decision - epa...page 2 of 26 decision on application for approval to import or manufacture zedd for...
TRANSCRIPT
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DECISION
31 March 2014
1. Summary
Substance Zedd
Application code APP202046
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”)
Application sub-type Category A
Applicant Zelam Limited
Purpose of the application To import or manufacture Zedd containing 50 g/L emamectin
benzoate as an insecticide for control of leafroller caterpillars in
berries, grapes, kiwifruit, avocados and pipfruit
Date application received 18 February 2014
Consideration date 1 April 2014
Considered by The Chief Executive1 of the Environmental Protection Authority (“the
EPA”)
Decision Approved with controls
Approval code HSR100922
Hazard classifications
(refer to Table 1, Section 4)
6.1D, 6.3B, 8.3A, 6.8B, 6.9B, 9.1A, 9.3B, 9.4A
1 The Chief Executive of the EPA has made the decision on this application under delegated authority in accordance with section 19 of the Act.
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2. Background
2.1. Zedd is a soluble concentrate containing emamectin benzoate as the active ingredient, plus other
components. It is intended for use as an insecticide for the control of leafroller insects in apples, pears,
berries, grapes, kiwifruit, avocados and pipfruit.
2.2. The applicant intends to import and manufacture Zedd into New Zealand. Zedd will be imported as a
fully formulated substance on pallets using approved registered carriers, packed and labelled in 0.2 to
10 L High Density Poly Ethylene (HDPE) containers. Each container is packaged into outers of 6 to 12
units.
2.3. Zedd will be manufactured at Zelam Ltd’s site in New Plymouth. This facility has ISO 9001
accreditation for the manufacturing and handling of chemicals, and quality control systems in place for
managing dust, spillage and wash-waters.
2.4. Zedd will be diluted in water for application on crops by conventional ground-based spray equipment
(ground-mounted spray boom) using high-volume directed foliar spray. The recommended application
rate for Zedd is 1 to 6 g active ingredient (a.i.)/ha in 1000 to 3000 L of water/ha for apples, pears,
berries, grapes, kiwifruit, avocados and pipfruit.
2.5. The product will be supplied to retailers and distributors, and used by commercial contractors and
farmers only. Domestic use of the product is not anticipated.
2.6. To avoid a requirement for disposal, the substance should be used completely, i.e. until the container
is emptied. Before disposing of the empty containers, users should triple rinse them and add the
rinsate to the spray tank for application ot crops requiring treatment. Empty containers can be recycled
through AgRecovery (0800 247 326, www.agrecovery.co.nz) or crushed or punctured and sent to a
landfill.
3. Process, consultation and reasons for non-notification
3.1. The application was lodged pursuant to section 28 of the Act.
3.2. The application contained sufficient information for the staff of the EPA (“the staff”) to undertake a full
assessment of the substance from a scientific and technical perspective.
3.3. WorkSafe New Zealand2, the Department of Conservation and the Ministry for Primary Industries
(ACVM group) were advised of the application on 20 February 2014 and invited to comment on it by
18 March 2014. No comments were received.
3.4. In accordance with section 53(2) of the Act, the application was not publicly notified as the staff
considered that there was unlikely to be significant public interest in it. This is because there are other
approved products available on the market containing the same active ingredient that are intended for
similar use as commercial insecticides.
2 previously The Ministry of Business, Innovation and Employment (Labour Group)
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4. Hazardous properties
4.1. The staff determined the hazard classification of Zedd based on the information provided by the
applicant and other available information as documented in Appendix A.
4.2. The classifications determined by the staff are the same as those submitted by the applicant (Table 1).
Table 1 Hazard classifications of Zedd as proposed by the applicant and the staff
Hazard Endpoint Applicant classification EPA classification
Acute toxicity (oral) 6.1D 6.1D
Skin irritancy 6.3B 6.3B
Eye corrosion 8.3A 8.3A
Respiratory sensitisation 6.5A 6.5A
Reproductive/ developmental toxicity 6.8B 6.8B
Target organ systemic toxicity 6.9B 6.9B
Aquatic ecotoxicity 9.1A 9.1A
Vertebrate ecotoxicity 9.3B 9.3B
Invertebrate ecotoxicity 9.4A 9.4A
5. Risk and benefit assessment
Assessment of risks to human health and the environment
5.1. Zedd is to be used in similar ways to other approved substances containing the same active
ingredient, emamectin benzoate. Accordingly, the risks to human health and the environment,
including acute toxicity (oral), skin irritancy, eye corrosion, reproductive and developmental toxicity,
target organ systemic toxicity, and toxicity to the aquatic environment and terrestrial environment
(vertebrates and invertebrates), are not likely to be significantly higher from the use of Zedd compared
to other approved substances containing the same active ingredient. Therefore, the assessment of
risks to human health and the environment for Zedd has been limited to a qualitative assessment.
5.2. The identification and qualitative assessment of the risks to human health and the environment
associated with Zedd are set out in Tables 2 and 3, respectively. More information is detailed in
Appendix B.
