Report and
have not been reproduced here.
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Identification of the potentially non-negligible risks, costs and benefits
of the substance
4.5
In its evaluation of Gaucho Clear, the Agency identified potentially significant,
and therefore non-negligible, risks, costs and benefits associated with the
substance.
Potentially non-negligible risks
4.6
The Agency considers that the potentially non-negligible risks associated with
Gaucho Clear relate to the substance’s toxic and ecotoxic properties. These risks
arise during all phases of its lifecycle including the use of seed treated with the
substance.
Potentially non-negligible costs
4.7
A “cost” is defined in Regulation 2 of the Methodology as “the value of a
particular adverse effect expressed in monetary or non-monetary terms”.
Accordingly, the costs were assessed in an integrated fashion together with the
risks in the Agency’s assessment.
Potentially non-negligible benefits
4.8
A “benefit” is defined in Regulation 2 of the Methodology as “the value of a
particular positive effect expressed in monetary or non-monetary terms”.
Benefits that may arise from any of the matters set out in clauses 9 and 11 were
considered in terms of clause 13.
4.9
The applicant indicated that the major benefit associated with the substance was
that, while it is similar to the approved seed treatment “Gaucho” (registered by
the applicant, Bayer New Zealand Limited) it is formulated without a dye. This
will allow different coloured dyes to be added to the seed treatment so that the
seeds can be differentiated in the market place.
Assessment of the potentially non-negligible risks and costs of the
substance
4.10
Taking into account the Agency’s assessment of the potentially non-negligible
risks and costs associated with Gaucho Clear in New Zealand, the Committee
considers that:
4.10.1
The risks associated with unintentional ingestion of a small amount of
Gaucho Clear or a single exposure via the skin or eyes are negligible.
4.10.2
The risks associated with chronic exposure to Gaucho Clear (via any
route) are negligible, particularly taking the approved handler
requirements into account.
4.10.1
Gaucho Clear presents a negligible risk to the environment during
transport, storage, manufacture, packing and disposal.
4.10.2
The risks to non-target organisms are negligible during the application
of Gaucho Clear to seeds at seed treatment facilities.
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4.10.3
The quantitative modelling indicates that all treated seed types, with the
exception of potato, pose a non-negligible risk (i.e. high acute, shortterm and long-term risk) to birds. The Committee considers that
drilling/incorporating the treated seeds into the soil will reduce their
availability to birds and should mitigate the acute risks to birds, and that
treated seeds should be labelled with instructions to cover seeds
completely with soil when sown.
4.10.4
Seeds treated with Gaucho Clear pose a risk to human health and the
environment. In order to manage these risks the committee considers
that additional identification controls should be imposed on the treated
seeds which require identification of:
 the substance with which the seeds have been treated;
 the hazardous properties of the substance;
 precautions to be taken in handling the seed; and
 appropriate means of disposing of unwanted seeds which have been
treated with Gaucho Clear.
4.10.5
There is a risk that seeds treated with Gaucho Clear may be consumed
by animals other than birds. Accordingly, the Committee considers that
treated seeds should be labelled as such and that this label should also
indicate that the seeds are not to be used for human and animal
consumption.
4.10.6
Assuming these additional controls are in place, the Committee
considers that the risks to the human health and the environment (other
than birds) from treated seeds are negligible.
4.10.7
Significant adverse impacts on the social or economic environment are
not anticipated with the controlled use of Gaucho Clear.
4.10.8
The overall level of risk to Māori culture or traditional relationships
with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or
other taonga is described as low.
4.10.9
There is no evidence to suggest that the controlled use of Gaucho Clear
will breach the principles of the Treaty of Waitangi.
5 Controls
5.1
The applicant was given an opportunity to comment on the proposed controls as
set out in the E&R Report (clause 35(b)).
5.2
In response, the applicant indicated that they did not believe any of the controls
to be impracticable or inappropriate.
