Environmental Protection Authority - EPA · 2019. 4. 6. · 2.02g emamectin benzoate /ha. The...

Environmental Protection Authority Te /VIana RauhT Taiao

DECISION

12 May 2014

1. Summary

S ubstance

Application code

Application type

Application sub-type

Applicant

Purpose of the application

Date application received

Consideration date

Considered by

Decision

Approval code

Hazard classifications

(refer to Table 1 , Section 4)

Wa rlock I nse ct icide

APP201 892

To import or manufacture for release any hazardous substance under

Section 28 of the Hazardous Substances and New Organisms Act

1 996 ("the Act")

Category A

Agronica New Zealand Limited

Warlock Insecticide is an emulsion concentrate containing 1 9.2 g/1

emamectin benzoate as active ingredient for the control of leafrollers

on avocados, grapes, kiwifruit and pipfruit

6 September 201 3

1 2 May 201 4

Further information was requested from the applicant during the

evaluation and review of the application in accordance with section 58

of the Act and consequently the consideration was postponed under

section 59

The Chief Executive 1 of the Environmental Protection Authority ("the

EPA")

Approved with controls

HSR1 00932

3 . 1 D

6 . 1 E, 6.38, 6.4A, 6.8A, 6.8C, 6.98

9 . 1 A, 9.38, 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.

New zealand Government

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Decision on application for approval to import or manufacture Warlock Insecticide for release (APP201 892)

2. Backg round

2 . 1 . Warlock Insecticide is an emulsifiable concentrate formulation containing emamectin benzoate as the

active ingredient at a concentration of 1 9.2 g I L. I t is intended for use as an insecticide for the control

of leafroller insects on avocados, grapes, kiwifruit and pipfruit.

2 .2 . Warlock Insecticide wi l l be imported either as a fin ished prod uct packed and label led in 0 .5 , 1 , 5 , 10 or

20 L High Density Poly Ethylene (HOPE) containers, or in bulk containers for repackaging by an

approved re-packer.

2 .3 . The product is applied using ground based spraying techniques and is sprayed onto target crops to

the point of run off. The applicant's proposed rates of d i lution are from 5 to 1 0. 5 ml of the product in

1 00 L of water. The maximum rate of application is 1 05 ml Warlock Insecticide /ha. I t is eq uivalent to

2.02g emamectin benzoate /ha. The number of applications/season ranges from 2 on grapes (with a

7-1 4 day interval) to 6 on avocados (with a 21 day interval) .

2 .4 . The product is intended to be used by commercial contractors who are approved hand lers. I ts use is ,

expected , therefore, to be confined to trained professionals.

2 .5. It is intended that the substance should be used completely ( i .e. until the conta iner is emptied) , to

avoid a requirement for disposal.

2.6. Before disposing of the empty containers, users should triple rinse them and add the rinsate to the

spray tank for appl ication to crops requiring treatment. Empty containers can be recycled through

AgRecovery (0800 247 326 , www . agrecoverv.co.nz) or crushed or punctured and sent to a landfi l l .

3. Process, consultation and reasons for non-notification

3. 1 . The appl ication was lodged pursuant to section 28 of the Act.

3 .2 . Once outstanding information was provided by the appl icant, the appl ication contained sufficient

information for the staff of the EPA ("the staff') to undertake a ful l assessment of the substance from a

scientific and technical perspective.

3 .3 . WorkSafe New Zealand2, the Department of Conservation and the Min istry for Primary I ndustries

(ACVM group) were advised of the appl ication on 9 October 201 3 and invited to comment on it by 3 1

October 201 3 . N o comments were received.

3.4. I n accordance with section 53(2) of the Act, the application was not publ icly notified as the staff

considered that there was unl ikely to be sign ificant 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.

4. Hazardous properties

4. 1 . The staff determined the hazard classification of Warlock I nsecticide based on the information

provided by the applicant and other available information as documented in Appendix A

2 previously The Ministry of Business, Innovation and Employment (Labour Group)

New zealand Government www.epa.govt.nz

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Decision on application for approval to import or manufacture Warlock Insecticide for release (APP201892)

4.2. The classifications determined by the staff are different to those submitted by the applicant (Table 1 ) .

The difference in classifications has arisen due to different interpretations of the studies submitted for

the skin irritancy classification and for the acute oral and inha lation toxicity classifications. The

classification 6 .8C is based on the classification and concentration of component D wh ich the

applicant may have overlooked. The staff have proposed that the aquatic ecotoxicity classification

should be more severe because the a pplicant did not apply a multiplying factor when using the mixture

rules. The d ifference in vertebrate ecotoxicity classification resulted from the appl icant considering that

the active ingredient, emamectin benzoate, is classified as 9 .3C, whereas it is actually classified as

9 .3A.

Table 1 Hazard classifications of Warlock Insecticide as proposed by the applicant and the staff

Hazard Endpoint Applica nt class ificat ion

Flammability

Acute toxicity (oral)

Acute toxicity (inhalation)

Acute toxicity (aspiration hazard)

Skin irritancy

Eye irritancy

Reproductive/ developmental toxicity

Reproductive/ developmental toxicity (via

lactation)

Target organ systemic toxicity

Aquatic ecotoxicity

Vertebrate ecotoxicity

Invertebrate ecotoxicity

5. Risk and benefit assessment

3 . 1 0

6 . 1 E

6 . 10

6. 1 E

6.3A

6.4A

6 .8A

No classification

6.98

9. 1 8

No classification

9.4A

Assessment of risks to human health and the environment

EPA class ificat ion

3 . 1 0

N o

6 . 1 E

6 . 1 E

6.38

6.4A

6.8A

6.8C

6.98

9 . 1A

9.38

9 .4A

5 . 1 . Warlock Insecticide is to be used in similar ways to other approved substances containing the same

active ingred ient, emamectin benzoate. Accordingly, the risks to human health and the environment,

including acute toxicity ( inhalation, aspiration hazard), skin and eye irritancy, 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

U!)e of_Warlo�k_ l n�e_f�cig�_ COJ!!pared to oth_er -�pproved substances containing the same active

ingredient and similar other components. Therefore the assessment of risks to human health and the

environment for Warlock Insecticide has been l im ited to a qual itative assessment.

5.2. The staff identification and qual itative assessment of the risks arising from the physical hazards,

human health risks and risks to the environment associated with Warlock I nsecticide are set out in

Tables 2, 3 and 4 respectively. More information is detailed in Appendix B.


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Decision on application for approval to import or manufacture Warlock I nsecticide for release (APP201892)

5.3 . Adverse effects to human health and the environment could arise due to the flammabil ity of the

substance. However, it is considered that in most cases these effects would be managed by the

default controls for flammable substances. Where this is not the case, additional controls have been

proposed to ensure the level of risk is neg l igible (see Section 6).

Relationship of Maori to the environment

5.4. The staff have advised me that Warlock I nsecticide triggers a number of hazardous properties g iving

rise to the potential for cultural risk (e.g. aquatic and soil ecotoxicity). Cultural risk includes the

deterioration of the mauri of taonga flora and fauna species, the environment and the general hea lth

and well-being of individuals and the community.

