EPA0316 - Application form to obtain ... - epa.govt.nz · New Zealand. If one has been provided...

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Send to Environmental Protection Authority preferably by email ([email protected]) or alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany application; see our fees and charges schedule for details.

To obtain approval to import or manufacture a pesticide

APPLICATION FORM Pesticides

This form should also be used for

Antifouling paints ☐

Fumigants ☐

Plant protection products ☒

Timber treatments ☐

Vertebrate Toxic Agents ☐

Name of the substance to be approved

DuPont™ Zorvec® Enicade® fungicide

Date

June 2015

mailto:[email protected]

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Application Form Approval to import or manufacture a pesticide

April 2014 EPA0316

Completing this application form

1. This form has been approved under section 28 of the Hazardous Substances and

New Organisms (HSNO) Act 1996. It only covers the import or manufacture of

pesticides to be released in New Zealand under section 28 of the HSNO Act. If you

wish to make an application for another type of substance (such as a veterinary

medicine or industrial chemical) or for another type of application (such as

emergency, special emergency or containment), a different form will have to be

used. All forms are available on our website.

2. It is recommended that you contact an Applications Advisor at the Environmental

Protection Authority (EPA) as early in the application process as possible. An

Applications Advisor can assist you with any questions you have during the

preparation of your application including advising on any consultation

requirements.

3. Before submitting this application, you may make an informal Status of Substance

(SOS) advice request to the EPA. Further information on this process is available

on our website. Please note that this is not mandatory and an SOS request is only

informal advice.

4. This application form may be used to seek approvals for more than one hazardous

substance, if the substances and their uses are of a similar nature.

5. Please make sure that you obtain all appropriate permissions for the use of any

data that you have used or provided in this application form, if you are not the

owner of such data.

6. Unless otherwise indicated, all sections of this form must be completed for the

application to be formally received and assessed. If a section is not relevant to

your application, please provide a comprehensive explanation why this does not

apply. If you choose not to provide the specific information, you will need to apply

for a waiver under section 59(3)(a)(ii) of the HSNO Act. This can be done by

completing the section on the last page of this form.

7. Any extra material that does not fit in the application form must be clearly

labelled, cross-referenced, and included with the application form when it is

submitted.

8. Please add extra rows or tables where needed.

9. You must sign the form (the EPA will accept electronically signed forms) and

enclose the application fee (including GST) unless you are already an approved

EPA customer. To be recognised by the EPA as an “Approved customer”, you must

have submitted more than one application per month over the preceding six

months, and have no history of delay in making payments, at the time of

presenting an application.

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April 2014 EPA0316

10. Information about application fees is available on the EPA website. If you wish to

claim a fee reduction for a reduced-risk-formulated product the appropriate

justification must be submitted at the pre-lodgement stage for consideration.

11. All application communications from the EPA will be provided electronically, unless

you specifically request otherwise.

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April 2014 EPA0316

Commercially sensitive information

12. Commercially sensitive information must be put in a confidential appendix to this

form (also available on our website) and be identified as confidential. If you

consider any information to be commercially sensitive, please show this in the

relevant section of this form and cross reference to where that information is

located in the confidential section.

13. Any information you supply to the EPA prior to formal lodgement of your

application will not be publicly released. Following formal lodgement of your

application any information in the body of this application form and any non-

confidential appendices will become publicly available.

14. Once you have formally lodged your application with the EPA, any information you

have supplied to the EPA about your application is subject to the Official

Information Act 1982 (OIA). If a request is made for the release of information

that you consider to be confidential, your view will be considered in a manner

consistent with the OIA and with section 57 of the HSNO Act. You may be

required to provide further justification for your claim of confidentiality.

Definitions

Active ingredient Component of a formulated substance responsible for the pesticidal effect

CAS Number Chemical Abstracts Service number. This is a unique identifier for a chemical substance

CIPAC Number Collaborative International Pesticides Analytical Council. The CIPAC code number system is a simple approach for an unambiguous coding of active ingredients and variants used in the area/field of pesticides

Hazardous substance

Any substance with one or more of the following intrinsic properties:

• Explosiveness

• Flammability

• A capacity to oxidise

• Corrosiveness

• Toxicity (including chronic toxicity)

• Ecotoxicity, with or without bioaccumulation, or

• which on contact with air or water (other than air or water where the temperature or pressure has been artificially increased or decreased) generates a substance with any one or more of the properties specified in this definition

EINECS European INventory of Existing Commercial chemical Substances

ELINCS European List of Notified Chemical Substances

IUPAC International Union of Pure and Applied Chemistry. The world authority on chemical nomenclature

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April 2014 EPA0316

Pesticide

Substance or mixture of substances intended to be used for preventing, controlling, repelling or mitigating any pest (including vertebrates) in areas such as, but not limited to, agriculture, home and garden, rights of way or industrial areas

Professional and non-professional users

Professional users are using pesticides in the course of their job or business (such as farmers and growers or amenity users). Professional use may include the use of formulated substances in order to deliver services to business or private customers

Non-professional users are not using pesticides in the course of their job or business (such as lifestyle block owners, general public using pesticides for domestic use, and so on)

Public register name Name of the formulated substance to be mentioned in a publicly available register and that can be different from the final marketing name

Relabelling

Action of changing the label of a formulated substance intended to be imported in New Zealand in order to meet the EPA criteria for information content. This action can also occur when the formulated substance is repacked into packaging of different sizes

Repackaging Movement or transfer of a substance from one container to another without a change in composition of the formulation or the labelling content, for sale or distribution

Status Of Substance (SOS) advice

The advice provided in a SOS advice request will include:

• Whether or not a substance is hazardous

• Whether the substance is covered or not by an existing approval

• The hazard classifications of the substance

• The potential relevant approval pathway for the substance

Substance

Any of the following:

• Any element, defined mixture of elements, compounds or defined mixture of compounds, either naturally occurring or produced synthetically, or any mixtures thereof;

• Any isotope, allotrope, isomer, congener, radical or ion of an element or compound which has been declared by the Authority, by notice in the Gazette, to be a different substance from that element or compound;

• Any mixtures or combinations of any of the above;

• Any manufactured article containing, incorporating or including any hazardous substance with explosive properties.

(section 2(1) HSNO Act)

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1. Applicant details

1.1. Applicant

Company Name: DuPont (New Zealand) Ltd

Contact Name: Andrew Dyson

Job Title: Regulatory Affairs Specialist ANZ

Postal Address (provide only if not the same as the physical): Private Bag 76911, Manukau,

2241, New Zealand

Physical Address: Level 1, 14 Ormiston Road, East Tamaki, Auckland 2016

Phone (office and / or mobile): 61 2 9923 6059

Fax: 61 2 9923 6132

Email: [email protected]

1.2. New Zealand agent or consultant (if applicable)

Company Name:

Contact Name:

Job Title:

Postal Address (provide only if not the same as the physical):

Physical Address:

Phone (office and / or mobile):

Fax:

Email:

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1.3. Formal correspondence contact

All formal correspondence will be sent to the contact person for the application identified here


Contact Name: Andrew Dyson

Job Title: Regulatory Affairs Specialist ANZ

Postal Address (provide only if not the same as the physical): Level 1, 14 Ormiston Road, East

Tamaki, Auckland 2016


Phone (office and / or mobile): 61 2 9923 6059

Fax: 61 2 9923 6132


1.4. Invoice contact

Only if different from 1.3. Formal correspondence contact - invoice will be sent to the contact person identified here


Contact Name: Sandra Read

Job Title: Administration Assistant/CSR Support

Postal Address (provide only if not the same as the physical): Level 1, 14 Ormiston Road, East

Tamaki, Auckland 2016


Phone (office and / or mobile): 09 271 7871

Fax: 09 271 2961


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2. Information about the substance

2.1. Purpose statement or executive summary of the application for the public register

No more than 1,100 characters including the description of the formulated substance to be approved, e.g. Soluble Concentrate 350-400 g active ingredient/L

This application is for approval to import for release into New Zealand the substance

DuPont™ Zorvec® Enicade® fungicide containing 100 g/L Oxathiapiprolin as a Oil

Dispersion formulation. The substance is used as a foliar applied fungicide for control of

Downy mildew in Onions.