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Setting of exposure limits and application rates
5.3
Control T1 relates to the requirement to limit public exposure to toxic
substances through the setting of Tolerable Exposure Limits (TELs).
Components E and H fulfil the requirements of Regulation 11(1)(a), (b) and (c)
of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
and therefore TELs are required to be set for these components. However, as
the Authority is intending to review the setting of TELs under section 77B, no
TEL values have been set at this time.
5.4
Control T2 relates to requirements to set Workplace Exposure Standards (WES)
which are designed to protect persons in the workplace from the adverse effects
of toxic substances. WES values have been set by the Department of Labour for
components C and D of Gaucho Clear. However, the Committee considers that
these values should not be applied to Gaucho Clear due to the low concentration
of components C and D in the substance. Therefore no WES values are set for
any components of Gaucho Clear at this time.
5.5
Control E1 relates to the requirement to limit exposure of non-target organisms
in the environment through the setting of Environmental Exposure Limits
(EELs). The Authority is intending to review the setting of EELs under section
77B. As this review has not been completed, EELs are not set at this time for
Gaucho Clear and the default values are deleted.
5.6
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. However, the Committee considers that the risks to birds
will be managed by burying the seed and that it is not necessary to set a
maximum application rate for Gaucho Clear at this time.
Additional controls under section 77A
5.7
Under section 77A, the Authority may impose as controls any obligations and
restrictions that it thinks fit. Before imposing a control under this section, the
Authority must be satisfied that, against any other specified controls that apply
to the substance:
(a) the proposed control is more effective in terms of its effect on the
management, use and risks of the substance; or
(b) the proposed control is more cost-effective in terms of its effect on the
management, use and risks of the substance; or
(c) the proposed control is more likely to achieve its purpose.
5.8
As discussed above, the Committee considers that restrictions on the use of
Gaucho Clear are necessary to mitigate the risks to non-target organisms.
Accordingly, the Committee considers that the application of controls addressing
these risks will be more effective than the specified (default) controls in terms of
their effect on the management, use and risks of the substance (section
77A(4)(a)). Consequently, the following additional controls are set for Gaucho
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Clear to further mitigate the risks to the environment and to human health and
safety:
5.9
5.8.1
At the time of treatment the seed must be dyed so as to differentiate it
from untreated seed.
5.8.2
Gaucho Clear shall only be used as a seed treatment.
5.8.3
Seed treated with Gaucho Clear must not be used for human or animal
consumption. The substance label shall include a statement to this
effect. Information to this effect shall be provided with treated seed.
5.8.4
Treated seed shall be completely covered by soil when sown. The
substance label shall include a statement to this effect. Information to
this effect shall be provided with treated seed.
5.8.5
Excess treated seed shall not be left in areas accessible to birds. The
substance label shall include a statement to this effect. Information to
this effect shall be provided with treated seed.
5.8.6
Appropriate PPE shall be used when handling seeds treated with
Gaucho Clear. The substance label shall include a statement to this
effect. Information to this effect shall be provided with treated seed.
5.8.7
Seeds treated with Gaucho Clear shall be disposed of in accordance
with the disposal requirements for toxic and ecotoxic substances. The
substance label shall include a statement to this effect. Information to
this effect shall be provided with treated seed.
5.8.8
Information shall be provided with treated seed that indicates the
substance that the seed has been treated with, its hazardous properties
and precautions to be taken in handling the seed.
The Committee notes that the specified controls do not address the risks
associated with stationary container systems, nor do they allow for dispensation
where it is unnecessary for any associated pipework to have secondary
containment. Accordingly, the Committee considers that the application of
controls addressing these risks will be more effective than the specified (default)
controls in terms of their effect on the management, use and risks of the
substance (section 77A(4)(a)). Such controls were applied to pesticides on
transfer to the HSNO regime. The Committee considers that these controls are
similarly appropriate for the management of the risks associated with Gaucho
Clear and has applied the following controls to the substance:
5.9.1
The controls relating to stationary container systems, as set out in
Schedule 8 of the Hazardous Substances (Dangerous Goods and
Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the
New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended,
shall apply to this substance, notwithstanding clause 1(1) of that
schedule.