5 .5 . I n general , the introduction and use of hazardous substances has the potential to inhibit the abi l ity of

iwi/Maori to fulfil their role as kaitiaki . This is particularly in relation to the guardiansh ip of waterways,

given the ecotoxic nature of some substances to aquatic species, and potential risks to the mauri ora

of human health under prolonged exposure to some substances.

5.6. The staff have advised me, based on the information provided, including the use pattern and default

controls for Warlock Insecticide, that the risks to Maori culture or traditional relationsh ips with ancestral

lands, water, sites, wah i tapu, valued flora and fauna or other taonga are l ikely to be neg l igible.

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 reg ion. This action should include advising them of

the extent of the contamination and the measures taken in response.

5 .7 . I n addition, there is no evidence to suggest that the controlled use of Warlock Insecticide wi l l breach

the principles of the Treaty of Waitangi.

Assessment of risks to society and the community and the market economy

5 .8 . The staff did not identify any risks associated with the approval of Warlock Insecticide to society,

communities or the market economy.

5 .9 . There are not expected to be any sign ificant adverse impacts on the social environment with the

controlled use of Warlock Insecticide, apart from the health effects and environmenta l effects already

discussed. Consequently, the staff consider that this aspect of potential risk need not be considered

further.

New Zealand Government www. epa.govt.nz

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Table 2: Risk assessment of physical hazards to the human health and the environment

Lifecycle Description Likelihood Magnitude Matrix Comment Level of risk

Manufacture* The staff note that manufacturing workers will be experienced, and will be Negligible

and packaging alerted to the hazard properties of the substance through identifiers on the

label and documentation. Additionally, workers will be required to use

personal protective equipment (PPE) when directly handling Warlock

Insecticide and treat any spillage in accordance with the HSNO emergency

management regulations.

Importation, Taking into account assumed compliance with HSNO controls in NZ (e.g. Negligible

transport and Adverse packaging controls and controls relating to adverse effects of unintended

storage effects to ignition of class 3 substances set out in Schedule 10 of the New Zealand human health

Highly Gazette Notice of Thursday, 25 March 2004, Issue Number 35 as amended) or the

improbable Moderate Negligible the staff consider it highly improbable that unintended ignition of the

environment substance will occur during importation, transport and storage. resulting from

Use fire There are potentia l risks to human health and the environment if the Neglig ible

substance is unintentionally ignited during use. The staff consider it highly

improbable that the substance will be exposed to a source of ignition

sufficient to ignite it during use.

Disposal G iven the small quantities likely to be disposed of, and controls in place, it is Negligible

considered highly improbable that disposal of Warlock Insecticide will result

in adverse effects to human health or the environment resulting from the

flammable properties of the substance.

*The applicant intends to import (not manufacture) Warlock Insecticide. However, it is possible that the substance could be manufactured in New Zealand in the future. Consequently,

the risks associated with the manufacture of Warlock Insecticide have been evaluated so the approval of this substance will be applicable to both the import and manufacture Warlock

Insecticide.


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Table 3: Qualitative assessment of human health risks

Lifecycle Descript ion Likel ihood Magnit ude Mat rix Comment Leve l of

ris k

Manufacture* Acute toxicity (inhalation, H ighly Moderate Negligible Manufacturing and packaging facilities in New Zealand will be required Negligible

and packaging aspiration hazard) improbable to meet the HSNO requirements for equipment, emergency

management and Personal Protective Equipment (PPE). The need for Negl igible Skin and eye i rritancy Highly Minimal Negligible compliance with HSNO information provisions (e.g. labels, Safety Data

improbable Sheets (SDSs), and Worksafe New Zealand'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.

Reproductive/developmental While the qualitative descriptors indicate a low level of risk driven by the

toxicity major chronic effects of Warlock Insecticide, such as neurotoxic and

reprotoxic effects, it is noted that manufacturing and packaging

processes in New Zealand will be required to meet the HSNO

Target organ or system H ighly

Major Low requirements for equipment, PPE, emergency management and Negligible

toxicity improbable provision of information as well as WorkSafe New Zealand's Health and

Safety regulations. These requirements will make the likelihood of

exposure that would lead to an adverse effect so highly improbable that

the level of risk for these adverse effects is negligible.

Importation, Acute toxicity (inhalation and Highly Moderate Negligible Workers and bystanders wil l only be exposed to the substance during Negligible

transport, aspiration hazard) improbable this part of the lifecycle in isolated incidents where spillage occurs,

storage therefore only risks from acute exposure are considered here. Negligible Skin and eye irritancy Highly Minimal Negligible Compliance with HSNO controls (e.g. labels, SDS) and adherence to

improbable the Land Transport Rule 45001 , Civil Aviation Act 1 990 and Maritime

Transport Act 1 994 (as applicable) is required.

Use Acute toxicity (inhalation and Highly Moderate Negligible The substance will be labelled to identify its potential risks minimising Negligible

aspiration hazard) improbable the opportunity for it to cause toxicity. HSNO requirements for PPE,


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Decision on application for approval to import or manufacture Warlock I nsecticide for release (APP201892)

Lifecycle Descri ption Li ke li hood Mag nit ude Mat rix Comme nt Leve l of

ris k

Skin and eye irritancy Highly Minimal Negligible packaging, identification and emergency management requirements Negl igible

improbable must be complied with.

It is not expected that bystanders will come into contact with the

substance as it is intended for commercial use.

Reproductive/developmental It is considered that, whilst the chronic toxic properties of this substance

toxicity could cause major adverse effects to the user, the voluntary risk wil l be

sufficiently managed by users involved in the application of this

substance to reduce the effect level from low to negligible. The

additional controls will ensure the low level of exposure of users,

bystanders, and workers entering an area on which the substance is Target organ or system H ighly applied. The likelihood of repeated exposure of sufficient magnitude to Negligible toxicity Major Low improbable cause adverse effects is therefore so remote that the risks have not

been considered further

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.

Disposal Acute toxicity (inhalation, Highly Moderate Negligible The applicant indicates that the preferred disposal method is to use the Negligible

aspiration hazard) improbable product according to label directions. Disposal of the substance and its

Skin and eye irritancy used containers in New Zealand, if required, shall be in accordance with

Highly Minimal Negligible the requirements of the Hazardous Substances (Disposal) Regulations Negligible

improbable 2001. Compliance with these will reduce the opportunity for individuals

to be exposed.

*The applicant intends to import (not manufacture) Warlock Insecticide. However, it is possible that the substance could be manufactured in New Zealand in the future. Consequently,


Insecticide.

New Zealand Government www.epa.govt.nz

Table 4: Qual itative assessment of risks to the environment

L ifecycle

Manufacture*,

importation,

transport and

storage

Use

(application)

Disposal

Description

Death or adverse effects to

aquatic or terrestrial

organisms.



organisms.



organisms.

Likelihood Magn itude Matrix

Highly

improbable

H ighly

improbable

Highly

improbable

Minor Negligible

Minor Negligible

Minor Negligible

Page B of 36


Comment

Provided the exercise of this approval is in adherence with the HSNO

controls (and the Land Transport Rule 45001 , Civil Aviation Act 1 990

and Maritime Transport Act "1 994 (as applicable)) , the staff consider a

spill to be highly improbable.

The staff consider that the use of labell ing and safety data sheets

prohibiting application of the substance onto, over or into water and

compliance with approved handler requirements and additional controls

will adequately manage the risks to the aquatic and terrestrial

environments.

