ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
31 July 2007
Application Code
HSR06141
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
Dow AgroSciences (NZ) Limited
Date Application Received
18 December 2006
Submission Period
26 January 2007 to 12 March 2007
Considered by
A Committee of the Authority
Purpose of the Application
GF-1640: to import or manufacture the formulated
product GF-1640, an insecticide containing spinetoram,
which is intended for use in commercial crops (eg
orchards) to control caterpillars and other insect pests
(Category C, reduced risk).
1 Summary of decision
1.1
The application to import or manufacture GF-1640 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 application to import spinetoram 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).
1.3
The substances have been given the following unique identifiers for the ERMA
New Zealand Hazardous Substances Register:
GF-1640
Spinetoram
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 in accordance with the Authority’s reduced
risk fee policy on 18 December 2006.
3.2
In accordance with sections 53(1) and 53A, and clauses 2(2)(b) and 7, public
notification was made on 26 January 2007.
3.3
Submissions closed on 12 March 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.
3.4.1
3.5
No comments or submissions were received.
The Ministry of Health, the Department of Labour, the New Zealand Food Safety
Authority (Agricultural Compounds and Veterinary Medicines (ACVM) Group),
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.
3.5.1
No responses were received.
3.6
No external experts were used in the consideration of this application (clause 17).
3.7
Two waivers were issued to adjust the time taken to complete the E&R Report to
the Authority.
3.8
The following members of the Authority considered the application (section
19(2)(b)): Dr. Max Suckling (chair), Dr. Manuka Henare and Dr. Deborah Read.
3.9
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 the formulated product
GF-1640, an insecticide containing spinetoram, which is intended for use in
commercial crops (eg orchards) to control caterpillars and other insect pests. The
application was extended to include approval to import the active ingredient,
spinetoram, for use in the manufacture of formulated products.
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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 substances 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 classifications
4.3
The Agency has classified GF-1640 as follows:
Hazardous Property
Target organ systemic toxicity
Aquatic ecotoxicity
Terrestrial invertebrate ecotoxicity
4.4
Classification
6.9B
9.1A
9.4A
The Agency has classified spinetoram as follows:
Hazardous Property
Contact sensitisation
Target organ systemic toxicity
Aquatic ecotoxicity
Terrestrial invertebrate ecotoxicity
Classification
6.5B
6.9B
9.1A
9.4A
Default controls
4.5
In the E&R Report, the Agency assigned default controls for GF-1640 and
spinetoram 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 GF-1640 and spinetoram
4.6
In its evaluation of GF-1640 and spinetoram, the Agency identified potentially
significant, and therefore non-negligible, risks, costs and benefits associated with
the substances.
Potentially non-negligible risks
4.7
In terms of the environment the Agency has identified that both GF-1640 and
spinetoram pose potentially non-negligible risks during several of their respective
lifecycle stages. Table 4.1 below sets out the lifecycle stages where potentially nonnegligible risks may arise and provides a brief description of the potential adverse
effects. The Committee notes that spinetoram will not be applied in its own right
into the environment.
Table 4.1: Sources of potentially non-negligible risks to the environment posed by GF-1640 and
spinetoram.
4.8
Lifecycle Stage
Potential Adverse Effect
Importation, transport, storage of either
substance and the use of spinetoram in
manufacture.
Manufacture of GF-1640 and repacking of
either substance
Spillage resulting in death or adverse effects to aquatic or
terrestrial organisms in the environment
Disposal of either substance.
Disposal resulting in death or adverse effects to aquatic or
terrestrial organisms in the environment
For GF-1640, the Agency has indicated that potentially non-negligible risks are
posed to human health during its manufacture, repacking or disposal as indicated in
Table 4.2. The Committee notes that these risks are only posed to workers, i.e.
those handling the substance on a regular basis. The Committee also notes that the
Agency’s quantitative risk assessment for use indicated that the risks to workers
using the substance are acceptable with the controls in place.
Table 4.2: Sources of potentially non-negligible risks to human health posed by GF-1640.
Lifecycle stage
Manufacture or repacking
Disposal
4.9
Potential Adverse Effect
Target organ toxicity
For spinetoram, the Agency has indicated that potentially non-negligible risks are
posed throughout its lifecycle in New Zealand, as indicated in Table 4.3.
Table 4.3: Potentially non-negligible risks to human health posed by spinetoram.
Lifecycle stage
Potential Adverse Effect
Importation, transport or storage
Skin sensitisation
Use – worker exposure (use in the
formulation of other substances)
Skin sensitisation
Disposal
Skin sensitisation
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Target organ toxicity
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Potentially non-negligible costs
4.10
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
4.11
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.
4.12
In its assessment the Agency has identified several potentially non-negligible
benefits associated with the substances. These benefits are:
 greater choice for end users of pesticides in terms of price competition and
availability of a relatively low risk product.
 the ability to manufacture GF-1640 in New Zealand and the associated benefits
for employment and trade.
 the availability of a “new” relatively low hazard insecticidal active ingredient that
may be used in the development of other products.
Assessment of the potentially non-negligible risks and costs of the
substances
4.13
In assessing the potentially non-negligible risks and costs identified for GF-1640
and spinetoram, in New Zealand, the Committee has taken the Agency’s
assessment into account and considers that:
 for spinetoram the risks to human health and safety are non-negligible during
use, i.e. when the substance is being repacked or used in the formulation of
other substances. The risks are considered non-negligible because individuals
will be in a position where they may be repeatedly exposed to the substance and
the potential permanence and severity of the effects that may result.
 for spinetoram the risks to human health during import, transportation, storage
and disposal are considered to be negligible. The Committee has reached this
conclusion based on the very low level of risk identified by the Agency and the
constraints of the risk assessment methodology. For spinetoram, the
Committee considers that, the chain of events required to result in exposure
during these lifecycle stages and the requirement for repeated exposures to result
in adverse effects, does not represent a significant level of risk to human health.
 for GF-1640, the risks to human health are considered to be non-negligible
during its manufacture and repacking. The risks are considered non-negligible
because individuals will be in a position where they may be repeatedly exposed
to the substance and the potential permanence and severity of the effects that
may result.
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 for GF-1640, the risks to human health are considered to be negligible during its
disposal because of the infrequency that the substance will need to be disposed
of, and the requirement for repeated exposures to occur to result in an
appreciable adverse effect. The insignificant to low level of risk identified in the
Agency’s assessment does not appear to reflect a realistic risk scenario in this
regard.
 for GF-1640 and spinetoram, the risks to the environment are considered to be
potentially non-negligible during all lifecycle stages, with the exception of when
GF-1640 is being used. The risks are considered to be non-negligible because of
the potential for greater quantities to be involved in any one incident.
 significant adverse impacts on the social or economic environment with the
controlled use of GF-1640 and spinetoram are not anticipated.
 it is unlikely that GF-1640 or spinetoram could have a significant impact on
Māori culture or traditional relationships with ancestral lands, water, sites, wāhi
tapu, valued flora and fauna or other taonga.
 there is no evidence to suggest that the controlled use of GF-1640 or
spinetoram 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)). The applicant was also given the
opportunity to comment on further additional controls that the Committee
considered necessary during their consideration of the application. The applicant’s
comments were taken into account during the consideration of the application.
Exposure Limits
Setting of exposure limits and application rates for GF-1640
5.2
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. Given the outcome of the human
health risk assessment the Committee does not consider that exposure to GF-1640
would result in an appreciable toxic effect (regulation 11 (1) (c) of the Hazardous
Substances (Classes 6, 8, and 9 Controls) Regulations 2001). Consequently, the
Committee has deleted control T1 for GF-1640, as provided for by section 77(4).
5.3
Because GF-1640 is intended for use on food crops and contains a new active
ingredient the New Zealand Food Safety Authority (NZFSA) may require an ADE
and PDEfood value to be set for spinetoram for which they can derive a Maximum
Residue Limit (MRL). The Committee has addressed this aspect through the
setting of a temporary ADE value and PDE values under section 77A.
5.4
Control T2 relates to the requirement to limit worker exposure to toxic substances
by the setting of Workplace Exposure Standards (WESs). The Committee notes
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that a WES value has been set for component D in GF-1640 by the Department
of Labour. This WES value is considered relevant by the Committee, and has
therefore been adopted for GF-1640. For this WES value refer to Workplace
Exposure Standards, Effective from 2002, published by the Occupational Safety and
Health Service, Department of Labour, January 2002, ISBN 0-477-03660-0.