The substance is formulated in France with active ingredient from Germany. The

substance will be imported fully labelled and packaged in sealed PE/EVOH containers.

The proposed hazardous properties trigger the HSNO classifications of toxic effects to

humans (6.3B and 6.5B) and aquatic organisms (9.1D).

To address the 6.3B and 6.5B classification, the substance will have the following PPE

requirements for users:

When opening the container, preparing spray and using the prepared spray, wear cotton

overalls buttoned to the neck and wrist (or equivalent clothing) and elbow length

chemical resistant gloves.

To address the 9.1D classification, the following label statements are proposed:

Toxic to aquatic life. Avoid contamination of any water supply with product or empty

container.

The substance remains in the original container until completely used. The empty

container is not reused but is rinsed with water, crushed and buried in an appropriate

landfill or recycled in an appropriate container recovery program. The rinsate being

diluted with water can be disposed of on an appropriate waste non-vegetative area or

included in the normal spray program.

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2.2. Type of application

Tick the box(es) that best describe your application

Has ‘Status of Substance (SOS) Advice’ been obtained from the EPA?

☐ Yes ☒ No

If yes, show the SOS reference number:

If yes, is the formulation of the substance different to that submitted at the SOS stage?

(In either case, please provide the composition as part of the confidential appendix)

☐ Yes ☐ No

Is the product a new active ingredient to New Zealand?

☒ Yes ☐ No

Does the product contain any viable new organisms, including GMOs?

☐ Yes ☒ No

Does the product contain an ingredient originating from an organism (plant, animal,

etc)?1

☐ Yes ☒ No

Does the formulated substance contain any nanomaterial?

☐ Yes ☒ No

1 If you tick ‘Yes’ and the product is being imported, then include a Biosecurity Clearance from the Ministry for Primary Industries New Zealand. If one has been provided with a previous application and is still valid, this may be referenced.

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3. Identity of the substance Include any commercially sensitive information in the confidential appendix of this form Provide details on the active ingredient(s) as well as the mixture in this section

3.1. Identity of the active ingredient(s)

Active ingredient (Common Name): Oxathiapiprolin

Chemical name (IUPAC): 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-

3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-

yl]ethanone

Chemical name (CA): 1-[4-[4-[5-(2,6-Difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-

thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone

Molecular formula: C24H22F5N5O2S

Structural formula:

Manufacturer development codes: DPX-QGU42

CIPAC No: 985

CAS No: 1003318-67-9

EEC No (EINECS or ELINCS): Not assigned

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Function:

For plant protection products

☐ Herbicide ☐ Microbial strain ☒ Fungicide

☐ Insecticide ☐ Semiochemical

(pheromone, attractant,

repellent etc.)

☐ Plant Extracts

☐ Other, eg plant growth regulators (specify):

For timber treatments, Vertebrate Toxic Agents (VTA), anti-fouling paints or fumigants,

please describe the function:

FAO Specification (including year of publication):

☐ Yes Year: ☒ No

Minimum purity of the active ingredient as manufactured (g/kg): 950 g/kg

Note: Any impurities must be specified in the confidential appendix.

3.2. Regulatory status of the active ingredient(s)

Jurisdiction Regulatory status

Comment* Never approved

Pending Approved Restricted Not renewed

Australia ☐ ☒ ☐ ☐ ☐

Canada ☐ ☒ ☐ ☐ ☐

Europe ☐ ☒ ☐ ☐ ☐

Japan ☐ ☒ ☐ ☐ ☐

New Zealand ☐ ☒ ☐ ☐ ☐

USA ☐ ☒ ☐ ☐ ☐

Other jurisdictions

(specify in comments)

☐ ☒ ☐ ☐ ☐

Japan, China, Korea, Vietnam, India, Brazil, Argentina, Chile Colombia, Guatemala, Malaysia

Other jurisdictions


☐ ☐ ☒ ☐ ☐ Singapore

*For instance, specify here under which regulation(s) or directive(s).

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When restricted or not renewed, explanations should be provided: Not applicable

3.3. Identity of the formulated substance

Formulated substance name: DuPont™ Zorvec® Enicade® fungicide

Manufacturer development codes: DPX-QGU42 100 OD

Unique names for public register: DuPont™ Zorvec® Enicade® fungicide

Active ingredient(s) and content (g/kg or L and % w/w): 100 g/L

3.4. Physical and chemical properties of the formulated substance Provide as much information as possible on the physical and chemical properties of the substance (at 20°C and 1 atmosphere unless otherwise stated)

Appearance (colour, odour, physical state or form): The formulation is off-white liquid

with a moderate, oily characteristic odour.

pH: 6.5 (1% dilution in water) for formulated product

Density: 0.987 g/mL at 20°C for formulated product

Vapour pressure: 1.141 × 10-6 Pa at 20°C for Oxathiapiprolin technical

Boiling/melting point: Melting point ~146°C for Oxathiapiprolin technical

Solubility in water: Water 0.1749 µg/mL for Oxathiapiprolin pure ingredient

Water/octanol partitioning co-efficient: log Kow = 3.6 for Oxathiapiprolin technical

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3.5. Regulatory status of the formulated substance

Jurisdiction Regulatory status

Comment* Never approved

Pending Approved Restricted Not renewed

Australia ☐ ☒ ☐ ☐ ☐ 100 OD only

Canada ☐ ☒ ☐ ☐ ☐ 100 OD and 200 SC

Europe ☐ ☒ ☐ ☐ ☐ 100 OD and various mixtures

Japan ☐ ☒ ☐ ☐ ☐ 100 OD and local mixtures

New Zealand ☐ ☒ ☐ ☐ ☐ 100 OD

USA ☐ ☒ ☐ ☐ ☐ 100 OD and 200 SC

Other jurisdictions


☐ ☒ ☐ ☐ ☐

Japan, China, Korea, Vietnam, India, Brazil, Argentina, Chile Colombia, Guatemala, Malaysia

Most registrations are for various local mixtures

Other jurisdictions


☐ ☐ ☒ ☐ ☐ Singapore

*For instance, specify here under which regulation(s) or directive(s).

Has an application been made for an approval under the Agricultural Compounds and Veterinary Medicines Act?

☒ Yes ☐ No

3.6. Composition details of the formulated substance

Full composition details for the substance must be provided in the confidential appendix

Composition has been provided in confidential appendix

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4. Life cycle of the substance

Manufacturing

Will your formulated substance be manufactured in New Zealand?

☐ Yes ☒ No

Importation

Will your formulated substance be imported into New Zealand by air and/or sea?

☒ Sea ☒ Air

Will your formulated substance be imported in bulk containers or packaged ready for

sale?

☐ Bulk Containers ☒ Packaged ready for sale

If your formulated substance will be imported in bulk containers, please describe these containers: Will repackaging of your formulated substance be carried out in New Zealand?

☐ Yes ☒ No

Will relabelling of your formulated product be carried out in New Zealand?

☐ Yes ☒ No

Please provide any additional relevant information relating to the importation of your

formulated substance:

Transport

Will your formulated substance be transported by road, rail, air and/or sea within New Zealand?

☒ Road ☒ Sea ☒ Rail ☐ Air

Please provide any additional information relating to transport of your formulated

substance:

UN Number: 3082

UN Transport Hazard Classes: 9

UN Packing Group Number (UN Model Regulations2): III

Marine Pollutant? (IMDG Code3): Yes

2 UN Model Regulations mean Model Regulations annexed to the most recently revised edition of the Recommendations on the Transport of Dangerous Goods published by the UN

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Packaging

Pack sizes: 1 to 5 L containers

Type of packaging: PE/EVOH containers

Type of closure (consider opening size, type of cap, child resistant packaging): 63 mm,

screw cap with internal heat seal

Please provide any additional information relating to the packaging of your formulated

substance:

The substance will be packed in containers suitable for Oil Dispersion formulations, and

have been tested in realtime and accelerated storage stability studies. The container will

be labelled with a label and leaflet. The front and back labels will be synthetic, with a

leaflet under the back label. The material used for the labels has previously being used

and are durable for the intended purpose.