Level of

risk

Negligible

Negligible

Users will in most cases utilise all of the substance by its normal use as Negligible

an insecticide. All cases of disposal are required to be in accordance

with the requirements of the Hazardous Substances (Disposal)

Regulations 2001 .

*The appl icant intends to import (not manufacture) Warlock Insecticide. However, it is possible that the substance could be manufactured in New Zealand in the future. Consequently,


Insecticide.


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New Zealand's international obligations

5.1 0. The staff did not identify international obl igations that may be impacted by the approval of Warlock

Insecticide.

Overall assessment of risks

5 . 1 1 . I consider that, with compl iance with the controls in place, the risks to human health and the

environment associated with Warlock Insecticide are mitigated and therefore negligible.

Identification of benefits

5 . 1 2. Accord ing to the appl icant, the approval of Warlock Insecticide wil l provide the following benefits:

• control of leafrollers in h igh va lue export crops such as avocados, grapes, kiwifruit and pipfruit

• an alternative to other emamectin formulations.

5 . 1 3. The staff consider that the approval of Warlock Insecticide wil l provide the following benefits:

• minimisation of the risk of resistance development, wh ich results in prolongment of the efficacy

of Warlock Insecticide

• flow-on financial effects to the local community and the New Zealand economy from the

financial benefits to individual contractors

• the ava i labi l ity of a solution for the control of leafrol lers suitable for an Integrated Pest

Management Program.

The effects of the substance being unavailable

5.1 4. The staff have advised me that the l ikely effects of the substance being unavailable relate to less

consumer choice resulting in less competitive pricing. This is because similar insecticide products are

ava ilable on the New Zealand market.

Overall assessment of benefits

5. 1 5. The staff are satisfied that the avai labi l ity of Warlock I nsecticide wi l l provide beneficial economic

effects for some businesses and individual farmers as well as flow-on effects to local communities and

the New Zealand economy.

6. Controls

6. 1 . Based on the hazard classifications determined for Warlock Insecticide, a set of associated default

controls specified by regulations under the Act has been identified by the staff as being applicable to

Warlock Insecticide. The default controls form the basis of the controls set out in Appendix C. Based

on the risk assessment, it is considered that the fol lowing exposure l im its are relevant and that the

additions and variations to the default controls set out below should be appl ied to Warlock I nsecticide.


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The setting of exposure limits

6.2. 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 Warlock I nsecticide at this time as the r isk of adverse effects to human health has been

qual itatively assessed as negligible, provided users demonstrate compliance with the controls as set

out in Table 7. The EPA is however, required to set AO E and POE values for new active ingredients

that may become present in food, to a l low the setting of Maximum Residue Level (MRL) values by

MPI . The following AOE and POE values have been set previously for emamectin benzoate: AO E =

0. 002 mg/kg bw/day, POEtood = 0.00 1 6 mg/kg bw/day and POEdrinkingwater = 0. 0004 mg/kg bw/day.

6.3. Workplace Exposure Standard (WES) values can be set to l imit the exposure of people to toxic

substances in places of work. The EPA typical ly adopts WES values l isted in WorkSafe New

Zealand's Workplace Exposure Standards document (effective from February 201 3):

http://www.business.govt.nz/worksafe/information-quidance/all-gu idance-items/workplace-exposure

sta n da rds-and -biolog ica l-exposu re-in d ices/workplace-exposu re-standards-and-b iolog ica l-indices-

201 3 .pdf

WorkSafe New Zealand's Workplace Exposure Standards document has set WES values for

components 0 and E of Warlock Insecticide. The staff consider these values to be applicable to

Warlock I nsecticide.

6.4. Environmental Exposure Limits (EELs) can be set to l imit hazardous substances from entering the

environment in quantities sufficient to present a risk to it. No EELs are set for any component of

Warlock I nsecticide at this time as the risk of adverse effects to the environment has been qual itatively

assessed as negl ig ible, provided users demonstrate compliance with the controls as set out in Table

7. The default EEL values are deleted.

6.5. The default controls require the EPA to set an appl ication 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 Warlock Insecticide, a maximum application rate is not able to be set under this

regulation. However, the staff note that the environmental exposure model l ing ind icates 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 appl ication rates u nder section 77 A Additional

controls.


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Decision on application for approval to import or manufacture Warlock Insecticide for release (APP20 1 892)

Additional controls

6.6. Due to the proposed use pattern of Warlock Insecticide, the staff note that significant environmental

exposure may potentially occur. It is therefore necessary to put restrictions on appl ication of Warlock

I nsecticide to mitigate the risk of death or adverse effects to human health and aquatic and terrestrial

organ isms. Accordingly, it is considered that the appl ication of controls addressing these risks wil l be

more effective than the default controls in terms of their effects on the management, use and risks of

the substance.

6 .7 . Due to the developmental toxicity of component E and its abi l ity to penetrate most types of protective

g loves, the following additional controls are appl ied to Warlock Insecticide:

• ( 1) The re-entry interval (REI) for this substance is 24 hours after the spraying of a crop or area has been completed.

(2) The person in charge of the application area shall ensure that no person who is authorised to be there enters the application area until the end of the REI.

(3) Despite (2), a person may enter the application area before the end of the REI if PPE is worn as if that person is applying the substance

LABEL STATEMENT

( 4) A person must not supply this substance to any other person unless the substance label shows the requirements for the REI in accordance with (1)

(5) A person who is in charge of this substance must ensure that the substance label shows

the information required by (4).

• A person who handles Warlock Insecticide must wear gloves that are not permeable to

Component E (e.g. made of layered polyethylene/ethane-vinyl alcohol or butyl) when mixing

and loading this substance.

6.8. The following additional controls are appl ied to Warlock Insecticide to restrict the level of risk to the

environment:

• Warlock Insecticide must not be applied into, onto or over water

• Warlock Insecticide shall be applied via ground-based methods only"

• The maximum application rate of Warlock Insecticide shall be 310 mL Warlock Insecticide /halapplication

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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6.9 . The staff note that the default controls do not address the risks associated with storage or use of the

substances with in stationary container systems (e.g. tanks). These risks include the fa i lure of primary

containment resulting in a large spil l of the substance into the environment. I n add ition , the default

controls do not a l low for d ispensation where it is unnecessary for any pipework associated with the

stationary container systems to have secondary containment. Accord ing ly, 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. The revised controls are shown in Appendix C.

6 . 1 0 . The staff note that the default controls do not address all the risks associated with the unintended

ign ition of flammable substances. These risks include risks to human health from the effects of fire.

These risks may occur where separation of the su bstances from areas where the general public may

be present is inadequate. Accord ing ly, 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.

The additional controls are shown in Appendix C.

6 . 1 1 . 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 Warlock I nsecticide

to manage any potential adverse effects on human health and the environment. The staff have also

advised me that it is necessary to include statements on the label detai l ing the restrictions relating to

the re-entry interval (REI) and the PPE to be worn during the mixing and loading stages.