5.5
Control E1 relates to the requirements to limit exposure of non-target organisms in
the environment through the setting of Environmental Exposure Limits (EELs).
Following the enactment of the Hazardous Substances and New Organisms
(Approvals and Enforcement) Act 2005, the Authority is intending to review the
setting of EELs under section 77B. As this review has not been completed, no
EELs are set for GF-1640 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. As no EELs have been set, no application rate is set at this
time.
Setting of exposure limits and application rates for spinetoram
5.7
Control T1 relates to the setting of Tolerable Exposure Limits (TELs). As
spinetoram is being limited to use as a manufacturing component the Committee
does not consider that the public will be exposed to the substance in its pure form
and therefore has deleted this control.
5.8
Control T2 relates to the setting of Workplace Exposure Standards (WESs). The
Committee notes that no WES values have been established for spinetoram and
further notes that assessment is continuing in other jurisdictions to establish the
requirements for WES values for spinetoram. The Committee therefore has not
set a WES for spinetoram at this time.
5.9
Control E1 relates to the setting of Environmental Exposure Limits (EELs). As the
review of setting of EELs under section 77B has not been completed, the
Committee has not set any EELs for spinetoram at this time and has deleted the
default values.
5.10
Control E2 relates to setting an application rates. As spinetoram is not intended to
be sprayed on an area of land (or air or water), the Committee has deleted this
control under section 77(4)(a), as the adverse effects of the substance are less than
the adverse effects which would normally be associated with substances of the
same hazard classifications.
Additional controls under section 77A
5.11
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
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(c) the proposed control is more likely to achieve its purpose.
Additional controls for GF-1640
5.12
The Committee notes that the risk assessment for GF-1640 has been based solely
upon the substance being used as an insecticide, but none of the specified (default)
controls limits how the substance may be used. Accordingly, the Committee has
applied the following control to GF-1640 as it is considered to be more effective
than the specified controls in terms of its effect on the management, use and risks
of the substance:
5.12.1
5.13
“GF-1640 shall only be used as a pesticide”
Because GF-1640 contains a new active insecticidal ingredient and is intended for
use on food crops the Committee considers it appropriate to set an ADE for
spinetoram so that the NZFSA is able to derive an MRL for the component in
foodstuffs. After the deletion of control T1 the Committee can set ADE values for
components in GF-1640 under section 77A. Given that additional toxicological
data is pending the Agency has proposed a temporary ADE for spinetoram of
0.3 mg/kg bw/day. This value is based on chronic animal data for spinetoram and
incorporates uncertainty factors and follows the principles taken for setting an ADI
(analogous to an ADE) for spinosad (an insecticidal active of similar chemistry).
From this ADE the Agency has also derived temporary potential daily intake
(PDE) values of spinetoram: 0.024 mg/kg bw/day for food and
0.006 mg/kg bw/day for water. The Committee considers these temporary ADE
and PDE values are applicable and has set them for spinetoram in GF-1640.
ADEspinetoram
spinetoram PDEfood
spinetoram PDEwater
0.03 mg/kg bw/day
0.024 mg/kg bw/day
0.006 mg/kg bw/day.
5.14
The Committee notes that these values will be reviewed and revised, if necessary,
under the appropriate reassessment pathway when the required data become
available.
5.15
As the ADE and PDE values are not based on a complete data package the
Committee requires that the supporting information be provided when it becomes
available. The applicant has stated that the required studies are in progress and is
willing to provide this data when necessary. Nevertheless, the Committee considers
that the supply of this data is essential and has therefore set the following controls
to mandate its supply.
5.15.1
The applicant, Dow AgroSciences (NZ) Limited, shall supply, at their
completion, the following studies:
 long term chronic toxicity/carcinogenicity studies for two mammalian
species.
 a multigenerational mammalian reproductive toxicity study.
5.15.2
The applicant, Dow AgroSciences (NZ) Limited, shall cover the costs
associated with the review of the required data and setting of a permanent
ADE value and associated PDE values for spinetoram and GF-1640.
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5.16
The default controls do not restrict how GF-1640 might be used. Given the aquatic
ecotoxicity of GF-1640 the Committee has set the following control for GF-1640
to mitigate risks to the aquatic environment:
5.16.1
5.17
“GF-1640 shall not be applied onto or into water.”
Export-only substances: In line with the Hazardous Substances (Pesticides)
Transfer Notice 2004 (as amended), the Committee has applied the following
clauses after regulation 30 of the Hazardous Substances (Identification) Regulations
2001:
30A Single container packaging for export-only substances
(1)
Packaging of export-only substances in single containers, whether contained within a
multiple package or not, may comply with the labelling requirements of—
(a)
the Food and Agricultural Organisation of the United Nations (FAO),
Guidelines on Good Labelling Practice for Pesticides 1995; or
(b)
the labelling requirements of a regulatory authority recognised by ERMA
New Zealand in the country of destination.
(2) If packaging complies with (1), it need not comply with—
(a)
regulations 11 and 12 of the Hazardous Substances (Disposal) regulations
2001; and
(b)
regulations 6 to 8 of the Hazardous Substances (Emergency Management)
Regulations 2001; and
(c)
regulations 6 to 9, 11, 13, 14, 18, 19, 20, 22, 24, 25, 36(8) of the
Hazardous Substances (Identification) Regulations 2001.
30B Multiple packaging for export-only substances
(1)
(2)
(3)
(4)
(5)
(6)
This subclause applies only to export-only substances in multiple packages.
The outer packaging of a multiple package to which subclause (1) applies must bear:
(a)
the information required by whichever of regulations 8 to 14 applies to the
substance; or
(b)
the labelling or marking required by—
(i)
the Land Transport Rule 45001/1: Dangerous Goods 2005; or
(ii)
Civil Aviation Rules: Part 92 – Carriage of Dangerous Goods; or
(iii)
Maritime Rules: Part 24A – Carriage of Cargoes – Dangerous
Goods (MR024A); or
(c)
the pictogram for “Dangerous to the Environment” as described in directive
92/32/EEC (instead of the identifier requirements of regulations 9 and
20); or
(d)
the relevant class or subclass label assigned by the UN Model Regulations.
An export-only substance to which subclause (1) applies must be identified by enough
information to enable its New Zealand supplier or manufacturer to be contacted, either
in person or by telephone.
An export-only substance to which subclause (1) applies shall not have on its
packaging, or with it, any information suggesting that it belongs to a class or subclass it
does not in fact belong to.
An export-only substance which complies with subclauses (2) to (4) of this regulation
need not comply with regulations 18 to 25 and 30.
Any requirement to label the outer packaging of a multiple package of an export-only
substance as containing a substance that is hazardous to the environment/ecotoxic,
specified in subclauses (2) to (4), is omitted when the substance is stored in New
Zealand in a secure warehouse or other secure storage facility owned, operated or
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otherwise under the control of the manufacturer or the shipping agent prior to
exportation from New Zealand.]
Additional controls for spinetoram
5.18
The Committee considers that there is insufficient data to assess the risks
associated with the manufacture of spinetoram in New Zealand. Consequently, the
Committee is restricting the substance from being in New Zealand by setting the
following control.
5.18.1
5.19
“Spinetoram shall not be manufactured in New Zealand.”
The Committee considers that the controls relating to the specification and
prohibition on use, consistent with Schedule 3 of the Hazardous Substances
(Chemicals) Transfer Notice (New Zealand Gazette Issue No. 72, 28 June 2006),
shall apply to spinetoram:
(1)
Prohibition on use of spinetoram
(1)
No person may use spinetoram for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or
product.
(2)
Despite subclause (1)(a), research and development using spinetoram does not include
investigation or experimentation in which the substance is discharged, laid or applied in
or to the outdoor environment.
(2)
(1)
Specification of spinetoram
Any person who (a) imports into New Zealand spinetoram, which that person has not previously
imported; or
(b) had previously imported spinetoram, but has since changed the source of
manufacture for that hazardous substance, must provide to the Authority in
writing the information required by subclauses (3) and (4).