The proposed containers and labels materials have previously been used for similar

products in the New Zealand market.

Storage

Provide details of how the substance will be stored, and the facilities it will be stored in:

Store in original container, tightly closed and under lock and key, in a cool well ventilated

area away from feed, seed and foodstuffs. Store in accordance with the NZS 8409

Management of Agrichemicals.

Warehouse storage

Provide details of how the formulated substance will be stored: A designated

locked chemical store for pesticidal substances and hazardous chemicals.

Containment of spillages: The warehouse is bunded to contain spillages and has a site

certification program under the HSNO legislation. The spillage is mixed with inert

absorbent material (such as sand, sawdust, earth, vermiculite or other dry inert

material). Spillage to be prevented from entering drains, waterways and around local

vegetation.

Decontamination of areas, personnel, vehicles and buildings: The use of a detergent and

water to clean contaminated articles or sites. Liquid contaminated waste is contained and

3 IMDG Code means that International Maritime Dangerous Goods code, as amended

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placed in a spill drum within the warehouse.

Disposal

Disposal of damaged packaging, contaminated absorbents and other materials: To be stored in a sealed container for disposal at an appropriate landfill. The

contaminated liquid waste is also retained for appropriate disposal to the local Council

waste dumping facility, according to the local Council by-laws.

Detailed instructions for safe disposal of the formulated substance and its packaging: The

substance is retained in its original packaging, sealed, and stored securely until

completely used.

Container disposal: Ensure the container is empty. Triple rinse empty container and add

rinsate to the spray tank. Recycle empty container through Agrecovery (0800 247 326,

www.agrecovery.co.nz) Otherwise crush and bury in a suitable landfill. DO NOT reuse

this container for any other purpose. Dispose of this product only by using according to

this label, or at an approved landfill, DO NOT burn the product.

Methods other than controlled incineration for disposal: Empty container to be rinsed

with detergent and water, crushed and buried in a suitable landfill. The larger cleaned

plastic containers may be suitable for appropriate container recycling recovery programs.

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5. Intended uses of the formulated substance

The information you provide here will be used by the EPA to assess the risks posed by the substance and the controls assigned to manage

these risks. You must outline either all the proposed uses of the product or the worst-case scenario for each application method

(considering both the application rate and the frequency). Please use table 5.1 for plant protection products or table 5.2 for all other types of pesticides. Explanatory notes are below each table.

5.1. Intended uses for plant protection products

You must outline either all the proposed uses of the product or the worst case scenario for each application method (considering both the application rate and frequency)

Crop and/or situation (a)

Product Code

F G or I (b)

Pest or group of pests controlled (c)

Formulation Application Application rate per treatment

PHI (days) (l)

Remarks (m)

Type (d-f)

Conc of as (i)

Method kind (f-h)

Growth stage and season (j)

Number min max (k)

Interval between applications (min)

Kg as/hL min max

Water L/ha min max

Kg as/ha min max

Onions Zorvec Enicade F Downy

mildew OD 100 g/L Foliar boom spray

09 -89 1 - 2 10

0.007 to 0.0175 to

200 – 500 L/ha

0.035 10 days

Application by ground only

SP5348

Typewritten Text

SP5348

Typewritten Text

SP5348

Typewritten Text

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(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (eg fumigation of a structure)

(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) eg biting and suckling insects, soil born insects, foliar fungi, weeds (d) eg wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, eg high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, eg overall, broadcast, aerial spraying, row, individual plant, between the plants -

type of equipment used must be described

(i) g/kg or g/l (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, season at time of application (k) The minimum and maximum number of applications possible under practical conditions of

use must be provided (l) PHI - minimum pre-harvest interval (m) Remarks may include: extent of use, economic importance and restrictions

5.2. Intended use for pesticides not used as plant protection products (eg timber treatments, Vertebrate Toxic Agents (VTA), anti-fouling paints or fumigants)

You must outline either all the proposed uses of the product or the worst case scenario for each application method (considering both the application rate and frequency)

User (a)

Area of Use (b)

Pest or group of pests controlled (c)

Application Application rate per treatment (f)

Remarks (g)

Method (d)

Number min max (e)

Interval between applications - days (minimum)

(a) Professional/non professional (b) Domestic/commercial/industrial (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

(e) The minimum and maximum number of applications possible under practical conditions of use

must be provided (f) g/kg and g/l or others (g) Remarks may include; extent of use, economic importance and restrictions

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6. HSNO hazard classifications of the formulated substance

The information you provide here will form the basis of your substance’s HSNO

classification.

Please consider each of the hazardous properties in the table below and provide

information on those properties that trigger any threshold level for your substance. Use

the justification column to record the reason for your classification. If your substance is a

mixture, you can apply mixture rules to the hazardous components of the mixture. If you

do this, you will need to provide information on the hazardous properties of each

hazardous component of the mixture, and show your workings. See Assigning A Product

to an HSNO Approval on our website for more information.

Please use the following abbreviations if needed.

NA: Not Applicable – For instance when testing is technically not possible: testing for a

specific endpoint may be omitted, if it is technically not possible to conduct the study as

a consequence of the properties of the substance: eg very volatile, highly reactive or

unstable substances cannot be used, mixing of the substance with water may cause

danger of fire or explosion or the radio-labelling of the substance required in certain

studies may not be possible.

ND: No Data or poor quality data (according to Klimisch criteria) – where there is a lack

of data.

No: Not Classified based on actual relevant data available for the substance – the data is

conclusive and shows the threshold for classification is not triggered.

Hazard Class/Subclass Formulated substance classification

Justification

Examples 3.1C 6.1D

Flashpoint = 46 deg C (closed cup) Calculated LD50 = 1250 mg/kg (mixture rules)

Class 1 Explosiveness Not classified The substance does not possess explosive properties. DuPont-32038

Class 2, 3 & 4 Flammability Not classified The substance does not possess flammability properties. DuPont-32038

Class 5 Oxidisers/Organic Peroxides Not classified The substance does not meet Oxidiser properties. DuPont-32038

Subclass 8.1 Metallic corrosiveness Not classified No data available

http://www.epa.govt.nz/Publications/hsnogen-gs-assigning.pdf

http://www.epa.govt.nz/Publications/hsnogen-gs-assigning.pdf

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Justification

Subclass 6.1 Acute toxicity (oral) Not classified Up-and-Down procedure – Rat LD50 > 5000 mg/kg The substance does not possess acute oral toxicity. DuPont-32681 RV2

Subclass 6.1 Acute toxicity (dermal) Not classified Acute dermal rat LD50 > 5000 mg/kg The substance does not possess acute dermal toxicity. DuPont-32683

Subclass 6.1 Acute toxicity (inhalation) Not classified Acute LC50 rat inhalation > 5.08 mg/L The substance does not possess acute inhalation toxicity. DuPont-32672 Rev 2

Subclass 6.1 Aspiration hazard Not classified The substance is liquid at room temperature; its physical properties do not indicate an aspiration hazard potential.