Variation and deletion of controls

6 . 1 2. The default controls include requirements for ecotoxic substances to be under the control of an

approved hand ler. Given the reduced ecotoxicity of Warlock Insecticide, it is considered that this

control can be modified for Warlock Insecticide so as to apply only when the substance is appl ied 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 Regu lation 9( 1 ) of the

Hazardous Substances (Classes 6, 8, and 9 Controls) Regu lations 200 1 :

"(1) This 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. "

6. 13. The default controls also include requ irements for certain substances to be tracked. Where the control

has been triggered by virtue of a substance's ecotoxicity the staff consider that any risks that may

arise during its lifecycle are adequately managed through other controls such as approved handler,

packaging, label l ing, and emergency management requirements, provided they are complied with .

Thus, this control has been deleted for Warlock Insecticide.

5 'wide dispersive': http://www.epa.qovt.nz/Publications/ER-IS-33-2.pdf


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Review of controls for cost-effectiveness

6. 1 4. The staff consider 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.

He has amended the list of identified benefits and proposed an amendement to the label statement of

the control relative to the re-entry interval . The staff has accepted this modifications and therefore the

appl icant indicated that they had no concerns with the controls assigned to Warlock Insecticide.

7. Environmental user charges

7. 1 . The staff have advised me that applying controls on Warlock I nsecticide is an effective means of

managing the 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 add itional means of achieving

effective risk management. Accord ingly, 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 Warlock

Insecticide (see section 5), I consider that, with controls in place:

• the risks to human health and the environment arising from the hazardous properties (acute

inhalation toxicity, skin and eye irritation, reproductive and neurological toxicity, ecotoxicity to

aquatic and terrestrial environments) and the use of Warlock I nsecticide are negl igible

• significant adverse impacts on the social or economic environment from the use of Warlock

I nsecticide are not anticipated

• significant impacts on Maori cu lture or traditional relationsh ips with ancestral lands, water,

sites, wahi 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 al lowing the use of Warlock I nsecticide.

9. Decision

9. 1 . Pursuant to section 29 of the Act, I have considered this appl ication to import or manufacture a

hazardous substance for release made under section 28 of the Act. In doing so, I have appl ied the

relevant sections of the Act and clauses of the Hazardous Substances and New Organisms

(Methodology) Order 1 998 ("the Methodology") as detailed in the decision path and explanatory notes.

9 .2 . I am satisfied with the hazard classifications identified by the staff in Table 1 (Section 4) and

accordingly confer them on Warlock I nsecticide.


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Decision on application for approval to i mport or manufacture Warlock Insecticide for release (APP201 892)

9.3. I consider that, with controls in place, the risks to human health and to the environment are negligible,

and there wil l be benefits associated with the release of Warlock Insecticide. 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 importation of the hazardous substance, Warlock Insecticide, is thus approved with controls as

l isted in Appendix C. I am also satisfied that, as the manufacture of Warlock Insecticide would not

impose any add itional risks over the importation of the substance, this approval should apply to both

importation and manufacture of Warlock Insecticide.

Rob Fo•long �---------Chief Executive, EPA


Date:

www.epa.govt.nz

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Decision on application for approval to i mport or manufacture Warlock Insecticide for release (APP20 1 892)

Appendix A: Staff classification of Warlock Insecticide

Formulation data were provided for some endpoints for Warlock Insecticide. Classification for endpoints

where data were not provided was estimated using information on the effects of the individual components

and mixture rules.

The mixture rules used for classifying substances can be found in the User Guide to Thresholds and

Classifications6.

The classifications of Warlock Insecticide are shown in Table 5.

Data quality - overall evaluation

The EPA has adopted the Klim isch et at ( 1 997)7 data rel iabi l ity scoring system for evaluating data used in the

hazard classification and risk assessment of chemica ls.

The staff acknowledge that there are frequently data gaps in the hazard classification for chemicals wh ich

have been in use internationally for a long time. International programmes such as the OECD High

Production Volume programme8, REACH9, and European Regu lation 1 1 07/2009/EC10 are progressively

working towards fi l l ing these data gaps. As new information becomes available, staff wil l update the

Hazardous Substances and New Organ isms (HSNO) classifications for those substances.

Table 5: Summary of the applicant's and staff's hazard classification

Mixture classification Method of

classifi cation

I'll en - en Hazard Class/Subclass I'll 0 Remarks

Applicant's Staff's , ... e "' Cll

classification classification I'll ... -:s , :s-- - en >< I'll >

of 36


Hazard Class/Subclass

Subclass 6 .1 Acute toxicity

(dermal)

Subclass 6 . 1 Acute toxicity

(inhalation)

Subclass 6 . 1 Aspiration hazard

Subclass 6.3/8 .2 Skin

irritancy/corrosion

Subclass 6.4/8.3 Eye

irritancy/corrosion

Subclass 6.5A Respiratory

sensitisation

Subclass 6.5B Contact

sensitisation

Subclass 6.6 Mutagenicity

Subclass 6.7 Carcinogenicity

Subclass 6.8 Reproductive/

developmental toxicity

Subclass 6 .8 Reproductive/

developmental toxicity (via

lactation)

Subclass 6.9 Target organ

systemic toxicity 12

Mixture classification

Applicant's Staff's

classification classification

ND

6 . 1 0 6 . 1 E

6. 1 E 6 . 1 E

6.3A 6.3B

6 .4A 6.4A

N D

N o

N D

N D

6 .8A 6.8A

6.8C

6.9B 6 .9B

Method of

classification

ns Ill - Ill Remarks ns 0

"C .. Cl) CJ Cl) ... ns .__ :::1 "C :::s-

>< ns >< :fi i Cl) i 2 0:::

0 0 �

EPA staff consider

the study data do

� 0 0 not support 6.1 D,

but propose 6.1 E

based on signs of

toxicity.

0 0 � Component F

EPA Staff

assessed the

� 0 0 study findings as 6.3B rather than

6.3A.

181 0 0

0 0 0

181 0 0

0 0 181

0 D 181

D D � Based on

component E

Based on D D �

component D.

Based on

emamectin

benzoate and

D D I2J component D • Applicant

triggered 6.9B for

both acute and

12 When appropriate include separate rows to address s ingle as well as repeat dose target organ toxicity, and any of the relevant routes (oral, dermal and/or inhalation).


of 36


Mixture classification Method of

classification

I'll II)

Hazard Class/Subclass - II)

Remarks I'll e Applicant's Staff's "C

CD u CD classification classification

... I'll ... -:l "C :l-

'$( I'll '$( = i & i2

repeat exposure,

whereas the

EPA's substance

database has the

active only

triggering from

repeat exposure.

Applicant

classified 9 . 18

Subclass 9 . 1 Aquatic ecotoxicity 9 . 1 8 9.1 A D D 121 because the M

factor was not

considered in the

mixture rules.