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5.9.2
The Committee considers that the following subclauses should be added
after subclause (3) of regulation 36 of the Hazardous Substances
(Emergency Management) Regulations 20011:
(4) For the purposes of this regulation, and regulations 37 to 40,
where this substance is contained in pipework that is installed and
operated so as to manage any loss of containment in the pipework
it—
(a) is not to be taken into account in determining whether a place
is required to have a secondary containment system; and
(b) is not required to be located in a secondary containment
system.
(5) In this clause, pipework—
(a) means piping that—
(i)
is connected to a stationary container; and
(ii) is used to transfer a hazardous substance into or out of the
stationary container; and
(b) includes a process pipeline or a transfer line.
5.10
Under section 77A(3)(b) an additional control may vary another specified
control if this variation is more cost-effective in terms of its effect on the risks of
the substance (section 77A(4)(b)).
5.10.1
Control EM12 relates to the requirements for secondary containment of
pooling substances (Regulations 35 – 41 of the Hazardous Substances
(Emergency Management) Regulations 2001). The Committee
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
less than those associated with class 1 to 5 substances. Consequently
the Agency considers that the secondary containment requirements of
regulations 37 and 38 can be reduced. The Committee considers that
the reduced secondary containment measures specified below are
adequate to manage the risks of a spillage of Gaucho Clear. Therefore,
the additional control, which varies the EM12 control, is considered
more cost-effective in terms of managing the risks of the substance.
5.10.2

Accordingly, the Committee considers that:
the following subclauses should be added after subclause (1) of
regulation 37 of the Hazardous Substances (Emergency Management)
Regulations 20012:
(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—
1
These sub-clauses were applied to pesticides on transfer to the Act.
2
These sub-clauses were applied to pesticides on transfer to the Act.
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(a) if the place’s total pooling potential is less than 20,000
litres, the secondary containment system must have a
capacity of at least 25% of that total pooling potential:
(b) if the place’s total pooling potential is 20,000 litres or
more, the secondary containment system must have a
capacity of the greater of—
(i)
5% of the total pooling potential; or
(ii) 5,000 litres.
(3)
Pooling substances to which subclause (2) applies must be
segregated where appropriate to ensure that leakage of one
substance may not adversely affect the container of another
substance.
and

the following subclauses should be added after subclause (1) of
regulation 38 of the Hazardous Substances (Emergency Management)
Regulations 20013:
(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)
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.
These sub-clauses were applied to pesticides on transfer to the Act.
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Variation of controls under section 77
5.11
Under section 77(3), (4) and (5), the default controls determined by the
hazardous properties of a substance may be varied.
5.12
The Committee has varied the following control under section 77(4)(b) for
Gaucho Clear, as the variation will not significantly increase the adverse effects
of the substance:
5.12.1
5.13
Control T7 relates to restrictions on the carriage of hazardous
substances on passenger service vehicles. The Committee considers that
the quantity of Gaucho Clear triggering these requirements should be
varied from 0.1 L to 1 L.
The Committee has combined the following controls under section 77(5) for
Gaucho Clear as they relate to the same requirements:
5.13.1
Controls T4 and E6 which relate to requirements for equipment used to
handle hazardous substances.
5.13.2
Controls T6 and E7 which relate to approved handler requirements.
5.13.3
Controls P13 and P15 which relate to requirements for packaging
hazardous substances.
5.13.4
Controls D4 and D5 which relate to requirements for disposal of
Gaucho Clear.
6 Overall evaluation of risks and costs
6.1
The Committee does not consider there to be significant risks to society or the
community, the market economy, or to New Zealand’s international obligations.
6.2
The Committee considers that, based on the Agency’s assessments, the use of
the Gaucho Clear poses non-negligible risks to birds while the risks to other
non-target organisms and human health are considered to be negligible.