(2)
The information required by subclause (1) must be provided prior to the substance being
imported; and
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the
previous source of manufacture, if such information has not previously
been provided to the Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of spinetoram;
(b) the specification of spinetoram including –
(i) the manufacturer’s specifications including purity of the hazardous
substance, isomeric ratio where applicable, maximum impurity content
and evidence to support these, including details of analytical methods used.
Where spinetoram is produced at more than one manufacturing site, this
information must be provided for each site separately;
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(ii) the identity of any impurity, its origin, and the nature of its relationship to
the active component when the impurity is present at a concentration of
10g/kg or more;
(iii) the identity of any impurity that is known to be of toxicological concern,
its origin, and the nature of its relationship to the active component when
the impurity is present at a concentration of less than 10g/kg.
(4)
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
Variation of controls for GF-1640 under section 77
5.20
Under section 77(3), (4) and (5), the default controls determined by the hazardous
properties of a substance may be varied.
5.21
The Committee considers that the following controls should be varied under
section 77(4)(b) for GF-1640, as the variations will not significantly increase the
adverse effects of the substance:
5.22
5.21.1
Controls E7 and AH1 relate to requirements for ecotoxic substances to be
under the control of an approved handler. The Committee has deleted
these controls for GF-1640 because their application would not
significantly affect the risks of the substance to the environment.
5.21.2
Control TR1 relates to the requirements for a substance to be tracked and
is triggered for GF-1640 only by virtue of its ecotoxicity. The Committee
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 is deleted
for GF-1640.
The Committee considers that the following controls may be combined under
section 77(5) for GF-1640 as they relate to the same requirements:
5.22.1
Controls T4 and E6, which relate to requirements for equipment used to
handle GF-1640.
5.22.2
Controls P3 and P15, which relate to requirements for packaging
GF-1640.
5.22.3
Controls D4 and D5, which relate to requirements for disposal of GF1640.
Variation of controls for spinetoram under section 77
5.23
The Committee considers that the following controls should be varied under
section 77(4)(b) for spinetoram, as the variations will not significantly increase the
adverse effects of the substance:
5.23.1
Controls E7 and AH1 relate to requirements for ecotoxic substances to be
under the control of an approved handler. The Committee considers that
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these controls are not relevant for spinetoram, given that the substance is
not used in a wide dispersive manner and is consequently of a lesser risk
to the environment. Thus, these controls are deleted for spinetoram.
5.23.2
5.24
Control TR1 relates to the requirements for a substance to be tracked and
is triggered for spinetoram only by virtue of its ecotoxicity. The
Committee 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 is deleted for spinetoram.
The Committee considers that the following controls may be combined under
section 77(5) for spinetoram as they relate to the same requirements:
5.24.1
Controls T4 and E6, which relate to requirements for equipment used to
handle spinetoram.
5.24.2
Controls P3 and P15, which relate to requirements for packaging
spinetoram.
5.24.3
Controls D4 and D5, which relate to requirements for the disposal of
spinetoram.
6 Overall evaluation of risks and costs
6.1
On the basis of the Agency’s risk assessment and the Committee’s subsequent
evaluation of these risks with the controls in place it is the Committee’s opinion
that:
 spinetoram poses potentially non-negligible risks to human health during use in
the formulation of other substances.
 GF-1640 poses potentially non-negligible risks to human health during its
manufacture and repacking.
 spinetoram poses potentially non-negligible risks to the environment during all
lifecycle stages.
 GF-1640 poses potentially non-negligible risks to the environment during all
lifecycle stages, with the exception of its use where the risks are considered to be
acceptable.
7 Approach to risk
7.1
Clause 33 requires the Authority to have regard for the extent to which a specified
set of risk characteristics exist when considering applications. This provides a route
for determining how cautious or risk averse the Authority should be in weighing up
adverse effects (risks and costs) and beneficial effects (benefits).
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7.2
The Committee considers that additional caution is not warranted for GF-1640 or
spinetoram as:
 the substance, GF-1640, is considered to be less hazardous than alternative
insecticides currently available in New Zealand.
 temporary ADE and PDE values have been set for the active ingredient,
spinetoram and provisions have been made for the supply and assessment of
additional data and any subsequent modification of controls.
 the risks to human health during use, the lifecycle stage where occupational
exposure is the greatest, are acceptable based on the quantitative modelling
conducted by the Agency.
 the potential adverse effects to workers from exposure to GF-1640 and
spinetoram, while irreversible, are voluntary.
8 Assessment of the potentially non-negligible benefits
8.1
The potentially non- negligible benefits associated with the approval of GF-1640
and spinetoram identified by the Agency are set out in paragraph 4.12. The
Committee considers that the following benefits are likely to be realised though the
approval of these substances:
8.1.1
Greater choice for end users of pesticides in terms of potential price
competition.
8.1.2
The availability of a relatively low risk product in terms of GF-1640. The
Committee considers this is a significant benefit from a human health
perspective and in terms the Authority’s risk reduction aims.
8.1.3
The ability to manufacture Gf-1640 in New Zealand. The Committee
considers and the potential benefits associated with manufacture of GF1640 in New Zealand relate to employment and trade opportunities.
8.1.4
The availability of a “new” relatively low hazard active ingredient,
spinetoram, that may be used in the development of other products. The
Committee considers this is of significant benefit from both a human
health perspective and in terms of the Authority’s risk reduction aims.
8.2
In assessing these benefits the Committee notes that it is unable to put any
monetary value on the benefits offered.
8.3
In accordance with sections 29(1)(a)(iii) and 29(1)(b)(iii), the Committee considers
that if GF-1640 and spinetoram were not made available, the benefits offered could
not be realised.
ERMA New Zealand Decision: Application HSR06141
Page 13 of 39
9 Comparison of risks, cost and benefits
9.1
As there are a number of non-negligible adverse effects, clause 27 applies and the
Committee must take into account the extent to which the risks and costs
associated with the manufacture or import for release of GF-1640 and import of
spinetoram as a component for manufacture may be outweighed by benefits,
several of which were determined to be significant or non-negligible.
9.2
Clause 34 sets out the process for evaluating the combined impact of risks, costs
and benefits. The use of common units of measurement is not feasible due to the
widely differing nature of the effects.
9.3
The Committee concluded that the risks associated with GF-1640 and spinetoram
are reasonably well understood and will be adequately managed by controls in the
interim. Any uncertainty is considered to be adequately covered by the temporary
ADE and PDE values, which will be reviewed when the additional data becomes
available.
9.4
Accordingly, while the Committee has identified potentially non-negligible risks
associated with the release of GF-1640 and spinetoram, the Committee is satisfied
that these risks and costs are outweighed by the benefits.
10 Recommendations
10.1
The Committee recommends that, should inappropriate or accidental use, transport
or disposal of either GF-1640 or spinetoram 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.
11 Environmental User Charges
11.1
The Committee considers that the application of controls to GF-1640 and
spinetoram 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 these substances as an alternative or
additional means of achieving effective risk management.
12 Decision
12.1
The Committee determines that:
12.1.1
GF-1640 has the following hazard classifications:
Hazardous Property
Target organ systemic toxicity
Aquatic ecotoxicity
Terrestrial invertebrate ecotoxicity
ERMA New Zealand Decision: Application HSR06141
Classification
6.9B
9.1A
9.4A
Page 14 of 39
12.1.2
Spinetoram has the following hazard classifications:
Hazardous Property
Contact sensitisation
Target organ systemic toxicity
Aquatic ecotoxicity
Terrestrial invertebrate ecotoxicity
Classification
6.5B
6.9B
9.1A
9.4A
12.1.3
pursuant to section 29 and clause 27, the positive effects (benefits) of the
substances outweigh the adverse effects (risks and costs).
12.1.4
the application for importation or manufacture and release of the
hazardous substance, GF-1640, is thus approved with controls as listed in
Appendix 1.
12.1.5
the application for importation and use of the hazardous substance,
spinetoram, as a component in the manufacture of other substances is
thus approved with controls as listed in Appendix 2.
12.2
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.
12.3
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.
31 July 2007
Dr. Max Suckling
Date:
Chair
Substance Identifier
ERMA New Zealand Approval Code:
GF-1640
HSR007822
Spinetoram
HSR007823
ERMA New Zealand Decision: Application HSR06141
Page 15 of 39
Appendix 1: Controls for GF-1640
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 4 of this document.