Subclass 9.2 Soil ecotoxicity No NO D D D

Applicant

considered that

Subclass 9.3 Terrestrial No 9 .38 D D 121

the active

vertebrate ecotoxicity ingredient was

9.3C whereas it is

9.3A

Subclass 9.4 Terrestrial 9.4A 9.4A D D 121

Emamectin

invertebrate ecotoxicity benzoate

Mammalian toxicity- Robust study summaries for the formulation13

Acute Oral Toxicity [6. 1 (oral)] Type of study: Acute oral toxicity in the rodent (up/down procedure)

Flag: Key study

Test substance: Emamectin Benzoate 19g/l EC (Synonyms: Emamectin Benzoate 2 . 1 5% w/w EC)

Endpoint: LD50, signs of toxicity

Value: > 2000 mg/kg bw

13 Standard terms and abbreviations are explained in Appendix E


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Reference: Bradshaw, J; 201 0. Emamectin Benzoate 1 9g/l EC (Synonyms: Emamectin Benzoate 2. 1 5%

w/w EC) Acute Oral Toxicity in the Rat- Up and Down Procedure. Harlan Laboratories Ltd, Shard low

Business Park, Shardlow, Derbysh i re DE72 2GD, UK. [Project No: 3070/0023]

Kl im isch Score: 1

Amendments/Deviations: Due to technician error cl in ical observations were not recorded for one an imal on

day 9 post dosing. Based on the previous and subseq uent observations it was considered un l ikely that

cl inical signs of toxicity were present at this time point, and the deviation was not considered to affect the

integrity of the study.

GLP: Yes

Test Guidelines: OECD No 425

Species: Rat

Stra in : Wistar (RccHan. WIST)

No/Sex/Group: 3 females

Dose Levels: 2000 mg/kg bw

Exposure Type: Oral, gavage

Study summary: The animals were dosed sequentia l ly. There were no deaths. One animal suffered

hunched posture and d iarrhoea 4 hour after dosing. At the next observation time (after 1 Day) , this an imal

had recovered and no subsequent find ing were reported (though the observation on th is rat were missed due

to a technical error on Day 9) . The animals gained the anticipated weight during the study. There were no

sign ificant findings at necropsy. The LD50 is >2000 mg/kg bw.

Conclusion: The substance does not trigger classification for acute oral toxicity.

Acute Inhalation Toxicity [6. 1 (inhalation)] Type of Study: Acute inhalation in the rat

Flag: Key study

Test Substance: Emamectin Benzoate 1 9g/l EC (Synonyms: Emamectin Benzoate 2 . 1 5% w/w EC)

Endpoint: LC50, signs of toxicity

Value: >5 . 5 mg/L, but significant clin ical signs of toxicity observed.

Reference: Griffiths, D . R. and Watson, P; 201 0. Emamectin Benzoate1 9g/L EC (Synonyms: Emamectin

Benzoate 2. 1 5% w/w EC) Acute Inha lation Toxicity (Nose Only) Study in the Rat. Harlan Laboratories Ltd,

Shardlow Business Park, Shardlow, Derbyshire DE72 2GD, UK. [Project No: 3070/0024]

Kl imisch Score: 1


9 of 36


Amendments/Deviations: Only 6 an imals were used (3 per sex) for the l imit test.

GLP: Yes

Test Gu idelines: OECD No 403. US OPPTS 870. 1 300. B2 of Commission Regu lation (EC) No 440/2008

Species: Rat

Stra in : Wistar (HsdHan :WIST)

No/Sex/Group: 3

Dose Levels: 5 . 5 mg/1 (SD ± 0.34 mg/1) .

Exposure Type:

• Whole animal/nose exposure: Nose only exposure

• Mass Median Aerodynamic Diameter and Geometic Standard Deviation: MMAD: 2 . 1 4 IJm. GSD: 2 . 57.

Study Summary: There was no mortality. There were sign ificant cl in ical signs of toxicity wh ich occurred to

the conclusion of the study. The findings included increased/decreased respiratory rate, labored respiration,

noisy respiration, ataxia, hu nched posture, pi lo-erection , red/brown staining around the snout, and wet fur.

Females recovered to appear normal from Day 5, but observations such as noisy respiration and increase

respiratory rate were observed two days later. Two male and one female animal appeared normal from

Days 21 - 27 post exposure, but the other animals exh ibited noisy respiration until the end of the study.

Body weight gains were variable, but not consistently lower at the end of the study. Necropsy revealed dark

patches in the lungs in one male animal only.

These data would g ive a classification of 6 . 1 E ( inha lation) based on signs of toxicity.

Conclusion : The clinical signs of toxicity support classification of the substance as 6 . 1 E ( inhalation) .

Skin Irritation [6. 318. 2]

Type of study: Skin irritation corrosion in the rabbit

Flag: Key study

Test Substance: Emamectin Benzoate 1 9g/l EC (Synonyms: Emamectin Benzoate 2 . 1 5% w/w EC)

Endpoint: Mean Draize Score

Value: Mean Draize Score: 2 .0 (erythema), 1 .78 (oedema)

Reference: Bradshaw, J . ; 201 0. Emamectin Benzoate1 9g/L EC (Synonyms: Emamectin Benzoate 2 . 1 5%

wlw EC) Acute Dermal Irritation in the Rabbit. Harlan Laboratories Ltd , Shardlow Business Park, Shard low,

Derbyshire DE72 2GD, U K. [Project No: 3070/0026]

Klimisch Score: 1

Amendments/Deviations: None

New Zealand Government www.epa.govt.nz -

of 36


GLP: Yes

Test Guidelines: OECD No 404. EU Method B4 Commission Regulation (EC) No 440/2008

Species: Rabbit

Strain: New Zealand White

No/Group: 3 males

Dose: 0 .5 mllpatch

Study Summary: The appl ication of the test substance produced well defined erythema and sl ight oedema.

Loss of skin elasticity and flexibi l ity and crust formation was also identified. Two treated sites appeared

normal at the 14 day observation. The reason for the lack of read ing of the third site is not entirely clear, but

appears to be crust formation . This find ing in a single animal does not trigger 6 .3A.

24, 48, 72 hour Mean Draize score for redness: 1 8/9 = 2

24, 48, 72 hour Mean Draize score for oedema: 1 6/9 = 1 . 78

Both these scores support 6 .3B .

Conclusion: The data support classification of the substance as a mi ld skin i rritant (6.3B) .

Eye Irritation [6. 418. 3]

Type of study: Eye irritation/corrosion in the rabbit

Flag: Key study

Test Substance: Emamectin Benzoate 1 9g/l EC (Synonyms: Emamectin Benzoate 2. 1 5% w/w EC)

Endpoint: Mean Draize Score

Value: Cornea (0), I ritis (0.33), Conjunctival redness (2.0), and Conjunctival chemosis ( 1 . 56)

Reference: Bradshaw, J . ; 201 0. Emamectin Benzoate1 9g/L EC (Synonyms: Emamectin Benzoate 2 . 1 5%

w/w EC) Acute Eye I rritation in the Rabbit. Harlan Laboratories Ltd , Shardlow Business Park, Shardlow,

Derbyshire DE72 2GD, UK. [Project No: 3070/0027]

Kl im isch Score: 1


GLP: Yes

Test Guidelines: OECD No 405. EU Method B5 Commission Regulation (EC) No 440/2008

Species: Rabbits

Strain : New Zealand White

No/ Sex/Group: 3 males

�wzealandGovemment www.epa.govt.nz

of 36

Decision on application for approval to import or manufacture Warlock I nsecticide for release (APP201 892)

Dose: 0 . 1 m lleye

Study Summary: Signs of i rritation were seen in al l eyes. There were no corneal findings. I ritis was visible

in al l eyes at the 24 hour wh ich cleared by 48 hours, the mean Draize score was 0.33. The score for

conjunctival redness was 1 8/9 = 2 . The score for conjunctival chemosis was 1 4/9 = 1 . 56. Conjunctival

redness was visible in all eyes on Day 7, but a l l other findings had cleared at that time, and on Day 14 no

abnormalities were reported.

