DECISION - EPA...Page 2 of 26 Decision on application for approval to import or manufacture Zedd for...

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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Decision on application for approval to import or manufacture Zedd for release (APP202046)

www.epa.govt.nz

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


Eye corrosive Highly improbable


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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risk


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


improbable


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


improbable



improbable


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Table 3: Qualitative assessment of risks to the environment


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


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


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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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


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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47 – 50

I22 Reg 40 Specific documentation requirements for

corrosive substances


ecotoxic substances


toxic substances

I29 Regs 51, 52 Signage requirements

I30 Reg 53 Advertising corrosive and toxic

substances

Hazardous Substances (Packaging) Regulations 2001


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


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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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


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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hazardous substance into

or out of the stationary

container; and

(b) includes a process pipeline or

a transfer line.


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


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.


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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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


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


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


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


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


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


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

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