To obtain approval to import or manufacture a pesticide · Application Form Approval to import or manufacture a pesticide Commercially sensitive information 12. The EPA strongly advises

APPLICATION FORM Pesticides

To obtain approval to import or manufacture a pesticide

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.

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

GF-3308

Date

December 2018

www.epa.govt.nz

http://www.epa.govt.nz/

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May 2015 EPA0316

Application Form Approval to import or manufacture a pesticide

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.

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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May 2015 EPA0316


Commercially sensitive information

12. The EPA strongly advises applicants to provide as much information relating to the hazard

classification and use of their substance as possible to help inform the EPA’s assessment as well

as for submitters and decision-makers. We expect this information to be publicly available in the

application unless there is a genuine argument for it to be considered as commercially sensitive.

13. Commercially sensitive information may 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 providing your detailed

reasons for considering it to be commercially sensitive and cross referencing to where that

information is located in the confidential section.

14. Any information you supply to the EPA prior to formal lodgement of your application will not be

publicly released, unless it has already been made publicly available as part of the consultation

process. Following formal lodgement of your application any information in the body of this

application form and any non-confidential appendices will become publicly available.

15. 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

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May 2015 EPA0316


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

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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May 2015 EPA0316


1. Applicant details

1.1. Applicant

Company Name: Dow AgroSciences (NZ) Ltd.

Contact Name: Emilia Cieslak

Job Title: Regulatory Manager

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

Physical Address: 89 Paritutu Rd, New Plymouth, 4310

Phone (office and / or mobile): 06 757 7812

Fax: 06 7512 858

Email: [email protected]

1.2. New Zealand agent or consultant (if applicable)

Company Name:

Contact Name:

Job Title:


Physical Address:

Phone (office and / or mobile):

Fax:

Email:

1.3. Formal correspondence contact

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


Contact Name: Emilia Cieslak

Job Title: Regulatory Manager

mailto:[email protected]

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May 2015 EPA0316


Postal Address (provide only if not the same as the physical): Locked Bag 502, Frenchs Forest, NSW

2086, Australia

Physical Address: Level 5, 20 Rodborough Road, Frenchs Forest, NSW 2086, Australia

Phone (office and / or mobile): +61 2 9776 3194 / +61 428 344 671

Fax: +61 2 9776 3199

Email: [email protected]

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:

Job Title:


Physical Address:

Phone (office and / or mobile):

Fax:

Email:

mailto:[email protected]

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May 2015 EPA0316


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

To import or manufacture for release GF-3308, an emulsifiable concentrate fungicide

containing 50 g a.i./L fenpicoxamid for the control of Septoria tritici in wheat.

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 to the EPA. This may be provided 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

☒ Yes2 ☐ 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. 2 Applicant’s note: An application for the Biosecurity Clearance will be filed with the MPI along with the A1 application.

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May 2015 EPA0316


3. Identity of the substance

Any commercially sensitive information may be provided 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): Fenpicoxamid

Chemical name (IUPAC): (3S,6S,7R,8R)-8-benzyl-3-{[(4-methoxy-3-{[(2-

methylpropanoyl)oxy]methoxy}pyridin-2-yl)carbonyl]amino}-6-methyl-4,9-dioxo-1,5-

dioxonan-7-yl 2-methylpropanoate

Chemical name (CA): Propanoic acid, 2-methyl-, [[4-methoxy-2-[[[(3S,7R,8R,9S)-9-

methyl-8-(2-methyl-1-oxopropoxy)-2,6-dioxo-7-(phenylmethyl)-1,5-dioxonan-3-

yl]amino]carbonyl]-3-pyridinyl]oxy]methyl ester

Molecular formula: C31H38N2O11

Structural formula:

Manufacturer development codes: XDE-777, XR-777, X772777

CIPAC No: Not available

CAS No: 517875-34-2

EEC No (EINECS or ELINCS): Not available

Function:

For plant protection products

☐ Herbicide ☐ Microbial strain ☒ Fungicide

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May 2015 EPA0316


☐ Insecticide ☐ Semiochemical

(pheromone, attractant,

repellent etc.)