The score for conjunctival redness triggers classification as an eye irritant (6.4A)

Conclusion: The data support classification as an eye irritant (6 .4A) .

Contact Sensitisation [6. 5]

Type of study: Contact sensitisation in the gu inea pig.

Flag: Key study

Test Substance: Emamectin Benzoate 1 9g/l EC

Endpoint: Contact sensitisation (skin reactions)

Value: No positive reactions

Reference: Mallaun , M . ; 20 10. Emamectin Benzoate 1 9g/l EC: Contact hypersensitivity in Albino Guinea

Pigs, Maximization-Test. Harlan Laboratories Ltd, Wolferstrasse 4, 441 4 Ful l insdorf, Switzerland. Harlan

Laboratories Study C9 1 668.

Kl imisch Score: 1


GLP: Yes

Test Guidel ines: OECD No 406. EU Method B6 Commision Regu lation. EC No 1 907/2006

Species: Guinea pig

Strain : Albino Dunkin Hartley.

No/Sex/Group: 10 (test), 5 (control) , a l l males.

Type of Exposure: I ntradermal induction fol lowed by epidermal chal lenge under an occlusive dressing ( 1 %

i n d isti l led water).

Study Summary: There were no dermal reactions to the challenge exposure in any animals.

Conclusion : The substance does not trigger classification for contact sensitisation .


of 36


Ecotoxicity - Robust study summaries for the formulation

Effects on beneficial arthropods

Type of study: Laboratory study

Flag: Supporting study

Test Substance: Proclaim 5 WG

Endpoint: Mean cumulative mortality

Value: 2% +/- 3% (95% confidence interval)

Reference: Mortal ity of the leafroller parasitoid Dolichogenidea tasmanica (Hym: Bracon idae) exposed to

orchard pesticide resid ues. IC Newman, JTS Walker, DJ Rogers. New Zealand Plant Protection 57: 8-1 2

(2004).

Klim isch Score: 2

Amendments/Deviations: No information

GLP: No information

Test Guidel ines: Adapted from IOBC guidelines

Species: Dolichogenidea tasmanica

No/Group: 4 repl icates of 1 5 adu lts

Type of Exposure: dried residues on petri d ishes.

Exposure duration : 7 days

Concentration: equivalent to 4 g ai/ha and 2000 L water/ha

Study Summary: Four replicates and water controls were included on each testing occasion . Both the base

and l id of 85 mm Petri d ishes were sprayed in a Potter tower operated at 1 03 kPa, using 2 ml of solution

with a settl ing period of 12 sec. Treated d ishes were left until dry ( 1 5-20 min) then 1 5 D. tasmanica adu lts

were selected at random from the colony and transferred into each dish with a sable hair brush. The transfer

was carried out in a room cooled to 8-1 2°C to reduce mobil ity of the parasitoids. A cotton wick contain ing 1 . 7

ml of 50:50 honey/water solution was placed into each Petri dish as a food source and was replenished in

al l dishes as necessary. The d ishes were held at 20°C for 7 days and mortal ity was assessed at 24 h

intervals. I nsects that did not move in response to probing with a sable hair brush were considered dead.

Data were adjusted for mortal ity in the water controls using Abbott's correction .

Mean corrected cumulative mortality with Proclaim SWG was 2 ± 3 %.

Conclusion: At the maximum field appl ication rate, emamectin benzoate is not harmful to the leafroller

parasitoid Do/ichogenidea tasmanica.


of 36


Type of study: Field study (greenhouse)

Flag: Supporting study

Test Substance: emamectin benzoate 95 g/kg SG

Endpoint: number of adults/plant a nd % of parasitism of Bemisia tabaci nymphs

Value: No effect on number of adults/plant and % of parasitism for Eretmocerus mundus. No effect on

number of adu lts/plant for Aphid ius co/emani . Less than 1 % parasitism was observed in control and treated

plots with Aphidius colemani so this endpoint was not evaluated for this species.

Reference: The effect of emamectin benzoate on two parasitoids Aphidius colemani Viereck (Hymenoptera:

Braconidae) and Eretmocerus mundus Mercet (Hymenoptera: Aphel in idae), used in pepper green houses. P

Bengochea et al . Spanish Journal of Agricultural Research 1 0(3): 806-8 1 4 (201 2) .

Kl imisch Score: 2

Amendments/Deviations: No information

GLP: No information

Test Guidel ines: EPPO, 2004

Species: Eretmocerus mundus and Aphidius colemani

No/Group: 3 repl icates of 1 60 m2 contain ing 272 plants with 1 0 adu lts I plant of E. mundus or 1 .8 adu iUplant

of A. colemani. 1 0 upper leaves of 20 plants per plot were randomly selected in the middle of the plot. The

number of adults and the level of parasitism was determined . Samples were collected at 7 and 0 days before

introduction and at 7, 1 5 , 22, 30 and 38 days after introduction .

Type of Exposure: aged residues on plants ( 1 , 3 or 7-day residues).

Concentration: equ ivalent to 8 .55 g ai/ha (1 4.25 mg ai/L, 600 L water/ha). Lambda-cyhalothrin formulation

has been included in the test as a toxic reference.

Study Summary: Trials were conducted under commercial greenhouses to assess the effect of 1 -, 3- and 7-

day-old residues of emamectin benzoate at the highest recommended concentration ( 1 4.25 mg/L) on the

popu lation dynamics of the parasitoids. A. colemani, a lthough released at h igher rates than those

commercially used , only reached low densities (less than 1 adu lt per plant), without significant differences

among control plots and those treated with the compound. On the contrary, a natural infestation by native Er.

mundus occurred and this trial can be considered as a direct-spray tria l . Neither adult popu lation nor

parasitism on emamectin benzoate treated plots d iffered sign ificantly from the control . Therefore, emamectin

benzoate residues d id not diminish A. co/emani popu lation densities if applied 1 day before the introduction

of the arthropod (exposure to 1 -day old residues). Simi larly, emamectin benzoate was compatible with Er.

mundus if a direct spray appl ication was used on developed populations.


of 36


Conclusion: No effect of emamectin benzoate on number of adults/plant and % of parasitism for

Eretmocerus mundus. No effect on number of adults/plant for Aphidius co/emani. Less than 1 % parasitism

was observed in control and treated plots so th is endpoint was not evaluated for Aphidius co/emani.


of 36


Appendix 8 : Staff risk and benefit assessment

The staff have evaluated the potential of Warlock Insecticide to cause adverse effects to during a l l stages of

the substance's l ifecycle. A qual itative risk assessment was carried out to assess these risks.

The process by which the risk assessment of substances is undertaken is specified in the Methodology14•

Guidance on risk assessment is provided on the EPA website15.

To facil itate the assessment of risks the appl icant and the staff identified the most common potential sources

of risk to the environment and to h uman health and safety through release, spil lage or exposure throughout

the lifecycle of the su bstance. These are tabulated in Table 6.