Relationship of Māori to the environment
5.3. Zedd triggers a number of hazardous properties giving rise to the potential for cultural risk.
5.4. The staff have considered this risk noting that the hazardous properties of Zedd have the potential to
cause the deterioration of the mauri of taonga, flora and fauna species, waterways, the environment
and the general health and well-being of individuals and the community. The introduction and use of
Zedd also has the potential to inhibit the ability of Māori to fulfil their role as kaitiaki.
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5.5. The staff have advised me that based on the information provided, including the use pattern and
default controls for Zedd, that the risks to Māori culture or traditional relationships with ancestral lands,
water, sites, wāhi tapu, valued flora and fauna or other taonga are likely to be negligible. However,
should inappropriate or accidental use, transport or disposal of the substance result in the
contamination of waterways, the user of the substance approval should notify the appropriate
authorities including the relevant iwi leaders of the region. This action should include advising them of
the extent of the contamination and the measures taken in response.
5.6. There is no evidence to suggest that the controlled use of Zedd will breach the principles of the Treaty
of Waitangi.
Assessment of risks to society and the community and the market economy
5.7. The staff did not identify any risks associated with the approval of Zedd to society, communities or the
market economy.
5.8. There are not expected to be any significant adverse impacts on the social environment with the
controlled use of Zedd, apart from the health effects and environmental effects already discussed.
Consequently, the staff consider that this aspect of potential risk need not be considered further.
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Table 2: Qualitative assessment of human health risks
Lifecycle Description Likelihood Magnitude Matrix Comment Level of
risk
Manufacture
and packaging
Acute toxicity (oral) Highly
improbable
Moderate Negligible Manufacturing and packaging facilities in New Zealand will be required
to meet the HSNO requirements for equipment, emergency
management and Personal Protective Equipment (PPE). The need for
compliance with HSNO information provisions (e.g. labels, advertising,
Safety Data Sheets (SDSs), and WorkSafe’s Health and Safety
requirements will also apply.
This means that workers handling the substance will need to be aware
of the hazards and the measures that need to be undertaken to ensure
their own safety. Provided these measures are taken, the level of risk is
negligible
Negligible
Skin irritancy Highly
improbable
Minimal Negligible Negligible
Eye corrosive Highly
improbable
Moderate Negligible Negligible
Reproductive/developmental
toxicity
Highly
improbable
Major Low While the qualitative descriptors indicate a low level of risk driven by the
major chronic effects of Zedd, such as reproductive/developmental and
target organ systemic toxicity, it is noted that manufacturing and
packaging processes in New Zealand will be required to meet the
HSNO requirements for equipment, PPE, emergency management and
provision of information as well as WorkSafe’s regulations. These
requirements will make the likelihood of exposure that would lead to an
adverse effect so highly improbable that the level of risk for these
adverse effects is negligible
Negligible
Target organ or systemic
toxicity
Negligible
Importation,
transport,
storage
Acute toxicity (oral) Highly improbable
Moderate Negligible Workers and bystanders will only be exposed to the substance during
this part of the lifecycle in isolated incidents where spillage occurs,
therefore only risks from acute exposure are considered here.
Compliance with HSNO controls (e.g. labels, SDS) and adherence to
the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime
Transport Act 1994 (as applicable) is required
Negligible
Skin irritancy Highly improbable
Minimal Negligible Negligible
Eye corrosive Highly improbable
Moderate Negligible Negligible
Use Acute toxicity (oral) Highly
improbable
Moderate Negligible The substance will be labelled to identify its potential risks minimising
the opportunity for it to cause toxicity. HSNO requirements for PPE,
Negligible
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Lifecycle Description Likelihood Magnitude Matrix Comment Level of
risk
Skin irritancy Highly
improbable
Minimal Negligible packaging, identification and emergency management requirements
must be complied with.
It is not expected that bystanders will come into contact with the
substance as it is intended for commercial use
Negligible
Eye corrosive Highly
improbable
Moderate Negligible Negligible
Reproductive/developmental
toxicity
Highly
improbable
Major Low It is considered that, whilst the chronic toxic properties of this substance
could cause major adverse effects to the user, the risk will be
sufficiently managed by users involved in the application of this
substance to reduce the effect level from low to negligible.