6.3
The Committee notes that the introduction and use of this substance has the
potential to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki,
particularly in relation to the guardianship of the mauri of valued native flora
and fauna taonga associated with aquatic environments, soil, terrestrial
invertebrates and vertebrates particularly birds; although the overall level of risk
is described as low.
Approach to risk
6.4
In establishing the approach to risk in relation to the non-negligible risks to the
environment, the Committee has considered the following, in accordance with
clause 33:

Exposure to the risk is involuntary;
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
The risk associated directly with the consumption of treated seeds by
birds will not persist over time, as the seeds will be buried as per the
additional control proposed under section 77A. The Committee
considers that the substance itself may persist in the aquatic and soil
environments should exposure to the seed treatment occur;

The risk is not subject to uncontrollable spread. The Agency’s risk
assessment indicating a high risk to birds is based on the consumption of
treated seeds; therefore the risk is associated with the treated seeds
themselves. The Committee considers that, should the soil or aquatic
environment be exposed to the substance at any time, the effects of the
exposure will be limited to the site of exposure;

There is potential for irreversible effects to occur to non-target organisms
exposed to Gaucho Clear;

The risks may not be known or understood by the general public;
however, this information is available. The HSNO controls require
identification of hazards and the means of avoiding and managing
adverse effects on the product label and in the supporting documentation.
6.5
The Committee notes that other seed treatments containing the same
concentration of imidacloprid are available, and therefore approving Gaucho
Clear will not have a significant impact on the quantity of the active ingredient
being used in New Zealand. Taking into account the additional controls
proposed for Gaucho Clear for the purposes of managing the risks to non-target
organisms (birds in particular) the introduction of the substance should not result
in an increase in risks to birds or other non-target organisms in the environment
relative to other seed treatments containing imidacloprid.
6.6
The Committee considers that, if in the future there is evidence to indicate that
substances containing imidacloprid present a more significant risk to bees than is
currently assumed, reassessment of this use of the substance would be the most
appropriate means of examining these risks and how they should be managed.
7 Assessment of the potentially non-negligible benefits
7.1
The Committee is unable to place an expected value on the benefits (clause
13(b)) but is satisfied that the ability of the substance to enter the market could
give rise to the associated benefits detailed in paragraph 4.9 above. The
Committee considers that the benefits associated with the release of Gaucho
Clear are potentially medium.
7.2
In accordance with sections 29(1)(a)(iii) and 29(1)(b)(iii), the Committee
considers that if Gaucho Clear were not made available, the benefits offered
would not be realised and consumers would have less choice.
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8 Comparison of risks, cost and benefits
8.1
As discussed above, the Committee considers that Gaucho Clear poses nonnegligible risks to birds and to the relationship of Māori with the environment.
8.2
The Committee also considers that Gaucho Clear offers a medium level of
benefit to users.
8.3
In considering the approach to risk, the Committee notes that seed treatments
containing 600 g/L imidacloprid are currently approved for use in New Zealand,
and that Gaucho Clear is unlikely to present any greater risks to the environment
than these substances. Taking the approach to risk into account, the Committee
considers that the residual non-negligible risks are outweighed by the potentially
significant benefits.
9 Recommendations
9.1
The Committee recommends that, should inappropriate or accidental use,
transport or disposal of Gaucho Clear result in the contamination of waterways,
the appropriate authorities, including the relevant iwi authorities in the region,
should be notified. This action should include advising them of the
contamination and the measures taken in response.
10 Environmental User Charges
10.1
The Committee considers that the application of controls to Gaucho Clear will
provide an effective means of managing risks associated with this substance. At
this time no consideration has been given to whether or not environmental
charges should be applied to this substance as an alternative or additional means
of achieving effective risk management.