Table 6 : Potential sources of risks associated with hazardous substances

Lifecycle Activity

Manufacture* I Import

Packag ing*

Transport or storage

Use

Disposal

Associated Source of Risk

An incident during the manufacture or importation of the substance

resulting in spil lage and subsequent exposure of people or the

environment to the substance.

An incident during the packaging of the substance resulting in

spil lage and subsequent exposure of people or the environment to

the substance.

An incident during the transport or storage of the substance

resulting in spil lage and subsequent exposure of people or the

environment to the substance.

Application of the substance resulting in exposure of users or

bystanders or the environment; or an incident during use resulting

in spil lage and subsequent exposure of users or the environment to

the substance.

Disposal of the substance or packaging resu lting in exposure of

people or the environment to the substance.

• The applicant intends to import (not manufacture) Warlock Insecticide. However, it is possible that the substance could be manufactured in New Zealand in the future. Consequently, the risks associated with the

manufacture of Warlock Insecticide have been evaluated so the approval of this substance will be appl icable to

both the import and manufacture Warlock I nsecticide.

1 4 http://www.epa.govt. nz/publications/methodology.pdf 1 5 http://www.epa.govt. nz/Publ ications/ER-TG-05-02-03-09-(Decision-Making).pdf


of 36


Appendix C : Controls applying to Warlock Insecticide

Notes: The controls for th is substance apply for the indefinite duration of the approval of this substance.

Please refer to the Hazardous Substances Regu lations16 for the requirements prescribed for each control

and the modifications l isted as set out in Section 6 of this document.

Table 7: Controls for Warlock I nsecticide - codes, regulations and variations

Hazardous Su bstances (Classes 1 to 5 Controls) Re g ulations 2001

Code Re gulation Description Variation

Restrictions on the carriage of flammable

F2 Reg 8 substances on passenger service

vehicles

Requirements to prevent unintended

F6 Regs 60 - 70 ignition of class 2. 1 . 1 , 2. 1 .2 and 3 . 1

substances

F1 1 Reg 76 Segregation of incompatible substances

Hazardous Su bstances (Classes 6, 8, and 9 Controls) Re g u lations 2001

Code Reg u lation

T1 Regs 1 1 - 27

T2 Regs 29, 30

T3 Regs 5(1 ) , 6

Description

Limiting exposure to toxic substances

through the setting of TELs

Controlling exposure in places of work

through the setting of WESs.

Requirements for keeping records of use

Variation

No TEL values are set for any component

of the substance at this time.

However, the following ADE and POE

values have been set previously for

emamectin benzoate:

ADE = 0.002 mg/kg bw/day;

PDEraad = 0.001 6 mg/kg bw/day and

PDEdrinking water = 0.0004 mg/kg bw/day

WES values have been set for

Components D and E as detailed in the

Workplace Exposure Standards

document:

http://www. business.qovt. nz/worksafe/info

rmation-quidance/al l-quidance

items/workplace-exposure-standards-and

biological-exposure-indices/workplace

exposure-standards-and-biological

indices-201 3.pdf

16 The regulations can be fou nd on the New Zealand Legislation website; http://www.leqislation.co.nz


Code Regulation

T4 Reg 7

T5 Reg 8

T7 Reg 1 0

E1 Regs 32 - 45

E2 Regs 46 - 48

E3 Reg 49

E5 Regs 5(2), 6

E6 Reg 7

E7 Reg 9

Page 27 of 36


Description

Requirements for equipment used to

handle substances

Requirements for protective clothing and

equipment

Restrictions on the carriage of toxic or

corrosive substances on passenger

service vehicles

Limiting exposure to ecotoxic substances

through the setting of EELs

Restrictions on the application of

substances within application areas

Controls relating to protection of terrestrial

invertebrates eg beneficial insects

Requirements for keeping records of use

Requirements for equipment used to

handle substances

Approved handler/security requirements

for certain ecotoxic substances

Variation

No EEL values are set at this time and the

default EELs are deleted

A maximum application rate has been set

for Warlock Insecticide under section 77A

The following control is substituted for Reg

9(1 ) of the Hazardous Substances

(Classes 6,8 and 9 Controls) Regulations

200 1 :

(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 Su bstances ( Identification) Regu lations 2001

Code Regulation Description Variation

1 1 Regs 6 , 7 , 32 - Identification requirements, duties of

35, 36(1 ) - (7) persons in charge, accessibil ity,

comprehensibility, clarity and durabil ity

13 Reg 9 Priority identifiers for ecotoxic substances

1 5 Reg 1 1 Priority identifiers for flammable

substances

18 Reg 1 4 Priority identifiers for toxic substances

19 Reg 1 8 Secondary identifiers for al l hazardous

substances


Code Regulation

1 1 1 Reg 20

1 1 3 Reg 22

1 1 6 Reg 25

1 1 7 Reg 26

1 1 8 Reg 27

1 1 9 Regs 29 - 31

121 Regs 37 - 39,

47 - 50

123 Reg 41

125 Reg 43

128 Reg 46

129 Regs 51 , 52

130 Reg 53

Page 28 of 36


Description

Secondary identifiers for ecotoxic

substances

Secondary identifiers for flammable

substances

Secondary identifiers for toxic substances

Use of generic names

Requirements for using concentration

ranges

Additional information requirements,

including situations where substances are

in multiple packaging

General documentation requirements

Specific documentation requirements for

ecotoxic substances


flammable substances


toxic substances

Signage requirements

Advertising corrosive and toxic

substances

Variation

Hazardous Su bstances ( Packaging) Regulations 2001


P 1 Regs 5 , 6 , General packaging requirements

7(1 } , 8

P3 Reg 9 Criteria that allow substances to be

packaged to a standard not meeting

Packing Group I, II or I l l criteria

P 1 3 Reg 1 9 Packaging requirements for toxic

substances

P 1 5 Reg 2 1 Packaging requirements for ecotoxic

substances

PG3 Schedule 3 Packaging requirements equivalent to UN

Packing Group I l l

PS4 Schedule 4 Packaging requirements as specified in

New zealand Government www. epa.govt.nz

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Schedule 4

Hazardous Su bstances (Disposal) Regulations 2001

Code Reg ulation Description Variation

D2 Reg 6 Disposal requirements for flammable

substances

D4 Reg 8 Disposal requirements for toxic and

corrosive substances

D5 Reg 9 Disposal requirements for ecotoxic

substances

D6 Reg 1 0 Disposal requirements for packages

D7 Regs 1 1 , 1 2 Information requirements for

manufacturers, importers and suppliers,

and persons in charge

D8 Regs 1 3, 1 4 Documentation requirements for

manufacturers, importers and suppl iers,

and persons in charge

Hazardous Substances ( Emergency Management) Regulations 2001

Code

EM1

EM6

EM?