It is also considered that the use pattern of this substance is similar to a
number of existing substances and therefore does not present a greater
risk to users than other substances currently available for similar end-
use
Negligible
Target organ or systemic
toxicity
Negligible
Disposal Acute toxicity (oral) Highly
improbable
Moderate Negligible The applicant indicates that the preferred disposal method is to use the
product according to label directions. Disposal of the substance and its
used containers in New Zealand, if required, shall be in accordance with
the requirements of the Hazardous Substances (Disposal) Regulations
2001. Compliance with these will reduce the opportunity for individuals
to be exposed
Negligible
Skin irritancy Highly
improbable
Minimal Negligible Negligible
Eye corrosive Highly
improbable
Moderate Negligible Negligible
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Table 3: Qualitative assessment of risks to the environment
Lifecycle Description Likelihood Magnitude Matrix Comment Level of
risk
Manufacture,
importation,
transport and
storage
Death or adverse effects to
aquatic or terrestrial
organisms
Highly
improbable
Minor Negligible Provided the exercise of this approval is in adherence with the HSNO
controls (and the Land Transport Rule 45001, Civil Aviation Act 1990
and Maritime Transport Act 1994 (as applicable)), the staff consider a
spill to be highly improbable
Negligible
Use
(application)
Death or adverse effects to
aquatic or terrestrial
organisms
Highly
improbable
Minor Negligible The staff consider that the use of labelling and safety data sheets
prohibiting application of the substance onto, over or into water and
compliance with approved handler requirements will adequately
manage the risks to the aquatic and terrestrial environments
Negligible
Disposal Death or adverse effects to
aquatic or terrestrial
organisms
Highly
improbable
Minor Negligible Users will in most cases utilise all of the substance by its normal use as
an insecticide. All cases of disposal are required to be in accordance
with the requirements of the Hazardous Substances (Disposal)
Regulations 2001
Negligible
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New Zealand’s international obligations
5.9. The staff did not identify international obligations that may be impacted by the approval of Zedd.
Overall assessment of risks
5.10. The staff have advised me that Zedd has the potential to present minimal (skin irritancy) to major
(reproductive developmental and target organ systemic toxicity) human health risks, and minor risks to
aquatic organisms and terrestrial organisms (vertebrates and invertebrates).
5.11. The staff consider that, with compliance with the controls in place, the risks to human health and the
environment associated with Zedd are mitigated and therefore negligible.
Identification of benefits
5.12. According to the applicant, the approval of Zedd will provide the following benefits:
end-user choice from the availability of a new formulation of an existing active
a reduction in welfare payments by providing employment to New Zealanders
financial return by increasing the portfolio and market share of the company, and profitability to
shareholders
an increase in consumer choice from the availability of another insecticide to control leafroller
insects in apples, pears, berries, grapes, kiwifruit, avocados and pipfruit which may result in
more competitive pricing
a reduction in the adverse reaction of workers to hazardous chemicals by using safer active
ingredients.
5.13. The staff consider that the approval of Zedd will provide the following benefits:
minimisation of the risk of resistance development which results in prolongment of the efficacy
of Zedd
flow-on financial effects to the local community and the New Zealand economy from the
financial benefits to individual contractors.
The effects of the substance being unavailable
5.14. I consider that the likely effects of the substance being unavailable relate to less consumer choice
resulting in less competitive pricing. This is because similar insecticide products are available on the
New Zealand market.
Overall assessment of benefits
5.15. I am satisfied that the availability of Zedd will provide beneficial economic effects for some businesses
and individual farmers as well as flow-on effects to local communities and the New Zealand economy.
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6. Controls
6.1. Based on the hazard classification determined for Zedd, a set of associated default controls specified
by regulations under the Act has been identified by the staff as being applicable to Zedd. The default
controls form the basis of the controls set out in Appendix C. Based on the risk assessment, it is
considered that the following exposure limits are relevant and that the additions, variations and
deletions to the default controls set out below should be applied to Zedd.
The setting of exposure limits
6.2. Control T1 relates to limiting exposure to toxic substances through the setting of TEL, ADE and PDE
values. Tolerable Exposure Limit (TEL) values can be set to control hazardous substances entering
the environment in quantities sufficient to present a risk to people. No TEL values have been set for
any component of Zedd at this time as the risk of adverse effects to human health has been
qualitatively assessed as negligible, provided users demonstrate compliance with the controls as set
out in Table 6. The EPA is however, required to set ADE and PDE values for new active ingredients
that may become present in food, to allow the setting of Maximum Residue Level (MRL) values by
MPI. The following ADE and PDE values have been set previously for emamectin benzoate: ADE =
0.002 mg/kg bw/day, PDEfood = 0.0016 mg/kg bw/day and PDEdrinking water = 0.0004 mg/kg bw/day.
6.3. Workplace Exposure Standard (WES) values can be set to limit the exposure of people to toxic
substances in places of work. The EPA typically adopts WES values listed in WorkSafe New
Zealand's Workplace Exposure Standards document (effective from February 2013):
http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-
standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-
2013.pdf
WorkSafe New Zealand's Workplace Exposure Standards document has set a WES value for
Component A of Zedd. The staff consider this value to be applicable to Zedd.
6.4. Environmental Exposure Limit (EEL) values can be set to limit hazardous substances from entering
the environment in quantities sufficient to present a risk to it. No EEL values are set for any
component of Zedd at this time as the risk of adverse effects to the environment has been qualitatively
assessed as negligible, provided users demonstrate compliance with the controls as set out in Table
6. The default EEL values are deleted.
6.5. Control E2 relates to restrictions on use of substances in application areas. The default controls
require the EPA 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 EEL has been proposed for Zedd, a
maximum application rate is not able to be set under this regulation. However, the staff note that the
environmental exposure modelling indicates that there may be a risk where the substance is used
outside the specific parameters used in the risk assessment. It is therefore considered appropriate to
set maximum application rates under section 77A Additional controls.
http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdf
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Additional controls
6.6. Due to the proposed use pattern of Zedd, the staff note that significant environmental exposure may
potentially occur. It is therefore necessary to put restrictions on the application of Zedd to mitigate the
risk of death or adverse effects to human health and aquatic and terrestrial organisms. Accordingly, it
is considered that the application of controls addressing these risks will be more effective than the
default controls in terms of their effects on the management, use and risks of the substance.