Control
Code1
Regulation2 Explanation3
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of toxic substances.
The DoL WES values for component D in GF-1640 are adopted.
T4/E6
7
T5
8
The value or values specified in the document described in “Workplace Exposure
Standards”, published by the Occupational Safety and Health Service, Department of
Labour, January 2002, ISBN 0-477-03660-0. Also available at
www.osh.govt.nz/order/catalogue/pdf/wes2002.pdf.
Requirements for equipment used to handle hazardous substances
Any equipment used to handle GF-1640 (e.g. spray equipment) must retain
and/or dispense the substance in the manner intended, i.e. without leakage,
and must be accompanied by sufficient information so that this can be
achieved.
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when GF-1640 is being
handled.
The clothing/equipment must be designed, constructed and operated to
ensure that the person does not come into contact with GF-1640, and is not
directly exposed to a concentration of GF-1640 that is greater than the WES
for that substance.
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how the
clothing/equipment may be used, and the requirements for maintaining the
clothing/equipment.
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
E1
32-45
Limiting exposure to ecotoxic substances
This control relates to the setting of environmental exposure limits (EELs).
An EEL establishes the maximum concentration of an ecotoxic substance
legally allowable in a particular (non target) environmental medium (e.g. soil
or sediment or water), including deposition of a substance onto surfaces (e.g.
as in spray drift deposition).
An EEL can be established by one of three means:
 applying the default EELs specified;
 adopting an established EEL;
 calculating an EEL from an assessment of available ecotoxicological data.
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.
2 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.
3 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
1
ERMA New Zealand Decision: Application HSR06141
Page 16 of 39
Control
Code1
E2
Regulation2
46-48
Explanation3
No EEL values are set, at this time, for GF-1640 and the default EELs
are deleted.
Restrictions on use within application area
These Regulations relate to controls on application areas. An application
(target) area is an area that the person using the substance either has control
over or is otherwise authorised to apply the substance to. For ecotoxic
substances that are intentionally released into the environment (e.g.
pesticides), any EEL controls will not apply within the application (target)
area providing the substance is applied at a rate that does not exceed the
allowed application rate. In addition, any approved handler controls (T6,
Regulation 9) do not apply once the substance has been applied or laid.
In recognition of the need to limit adverse effects within the target area,
Regulations have been prescribed to restrict the use of the substance within
the target area. These include a requirement to set an application rate for any
substance designed for biocidal action for which an EEL has been set. The
application rate must not be greater than the application rate specified in the
application for approval, or not greater than a rate calculated in a similar
manner to that used to calculate EELs (with the proviso that the product of
the uncertainty factors must not exceed 100).
No maximum application rate is set for GF-1640 at this time.
E3
E5
49
5(2), 6
Controls relating to protection of beneficial non-target terrestrial
invertebrates
GF-1640 must not be used in situations where it may pose a high risk to
honeybees.
A person must not apply GF-1640:
 in an area where bees are foraging and the substance is in a form in which
bees are likely to be exposed to it; or
 on specific plants likely to be visited by bees if the plant is in open flower
or part bloom, or is likely to flower within a specified period of time
following application of the substance (not longer than 10 days).
Requirements for keeping records of use
A person using GF-1640 must keep written records of that use if 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 information to be provided in the record is described in Regulation 6(1).
The record must be kept for a minimum of three years following the use and
must be made available to an enforcement officer on request.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of GF-1640, in terms of:
 information that must be “immediately available” (i.e. priority and
secondary identifiers), which is generally provided by way of the product
label;
 documentation that must be available in the workplace, which is generally
provided by way of SDS;
 signage at a place where there is a large quantity of GF-1640.
ERMA New Zealand Decision: Application HSR06141
Page 17 of 39
Control
Code1
I1
Regulation2
6, 7, 32-35,
36 (1)-(7)
Explanation3
General identification requirements
These controls relate to the duties of suppliers and persons in charge of GF1640 with respect to identification (essentially labelling) (Regulations 6 and 7),
accessibility of the required information (Regulations 32 and 33) and
presentation of the required information with respect to comprehensibility,
clarity and durability (Regulations 34, 35, 36(1)-(7)).
Regulation 6 – Identification duties of suppliers
Suppliers of GF-1640 must ensure it is labelled with all relevant priority
identifier information (as required by Regulations 8-17) and secondary
identifier information (as required by Regulations 18-30) before supplying it
to any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within two
seconds (Regulation 32), and the secondary identifier information available
within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does not
in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of GF-1640 must ensure it is labelled with all relevant
priority identifier information (as required by Regulations 8 to 17) and
secondary identifier information (as required by Regulations 18 to 30) before
supplying it to any other person. This includes ensuring that the priority
identifier information is available to any person handling the substance within
two seconds (Regulation 32), and the secondary identifier information is
available within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, e.g. on the label.
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, e.g. on the label.
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way that
meets the performance standards in these Regulations. In summary:
 any information provided (either written or oral) must be readily
understandable and in English;
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions;
 any information provided in an audible form must be able to be easily
heard by a person with average hearing;
 any information provided must be in a durable format i.e. the
information requirements with respect to clarity must be able to be met
throughout the lifetime of the (packaged) substance under the normal
conditions of storage, handling and use.
ERMA New Zealand Decision: Application HSR06141
Page 18 of 39
Control
Code1
I3
Regulation2
9
I9
18
I11
20
I16
25
I17
26
Explanation3
Priority identifiers for ecotoxic substances
This requirement specifies that GF-1640 must be prominently identified as
being ecotoxic.
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Secondary identifiers for all hazardous substances
This control relates to detail required on the product label for GF-1640. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it; and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone; and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for GF-1640. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information must be provided on the GF-1640 label:
 an indication of the circumstances in which it may harm living organisms;
 an indication of the kind and extent of the harm it is likely to cause to
living organisms;
 an indication of the steps to be taken to prevent harm to living
organisms;
an indication of the general type and degree of hazard (e.g. very toxic to
aquatic life, very toxic to terrestrial invertebrates).
Secondary identifiers for toxic substances
This control relates to the additional label detail required for GF-1640. This
information must be accessible within 10 seconds (Regulation 33) and could
be provided on secondary panels on the product label. The following
information must be provided:
 an indication of its general type and degree of toxic hazard;
 an indication of the circumstances in which it may harm human beings;
 an indication of the kinds of harm it may cause to human beings, and the
likely extent of each kind of harm;
 an indication of the steps to be taken to prevent harm to human beings.
 the name and concentration of spinetoram.
Use of Generic Names
This control provides the option of using a generic name to identify groups
of ingredients where such ingredients are required to be listed on the GF1640 product label as specified by Regulations 19(f) and 25(e) and (f).
The generic name must identify the key chemical entities and functional
groups in the ingredients that contribute to their hazardous properties.
[Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the
ERMA New Zealand Decision: Application HSR06141
Page 19 of 39
Control
Code1
Regulation2
I18
27
I19
29-31
Explanation3
product label, the name and concentration of spinetoram].
Use of Concentration Ranges
This control provides the option of providing concentration ranges for those
ingredients in GF-1640 whose concentrations are required to be stated on the
product label as specified by Regulations 19(f) and 25(e) and (f).
[Regulations 19(f) and 25 (e) and (f) specify a requirement to list on the
product label, the name and concentration of spinetoram].
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when GF1640 is contained in fixed bulk containers or bulk transport containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of GF-1640.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if GF-1640 is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when GF-1640 is in multiple packaging
and the outer packaging obscures some or all of the required substance
information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information (i.e. the
hazardous properties of the substance must be identified); or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant; or
 bear the EU pictogram “Dangerous to the Environment” (‘dead fish and
tree’ on orange background); or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
Regulations inserted under section 77A:
30A Single container packaging for export-only substances
(1)
Packaging of export-only substances in single containers, whether
contained within a multiple package or not, may comply with the
labelling requirements of—
(a)
the Food and Agricultural Organisation of the United
Nations (FAO), Guidelines on Good Labelling Practice for
Pesticides 1995; or
(b)
the labelling requirements of a regulatory authority recognised
by ERMA New Zealand in the country of destination.