EM8

EM9

EM1 0

EM1 1

Regulation

Regs 6, 7 , 9 -

1 1

Reg 8(e)

Reg 8(f)

Regs 1 2 - 1 6,

1 8 - 20

Reg 1 7

Regs 21 - 24

Regs 25 - 34

Newlealand Government

Description

Level 1 information requirements for

suppliers and persons in charge

Information requirements for toxic

substances

Information requirements for ecotoxic

substances

Level 2 information requirements for

suppliers and persons in charge

Additional information requirements for

flammable and oxidising substances and

organic peroxides

Fire extinguisher requirements

Level 3 emergency management

requirements: duties of person in charge,

Variation

www.epa.govt.nz

of 36



emergency response plans

EM12 Regs 35 - 41 Level 3 emergency management The following subclauses are added after

requirements: secondary containment subclause (3) of regulation 36:

(4) For the purposes of this regulation,

and regulations 37 to 40, where this

substance is contained in pipework

that is installed and operated so as

to manage any loss of containment

in the pipework it-

(a) is not to be taken into account

in determining whether a place

is required to have a secondary

containment system; and

(b) is not required to be located in

a secondary containment

system.

(5) In this clause, pipework-

(a) means piping that-

(i) is connected to a

stationary container; and

(ii) is used to transfer a

hazardous substance into

or out of the stationary

container; and

(b) includes a process pipeline or a

transfer line.

E M 1 3 Reg 42 Level 3 emergency management

requirements: signage

Hazardous Substances ( Personnel Qual ifications) Reg ulations 2001

Code Regulation

AH 1 Regs 4 - 6

Description

Approved Handler requirements (including

test certificate and qualification

requirements)

Variation

Hazardous Su bstances (Tank Wagon and Transporta ble Containers) Regulations 2004

Code

Tank

Wagon

Regulation

Regs 4 to 43

as appl icable


Description

Controls relating to tank wagons and

transportable containers

Variation

www.epa.govt.nz

of 36


Schedule 8, 9 and 1 0 of the Hazardous Su bstances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004

Code

Sch 8 , 9 &

1 0

Regulation

Schedule 8, 9

and 1 0

Additional controls

Code

Water

App Rate

Application

method

Re-entry

Reg ulation

77A

77A

77A

77A

Description

The controls relating to stationary

container systems, secondary

containment and unintended ignition of

flammable substances, as set out in

schedules 8 , 9 and 10 of the Hazardous

Substances (Dangerous Goods and

Scheduled Toxic Substances) Transfer

Notice 2004 (Supplement to the New

Zealand Gazette, 26 March 2004, No 35,

page 767), as amended, shall apply to this

substance, notwithstanding clause 1 ( 1 ) of

Schedules 8 and 9 and clause 1 of

Schedule 1 0

Description

The substance m ust not be applied into,

onto or over water.

A maximum application rate is set for this

substance.

This substance must be applied via

ground-based methods only

If re-entry work is required within 24 hours

of application , personal protective

equipment shall be worn . Public access

shall not occur during this period .

Variation

Schedule 1 0 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 Clause 1 : This clause applies as if the words "every class 2 and every class 3 . 1 hazardous substance described in Schedule 1" was replaced by: "this substance".

Variation

Warlock Insecticide must not be applied

into, onto or over water17

The maximum application rate of Warlock

Insecticide shall be 310 mL Warlock

Insecticide /ha !application

The appl ication of Warlock Insecticide

must be l imited to ground-based

application methods only 18

(1) The re-entry interval (REI) for this

substance is 24 hours after the spraying of a crop or area has been completed.

(2) The person in charge of the application area shall ensure that no person enters

the application area until the end of the

REI.

(3) Despite (2), a person may enter the application area before the end of the REI

if PPE is worn as if that person is applying

the substance

LABEL STA TEMENT

17 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. 18 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


Code Regulation

PPE 77A

Label 77A

New Zealand Government -= �

Page 32 of 36


Description

Appropriate personal protection

equipment shall be used when handling

this substance.

Additional information that must be

Variation

(4) A person must not supply this substance to any other person unless the

substance label shows the requirements

for the REI, in accordance with (1).

(5) A person who is in charge of this substance must ensure that the substance

label shows the information required by

(4).

A person who handles Warlock Insecticide

must wear gloves that are not permeable

to Component E (e.g. made of layered

polyethylene/ethane-vinyl alcohol or butyl)

when mixing and loading this substance

The maximum application rate (31 0 ml

included on the label has been prescribed Warlock Insecticide /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 1 0 seconds

The label must identify the specific type of

gloves which must be worn during mixing

and loading of the substance

www.epa.govt.nz

of 36


Appendix D: Confidential Information


of 36


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- (x1 o-2)

CA controlled atmosphere

Cl 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

ED 50 median effective dose

ERC environmentally relevant

concentration

F field

New zealand Government --- =-

FO parental generation

F1 fi l ial 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 l iquid 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

H PLC high pressure l iquid chromatography

or high performance liquid

chromatography

HPLC-MS high pressure l iquid chromatography -

mass spectrometry

indoor

150 inhibitory dose, 50%

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of 36


IC50 median immobilization concentration LOQ l imit of quantification (determination)

or median inhibitory concentration 6 LPLC low pressure l iquid chromatography

ID ionization detector LSC l iquid scintillation counting or counter

lm intramuscular LSS l iquid scintillation spectrometry

inh inhalation LT lethal threshold

i p intraperitoneal M molar

IPM integrated pest management pm micrometer (micron)

iv intravenous MDL method detection l imit

IVF in vitro fertilization MFO mixed function oxidase

K Kelvin or Henry's Law constant (in

atmospheres per cubic meter per 119 microgram

mole) (see also H) MLT median lethal time

Kads adsorption constant MLD median lethal dose

Kdes apparent desorption coefficient mol Mole(s)

Koc organic carbon adsorption coefficient MOS margin of safety

Kom organic matter adsorption coefficient melting point m p

kg kilogram MS mass spectrometry

LC l iquid chromatography MSDS material safety data sheet

LC-MS l iquid chromatography- mass

spectrometry NAEL no adverse effect level

LC50 lethal concentration, median nd not detected

LCA l ife cycle analysis NEL no effect level

LC-MS-MS liquid chromatography with tandem ng nanogram

mass spectrometry nm nanometer

LD50 lethal dose, median; dosis letalis NOAEC no observed adverse effect media concentration

LDH lactate dehydrogenase NOAEL no observed adverse effect level

LOAEC lowest observable adverse effect NOEC no observed effect concentration concentration

NOEL no observed effect level LOAEL lowest observable adverse effect

level N R not reported

LOD l imit of detection oc organic carbon content

LOEC lowest observable effect ODP ozone-depleting potential

concentration OM organic matter content

LOEL lowest observable effect level


of 36


Pa

PEC

PECS

PECSW

PECGW

PHI

pKa

PNEC

POW

ppb

PPE

ppm

ppp

ppq

ppt

PTDI

r

r2

REI

Rf

RfD

RL50

RP

pascal

predicted environmental

concentration


concentration in soil


concentration in surface water


concentration in ground water

pre-harvest interval

negative logarithm (to the base 1 0) of the dissociation constant)

predicted no effect concentration

partition coefficient between n-octanol

and water

parts per bil l ion (1 o-9)

personal protective equipment

parts per million (1 o-6)

plant protection product

parts per quadrillion (1 o-24)

parts per tri l l ion (1 0-12)

provisional tolerable daily intake

correlation coefficient

coefficient of determination

restricted entry interval

retardation factor

reference dose

median residual l ifetime

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 l imit

t% 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)

U LV ultra low volume

uv ultraviolet

v/v volume ratio (volume per volume)

w/v weight per volume

ww wet weight

wlw weight per weight

www.epa.govt.nz

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