Consequently, the following additional controls are applied to Zedd to restrict the level of risk to the
environment:
Zedd must not be applied into, onto or over water3
Zedd shall be applied via ground-based methods only4
The maximum application rate of Zedd shall be 120 ml Zedd/ha.
6.7. The staff note that the default controls do not address the risks associated with storage or use of the
substances within stationary container systems (e.g. tanks). These risks include the failure of primary
containment resulting in a large spill of the substance into the environment. In addition, the default
controls do not allow for dispensation where it is unnecessary for any pipework associated with the
stationary container systems to have secondary containment. Accordingly, controls addressing these
risks are considered more effective than the default controls in terms of their effect on the
management, use and risks of the substance.
6.8. The default controls do not include requirements for the inclusion of specific label statements. The
staff have advised me that additional controls placed on previously approved substances containing
emamectin benzoate included statements to inform the user of the maximum application rate and of
the increased risk to estuarine environments arising from spray drift, when using these substances.
The staff consider that these label statements are also applicable to Zedd to manage any potential
adverse effects on human health and the environment.
Variation and deletion of controls
6.9. The default controls include requirements for ecotoxic substances to be under the control of an
approved handler. The staff have advised me that because this control is triggered solely by virtue of
the ecotoxicity of Zedd, it is considered that this control can be modified so as to apply only when the
substance is applied in a wide dispersive manner (e.g. when sprayed on large areas such as crops) or
by a commercial contractor. Accordingly, the following control has been substituted for Regulation 9(1)
of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001:
“(1) Zedd must be under the personal control of an approved handler when the substance is – (a) applied in a wide dispersive manner5; or
3 Where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application. 4 Ground-based methods of applying pesticides include, but are not limited to, application by ground boom, airblast or knapsack, and do not include aerial application methods
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(b) used by a commercial contractor.”
6.10. The default controls include requirements for secondary containment of pooling substances. It is
considered that the risks associated with the containment of substances which are not class 1 to 5
substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5
substances. Consequently the secondary containment requirements can be reduced. It is considered
that these reduced secondary containment measures are adequate to manage the risks of a spillage
of Zedd as this substance does not ignite or explode. Therefore, the proposed variation is more cost-
effective in terms of managing the risks of the substance.
Review of controls for cost-effectiveness
6.11. The staff have advised me that the proposed controls, provided they are complied with, are the most
cost-effective means of managing the identified potential risks associated with this application. The
applicant was given an opportunity to comment on the proposed controls as set out in this decision.
The applicant indicated that they had no concerns with the proposed controls.
7. Environmental user charges
7.1. The staff have advised me that applying controls on Zedd is an effective means of managing risks
associated with this substance. It is considered that it is not necessary to apply environmental user
charges to this substance as an alternative or additional means of achieving effective risk
management. Accordingly, no report has been made to the Minister for the Environment.
8. Conclusion 8.1. Taking into account the staff assessment of the potential risks and benefits associated with Zedd (see
section 5), I consider that, with controls in place:
the risks to human health and the environment arising from the hazardous properties (acute
toxicity, skin irritation, eye corrosivity, reproductive and developmental toxicity, target organ
systemic toxicity, and toxicity to the aquatic and terrestrial environments) and the use of Zedd
are negligible
significant adverse impacts on the social or economic environment from the use of Zedd are
not anticipated
significant impacts on Māori culture or traditional relationships with ancestral lands, water,
sites, wāhi tapu, valued flora and fauna or other taonga that will breach the principles of the Te
Tiriti o Waitangi/Treaty of Waitangi are not anticipated
benefits will be derived for New Zealand by allowing the use of Zedd.
5 'Wide dispersive' use refers to activities which deliver uncontrolled exposure — also refer to: http://www.epa.govt.nz/Publications/ER-IS-33-2.pdf
http://www.epa.govt.nz/Publications/ER-IS-33-2.pdf
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9. Decision
9.1. Pursuant to section 29 of the Act, I have considered this application to import or manufacture a
hazardous substance for release made under section 28 of the Act. In doing so, I have applied the
relevant sections of the Act and clauses of the Hazardous Substances and New Organisms
(Methodology) Order 1998 (“the Methodology”) as detailed in the decision path and explanatory notes
available from our website6.
9.2. I am satisfied with the hazard classifications identified by the staff in Table 1 (Section 4) and
accordingly confer them on Zedd.
9.3. I consider that, with controls in place, the risks to human health and to the environment are negligible,
and there will be benefits associated with the release of Zedd. Therefore, I consider that the
application may be approved in accordance with clause 26, with the controls proposed by the staff and
documented in Appendix C.
9.4. The import or manufacture of the hazardous substance, Zedd, is thus approved with controls as listed
in Appendix C.