☐ Plant Extracts

☐ Other, e.g. plant growth regulators (specify):

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

describe the function:

N/A

FAO Specification (including year of publication): ☐ Yes Year: ☒ No

Minimum purity of the active ingredient as manufactured (g/kg): 750 g/kg

Note: Any impurities must be provided to the EPA. A certificate of analysis may be included 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)

☐

☐

☐

☐

☐

Approved in Guatemala,

Panama and Ecuador

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

When restricted or not renewed, explanations should be provided:

May 2015 EPA0316

10


3.3. Identity of the formulated substance

Formulated substance name: GF-3308

Manufacturer development codes: GF-3308

Unique names for public register: GF-3308

Active ingredient(s) and content (g/kg or L and % w/w): 50 g/L; 4.92% (w/w)

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 and form): Clear light yellow liquid with a fruity odour

pH: 4.35 at 20.0 °C

Density: 1.016 g/mL

Vapour pressure: No data for the formulated product, 2.0 × 10-7 Pa (1.5 × 10-9 mmHg) at

25 °C for fenpicoxamid

Boiling/melting point: No data for the formulated product, fenpicoxamid decomposes before

boiling, melting point for fenpicoxamid is 158.3 ºC

Solubility in water: Excellent solubility in water, GF-3308 is to be sprayed after diluting in

water

Water/Octanol partitioning co-efficient: No data for the formulated product, log10 Pow = 4.4 ±

0.2 at pH 7 (Pow = 26,800 – 9,400) for fenpicoxamid

3.5. Regulatory status of the formulated substance

Jurisdiction

Regulatory status

Comment*

Never

approved

Pending

Approved

Restricted

Not

renewed

Australia ☒ ☐ ☐ ☐ ☐

Canada ☒ ☐ ☐ ☐ ☐

Europe ☐ ☒ ☐ ☐ ☐

Japan ☒ ☐ ☐ ☐ ☐

May 2015 EPA0316

11


New Zealand ☒ ☐ ☐ ☐ ☐

USA ☒ ☐ ☐ ☐ ☐

Other

jurisdictions

(specify in

comments)

☒

☐

☐

☐

☐

*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 to the EPA. These may be included in the

confidential appendix The full formulation composition is provided in the Confidential Appendix

May 2015 EPA0316

12


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:

100 kg drums with a HDPE liner

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:

GF-3308 will primarily be imported by sea fright packed, labelled and ready for sale. In

some instances it may also be imported in bulk packs, in which case the final packaging

and labelling will take place in New Zealand. Upon customs clearance, GF-3308 will be

transported to a Dow AgroSciences (NZ) Ltd. warehouse designed for the secure storage

of agricultural compounds. In the future, GF-3308 may be formulated in New Zealand.

Bulk distribution will occur by way of designated trucks and rail wagons designed for the

transportation of hazardous goods. Transportation will comply with the UNRTG

May 2015 EPA0316

13


requirements for dangerous goods for marine transport. Distribution will involve

transport by road and sea using dedicated chemical transport companies to retail farm

supply distributors.

UN Number: 3082

UN Transport Hazard Classes: 9

UN Packing Group Number (UN Model Regulations3): III

Marine Pollutant? (IMDG Code4): No

Packaging

Pack sizes: 15 L

Type of packaging: fluorinated high density polyethylene (F-HDPE) drums

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

compression or vented 63 mm caps

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

Storage

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

The proposed label storage directions include the following:

• Store in the original container tightly closed and in a locked, dry, cool, well-

ventilated area, away from foodstuffs. Storage must be generally in accordance

with the New Zealand Standard for the Management of Agrichemicals (NZS

8409).

• Stores containing more than 100 L of GF-3308 (or substances of the same hazard

class) require containment, emergency response plans and are subject to

signage. See the Hazardous Substances Emergency Management Regulations

and the New Zealand Standard for the Management of Agrichemicals (NZS 8409)

for further information.

3 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 4 IMDG Code means that International Maritime Dangerous Goods code, as amended

May 2015 EPA0316

14


Warehouse storage

Provide details of how the formulated substance will be stored: During the distribution phase of

the product’s life cycle, GF-3308 will be stored in suitably approved facilities. The plant

warehouses are under the control of the personnel qualified and experienced in handling

agricultural chemicals. Appropriate procedures and SOPs apply to a variety of plant

protection products. When collected from the Dow AgroSciences site, the substance is

to be stored by distributors, who also have dedicated pesticide storage facilities, until

sold to farmers.