Subclass 6.3/8.2 Skin irritancy/corrosion 6.3B The substance is a mild irritant. DuPont-32675 RV1

Subclass 6.4/8.3 Eye irritancy/corrosion Not classified The substance does not possess eye irritancy/corrosion. DuPont-32673 RV1

Subclass 6.5A Respiratory sensitisation Not classified No data available

Subclass 6.5B Contact sensitisation 6.5B The substance is classified as a skin sensitiser based on the results of a study conducted with the mixture. DuPont-32677 RV1

Subclass 6.6 Mutagenicity Not classified No evidence for mutagenicity in a battery of in vitro tests & in an in vivo test DuPont-30255, DuPont-30256, DuPont-30257, DuPont-31004

Subclass 6.7 Carcinogenicity Not classified No evidence for a carcinogenic effect in oral studies in rats and mice. DuPont-30180, DuPont-30263

Subclass 6.8 Reproductive or developmental toxicity Not classified No effects on fertility in rats; effects on animal body weight only at dietary concentrations that greatly exceeded the maximum guideline concentrations; slight delays in maturation of males was the basis for the NOAEL/LOAEL, but were in isolation, were not of a severity warranting classification & may have been influenced at higher doses by the influence of body weight loss DuPont-28631 RV1, DuPont-30258

Subclass 6.8 Reproductive or developmental toxicity (known, presumed or suspected)

Not classified

Subclass 6.8 Reproductive or developmental toxicity (via lactation)

Not classified

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Justification

Subclass 6.9 Target organ systemic toxicity4 Not classified Single exposure No effects noted in the rat acute neurotoxicity test cited here, nor in any of the acute toxicity tests cited above DuPont-29440 Repeat exposure No severe effects in a battery of oral studies ranging from 14 to 90 days in rats, 28 to 90 days in mice, 28 to 1-year in dogs, or in a 28-day dermal study in rats DuPont-24634, DuPont-28294, DuPont-28295, Revision No. 1, DuPont-28296, DuPont-28947, DuPont-28946, DuPont-30047, DuPont-30254, DuPont-32338

Subclass 9.1 Aquatic ecotoxicity 9.1D All the acute L(E)C50 values for aquatic organisms are above the water solubility of the technical which is 0.184 mg/L, so acute tests do not provide a true measure of the intrinsic toxicity. No chronic test conducted with substance. The most sensitive chronic NOEC values are for brackish species 0.058 mg/L (Americamysis bahia) and for sediment dwelling organisms 0.11 mg/L (Chironomus riparius). As the chronic NOEC < 1 mg/L, and there is no other evidence to show the classification is unnecessary, the substance is a 9.1D . This classification is supported as the substance is a fungicide designed to control fungal diseases, the 9.1D (biocide) classification is considered appropriate DuPont-32456, DuPont-36043

Subclass 9.2 Soil ecotoxicity Not classified Predatory soil mite EC50 > 1000 mg/kg soil d.w. DuPont-35839 Earthworms EC50 > 100 mg/kg soil d.w. DuPont-35836 Terrestrial plants EC50 > 650 g as/ha DuPont-32478, DuPont-32479

4 identify classification for single and/or repeat dose target organ toxicity for oral, dermal or inhalation routes

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Justification

Subclass 9.3 Terrestrial vertebrate ecotoxicity Not classified Rat LD50 > 5000 mg/kg DuPont-32681 Revision No. 2 Northern bobwhite > 2250 mg/kg bw/day DuPont-31753 Zebra finch > 2250 mg/kg bw/day DuPont-31764 Short term Northern bobwhite >1280 mg a.i./kg body weight/day DuPont-31764 Mallard >2728 mg a.i./kg body weight/day DuPont-31765

Subclass 9.4 Terrestrial invertebrate ecotoxicity Not classified Bee - Acute oral LD50 >137 ug as/bee Bee - Acute contact LD50 > 100 ug as/bee DuPont-31006 No negative impact on: Predatory mite - Typhlodromus pyri, Parasitic wasp - Aphidius rhopalosiphi, Green lace wing - Chrysoperla carnea Collembola - Folsomia candida Predatory mite - Hypoaspis aculeifer DuPont-33193, DuPont-32696, DuPont-34267, DuPont-34209, DuPont-34111, DuPont-32458, DuPont-33723

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April 2014 EPA0316

7. Risks, costs and benefits These are the positive and adverse effects referred to in the HSNO Act. It is easier to

regard risks and costs as being adverse (or negative) and benefits as being positive. In

considering risks, cost and benefits, it is important to look at both the likelihood of

occurrence (probability) and the potential magnitude of the consequences, and to look at

distribution effects (who bears the costs, benefits and risks).

You will need to consider the effects on the environment and human health and welfare,

including any social effects.

In each section below, set out the information under the following three sub-headings:

• Costs and benefits which can be stated in monetary (dollar) terms

• Non-monetary risks and costs

• Non-monetary benefits.

You must fully complete this section, referencing supporting material. You will need to

provide a description of where the information in the application has been sourced from,

e.g. from; in-house research, independent research, technical literature, community or

other consultation, and provide that information with this application.

7.1. Identify all of the potential risks, costs and benefits of the substance(s)

Identification is the first step in assessing risks, costs and benefits. It is important to think about the source of the risk, i.e. the way in which the risk is created (the exposure pathway), and then the consequences and likelihood of exposure.

You should try to think as widely as possible about every potential risk, cost and benefit and give a brief description.

The possible risks associated with DuPont™ Zorvec® Enicade® fungicide are tabulated in

the following table

Lifecycle Activity Associated Source of Risk Import An incident during the 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

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April 2014 EPA0316

The benefits associated with DuPont™ Zorvec® Enicade® fungicide are identified in the

following table:

Item Benefit

Disease control Improved yield including size, and improved storage quality

Low use rate Low environmental loading, less product to handle and transport

Low ecotoxicity Less environmental classifications compared to current registered products

Quickly rainfast Application flexability

7.2. Provide an assessment of those risks, costs, and benefits identified in Section 7.1

This section excludes risks, costs, and benefits which relate specifically to Māori taonga or to international agreements. See Sections 7.3 and 7.4 for those aspects.

A full assessment must be provided of all the risks, costs and benefits identified in Section 7.1.For the risk assessment our preferred format is quantitative, however, you may also provide a qualitative assessment if you can justify this. If you are providing your risk assessment in supporting documentation with this application you can provide a summary of all the risks this in this section.

Please note that if you do not complete a full assessment of all risk, costs and benefits this may result in the EPA requesting further information from you, which will mean that your application takes longer to process.

Costs of Downy mildew in Onions

Downy mildew can be responsible for large losses in Onion production in some years in

North Island growing areas. Losses arise when damage to foliage leads to small size and

poor storage quality of Onion bulbs. Management of Onion downy mildew in New Zealand

involves applications of protective fungicides at 7 to 10 day intervals during the growing

season, with additional applications of curative (systemic) fungicides when disease risk is

perceived to be high.

Benefits

DuPont™ Zorvec® Enicade® fungicide will form an important role in the spray program

for the control of Downy mildew in Onions. The alternate mode of action will assist in

resistance management, whilst having minimal impact on the environment and safety to

beneficials.

DuPont™ Zorvec® Enicade® fungicide offers excellent disease control at low use rates

(35 gai/ha) compared to the current industry standard treatments (Mandipropamid 100 to

150 gai/ha, Fenamidone 150 gai/ha, Dimethomorph 180 gai/ha).

Foliar application of this substance results in rapid movement into treated tissues to

prevent wash-off and provides good redistribution of the active ingredient for more

thorough protection against disease -

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April 2014 EPA0316

• Systemic movement - protects underside of plant and

new growth.

• A significant portion of Zorvec is absorbed on and within

the epicuticular waxy layer following application for

superior rainfastness. Controlled washoff studies have

demonstrated Zorvec is secure and protected

from wash-off just 20 minutes after application.

• Translaminar, acropetal systemic movement enables

uniform protection of foliage.

DuPont Zorvec Enicade fungicide will give growers an additional option for Downy mildew

controls. Downy mildew reduces the photosynthetic area of the leaves and in severe

cases causes defoliation leading to reduced crop yields and quality, thus resulting in

diminished returns to growers and reduced export earnings for New Zealand.

Human health

The proposed human health classification for DuPont Zorvec Enicade fungicide is Skin

irritancy 6.3B and Contact sensitisation 6.5B. The risks associated with DuPont Zorvec

Enicade fungicide to human health and safety at various stages of the lifecycle are

summarised in Table 1.

Based on the toxicological profile of oxathiapiprolin, an Acute Reference Dose (ARfD) is

not proposed. Oxathiapiprolin did not induce any toxicological effects following single,

acute exposures via the oral, dermal or inhalation exposure pathways. No adverse effects

were observed in short term toxicity studies.