Rob Forlong Date:
Chief Executive, EPA
6 http://www.epa.govt.nz/publications/er-pr-02-decision-paths.pdf
http://www.epa.govt.nz/publications/er-pr-02-decision-paths.pdf
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Appendix A: Staff classification of Zedd
Hazard classifications for Zedd were estimated using information on the effects of the individual components
and application of mixture rules.
The mixture rules used for classifying substances can be found in the User Guide to Thresholds and
Classifications7.
The classifications of Zedd are shown in Table 5.
Data quality – overall evaluation
The staff acknowledge that there are frequently data gaps in the hazard classification for chemicals which
have been in use internationally for a long time. International programmes such as the OECD High
Production Volume programme8, REACH9, and European Regulation 1107/2009/EC10 are progressively
working towards filling these data gaps. As new information becomes available, staff will update the
Hazardous Substances and New Organisms (HSNO) classifications for those substances.
Table 5: Summary of the applicant’s and staff’s hazard classification
Hazard Class/Subclass
Mixture classification Method of
classification
Remarks Applicant’s
classification
Staff’s
classification
Mix
ture
data
Read
acro
ss
Mix
ture
rule
s1
1
Class 1 Explosiveness No ND
Class 2, 3 & 4 Flammability No ND
Class 5 Oxidisers/Organic
Peroxides No ND
Subclass 8.1 Metallic
corrosiveness - ND
Subclass 6.1 Acute toxicity (oral) 6.1D 6.1D
Emamectin
benzoate,
Components C1,
D1, and D2
Subclass 6.1Acute toxicity
(dermal) - ND
7 http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf
8 http://www.icca-chem.org/Home/ICCA-initiatives/High-production-volume-chemicals-initiative-HPV/ 9 http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm 10 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF 11 Use of mixture rules may not adequately take into account interactions between different components in some circumstances and must be considered of lower reliability than data on the mixture itself.
http://www.epa.govt.nz/Publications/ER-UG-03-2.pdfhttp://www.epa.govt.nz/Publications/ER-UG-03-2.pdfhttp://www.epa.govt.nz/Publications/ER-UG-03-2.pdfhttp://www.icca-chem.org/Home/ICCA-initiatives/High-production-volume-chemicals-initiative-HPV/http://ec.europa.eu/environment/chemicals/reach/reach_intro.htmhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF
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Hazard Class/Subclass
Mixture classification Method of
classification
Remarks Applicant’s
classification
Staff’s
classification
Mix
ture
data
Read
acro
ss
Mix
ture
rule
s1
1
Subclass 6.1 Acute toxicity
(inhalation) - ND
Subclass 6.1 Aspiration hazard - -
Subclass 6.3/8.2 Skin
irritancy/corrosion 6.3B 6.3B Component C1
Subclass 6.4/8.3 Eye
irritancy/corrosion 8.3A 8.3A
Emamectin
benzoate,
components C1
and F
Subclass 6.5A Respiratory
sensitisation - ND
Subclass 6.5B Contact
sensitisation - ND
Subclass 6.6 Mutagenicity - ND
Subclass 6.7 Carcinogenicity - ND
Subclass 6.8 Reproductive/
developmental toxicity 6.8B 6.8B
Emamectin
benzoate
Subclass 6.8 Reproductive/
developmental toxicity (via
lactation)
- ND
Subclass 6.9 Target organ
systemic toxicity12 6.9B 6.9B (oral)
Emamectin
benzoate
Subclass 9.1 Aquatic ecotoxicity 9.1A 9.1A Emamectin
benzoate
Subclass 9.2 Soil ecotoxicity - ND
Subclass 9.3 Terrestrial
vertebrate ecotoxicity 9.3B 9.3B
Emamectin
benzoate
Subclass 9.4 Terrestrial
invertebrate ecotoxicity 9.4A 9.4A
Emamectin
benzoate
12 When appropriate include separate rows to address single as well as repeat dose target organ toxicity, and any of the relevant routes (oral, dermal and/or inhalation).
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Appendix B: Staff risk and benefit assessment
The staff have evaluated the potential of Zedd to cause adverse effects to during all stages of the
substance’s lifecycle. A qualitative risk assessment was carried out to assess these risks.
The process by which the risk assessment of substances is undertaken is specified in the Methodology13.
Guidance on risk assessment is provided on the EPA website14.
To facilitate the assessment of risks the applicant and the staff identified the most common potential sources
of risk to the environment and to human health and safety through release, spillage or exposure throughout
the lifecycle of the substance. These are tabulated in Table 6.
Table 6: Potential sources of risks associated with hazardous substances
Lifecycle Activity Associated Source of Risk
Manufacture / Import An incident during the manufacture or importation of the substance
resulting in spillage and subsequent exposure of people or the
environment to the substance
Packing An incident during the packing of the substance resulting in spillage
and subsequent exposure of people or the environment to the
substance
Transport or storage An incident during the transport or storage of the substance
resulting in spillage and subsequent exposure of people or the
environment to the substance
Use Application of the substance resulting in exposure of users or
bystanders or the environment; or an incident during use resulting
in spillage and subsequent exposure of users or the environment to
the substance
Disposal Disposal of the substance or packaging resulting in exposure of
people or the environment to the substance
13 http://www.epa.govt.nz/publications/methodology.pdf 14 http://www.epa.govt.nz/Publications/ER-TG-05-02-03-09-(Decision-Making).pdf
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Appendix C: Controls applying to Zedd
Notes: The controls for this substance apply for the indefinite duration of the approval of this substance.