(2) If packaging complies with (1), it need not comply with—
(a)
regulations 11 and 12 of the Hazardous Substances
(Disposal) regulations 2001; and
(b)
regulations 6 to 8 of the Hazardous Substances (Emergency
Management) Regulations 2001; and
ERMA New Zealand Decision: Application HSR06141
Page 20 of 39
Control
Code1
Regulation2
Explanation3
(c)
regulations 6 to 9, 11, 13, 14, 18, 19, 20, 22, 24, 25,
36(8) of the Hazardous Substances (Identification)
Regulations 2001.
30B Multiple packaging for export-only substances
(1)
(2)
(3)
(4)
(5)
(6)
I21
37-39, 47-50
This subclause applies only to export-only substances in multiple
packages.
The outer packaging of a multiple package to which subclause (1)
applies must bear:
(a)
the information required by whichever of regulations 8 to 14
applies to the substance; or
(b)
the labelling or marking required by—
(i)
the Land Transport Rule 45001/1: Dangerous
Goods 2005; or
(ii)
Civil Aviation Rules: Part 92 – Carriage of
Dangerous Goods; or
(iii)
Maritime Rules: Part 24A – Carriage of Cargoes
– Dangerous Goods (MR024A); or
(c)
the pictogram for “Dangerous to the Environment” as
described in directive 92/32/EEC (instead of the identifier
requirements of regulations 9 and 20); or
(d)
the relevant class or subclass label assigned by the UN
Model Regulations.
An export-only substance to which subclause (1) applies must be
identified by enough information to enable its New Zealand supplier or
manufacturer to be contacted, either in person or by telephone.
An export-only substance to which subclause (1) applies shall not have
on its packaging, or with it, any information suggesting that it belongs
to a class or subclass it does not in fact belong to.
An export-only substance which complies with subclauses (2) to (4) of
this regulation need not comply with regulations 18 to 25 and 30.
Any requirement to label the outer packaging of a multiple package of
an export-only substance as containing a substance that is hazardous
to the environment/ecotoxic, specified in subclauses (2) to (4), is
omitted when the substance is stored in New Zealand in a secure
warehouse or other secure storage facility owned, operated or otherwise
under the control of the manufacturer or the shipping agent prior to
exportation from New Zealand.]
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for GF-1640
when imported into New Zealand in a closed package or in a freight
container and will be transported to its destination without being removed
from that package or container. In these situations, it is sufficient compliance
with HSNO if the package or container is labelled or marked in compliance
with the requirements of the Land Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially Safety
Data Sheets) (Regulations 37, 38 and 50); the general content requirements of
the documentation (Regulation 39 and 47); the accessibility and presentation
of the required documentation with respect to comprehensibility and clarity
(Regulation 48).
These controls are triggered when GF-1640 is held in the workplace in
ERMA New Zealand Decision: Application HSR06141
Page 21 of 39
Control
Code1
Regulation2
Explanation3
quantities equal to or greater than 3 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of GF-1640 equal to or greater than 3 kg, if the substance is to be
used in a place of work and the supplier has not previously provided the
documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where GF-1640 is present in
quantities equal to or greater than 3 kg, must ensure that every person
handling the substance has access to the documentation required. The
person in charge must also ensure that the documentation does not contain
any information that suggests that GF-1640 belongs to a class or subclass it
does not in fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with GF-1640 must include the following
information:
 the unequivocal identity of the substance (e.g. the CAS number, chemical
name, common name, UN number, registered trade name(s));
 a description of the physical state, colour and odour of the substance;
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and the
nature of those changes;
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur;
 contact details for the New Zealand supplier / manufacturer /importer;
 all emergency management and disposal information required for the
substance;
 the date on which the documentation was prepared;
 the name, concentration and CAS number of spinetoram.
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (e.g. as provided on an SDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3 m.
ERMA New Zealand Decision: Application HSR06141
Page 22 of 39
Control
Code1
Regulation2
I23
41
I28
46
I29
51-52
Explanation3
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
Specific documentation requirements for ecotoxic substances
The documentation provided with GF-1640 must include the following
information:
 its general degree and type of ecotoxic hazard (e.g. very ecotoxic in the
aquatic environment);
 a full description of the circumstances in which it may harm living
organisms and the extent of that harm;
 a full description of the steps to be taken to prevent harm to living
organisms;
 a summary of the available acute and chronic (ecotox) data used to define
the (ecotox) subclass or subclasses in which it is classified;
 its bio-concentration factor or octanol-water partition coefficient;
 its expected soil or water degradation rate;
 any EELs set by the Authority.
Specific documentation requirements for toxic substances
The documentation provided with GF-1640 must include the following
information:
 its general degree and type of toxic hazard;
 a full description of the circumstances in which it may harm human
beings;
 the kinds of harm it may cause to human beings;
 a full description of the steps to be taken to prevent harm to human
beings;
 the percentage of volatile substance in the liquid formulation, and the
temperature at which the percentages were measured;
 a summary of the available acute and chronic (toxicity) data used to
define the (toxic) subclass or subclasses in which it is classified;
 the symptoms or signs of injury or ill health associated with each likely
route of exposure;
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health;
 any TELs or WESs set by the Authority.
Duties of persons in charge of places with respect to signage
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where hazardous substances are held in
quantities exceeding the amounts specified in Schedule 3 of the Identification
Regulations. Where a substance triggers more than one hazard classification,
the most stringent quantity generally applies.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
ERMA New Zealand Decision: Application HSR06141
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Control
Code1
Regulation2
Explanation3
 at each entrance to rooms or compartments where hazardous substances
are present;
 immediately adjacent to the area where hazardous substances are located
in an outdoor area.
The information provided in the signage needs to be understandable over a
distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances;
 describe the general type of hazard of each substance (e.g. flammable);
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (e.g. a 'No Smoking' warning near flammable substances).
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
affecting choice of suitable packaging, and compatibility of the substance with
any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for GF-1640 must ensure that, when the package is closed, there is
no visible release of the substance, and that it maintains its ability to retain its
contents in temperatures from –10oC to +50oC. The packaging must also
maintain its ability to retain its remaining contents if part of the contents is
removed from the package and the packaging is then re-closed. The
packaging in direct contact with the substance must not be significantly
affected or weakened by contact with the substance such that the foregoing
requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing GF-1640 must not be marked in accordance with the
UN Model Regulations unless:
 the markings comply with the relevant provisions of that document; and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively; and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
When packing GF-1640, account must be taken of its physical state and
properties, and packaging must be selected that complies with the
requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
GF-1640 must not be packed in packaging that has been previously packed
with substances with which it is incompatible unless all traces of the previous
substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain GF-1640 in New Zealand if it has
been constructed, marked and tested as a large package as provided in
Chapter 6.6 of the 13th revised edition of the UNRTDG, 2003.
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Control
Code1
Explanation3
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004; or
 a stationary container system, a stationary tank or a tank (as defined in the
Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
P3
9
Packaging requirements for ecotoxic substances
P15
21
GF-1640 that is packaged in quantities of more than 5 L must be packaged
according to Schedule 3 (UN PGIII), but must be packaged according to
either Schedule 3 or Schedule 4 when in quantities equal to or less than 5 kg.
PG3
Schedule 3
This schedule describes the (minimum) packaging requirements that must be
complied with for GF-1640 when packaged in quantities of more than 5 kg
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 for GF-1640 when packaged in quantities equal to or less than
5 kg.
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for GF-1640
D5
9
GF-1640 must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with any
other substance prior to discharge to the environment; or
 discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of the
environment outside the mixing zone does not exceed any TEL (tolerable
exposure limit) or EEL (environmental exposure limit) set by the
Authority for that substance; or
 exporting the substance from New Zealand as a hazardous waste.
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained GF1640 and are no longer to be used for that purpose. Such packages must be
either decontaminated/treated or rendered incapable of containing any
substance (hazardous or otherwise) and then disposed of in a manner that is
consistent with the disposal requirements for the substance. In addition, the
manner of disposal must take into account the material that the package is
manufactured from.
D7
11, 12
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying a
quantity of GF-1640 that exceeds 0.1 kg.