There are no chronic hazards associated with repeat exposures to DuPont Zorvec Enicade

fungicide.

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April 2014 EPA0316

Environment

The proposed environmental classification for DuPont Zorvec Enicade fungicide is 9.1D

and is favourable when compared to currently used products.

Active and concentration HSR number HSNO classification

Oxathiapiprolin 100 g/L Pending 6.3B, 6.5B (proposed) 9.1D (Proposed)

Dimethomorph 90 g/kg

Mancozeb 600 g/kg

000531 6.3A, 6.4A, 6.9B 9.1A

Azoxystrobin 500 g/kg 000616 6.1D, 6.4A 9.1A

Mandipropamid 250 g/L 007779 6.9B 9.1D

Ametoctradin 300 g/L

Dimethomorph 225 g/L

100709 6.1D, 6.9B 9.1C, 9.3C

Dimethomorph 500 g/L 007636 6.9B 9.1B

Fenamidone 500 g/L 001758 6.9B 9.1A, 9.2D

Metalaxyl-M 40 g/kg

Mancozeb 640 g/kg

000470 6.5B, 6.9B 9.1A

Mancozeb 750 g/kg 000808 6.3B, 6.4A, 6.5B, 6.9B 9.1A, 9.1D

Green DuPont™ Zorvec® Enicade® fungicide proposed classifications better than currently registered products used for Downy mildew control in Onions

Red Alternative products classifications with higher levels compared to those proposed for DuPont™ Zorvec® Enicade® fungicide

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April 2014 EPA0316

Table 1 Level of risk of DuPont Zorvec Enicade™ fungicide to human health and safety

Lifecycle stage Adverse Effect Likelihood Magnitude Matrix Comments Effect level

Manufacture/ packing

Acute toxicity (oral, dermal)

Highly improbable

Minimal Negligible Product will be imported into New Zealand fully packed and labelled.

Negligible

Skin sensitisation

Highly improbable

Moderate Negligible

Eye corrosivity Highly improbable

Minimal Negligible

Carcinogenicity Reproductive/ Developmental toxicity

Highly improbable

Minimal Negligible Negligible

Importation, transport or storage


Highly improbable

Minimal Negligible Workers and bystanders will only be exposed to the substance during this part of the lifecycle in isolated incidents where spillage occurs. 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) will apply.

Negligible

Skin sensitisation

Highly improbable

Moderate Negligible


Minimal Negligible

Use

Acute effects: users & bystanders (qualitative assessment)


Highly improbable

Minimal Negligible The substance will be labelled to identify its potential risks minimising the opportunity for it to cause toxicity. HSNO requirements for PPE, packaging, identification and emergency management will be apply. Additionally, it is highly improbable that bystanders will be exposed to DuPont Zorvec Enicade fungicide to product acute effects.

Negligible

Skin sensitisation

Highly improbable

Moderate Negligible


Minimal Negligible

Chronic effects: users (quantitative assessment)

Carcinogenicity Target organ toxicity

Quantitative assessment indicates that the chronic risk to the health and safety of operators are acceptable even if PPE is not worn during mixing, loading and application. The use of PPE will further reduce this risk to negligible.

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Lifecycle stage Adverse Effect Likelihood Magnitude Matrix Comments Effect level

Chronic effects: bystanders (quantitative assessment)


Quantitative assessment indicated that the chronic risks to bystander health and safety are acceptable and the level of risk is considered negligible.

Disposal Acute toxicity (oral, dermal)

Highly improbable

Minimal Negligible DuPont Zorvec Enicade fungicide will be utilised in accordance with the label. In all cases of disposal, the substance will be disposed of in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991.

Negligible

Skin sensitisation

Highly improbable

Moderate Negligible


Minimal Negligible


Highly improbable

Minimal Negligible There are no chronic toxic properties of DuPont Zorvec Enicade fungicide that could cause major adverse effects.

Negligible

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Table 2 Level of risk of DuPont Zorvec Enicade™ fungicide to the environment

Lifecycle stage Potential Adverse Effect

Likelihood of Adverse Effect Occurring

Magnitude of Adverse Effect

Matrix Comments Level of Risk

Manufacture, importation, transport and storage

Spillage resulting in death or adverse effects to organisms in the aquatic environment.

Highly improbable

Moderate Negligible Adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable) would mean any spill would involve small quantities which would lead to localised effects only.

Negligible

Use Use resulting in death or adverse effects to organisms in the aquatic environment.

Quantitative assessment indicates that there is a low risk to the aquatic environment.

Use resulting in death or adverse effects to earthworms.

Quantitative assessment indicates that there is a negligible acute and chronic risk to earthworms during the use

Use resulting in death or adverse effects terrestrial vertebrates

Quantitative assessment indicates that there is negligible acute and chronic risk to birds during the use.

Use resulting in death or adverse effects terrestrial invertebrates

Quantitative assessment indicates that DuPont Zorvec Enicade fungicide is unlikely to present a risk to bees.

Disposal Disposal resulting in death or adverse effects to organisms in the aquatic environment..

Highly improbable

Minor Negligible DuPont will advise users that DuPont Zorvec Enicade fungicide should be completely used in accordance with its registered use. In all cases of disposal, the substance will be disposed of in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991.

Negligible

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7.3. Provide an assessment of any risks, costs and benefits which arise from the kaitiaki relationship of Māori and their culture to the environment

Please note that consultation with Māori may be appropriate for this application. Please refer to the EPA policy ‘Engaging with Māori for applications to the EPA’ which can be found on the EPA website (www.epa.govt.nz) or contact the EPA for advice.

An example of the issues to consider include whether the substance poses any risk to native or valued species, or waterways.

An overview of the application was distributed to the Te Herenga Group by the EPA on

behalf of DuPont; no comments were received. As such, an assessment of comments

received by the EPA for previous applications for other fungicides used in Onions for

Downy mildew control was undertaken. From this review, areas of possible Māori concern

were identified. It is acknowledged that the use of DuPont™ Zorvec® Enicade® fungicide

may cause some concern to kaitiaki relationship of Māori and their culture to the

environment.

The possible areas of concerns are associated with aquatic ecotoxicity (9.1D) and to a

much lesser extent skin irritation (6.3B), skin sensitisation (6.5B). These risks can be

managed by the proper use of the substance in accordance with the label and good

agricultural practise. A detailed summary of the risks and management are summarised

below:

Any risks associated with ecotoxicity can be managed by correct product usage thus

minimising off target movement. Modelling of acute and long-term ecotoxicity were

undertaken and are summarised as follows:

Predicted environmental concentrations used in modelling

Modelling Methodologies

Predicted environmental concentration in

soil

FOCUS (1996 and 2011) using ESCAPE model

(ver. 2.0)


groundwater

FOCUS Groundwater Working Group (2000

and 2012) using the following FOCUS models:

PEARL (ver. 4.4.4) and PELMO (ver. 5.5.3)


surfacewater and sediment

Surface water and sediment were calculated

using a stepwise approach as recommended

by the FOCUS Surface Water Working Group

(2001 and 2012).

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Environmental Fate/Ecotoxicology

A full battery of environmental fate and non-target ecotoxicity studies was conducted on

oxathiapiprolin. Oxathiapiprolin is hydrolytically stable in water at environmentally

relevant pH values. The aqueous photolysis DT50 for oxathiapiprolin in the laboratory is

15.4 days. Oxathiapiprolin has low water solubility, 0.184 mg/L; therefore exposure will

often be limited by the solubility. The rate of aerobic degradation of oxathiapiprolin in

the laboratory was measured in five different soils. Under laboratory conditions, the

DT50 values ranged from 18.2 to 134.4 days at 20°C. No correlation was observed

between the rate of degradation of oxathiapiprolin and soil pH. In addition, laboratory

studies show that the degradation of oxathiapiprolin in soil results in the formation of

several metabolites, including CO2 and non extractable residue.