Please refer to the Hazardous Substances Regulations15 for the requirements prescribed for each control
and the modifications listed as set out in Section 6 of this document.
Table 7: Controls for Zedd – codes, regulations and variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code Regulation Description Variation
T1 Regs 11 – 27 Limiting exposure to toxic substances
through the setting of TEL, ADE and PDE
values
No TEL values are set for any component
of the substance at this time. However,
the following ADE and PDE values have
been set previously for emamectin
benzoate: ADE = 0.002 mg/kg bw/day,
PDEfood = 0.0016 mg/kg bw/day and
PDEdrinking water = 0.0004 mg/kg bw/day
T2 Regs 29, 30 Controlling exposure in places of work
through the setting of WES values
A WES value has been set for Component
A as detailed in the Workplace Exposure
Standards document:
http://www.business.govt.nz/worksafe/info
rmation-guidance/all-guidance-
items/workplace-exposure-standards-and-
biological-exposure-indices/workplace-
exposure-standards-and-biological-
indices-2013.pdf
T4 Reg 7 Requirements for equipment used to
handle substances
T5 Reg 8 Requirements for protective clothing and
equipment
T7 Reg 10 Restrictions on the carriage of toxic or
corrosive substances on passenger
service vehicles
E1 Regs 32 – 45 Limiting exposure to ecotoxic substances
through the setting of EEL values
No EEL values are set at this time and the
default EEL values are deleted
E2 Regs 46 – 48 Restrictions on the application of
substances within application areas
A maximum application rate (120 ml
Zedd/ha) has been set for Zedd under
section 77A
E3 Reg 49 Controls relating to protection of terrestrial
invertebrates eg beneficial insects
15 The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
http://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.business.govt.nz/worksafe/information-guidance/all-guidance-items/workplace-exposure-standards-and-biological-exposure-indices/workplace-exposure-standards-and-biological-indices-2013.pdfhttp://www.legislation.co.nz/
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Code Regulation Description Variation
E5 Regs 5(2), 6 Requirements for keeping records of use
E6 Reg 7 Requirements for equipment used to
handle substances
E7 Reg 9 Approved handler/security requirements
for certain ecotoxic substances
The following control is substituted for Reg
9(1) of the Hazardous Substances
(Classes 6,8 and 9 Controls) Regulations
2001:
(1) The substance must be under the
personal control of an approved
handler when the substance is:
(a) applied in a wide dispersive
manner; or
(b) used by a commercial contractor
Hazardous Substances (Identification) Regulations 2001
Code Regulation Description Variation
I1 Regs 6, 7, 32 –
35, 36(1) – (7)
Identification requirements, duties of
persons in charge, accessibility,
comprehensibility, clarity and durability
I2 Reg 8 Priority identifiers for corrosive substances
I3 Reg 9 Priority identifiers for ecotoxic substances
I8 Reg 14 Priority identifiers for toxic substances
I9 Reg 18 Secondary identifiers for all hazardous
substances
I10 Reg 19 Secondary identifiers for corrosive
substances
I11 Reg 20 Secondary identifiers for ecotoxic
substances
I16 Reg 25 Secondary identifiers for toxic substances
I17 Reg 26 Use of generic names
I18 Reg 27 Requirements for using concentration
ranges
I19 Regs 29 – 31 Additional information requirements,
including situations where substances are
in multiple packaging
I20 Reg 36(8) Durability of information for class 6.1
substances
I21 Regs 37 – 39, General documentation requirements
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Code Regulation Description Variation
47 – 50
I22 Reg 40 Specific documentation requirements for
corrosive substances
I23 Reg 41 Specific documentation requirements for
ecotoxic substances
I28 Reg 46 Specific documentation requirements for
toxic substances
I29 Regs 51, 52 Signage requirements
I30 Reg 53 Advertising corrosive and toxic
substances
Hazardous Substances (Packaging) Regulations 2001
Code Regulation Description Variation
P1 Regs 5, 6,
7(1), 8
General packaging requirements
P3 Reg 9 Criteria that allow substances to be
packaged to a standard not meeting
Packing Group I, II or III criteria
P13 Reg 19 Packaging requirements for toxic
substances
P14 Reg 20 Packaging requirements for corrosive
substances
P15 Reg 21 Packaging requirements for ecotoxic
substances
PG3 Schedule 3 Packaging requirements equivalent to UN
Packing Group III
PS4 Schedule 4 Packaging requirements as specified in
Schedule 4
Hazardous Substances (Disposal) Regulations 2001
Code Regulation Description Variation
D4 Reg 8 Disposal requirements for toxic and
corrosive substances
D5 Reg 9 Disposal requirements for ecotoxic
substances
D6 Reg 10 Disposal requirements for packages
D7 Regs 11, 12 Information requirements for
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Code Regulation Description Variation
manufacturers, importers and suppliers,
and persons in charge
D8 Regs 13, 14 Documentation requirements for
manufacturers, importers and suppliers,
and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code Regulation Description Variation
EM1 Regs 6, 7, 9 –
11
Level 1 information requirements for
suppliers and persons in charge
EM2 Reg 8(a) Information requirements for corrosive
substances
EM6 Reg 8(e) Information requirements for toxic
substances
EM7 Reg 8(f) Information requirements for ecotoxic
substances
EM8 Regs 12 – 16,
18 – 20
Level 2 information requirements for
suppliers and persons in charge
EM11 Regs 25 – 34 Level 3 emergency management
requirements: duties of person in charge,
emergency response plans
EM12 Regs 35 – 41 Level 3 emergency management
requirements: secondary containment
The following subclauses are added after
subclause (3) of regulation 36:
(4) For the purposes of this regulation,
and regulations 37 to 40, where this
substance is contained in pipework
that is installed and operated so as
to manage any loss of containment
in the pipework it—
(a) is not to be taken into account
in determining whether a place
is required to have a secondary
containment system; and
(b) is not required to be located in
a secondary containment
system.