D8
Regulation2
13, 14
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in an SDS) that must be provided when selling or supplying a
ERMA New Zealand Decision: Application HSR06141
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Control
Code1
Regulation2
Explanation3
quantity of GF-1640 that exceeds 3 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in Regulations
48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with GF-1640 when present in
quantities equal to or greater than 0.1 kg.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
EM7
8(f)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for ecotoxic substances
The following information must be provided when GF-1640 is present in
quantities equal to or greater than 0.1 kg:
 a description of the parts of the environment likely to be immediately
affected by it;
 a description of its typical effects on those parts of the environment;
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management documentation requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Safety Data Sheets). This documentation must be
provided where GF-1640 is sold or supplied, or held in a workplace, in
quantities equal to or greater than 3 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes
the duties of persons in charge of places of work, regulation 15 provides for
the option of complying with documentation requirements of the transport
rules when the substance is being transported, and regulation 16 specifies
requirements for general contents of the documentation.
EM11
25-34
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
regulations (code I21).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where hazardous
ERMA New Zealand Decision: Application HSR06141
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Control
Code1
EM13
Regulation2
42
Explanation3
substances are held (or reasonably likely to be held on occasion) in quantities
greater than 100 kg.
The emergency response plan must describe all of the likely emergencies that
may arise from the breach or failure of controls. The type of information
that is required to be included in the plan is specified in Regulations 29 to 30.
Requirements relating to the availability of equipment, materials and people
are provided in Regulation 31, requirements regarding the availability of the
plan are provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where GF-1640 are held at quantities equal to or greater
than 100 kg.
The signage must advise of the action to be taken in an emergency and must
meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
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.
Section 77A Additional Controls
GF-1640 shall only be used as a pesticide.
GF-1640 shall not be applied onto or into water.
The following temporary ADE and PDE values are set for spinetoram in GF-1640
ADEspinetoram
0.03 mg/kg bw/day
spinetoram PDEfood
0.024 mg/kg bw/day
spinetoram PDEwater
0.006 mg/kg bw/day
The applicant, Dow AgroSciences (NZ) Limited shall supply; at their completion, the following studies:
 long term chronic toxicity/carcinogenicity studies for two mammalian species.
 a multigenerational mammalian reproductive toxicity study.
The applicant, Dow AgroSciences (NZ) Limited shall cover the costs associated with the review of the
required data and setting of a permanent ADE value and associated PDE values for spinetoram and GF1640.
Clauses 30A and 30B have been inserted immediately after regulation 30 of the Hazardous Substances
(Identification) Regulations 2001, refer control I19.
Note: The regulations 30A and 30B apply to substances that are destined for export from New Zealand.
ERMA New Zealand Decision: Application HSR06141
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Appendix 2: Controls for spinetoram.
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 4 of this document.
Control
Code4
Regulation5 Explanation6
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property Controls
T2
29, 30
Controlling exposure in places of work
A workplace exposure standard (WES) is designed to protect persons in the
workplace from the adverse effects of toxic substances.
No WES values are set for spinetoram at this time.
T4/E6
7
T5
8
Requirements for equipment used to handle hazardous substances
Any equipment used to handle spinetoram (e.g. packaging equipment) must
retain and/or dispense the substance in the manner intended, i.e. without
leakage, and must be accompanied by sufficient information so that this can
be achieved.
Requirements for protective clothing and equipment
Protective clothing/equipment must be employed when spinetoram is being
handled.
The clothing/equipment must be designed, constructed and operated to
ensure that the person does not come into contact with spinetoram, and is
not directly exposed to a concentration of spinetoram that is greater than the
WES for that substance.
The person in charge must ensure that people using the protective
clothing/equipment have access to sufficient information specifying how the
clothing/equipment may be used, and the requirements for maintaining the
clothing/equipment.
T7
10
Restrictions on the carriage of hazardous substances on passenger
service vehicles
In order to limit the potential for public exposure to hazardous substances,
the maximum quantity per package of spinetoram permitted to be carried on
passenger service vehicles is 0.5 kg.
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 - Ecotoxic Property
Controls
E1
32-45
Limiting exposure to ecotoxic substances
This control relates to the setting of environmental exposure limits (EELs).
An EEL establishes the maximum concentration of an ecotoxic substance
legally allowable in a particular (non target) environmental medium (e.g. soil
or sediment or water), including deposition of a substance onto surfaces (e.g.
as in spray drift deposition).
An EEL can be established by one of three means:
(2) applying the default EELs specified;
(3) adopting an established EEL;
(4) calculating an EEL from an assessment of available ecotoxicological data.
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.
6 These explanations are for guidance only. Refer to the cited Regulations for the formal specification, and for definitions and exemptions.
4
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Control
Code4
E3
E5
Regulation5
49
5(2), 6
Explanation6
No EEL values are set, at this time, for spinetoram and the default
EELs are deleted.
Controls relating to protection of beneficial non-target terrestrial
invertebrates
Spinetoram must not be used in situations where it may pose a high risk to
honeybees.
A person must not apply spinetoram:
 in an area where bees are foraging and the substance is in a form in which
bees are likely to be exposed to it; or
 on specific plants likely to be visited by bees if the plant is in open flower
or part bloom, or is likely to flower within a specified period of time
following application of the substance (not longer than 10 days).
Requirements for keeping records of use
A person using spinetoram must keep written records of that use if 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 information to be provided in the record is described in Regulation 6(1).
The record must be kept for a minimum of three years following the use and
must be made available to an enforcement officer on request.
E6
7
Requirements for equipment used to handle ecotoxic substances
Any equipment used to handle spinetoram (e.g. spray equipment) must retain
and/or dispense the substance in the manner intended, i.e. without leakage,
and must be accompanied by sufficient information so that this can be
achieved.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of spinetoram, in terms of:
 information that must be “immediately available” (i.e. priority and
secondary identifiers), which is generally provided by way of the product
label;
 documentation that must be available in the workplace, which is generally
provided by way of SDS;
 signage at a place where there is a large quantity of spinetoram.
I1
6, 7, 32-35,
General identification requirements
36 (1)-(7)
These controls relate to the duties of suppliers and persons in charge of
spinetoram with respect to identification (essentially labelling) (Regulations 6
and 7), accessibility of the required information (Regulations 32 and 33) and
presentation of the required information with respect to comprehensibility,
clarity and durability (Regulations 34, 35, 36(1)-(7)).
Regulation 6 – Identification duties of suppliers
Suppliers of spinetoram must ensure it is labelled with all relevant priority
identifier information (as required by Regulations 8-17) and secondary
identifier information (as required by Regulations 18-30) before supplying it
to any other person. This includes ensuring that the priority identifier
information is available to any person handling the substance within two
seconds (Regulation 32), and the secondary identifier information available
within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with the substance
(or its packaging) that suggests it belongs to a class or subclass that it does not
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
Explanation6
in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of spinetoram must ensure it is labelled with all relevant
priority identifier information (as required by Regulations 8 to 17) and
secondary identifier information (as required by Regulations 18 to 30) before
supplying it to any other person. This includes ensuring that the priority
identifier information is available to any person handling the substance within
two seconds (Regulation 32), and the secondary identifier information is
available within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with the
substance (or its packaging) that suggests it belongs to a class or subclass that
it does not in fact belong to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17) must
be available within two seconds, e.g. on the label.
All secondary identifier Information (as required by Regulations 18 to 30)
must be available within 10 seconds, e.g. on the label.
I3
I9
9
18
Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of
information
All required priority and secondary identifiers must be presented in a way that
meets the performance standards in these Regulations. In summary:
 any information provided (either written or oral) must be readily
understandable and in English;
 any information provided in written or pictorial form must be able to be
easily read or perceived by a person with average eyesight under normal
lighting conditions;
 any information provided in an audible form must be able to be easily
heard by a person with average hearing;
 any information provided must be in a durable format i.e. the
information requirements with respect to clarity must be able to be met
throughout the lifetime of the (packaged) substance under the normal
conditions of storage, handling and use.
Priority identifiers for ecotoxic substances
This requirement specifies that spinetoram must be prominently identified as
being ecotoxic.
This information must be available to any person handling the substance
within two seconds (Regulation 32) and can be provided by way of signal
headings or commonly understood pictograms on the label.
Secondary identifiers for all hazardous substances
This control relates to detail required on the product label for spinetoram.