Laboratory rate of degradation studies were performed on IN-RDT31, IN-RAB06, IN-

QPS10, and IN-E8S72. In addition, attempts were made to derive DT50 values for IN-

RDT31, IN-RAB06, IN-QPS10 and IN-E8S72 from the laboratory degradation studies

performed with oxathiapiprolin as the applied test material. All DT50 values were

derived following FOCUS guidance.

Numerous studies have been performed to understand the factors that influence the

dissipation and degradation of oxathiapiprolin in aquatic systems: hydrolysis as affected

by pH; aqueous photolysis in buffers and natural water under simulated sunlight; aerobic

and anaerobic aquatic metabolism studies; and mineralization in surface water. The

DT50 and DT90 values for oxathiapiprolin in the water phase of the aerobic sediment

systems ranged from 5.5 to 13.6 days and 38.3 to 45.1 days, respectively, in the two

water/sediment systems. The DT50 and DT90 values for oxathiapiprolin in the sediments

ranged from 112.7 to 249.2 days and 374.3 to 827.9 days, respectively, in the two

water/sediment systems. For the total system, the DT50 and DT90 values for

oxathiapiprolin ranged from 18.6 to 44.9 days and 267.9 to 149.2 days, respectively in

the two water/sediment systems. Based on the results of this study, oxathiapiprolin and

its metabolites would dissipate from aerobic water sediment systems in the environment.

The fate of oxathiapiprolin was studied in two disparate water/sediment systems

incubated in the dark at 20ºC under anaerobic conditions: sand sediment (water: pH

6.5-7.0 and sediment: pH 5.8-5.9) and silt loam sediment (water: pH 7.5-7.8 and

sediment: pH 7.3-7.5). In both test systems, oxathiapiprolin partitioned from the water

into the sediment phase and underwent further degradation in the sediment phase. The

DT50 and DT90 values for oxathiapiprolin in the water phase of the anaerobic sediment

systems ranged from 14.6 to 33.1 days and 48.6 to 109.9 days, respectively, in the two

water/sediment systems. The DT50 and DT90 values for oxathiapiprolin in the sediments

ranged from 37.9 to 224.4 days and 126.0 to 745.5 days, respectively, in the two

water/sediment systems. For the total system, the DT50 and DT90 values for

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April 2014 EPA0316

oxathiapiprolin ranged from 49.0 to 54.6 days and 162.7 to 407.9 days, respectively, in

the two water/sediment systems. Based on the results of this study, oxathiapiprolin and

its metabolites would dissipate from anaerobic water sediment systems in the

environment.

Birds

Effects of oxathiapiprolin on birds were investigated in acute, short-term and

reproductive toxicity studies. Also studies on acute and short-term toxicity of the

formulated substance were performed. All studies were performed in line with

recommendations of validated and agreed guidelines. Oxathiapiprolin has negligible

acute, dietary, and reproductive effects in birds. The oral acute and oral dietary LD/LC50

values were greater than the highest doses tested. The no observed test levels (NOEL)

for the reproduction tests were the highest doses tested.

Aquatic organisms

Effects of oxathiapiprolin on aquatic organisms were investigated in acute and long-term

toxicity studies performed with numerous species representative for each group.

Toxicity of metabolites to fish and aquatic invertebrates were examined only in acute

toxicity studies. Chronic studies with algae were also performed. Studies on acute

toxicity to fish and Daphnia as well as chronic toxicity study to algae were carried out

with the formulated substance. All studies were performed in line with recommendations

of validated and agreed guidelines.

Oxathiapiprolin has negligible acute and chronic toxicity to fish and negligible

bioconcentration in fish (BCF <100). Oxathiapiprolin has low water solubility, 0.184

mg/L; therefore all aquatic testing was conducted at or slightly above the water solubility

limit. A similar approach was followed for aquatic testing of those metabolites of

oxathiapiprolin which demonstrated a similar low level of solubility. Freshwater and

marine fish species show a similar sensitivity to oxathiapiprolin; measured, acute LD50

values are greater than 0.69 mg/L (Oncorhynchus mykiss) and greater than 0.65 mg/L

(Cyprinodon variegatus). In both cases this represents the highest mean, measured

concentration tested, and also the apparent limit of solubility in that test system. The

most sensitive chronic no observed effects concentration (NOEC) for freshwater fish is

0.46 mg/L (Oncorhynchus mykiss) and for marine fish is 0.34 mg/L (Cyprinodon

variegatus). Oncorhynchus mykiss were less sensitive to metabolites of oxathiapiprolin

than to parent oxathiapiprolin in acute toxicity tests.

Oxathiapiprolin has negligible effects on algae and aquatic plants. The most sensitive

ErC50 values for freshwater algae (Pseudokirchneriella subcapitata) and aquatic plants

(Lemna gibba) were >0.142 and >0.79 mg/L, respectively; the highest concentration

tested and also the apparent limit of solubility in that test system. Algae and aquatic

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April 2014 EPA0316

plants were less sensitive to metabolites of oxathiapiprolin than to parent oxathiapiprolin

in acute toxicity tests. Oxathiapiprolin has negligible acute and low chronic toxicity to

aquatic invertebrates. The most sensitive acute freshwater and marine species EC50

values are 0.67 mg/L (Daphnia magna) and >0.33 mg/L (Crassostrea virginica), the

highest mean, measured concentration tested and the apparent limit of solubility in that

test system. The most sensitive chronic NOEC values are for brackish species 0.058 mg/L

(Americamysis bahia) and for sediment dwelling organisms 0.11 mg/L (Chironomus

riparius). Daphnia magna were less sensitive to metabolites of oxathiapiprolin than to

parent oxathiapiprolin in acute toxicity tests.

A risk assessment for aquatic organisms was performed according to recommendations

of the Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev. 4 (final).

All TER values calculated for particular groups of organisms using worst case exposure

estimates (Step 1 and Step 2) are above the respective triggers indicating acceptable

acute and long-term risk to aquatic organisms following application of Zorvec Enicade

according to the intended use pattern.

Bees

Effects of oxathiapiprolin and the formulated substance on bees were addressed in acute

oral and contact toxicity studies. In order to address effects on the bee brood and bee

colony, semi-field study was performed with formulation applied to flowering Phacelia

tanacetifolia during the bee-flight. All studies were performed in line with

recommendations of validated and agreed guidelines.

During the semi-field study no biologically significant and treatment related effects were

observed on mortality and flight activity of adult worker bees, brood development and

colony condition in all treatment plots during the whole period of study up to rate of

180 g a.s./ha.

A risk assessment for bees was performed according to requirements of the Guidance

Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2 final of 17th October

2002) on the basis of results of laboratory studies on oral and contact toxicity to bees.

Studies performed with formulated substance did not indicated higher toxicity.

The risk assessment concluded that neither oxathiapiprolin nor its metabolites pose an

unacceptable risk to bees following application of Zorvec Enicade according to the

intended use pattern.

Non-target arthropods other than bees

Effects of Zorvec Enicade on non-target arthropods other than bees were investigated in

laboratory and extended laboratory studies performed with two standard indicator

species (Typhlodromus pyri and Aphidius rhopalosiphi) and one additional species

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April 2014 EPA0316

(Chrysoperla carnea). All studies were performed in line with recommendations of

validated and agreed guidelines.

A risk assessment for non-target arthropods other than bees was performed according to

requirements of the ESCORT 2 Guidance Document (Candolfi, M.P. et al., 2000).

The risk assessment was performed by calculation of HQ values for standard indicator

species with assumption of laboratory toxicity data and relevant exposure estimates. All

calculated HQ values are below the trigger value indicating acceptable risk to in- and off-

field population of non-target arthropods.