11 Decision
11.1
The Committee determines that:
11.1.1
Gaucho Clear has the following hazard classifications:
Hazardous Property
Acute Toxicity (Oral)
Skin Irritancy
Eye Irritancy
Dermal Sensitisation
Target Organ Toxicity
Aquatic Ecotoxicity
Soil Ecotoxicity
Terrestrial Vertebrate Ecotoxicity
Terrestrial Invertebrate Ecotoxicity
11.1.2
Classification
6.1C
6.3A
6.4A
6.5B
6.9B
9.1A
9.2A
9.3A
9.4A
pursuant to section 29 and clause 27, the positive effects (benefits) of
the substance outweigh the adverse effects (risks and costs).
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11.1.3
the application for importation or manufacture and release of the
hazardous substance, Gaucho Clear, is thus approved with controls as
listed in Appendix 1.
11.2
In accordance with clause 36(2)(b), the Committee records that, in reaching this
conclusion, it has applied the balancing tests in section 29 and clause 27.
11.3
It has also applied the following criteria in the Methodology:
 clause 9 – equivalent of sections 5, 6 and 8;
 clause 11 – characteristics of substance;
 clause 12 – evaluation of assessment of risks;
 clause 13 – evaluation of assessment of costs and benefits;
 clause 14 – costs and benefits accruing to New Zealand
 clause 21 – the decision accords with the requirements and regulations;
 clause 22 – the evaluation of risks, costs and benefits – relevant
considerations;
 clause 24 – the use of recognised risk identification, assessment,
evaluation and management techniques;
 clause 25 – the evaluation of risks;
 clause 33 – risk characteristics;
 clause 34 – the aggregation and comparison of risks, costs and benefits;
and
 clause 35 – the costs and benefits of varying the default controls.
signed
Professor George Clark
Chair
ERMA New Zealand Approval Code:
ERMA New Zealand Decision: Application HSR07052
Date: 14 January 2008
HSR007890
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Appendix 1: Controls for Gaucho Clear
Note: The control explanations as listed below have been provided as guidance only and do
not have legal standing. Please refer to the regulations for the requirements prescribed for
each control and the modifications listed set out in section 5 of this document.
Control
Code4
Regulation5 Topic
Variations
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property
Controls
T1
11-27
Limiting exposure to toxic substances No TEL values set for Gaucho
Clear at this time.
T2
29, 30
Controlling exposure in places of
work
T3
5(1), 6
Requirements for keeping records of
use
T4/E6
7
Requirements for equipment used to
Controls T4 and E6 are
handle hazardous substances
combined.
T5
8
Requirements for protective clothing
and equipment
T6/E7
9
Approved handler requirements
Controls T6 and E7 are
combined.
T7
10
Restrictions on the carriage of
The trigger level for this control
hazardous substances on passenger
is varied from 0.1 L to 1 L.
service vehicles
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
E1
32-45
Limiting exposure to ecotoxic
No EEL values are set for
substances
Gaucho Clear at this time.
E2
46-48
Restrictions on use within application No maximum application rate is
area
set for Gaucho Clear at this
time.
E3
49
Controls relating to protection of
terrestrial invertebrates e.g. beneficial
insects
E4
50-51
Controls relating to protection of
terrestrial vertebrates
E5
5(2), 6
Requirements for keeping records of
use
Hazardous Substances (Identification) Regulations 2001
I1
6, 7, 32-35, General identification requirements
36 (1)-(7)
Regulation 6 – Identification duties of
suppliers
Regulation 7 – Identification duties of
persons in charge
Regulations 32 and 33 – Accessibility
4
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.
5
These Regulations form the controls applicable to this substance. Refer to the cited Regulations for the formal specification, and for
definitions and exemptions. The accompanying explanation is intended for guidance only.
ERMA New Zealand Decision: Application HSR07052
Page 14 of 19
Control
Code4
Regulation5
I3
9
I8
14
I9
18
I11
20
I16
25
I17
I18
I19
26
27
29-31
Topic
of information
Regulations 34, 35, 36(1)-(7) –
Comprehensibility, Clarity and
Durability of information
Priority identifiers for ecotoxic
substances
Priority identifiers for certain toxic
substances
Secondary identifiers for all
hazardous substances
Secondary identifiers for ecotoxic
substances
Secondary identifiers for toxic
substances
Use of Generic Names
Use of Concentration Ranges
Alternative information in certain
cases
Variations
See additional s77A controls
below.