(5) In this clause, pipework—
(a) means piping that—
(i) is connected to a stationary
container; and
(ii) is used to transfer a
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Code Regulation Description Variation
hazardous substance into
or out of the stationary
container; and
(b) includes a process pipeline or
a transfer line.
The following subclauses are added after
subclause (3) of regulation 37 (control
EM12) to take into account any risk of
adverse effects posed by pooling
hazardous substances:
(2) If pooling substances which do not
have class 1 to 5 hazard
classifications are held in a place
above ground in containers each of
which has a capacity of 60 litres or
less—
(a) if the place’s total pooling
potential is less than 20,000
litres, the secondary
containment system must have
a capacity of at least 25% of
that total pooling potential:
(b) if the place’s total pooling
potential is 20,000 litres or
more, the secondary
containment system must have
a capacity of the greater of—
(i) 5% of the total pooling
potential; or
(ii) 5,000 litres.
(3) Pooling substances to which
subclause (2) applies must be
segregated where appropriate to
ensure that leakage of one
substance may not adversely affect
the container of another substance.
The following subclauses are added after
subclause (3) of regulation 38 (control
EM12) to take into account any risk of
adverse effects posed by pooling
hazardous substances:
(2) If pooling substances which do not
have class 1 to 5 hazard
classifications are held in a place
above ground in containers 1 or
more of which have a capacity of
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Code Regulation Description Variation
more than 60 litres but none of
which have a capacity of more than
450 litres—
(a) if the place’s total pooling
potential is less than 20,000
litres, the secondary
containment system must have
a capacity of either 25% of that
total pooling potential or 110%
of the capacity of the largest
container, whichever is the
greater:
(b) if the place’s total pooling
potential is 20,000 litres or
more, the secondary
containment system must have
a capacity of the greater of—
(i) 5% of the total pooling
potential; or
(ii) 5,000 litres
(3) Pooling substances to which
subclause (2) applies must be
segregated where appropriate to
ensure that the leakage of one
substance may not adversely affect
the container of another substance.
EM13 Reg 42 Level 3 emergency management
requirements: signage
Hazardous Substances (Personnel Qualifications) Regulations 2001
Code Regulation Description Variation
AH 1 Regs 4 – 6 Approved Handler requirements (including
test certificate and qualification
requirements)
Refer to control E7
Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004
Code Regulation Description Variation
Tank
Wagon
Regs 4 to 43
as applicable
Controls relating to tank wagons and
transportable containers
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Schedule 8 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances)
Transfer Notice 2004
Code Regulation Description Variation
Sch 8 Schedule 8 This schedule prescribes the controls for
stationary container systems. The
requirements of this schedule are detailed
in the consolidated version of the
Hazardous Substances (Dangerous
Goods and Schedule Toxic Substances)
Transfer Notice 2004, available from
http://www.epa.govt.nz/Publications/Trans
fer-Notice-35-2004.pdf
Additional controls
Code Regulation Description Variation
Water 77A The substance must not be applied into,
onto or over water
Zedd must not be applied into, onto or
over water16
Application
rate
77A A maximum application rate (120 ml
Zedd/ha) is set for this substance
See E2
Application
method
77A This substance must be applied via
ground-based methods only
The application of Zedd must be limited to
ground-based application methods only17
Label
77A
Additional information that must be
included on the label has been prescribed
The maximum application rate (120 ml
Zedd/ha) must be mentioned on the label
A statement indicating the higher risk to
estuarine environments and steps to be
taken to avoid spray drift must be included
on the label. This information should be
accessible within 10 seconds
16 where ‘water‘ means water in all its physical forms, whether flowing or not, and whether over or under ground, but does not include water in any form while in a pipe, tank or cistern or water used in the dilution of the substance prior to application. 17 Ground-based methods of applying pesticides include, but are not limited to, application by ground boom, airblast or knapsack, and do not include aerial application methods
http://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdfhttp://www.epa.govt.nz/Publications/Transfer-Notice-35-2004.pdf
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Appendix D: Confidential Information