Soil non-target macro- and mesofauna

Oxathiapiprolin has negligible acute and sub-lethal effects in earthworms. The LC50 and

NOEC for oxathiapiprolin were greater than 1000 and 1000 mg/kg, respectively. Similarly

the oxathiapiprolin soil metabolites, IN-RDT31, IN-RAB06, IN-QPS10 and IN-E8S72, also

had negligible effects on earthworms; LC50 and NOEC values were greater than the

highest rate and the highest rate tested, respectively. During a sublethal earthworm test

with Oxathiapiprolin 100 g/L OD the lowest NOEC with respect to growth in terms of

biomass was determined to be 308.6 mg Zorvec Enicade/kg dry soil (equivalent to 30.86

mg a.s./kg dry soil).

Mortality and reproduction studies conducted with the collembola, Folsomia candida, to

evaluate the effect of oxathiapiprolin, Zorvec Enicade and soil metabolites IN-RDT31, IN-

RAB06, IN-QPS10 and IN-E8S72 indicated no significant mortality or reproduction

effects, following 28-day exposure to soil, treated with oxathiapiprolin, Oxathiapiprolin

100 g/L OD and soil metabolites, respectively. The EC50 and NOEC value for

oxathiapiprolin was greater than 100 mg a.s./kg soil d.w. and 25 mg a.s./kg soil d.w.,

respectively.

Collembola were not as sensitive to soil metabolites of oxathiapiprolin, with EC50 and

NOEC values equal to or greater than 100 mg/kg soil d.w..

Oxathiapiprolin has negligible acute and sub-lethal effects in soil mites (Hypoaspis

aculeifer), with a 14-day NOEC of 1000 mg/kg soil d.w. During a test with

Oxathiapiprolin 100 g/L OD the EC50 and NOEC values were determined to be greater

than or equal to 1000 mg Zorvec Enicade /kg dry soil (equivalent to 100 mg a.s./kg dry

soil). Zorvec Enicade was not more toxic than the active substance.

Oxathiapiprolin soil metabolites IN-RDT31, IN-RAB06, IN-QPS10 and IN-E8S72 also had

negligible effects on soil mites, with NOEC values of 25 mg/kg soil d.w. (IN-RAB06), 50

mg/kg soil d.w. (IN-QPS10) and 100 mg/kg soil d.w. (IN-E8S72 and IN-RDT31).

Therefore, oxathiapiprolin, when applied according to Good Agricultural Practice, is

expected to pose little risk to soil non-target macro-organisms.

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A risk assessment for soil macro- and mesofauna was performed according to

requirements of the Guidance Document on Terrestrial Ecotoxicology

(SANCO/10329/2002 rev 2 final of 17th October 2002).

TER values calculated for all species are above the respective triggers indicating

acceptable acute and long-term risk to soil macro and mesofauna following application of

Zorvec Enicade according to the intended use pattern.

The quantitative environmental risk assessment of Zorvec Enicade indicate it presents a

low risk to the aquatic enviroment. This low risk can be managed by the following label

statements:

HARMFUL – Toxic to aquatic life. Avoid contamination of any water supply with

product or empty container.

STORAGE - Store in original container, tightly closed and under lock and key, in a

cool well ventilated area away from feed, seed and foodstuffs. Store in accordance

with the NZS 8409 Management of Agrichemicals.

DISPOSAL - Container disposal: Ensure the container is empty. Triple rinse empty

container and add rinsate to the spray tank. Recycle empty container through

Agrecovery (0800 247 326, www.agrecovery.co.nz) Otherwise crush and bury in a

suitable landfill. DO NOT reuse this container for any other purpose. Dispose of

this product only by using according to this label, or at an approved landfill, DO

NOT burn the product.

SPILLAGE -Wear appropriate protective clothing. Exclude all bystanders from

vicinity of the spill. Contain liquid spills and prevent the substance from entering

waterways. Absorb spills with inert material and place in waste containers labelled

for disposal. Wash area with water and detergent, absorb with further inert

material and dispose of waste material in an approved landfill.

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April 2014 EPA0316

The risks associated with skin irritation and sensitisation can be managed by correct PPE

during handling, mixing and application. Modelling to determine operator exposure, post

application exposure and bystander exposure indicated that there is an extremely low

risk from the intended use of DuPont™ Zorvec® Enicade® fungicide in Onions for Downy

mildew control.

Exposure Model used Result

Applicator exposure German BBA Model No PPE during mixing, loading and application

Risk quotient 1%

Gloves only during mixing and loading

Risk quotient 0.5%

Gloves only during application

Risk quotient 1%

Full PPE during mixing, loading and application (including respirator)

Risk quotient 0.1%

Post-application exposure Schutz von Personen

bei Nachfolgearbeiten

(Safeguarding the

Health of Workers -

Re-Entry Exposure)

No PPE Risk quotient 0.2%

With PPE Risk quotient 0%

Bystander exposure UK CRD guidance

(CRD 2008)

Adult Risk quotient < 0.1%

Any risk will be addressed by the following label statements:

HARMFUL – Causes mild skin irritation. May cause an allergic skin reaction. Avoid

skin contact.

PRECAUTIONS

PERSONAL PROTECTION

Read label before use. Avoid breathing concentrate or spray mist. Contaminated

work clothing should not be allowed out if the workplace.

When opening the container, preparing spray and using the prepared spray, wear

cotton overalls buttoned to the neck and wrist (or equivalent clothing) and elbow

length chemical resistant gloves.

Wash hands after use. After each day’s use wash gloves and contaminated

clothing.

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RESTRICTED ENTRY INTERVAL (REI) - DO NOT allow entry into treated areas until

the spray has dried. When prior entry is necessary, wear cotton overalls buttoned

to the neck and wrist (or equivalent clothing) and elbow length chemical resistant

gloves. Clothing must be washed after each day’s use.

Diet

Onions do form part of the Mãori diet, but as Oxathiapiprolin residues in Onions are

below LOQ (0.01 mg/kg) any dietary exposure would be extremely low.

Proposed label statement:

WITHHOLDING PERIODS - Onions: DO NOT apply later than 10 days before harvest.

GRAZING - DO NOT graze or feed treated produce to livestock.

Benefits to Mãori culture

One of the benefits of DuPont™ Zorvec® Enicade® fungicide, Oxathiapiprolin is more

active than the current registered products, providing greater control at substantially

lower rates. This results in a reduced environmental loading, lower worker exposure,

and reduced impact on non-targets species. Oxathiapiprolin has a toxicity profile more

favorable than the competitive products it will replace, some of which have, themselves,

been classified as lower risk substances e.g. products containing mandipropamid,

cyazofamid (pending approval) and older products e.g. chlorothalonil and mancozeb.

Details of the comparision are presented in Section 7.1.

7.4. Provide an assessment of any risks, costs or benefits to New Zealand’s international obligations

Please show if approving or declining the substance would have any impact upon New Zealand’s international obligations

There are no risks associated with the approval and use of DuPont Zorvec Enicade

fungicide in New Zealand for control of Downy mildew in Onion. Any treated produce will

not contain residues above limit of quantification, as such, there are no trade issues

associated with countries that don't have import tolerances for Oxathiapiprolin.

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7.5. Provide information on the proposed management of the substance

Please outline how the risks of the substance will be managed. This may include default controls triggered by the hazardous property classification(s) and reference to Codes of Practice or to standard operating procedures that will be followed

All risks associated with DuPont Zorvec Enicade fungicide will be managed by:

- correct labelling of the product identifing risks and controls;

- product stewardship training for resellers and users.