This information must be accessible within 10 seconds (Regulation 33) and
could be provided on secondary panels on the product label. The following
information is required:
 an indication (which may include its common name, chemical name, or
registered trade name) that unequivocally identifies it; and
 enough information to enable its New Zealand importer, supplier, or
manufacturer to be contacted, either in person or by telephone; and
 in the case of a substance which, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class or
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Control
Code4
Regulation5
I11
20
I16
25
I17
26
Explanation6
subclass, a description of each likely change and the date by which it is
likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for spinetoram.
This information must be accessible within 10 seconds (Regulation 33) and
could be provided on secondary panels on the product label. The following
information must be provided on the spinetoram label:
 an indication of the circumstances in which it may harm living organisms;
 an indication of the kind and extent of the harm it is likely to cause to
living organisms;
 an indication of the steps to be taken to prevent harm to living
organisms;
 an indication of the general type and degree of hazard (e.g. very toxic to
aquatic life and very toxic to terrestrial invertebrates).
Secondary identifiers for toxic substances
This control relates to the additional label detail required for spinetoram.
This information must be accessible within 10 seconds (Regulation 33) and
could be provided on secondary panels on the product label. The following
information must be provided:
 an indication of its general type and degree of toxic hazard;
 an indication of the circumstances in which it may harm human beings;
 an indication of the kinds of harm it may cause to human beings, and the
likely extent of each kind of harm;
 an indication of the steps to be taken to prevent harm to human beings;
 the name and concentration of spinetoram.
Use of Generic Names
This control provides the option of using a generic name to identify groups
of ingredients where such ingredients are required to be listed on the
spinetoram product label as specified by Regulation 25(e).
The generic name must identify the key chemical entities and functional
groups in the ingredients that contribute to their hazardous properties.
I18
I19
27
29-31
[Regulation 25(e) specifies a requirement to list on the product label the name
of spinetoram].
Use of Concentration Ranges
This control provides the option of providing concentration ranges for those
ingredients in spinetoram whose concentrations are required to be stated on
the product label as specified by Regulation 25(e).
[Regulation 25(e) specifies a requirement to list on the product label the name
of spinetoram].
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority and
secondary identifier information required by Regulations 8 to 25 when
spinetoram is contained in fixed bulk containers or bulk transport containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of
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Control
Code4
Regulation5
Explanation6
spinetoram.
Regulation 29(2) specifies that for bulk transport containers, it is sufficient
compliance if spinetoram is labelled or marked in compliance with the
requirements of the Land Transport Rule 45001, Civil Aviation Act 1990 or
Maritime Transport Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when spinetoram is in multiple packaging
and the outer packaging obscures some or all of the required substance
information. In such cases, the outer packaging must:
 be clearly labelled with all relevant priority identifier information (i.e. the
hazardous properties of the substance must be identified); or
 be labelled or marked in compliance with either the Land Transport Rule
45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as
relevant; or
 bear the EU pictogram “Dangerous to the Environment” (‘dead fish and
tree’ on orange background); or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
I21
37-39, 47-50
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for
spinetoram when imported into New Zealand in a closed package or in a
freight container and will be transported to its destination without being
removed from that package or container. In these situations, it is sufficient
compliance with HSNO if the package or container is labelled or marked in
compliance with the requirements of the Land Transport Rule 45001.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially Safety
Data Sheets) (Regulations 37, 38 and 50); the general content requirements of
the documentation (Regulation 39 and 47); the accessibility and presentation
of the required documentation with respect to comprehensibility and clarity
(Regulation 48).
These controls are triggered when spinetoram is held in the workplace in
quantities equal to or greater than 3 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant information
required by Regulations 39 to 48 when selling or supplying to another person
a quantity of spinetoram equal to or greater than 3 kg, if the substance is to
be used in a place of work and the supplier has not previously provided the
documentation to that person.
Regulation 38 – Documentation duties of persons in charge of places of work
The person in charge of any place of work where spinetoram is present in
quantities equal to or greater than 3 kg, must ensure that every person
handling the substance has access to the documentation required. The
person in charge must also ensure that the documentation does not contain
any information that suggests that spinetoram belongs to a class or subclass it
does not in fact belong to.
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
Explanation6
Regulation 39 – General content requirements for documentation
The documentation provided with spinetoram must include the following
information:
 the unequivocal identity of the substance (e.g. the CAS number, chemical
name, common name, UN number, registered trade name(s));
 a description of the physical state, colour and odour of the substance;
 if the substance’s physical state may alter over the expected range of
workplace temperatures, the documentation must include a description of
the temperatures at which the changes in physical state may occur and the
nature of those changes;
 in the case of a substance that, when in a closed container, is likely to
become more hazardous over time or develop additional hazardous
properties, or become a hazardous substance of a different class, the
documentation must include a description of each likely change and the
date by which it is likely to occur;
 contact details for the New Zealand supplier / manufacturer /importer;
 all emergency management and disposal information required for the
substance;
 the date on which the documentation was prepared;
 the name, concentration and CAS number of spinetoram.
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (e.g. as provided on an SDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of the substance by the Authority, it is sufficient compliance with
those Regulations if reference is made to that information requirement along
with a comment indicating that such information is not applicable to that
substance.
Regulation 48 – Location and presentation requirements for documentation
All required documentation must be available to a person handling the
substance in a place of work within 10 minutes. The documentation must be
readily understandable by any fully-trained worker required to have access to
it and must be easily read, under normal lighting conditions, at a distance of
not less than 0.3 m.
Regulation 49 – Documentation requirements for vehicles
This Regulation provides for the option of complying with documentation
requirements as specified in the various Land, Sea and Air transport rules
when the substance is being transported.
I23
41
Regulation 50 – Documentation to be supplied on request
Notwithstanding Regulation 37 above, a supplier must provide the required
documentation to any person in charge of a place of work (where a hazardous
substance is present) if asked to do so by that person.
Specific documentation requirements for ecotoxic substances
The documentation provided with spinetoram must include the following
information:
 its general degree and type of ecotoxic hazard (e.g. very ecotoxic in the
aquatic environment, very toxic to terrestrial invertebrates);
 a full description of the circumstances in which it may harm living
organisms and the extent of that harm;
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
I28
46
I29
51-52
Explanation6
 a full description of the steps to be taken to prevent harm to living
organisms;
 a summary of the available acute and chronic (ecotox) data used to define
the (ecotox) subclass or subclasses in which it is classified;
 its bio-concentration factor or octanol-water partition coefficient;
 its expected soil or water degradation rate;
 any EELs set by the Authority.
Specific documentation requirements for toxic substances
The documentation provided with spinetoram must include the following
information:
 its general degree and type of toxic hazard;
 a full description of the circumstances in which it may harm human
beings;
 the kinds of harm it may cause to human beings;
 a full description of the steps to be taken to prevent harm to human
beings;
 the percentage of volatile substance in the liquid formulation, and the
temperature at which the percentages were measured;
 a summary of the available acute and chronic (toxicity) data used to
define the (toxic) subclass or subclasses in which it is classified;
 the symptoms or signs of injury or ill health associated with each likely
route of exposure;
 the dose, concentration, or conditions of exposure likely to cause injury
or ill health;
 any TELs or WESs set by the Authority.
Duties of persons in charge of places with respect to signage
Duties of persons in charge of places with respect to signage
These controls specify the requirements for signage, in terms of content,
presentation and positioning at places where hazardous substances are held in
quantities exceeding the amounts specified in Schedule 3 of the Identification
Regulations. Where a substance triggers more than one hazard classification,
the most stringent quantity generally applies.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where hazardous substances are present
 at each entrance to rooms or compartments where hazardous substances
are present;
 immediately adjacent to the area where hazardous substances are located
in an outdoor area.
The information provided in the signage needs to be understandable over a
distance of 10 metres and be sufficient to:
 advise that the location contains hazardous substances;
 describe the general type of hazard of each substance (e.g. flammable);
 where the signage is immediately adjacent to the hazardous substance
storage areas, describe the precautions needed to safely manage the
substance (e.g. a 'No Smoking' warning near flammable substances).
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
These controls relate to the ability of the packaging to retain its contents,
allowable packaging markings with respect to design approvals, factors
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
Explanation6
affecting choice of suitable packaging, and compatibility of the substance with
any previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for spinetoram must ensure that, when the package is closed, there
is no visible release of the substance, and that it maintains its ability to retain
its contents in temperatures from –10oC to +50oC. The packaging must also
maintain its ability to retain its remaining contents if part of the contents is
removed from the package and the packaging is then re-closed. The
packaging in direct contact with the substance must not be significantly
affected or weakened by contact with the substance such that the foregoing
requirements cannot be met.