See additional s77A controls
below.
See additional s77A controls
below.
Regulation 29 – Substances in fixed
bulk containers or bulk transport
containers
Regulation 30 – Substances in
multiple packaging
I20
36(8)
I21
37-39,
50
Regulation 31 – Alternative
information when substances are
imported
Durability of information for class 6.1
substances
47- 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
ERMA New Zealand Decision: Application HSR07052
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Control
Code4
Regulation5
Topic
requirements for vehicles
Variations
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
P13, P15
19, 21
PG3
Schedule 3
PS4
Schedule 4
Regulation 9A and 9B – Large
Packaging
Packaging requirements for
substances packed in limited
quantities
Packaging requirements for toxic and
ecotoxic substances
The tests in Schedule 3 correlate to
the packaging requirements of UN
Packing Group III (UN PGIII).
This schedule describes the minimum
packaging requirements that must be
complied with for this substance
when packaged in limited quantities.
Controls P13 and P15 are
combined.
Hazardous Substances (Disposal) Regulations 2001
D4, D5
8, 9
Disposal requirements for toxic and
Controls D4 and D5 are
ecotoxic substances
combined.
D6
10
Disposal requirements for packages
D7
11, 12
Disposal information requirements
D8
13, 14
Disposal documentation requirements
Hazardous Substances (Emergency Management) Regulations 2001
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
ERMA New Zealand Decision: Application HSR07052
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Control
Code4
EM8
EM11
Regulation5
12-16, 1820
25-34
EM12
35-41
Topic
Level 2 emergency management
documentation requirements
Level 3 emergency management
requirements – emergency response
plans
Level 3 emergency management
requirements – secondary
containment
Variations
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 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
ERMA New Zealand Decision: Application HSR07052
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Control
Code4
Regulation5
Topic
Variations
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)
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 (Personnel Qualification) Regulations 2001
AH1
4-6
Approved Handler requirements
ERMA New Zealand Decision: Application HSR07052
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Control
Code4
Regulation5 Topic
Variations
Hazardous Substances (Tracking) Regulations 2001
TR1
4(1), 5, 6
General tracking requirements
Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004
Regulations 4 to 43 The Hazardous Substances (Tank Wagons and Transportable Containers)
where applicable
Regulations 2004 prescribe a number of controls relating to tank wagons
and transportable containers and must be complied with as relevant.
Additional controls set under s77A
The controls relating to stationary container systems, as set out in Schedule 8 of the Hazardous
Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement
to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, apply to this
substance, notwithstanding clause 1(1) of that schedule.
At the time of treatment the seed must be dyed so as to differentiate it from untreated seed.
Gaucho Clear shall only be used as a seed treatment.
Seed treated with Gaucho Clear shall not be used for human or animal consumption.
The substance label shall include a statement to this effect.
Information to this effect shall be provided with treated seeds.
Treated seed shall be completely covered by soil when sown.
The substance label shall include a statement to this effect.
Information to this effect shall be provided with treated seeds.
Excess treated seed shall not be left in areas accessible to birds.
The substance label shall include a statement to this effect.
Information to this effect shall be provided with treated seeds.
Appropriate PPE shall be used when handling seeds treated with Gaucho Clear.
The substance label shall include a statement to this effect.
Information to this effect shall be provided with treated seeds.
Seeds treated with Gaucho Clear shall be disposed of in accordance with the disposal requirements
for toxic and ecotoxic substances.
The substance label shall include a statement to this effect.
Information to this effect shall be provided with treated seeds.
Information shall be provided with treated seed that indicates the substance that the seed has been
treated with, its hazardous properties and precautions to be taken in handling the seed.
ERMA New Zealand Decision: Application HSR07052
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