The default controls associated with the classification of the substance are summarised in

the following tables:

Default controls by classification

Classification Code

6.3B

T1,T2,T4,T7 I1,I9,I16,I19,I21,I28 P1,P3,P13* D4,D6,D7,D8 EM1,EM6,EM8, EM11,EM12

6.5B

T1,T2,T4,T5,T7 I1,I9,I16,I17,I18,I19,I21,I28 P1,P3,P13,PG3 D4,D6,D7,D8 EM1,EM6,EM8, EM11,EM12

9.1 D

E1,E2,E6,E8 I1,I9,I11,I19,I21,I29 P1,P3 D5,D6,D7,D8 EM1,EM7,EM8,EM11, EM12,EM13

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Consolidated controls:

Toxicity T 1, 2, 4, 5, 7

Ecotoxicity E 1, 2, 6, 8

Identification I 1, 9, 11, 16, 17, 18, 19, 21, 28

Packaging P 1, 3, 13*

PG 3

Disposal D 4, 5, 6, 7, 8

Emergency management EM 1, 6, 7, 8, 11

Tracking TR -

Approved Handler AH -

Code Regulation Description

T1 Regs 11-27 Limiting exposure to toxic substances; setting values for acceptable daily exposure (ADE)/reference dose (RfD), potential daily exposure (PDE), tolerable exposure limit (TEL); prohibition on use of substances in excess of TEL

T2 Regs 29-30 Controlling exposure in places of work and other ‘use’ situations; setting of workplace exposure standards (WES)

T4 Reg 7 Requirements for equipment used to handle substances

T5 Reg 8 Requirements for protective clothing and equipment

T7 Reg 10 Restrictions on carriage of toxic substances on passenger service vehicles


E1 Regs 32 – 45 Limiting exposure to ecotoxic substances, the environmental exposure limit (EEL) approach

E2 Regs 46 – 48 Restrictions on use of substances in application areas

E6 Reg 7 Requirements for equipment used to handle substances

E8 Reg 10 Restrictions on carriage of ecotoxic substances on passenger service vehicles

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I1 Regs 6, 7, 32 – 35, 36(1) – (7) Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability

I9 Reg 18 Secondary identifiers for all hazardous 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

I21 Regs 37-39, 47-50 General documentation requirements

I28 Reg 46 Specific documentation requirements for toxic substances

I29 Regs 51, 52 Signage requirements


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 (class 6)

PG3 Schedule 3 Packaging requirements equivalent to UN Packing Group III


D4 Reg 8 Disposal requirements for class 6,8 substances (toxics and corrosives)

D5 Reg 9 Disposal requirements for class 9 substances (ecotoxics)

D6 Reg 10 Disposal requirements for packages

D7 Regs 11, 12 Information requirements for manufacturers, importers and suppliers, and persons in charge

D8 Regs 13, 14 Documentation requirements for manufacturers, importers and suppliers, and persons in charge


EM1 Regs 6, 7, 9 – 11 Level 1 information requirements for suppliers and

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persons in charge

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

Proposed label statements to address controls:

HAZARD CLASSIFICATION 6.3B, 6.5B, 9.1D Use of this product in any manner contrary to this label may be an offence under the HSNO Act.

HARMFUL – Causes mild skin irritation. May cause an allergic skin reaction. Avoid skin contact. Toxic to aquatic life. Avoid contamination of any water supply with product or empty container.

PRECAUTIONS PERSONAL PROTECTION Read label before use. Avoid breathing concentrate or spray mist. Contaminated work clothing should not be allowed out if the workplace. When opening the container, preparing spray and using the prepared spray, wear cotton overalls buttoned to the neck and wrist (or equivalent clothing) and elbow length chemical resistant gloves. Wash hands after use. After each day’s use wash gloves and contaminated clothing. STORAGE Store in original container, tightly closed and under lock and key, in a cool well ventilated area away from feed, seed and foodstuffs. Store in accordance with the NZS 8409 Management of Agrichemicals. DISPOSAL Container disposal: Ensure the container is empty. Triple rinse empty container and add rinsate to the spray tank. Recycle empty container through Agrecovery (0800 247 326, www.agrecovery.co.nz) Otherwise crush and bury in a suitable landfill. DO NOT reuse this container for any other purpose. Dispose of this product only by using according to this label, or at an approved landfill, DO NOT burn the product.

http://www.agrecovery.co.nz/

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7.6. Provide an overall evaluation of the combined impact of all of the risks, costs and benefits set out in sections 7.2, 7.3 and 7.4

Please express a view on the relative importance of the different risks, costs and benefits and how they should be brought together in making a decision

The likelihood of risks to human health and the environment arising from the hazardous

properties (skin irritation, dermal sensitivity and aquatic toxicity) in the handling, storage

and use of DuPont Zorvec Enicade fungicide by Onion growers and contractors are very

unlikely and the level of risk considered very low.

DuPont believe there are negligible risks to human health and to the environment and no

potentially significant costs associated with the release of DuPont Zorvec Enicade

fungicide.

It is possible that there is some limited impact on Maori culture and traditional

relationships with ancestral land, water, sites, wahi tapu, valued flora, fauna and other

taonga. DuPont are happy to work the EPA, and the Maori community to ensure the

approval of DuPont Zorvec Enicade fungicide will not breach the principles of the Treaty

of Waitangi.

Significant benefits will be derived for New Zealand Onion growers from the approval of

the importation of DuPont Zorvec Enicade fungicide containing a novel active ingredient

for commercial release.

DuPont Zorvec Enicade Fungicide will provide Onion growers with a highly efficacious

product with a new mode of action.

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8. Pathway determination and rapid assessment Under the HSNO Act, applications may be processed under different pathways, including

a rapid assessment. The pathway for your application will be determined after its formal

receipt, based on the data provided in this application form. If you would like your

application to be considered for rapid assessment (as per the criteria below), we require

you to complete the attached statutory declaration and provide a signed hard copy.

Please note that the EPA will not be able to proceed with the rapid assessment without

the statutory declaration.

8.1. Rapid assessment

Under the HSNO Act, a hazardous substance may be approved under a rapid assessment

if one of the three following options is satisfied. Please show the section that is relevant

to your application.

A substance having a similar composition and similar

hazardous properties has been approved

☐ Yes ☒ No

If Yes, please give the name of the

reference substance:

The substance has one or more hazardous

properties and each has the least degree of hazard

for that property; or

☐ Yes ☒ No

The substance has been formulated so that one or

more of its hazardous properties has a lesser degree

of hazard than any substance that has been

approved under the Act.

☐ Yes ☒ No

If Yes, please give the name of the

reference substance:

SP5348

Typewritten Text

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9. Checklist This checklist is to be completed by the applicant Application Comments/justifications

All sections of the application form completed or you have requested an information waiver under section 59 of the HSNO Act

☒ Yes ☐ No

(If No, please discuss with an advisor to enable your application to be further processed)

Confidential data as part of the confidential form

☒ Yes ☐ No Confidential data to address submission requirement are provided with this application.

A copy of the Global Joint Review and EU dossier has been provided electronically with this application as part of the confidential form

Supplementary optional information attached:

• Copies of additional references ☒ Yes ☐ No

• Letter(s) of access ☐ Yes ☒ No

• Relevant correspondence ☐ Yes ☒ No

• Draft label ☒ Yes ☐ No

• Draft Safety Data Sheet (SDS) ☒ Yes ☐ No Draft NZ SDS for DuPont Zorvec Enicade fungicide has been provided

No NZ SDS has been provided for Oxathiapiprolin Technical as this will not be imported unformulated

Administration

Are you an approved EPA customer? ☒ Yes ☐ No

If yes are you an:

Applicant: ☒

Agent: ☐

If you are not an approved customer, payment of fee will be by:

• Direct credit made to the EPA bank account (preferred method of payment) Date of direct credit:

☐ Yes ☐ No

☐ Payment to follow

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• Cheque for application fee enclosed

☐ Yes ☐ No

☐ Payment to follow

Electronic signed copy of application e-mailed to the EPA

☒ Yes

Physical copy of signed statutory declaration sent to the EPA, (rapid assessment only)

☒ Yes

Signature of applicant or person authorised to sign on behalf of applicant

☒ I am making this application, or am authorised to sign on behalf of the applicant or applicant organisation.

☒ I have completed this application to the best of my ability and, as far as I am

aware, the information I have provided in this application form is correct.

Signature Date

Request for information waiver under section 59 of the HSNO Act

☐

I request for the Authority to waive any legislative information requirements (i.e. concerning the information that has been supplied in my application) that my application does not meet (tick if applicable).

Please list below which section(s) of this form are relevant to the information waiver

request:

EPA0316 - Application form to obtain ... - epa.govt.nz · New Zealand. If one has been provided...

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