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Appendix E: Standard terms and abbreviations
ai active ingredient
ALD50 approximate median lethal dose, 50%
AOEL acceptable operator exposure level
ARfD acute reference dose
as active substance
BCF bioconcentration factor
bfa body fluid assay
BOD biological oxygen demand
BSAF biota-sediment accumulation factor
bw body weight
c centi- (x10-2
)
CA controlled atmosphere
CI confidence interval
CL confidence limits
CNS central nervous system
COD chemical oxygen demand
DFR dislodgeable foliar residue
DO dissolved oxygen
DOC dissolved organic carbon
DT50 period required for 50 percent
dissipation (define method of
estimation)
DT90 period required for 90 percent
dissipation (define method of
estimation)
dw dry weight
ED50 median effective dose
ERC environmentally relevant
concentration
F field
F0 parental generation
F1 filial generation, first
F2 filial generation, second
fp freezing point
G glasshouse
GAP good agricultural practice
GC gas chromatography
GC-EC gas chromatography with electron
capture detector
GC-FID gas chromatography with flame
ionization detector
GC-MS gas chromatography-mass
spectrometry
GC-MSD gas chromatography with mass-
selective detection
GLC gas liquid chromatography
GLP good laboratory practice
GM geometric mean
H Henry’s Law constant (calculated as a
unitless value) (see also K)
ha hectare
Hb haemoglobin
HCG human chorionic gonadotropin
Hct haematocrit
HPLC high pressure liquid chromatography
or high performance liquid
chromatography
HPLC-MS high pressure liquid chromatography -
mass spectrometry
I indoor
I50 inhibitory dose, 50%
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IC50 median immobilization concentration
or median inhibitory concentration 6
ID ionization detector
Im intramuscular
inh inhalation
ip intraperitoneal
IPM integrated pest management
iv intravenous
IVF in vitro fertilization
K Kelvin or Henry’s Law constant (in
atmospheres per cubic meter per
mole) (see also H)
Kads adsorption constant
Kdes apparent desorption coefficient
Koc organic carbon adsorption coefficient
Kom organic matter adsorption coefficient
kg kilogram
LC liquid chromatography
LC-MS liquid chromatography- mass
spectrometry
LC50 lethal concentration, median
LCA life cycle analysis
LC-MS-MS liquid chromatography with tandem
mass spectrometry
LD50 lethal dose, median; dosis letalis
media
LDH lactate dehydrogenase
LOAEC lowest observable adverse effect
concentration
LOAEL lowest observable adverse effect
level
LOD limit of detection
LOEC lowest observable effect
concentration
LOEL lowest observable effect level
LOQ limit of quantification (determination)
LPLC low pressure liquid chromatography
LSC liquid scintillation counting or counter
LSS liquid scintillation spectrometry
LT lethal threshold
M molar
μm micrometer (micron)
MDL method detection limit
MFO mixed function oxidase
μg microgram
MLT median lethal time
MLD median lethal dose
mol Mole(s)
MOS margin of safety
mp melting point
MS mass spectrometry
MSDS material safety data sheet
NAEL no adverse effect level
nd not detected
NEL no effect level
ng nanogram
nm nanometer
NOAEC no observed adverse effect
concentration
NOAEL no observed adverse effect level
NOEC no observed effect concentration
NOEL no observed effect level
NR not reported
OC organic carbon content
ODP ozone-depleting potential
OM organic matter content
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Pa pascal
PEC predicted environmental
concentration
PECS predicted environmental
concentration in soil
PECSW predicted environmental
concentration in surface water
PECGW predicted environmental
concentration in ground water
PHI pre-harvest interval
pKa negative logarithm (to the base 10) of
the dissociation constant)
PNEC predicted no effect concentration
POW partition coefficient between n-octanol
and water
ppb parts per billion (10-9
)
PPE personal protective equipment
ppm parts per million (10-6
)
ppp plant protection product
ppq parts per quadrillion (10-24
)
ppt parts per trillion (10-12
)
PTDI provisional tolerable daily intake
r correlation coefficient
r2 coefficient of determination
REI restricted entry interval
Rf retardation factor
RfD reference dose
RL50 median residual lifetime
RP reversed phase
RRT relative retention time
RSD relative standard deviation
sc subcutaneous
SD standard deviation
se standard error
SF safety factor
SIMS secondary ion mass spectroscopy
SOP standard operating procedures
sp species (only after a generic name)
SPE solid phase extraction
spp subspecies
SSD sulphur specific detector
STEL short term exposure limit
t½ half-life (define method of estimation)
TCLo toxic concentration, low
TER toxicity exposure ratio
TIFF tag image file format
TOC total organic carbon
TWA time weighted average
UF uncertainty factor (safety factor)
ULV ultra low volume
UV ultraviolet
v/v volume ratio (volume per volume)
w/v weight per volume
ww wet weight
w/w weight per weight