Regulation 6 – Packaging markings
Packages containing spinetoram must not be marked in accordance with the
UN Model Regulations unless:
 the markings comply with the relevant provisions of that document; and
 the packaging complies with the tests set out in Schedule 1, 2 or 3
(Packaging Regulations) respectively; and
 the design of the packaging has been test certified as complying with
those tests.
Regulation 7(1) – Requirements when packing hazardous substance
When packing spinetoram, account must be taken of its physical state and
properties, and packaging must be selected that complies with the
requirements of Regulation 5, and Regulations 9 to 21.
Regulation 8 – Compatibility
spinetoram must not be packed in packaging that has been previously
packed with substances with which it is incompatible unless all traces
of the previous substance have been removed.
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain spinetoram in New Zealand if
it has been constructed, marked and tested as a large package as
provided in Chapter 6.6 of the 13th revised edition of the UNRTDG,
2003.
“Large Packaging” does not include:

P3
P15
9
21
PG3
Schedule 3
a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable Containers)
Regulations 2004; or
 a stationary container system, a stationary tank or a tank (as defined in the
Hazardous substances (Dangerous Goods and Scheduled Toxic
Substances) Transfer Notice 2004.
Packaging requirements for ecotoxic substances
spinetoram that is packaged in quantities of more than 5 L must be packaged
according to Schedule 3 (UN PGIII), but must be packaged according to
either Schedule 3 or Schedule 4 when in quantities equal to or less than 5 kg.
This schedule describes the (minimum) packaging requirements that must be
complied with for spinetoram when packaged in quantities of more than
5 kg. The tests in Schedule 3 correlate to the packaging requirements of UN
Packing Group III (UN PGIII).
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
PS4
Regulation5
Schedule 4
D7
11, 12
Explanation6
This schedule describes the minimum packaging requirements that must be
complied with for spinetoram when packaged in quantities equal to or less
than 5 kg
Hazardous Substances (Disposal) Regulations 2001
D4
8
Disposal requirements for spinetoram
D5
9
spinetoram must be disposed of by:
 treating the substance so that it is no longer a hazardous substance,
including depositing the substance in a landfill, incinerator or sewage
facility. However, this does not include dilution of the substance with any
other substance prior to discharge to the environment; or
 discharging the substance to the environment provided that after
reasonable mixing, the concentration of the substance in any part of the
environment outside the mixing zone does not exceed any TEL (tolerable
exposure limit) or EEL (environmental exposure limit) set by the
Authority for that substance; or
 exporting the substance from New Zealand as a hazardous waste.
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that contained
spinetoram and are no longer to be used for that purpose. Such packages
must be either decontaminated/treated or rendered incapable of containing
any substance (hazardous or otherwise) and then disposed of in a manner that
is consistent with the disposal requirements for the substance. In addition, the
manner of disposal must take into account the material that the package is
manufactured from.
Disposal information requirements
These controls relate to the provision of information concerning disposal
(essentially on the label) that must be provided when selling or supplying any
quantity of spinetoram.
Information must be provided on appropriate methods of disposal and
information may be supplied warning of methods of disposal that should be
avoided, i.e. that would not comply with the Disposal Regulations. Such
information must be accessible to a person handling the substance within 10
seconds and must comply with the requirements for comprehensibility,
clarity and durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
D8
13, 14
Disposal documentation requirements
These controls relate to the provision of documentation concerning disposal
(essentially in an SDS) that must be provided when selling or supplying a
quantity of spinetoram that exceeds 3 kg.
The documentation must describe one or more methods of disposal (that
comply with the Disposal Regulations) and describe any precautions that
must be taken. Such documentation must be accessible to a person handling
the substance at a place of work within 10 minutes and must comply with
the requirements for comprehensibility and clarity as described in Regulations
48(2), (3) and (4) of the Identification Regulations (code I21).
Hazardous Substances (Emergency Management) Regulations 2001
EM1
6, 7, 9-11
Level 1 emergency management information: General requirements
These controls relate to the provision of emergency management information
(essentially on the label) that must be provided with spinetoram when present
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
Explanation6
in quantities equal to or greater than 0.1 kg.
Regulation 6 describes the duties of suppliers, Regulation 7 describes the
duties of persons in charge of places, Regulation 9 describes the requirement
for the availability of the information (10 seconds) and Regulation 10 gives
the requirements relating to the presentation of the information with respect
to comprehensibility, clarity and durability. These requirements correspond
with those relating to secondary identifiers required by the Identification
Regulations (code I1, Regulations 6, 7, 32–35, 36(1)-(7)).
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the information
requirements of the transport rules when the substance is being transported.
Information requirements for toxic substances
The following information must be provided when spinetoram is present in
quantities equal to or greater than 1 kg:
 a description of the first aid to be given;
 a 24-hour emergency service telephone number.
Information requirements for ecotoxic substances
The following information must be provided when spinetoram is present in
quantities equal to or greater than 0.1 kg:
 a description of the parts of the environment likely to be immediately
affected by it;
 a description of its typical effects on those parts of the environment;
 a statement of any immediate actions that may be taken to prevent the
substance from entering or affecting those parts of the environment.
Level 2 emergency management documentation requirements
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to the provision of emergency management
documentation (essentially Safety Data Sheets). This documentation must be
provided where spinetoram is sold or supplied, or held in a workplace, in
quantities equal to or greater than 3 kg.
Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes
the duties of persons in charge of places of work, regulation 15 provides for
the option of complying with documentation requirements of the transport
rules when the substance is being transported, and regulation 16 specifies
requirements for general contents of the documentation.
EM11
25-34
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements correspond
with those relating to documentation required by the Identification
regulations (code I21).
Level 3 emergency management requirements – emergency response
plans
These Regulations relate to the requirement for an emergency response plan
to be available at any place (excluding aircraft or ships) where hazardous
substances are held (or reasonably likely to be held on occasion) in quantities
greater than 100 kg.
The emergency response plan must describe all of the likely emergencies that
may arise from the breach or failure of controls. The type of information
that is required to be included in the plan is specified in Regulations 29 to 30.
Requirements relating to the availability of equipment, materials and people
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5
EM13
42
Explanation6
are provided in Regulation 31, requirements regarding the availability of the
plan are provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management information
on signage at places where spinetoram are held at quantities equal to or
greater than 100 kg
The signage must advise of the action to be taken in an emergency and must
meet the requirements for comprehensibility and clarity as defined in
Regulations 34 and 35 of the Identification Regulations.
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.
Section 77A Additional Controls
Spinetoram shall not be manufactured in New Zealand.
(1)
Prohibition on use of spinetoram
(1)
No person may use spinetoram for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of another substance or product.

(2)
(1)
Despite subclause (1)(a), research and development using spinetoram does not include investigation
or experimentation in which the substance is discharged, laid or applied in or to the outdoor
environment.
Specification of spinetoram
Any person who (a) imports into New Zealand spinetoram, which that person has not previously imported; or
(b) had previously imported spinetoram, but has since changed the source of manufacture for
that hazardous substance,
must provide to the Authority in writing the information required by subclauses (3) and (4).
(2) The information required by subclause (1) must be provided prior to that substance being
imported; and
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the previous
source of manufacture, if such information has not previously been provided to the
Authority.
(3)
The information to be provided is (a) the name and address of the manufacturer of spinetoram;
(b) the specification of spinetoram including –
the manufacturer’s specifications including purity of the hazardous substance,
isomeric ratio where applicable, maximum impurity content and evidence to
support these, including details of analytical methods used. Where spinetoram
is produced at more than one manufacturing site, this information must be
provided for each site separately;
 the identity of any impurity, its origin, and the nature of its relationship to the active
component when the impurity is present at a concentration of 10g/kg or more;
 the identity of any impurity that is known to be of toxicological concern, its origin, and the
nature of its relationship to the active component when the impurity is present at a
concentration of less than 10g/kg.
ERMA New Zealand Decision: Application HSR06141
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Control
Code4
Regulation5 Explanation6
(4)
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c) its maximum concentration in the substance.
ERMA New Zealand Decision: Application HSR06141
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