Containment of spillages: Accidental spillage can be absorbed with material such as sand,

soil or sawdust. Spilled product should be collected and placed in a sealable container

for appropriate disposal.

Decontamination of areas, personnel, vehicles and buildings: Spill residues may be cleaned

using water and detergent. The wash water should also be contained and absorbed for

disposal.

Disposal

Disposal of damaged packaging, contaminated absorbents and other materials: The same as for

GF-3308 and its packaging below.

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

disposal direction are proposed for the product label:

• Dispose of the product only by using according to the label, via Agrecovery, the

the Rural Recycling Programme, which is an industry stewardship scheme, or at

an approved landfill.

• DO NOT burn.

• Triple rinse empty containers and add rinsate to spray tank.

• Triple rinsed containers containing the Agrecovery logo on the label, which are

free of all residues (liquid and dry) and have an intact legible label should be

taken to an Agrecovery container collection site.

• Otherwise crush and bury in a suitably approved landfill.

• DO NOT burn empty containers.

• Dispose of equipment cleaning water onto ground away from edible crops.

• DO NOT dispose of this product, spray mix or equipment cleaning water down

drains or sewers.

Methods other than controlled incineration for disposal: As described above.

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May 2015 EPA0316


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)

Numbe

r

min

max

(k)

Interval

between

application

s (min)

Kg

as/hL

min

max

Water

L/ha min

max

Kg

as/ha

min

max

Wheat

GF-3308

F

Septoria

tritici

EC

Fenpico

xamid,

50 g/L

Ground

broadca

st

GS30 –

GS69

1 or 2

14 days

0.0375

– 0.1

kg/hL

100 –

200

L/ha

0.075

– 0.1

kg

a.i./ha

Not

require

d when

used as

Does not

require a

separate

adjuvant

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May 2015 EPA0316


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)

Numbe

r

min

max

(k)

Interval

between

application

s (min)

Kg

as/hL

min

max

Water

L/ha min

max

Kg

as/ha

min

max

directe

d

Wheat

GF-3308

F

Septoria

tritici

EC

Fenpico

xamid,

50 g/L

Aerial

broadca

st

GS30 –

GS69

1 or 2

14 days

0.075

– 0.2

kg/hL

50 –

100

L/ha

0.075

– 0.1

kg

a.i./ha

Not

require

d when

used as

directe

d

Does not

require a

separate

adjuvant

17

May 2015 EPA0316


(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

The proposed use pattern is also summarised in a differently formatted table below:

GF-3308 use pattern

Formulation Emulsifiable concentrate containing 50 g/L fenpicoxamid

Target crop Wheat

Target pest Speckled leaf blotch (Septoria tritici) – control

Brown (leaf) rust (Puccinia triticina) - suppression

Application rate 1.5 - 2 L/ha (75 – 100 g a.i./ha)

Number of applications 1 or 2

Application timing Between the first node (GS30) and early post flower (GS69) wheat growth stages

Application interval Min 14 days

Application method Broadcast ground and aerial (medium droplet)

Adjuvant Not required

WHP Do not graze or cut for feed for 2 weeks after the last application.

PHI No pre-harvest interval is required when used as directed (i.e. applied no later than

at GS69).

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May 2015 EPA0316


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.

Formulated

Hazard Class/Subclass substance Justification

classification

Examples

3.1C

6.1D

Flashpoint = 46 deg C (closed cup)

Calculated LD50 = 1250 mg/kg (mixture

rules)

Class 1 Explosiveness

No Substance data (EC method

A.14)

Class 2, 3 & 4 Flammability

3.1D

Substance data (Flashpoint of

80.5 °C, OPPTS 830.6315

guideline)

Class 5 Oxidisers/Organic Peroxides

No Substance data (OPPTS

830.6314 guideline)

Subclass 8.1 Metallic corrosiveness

No Mixture rules (no components

corrosive to metals)

Subclass 6.1 Acute toxicity (oral)

6.1E Data on a closely similar

substance (LD50 between 2,000

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

19

May 2015 EPA0316


and 5,000 mg/kg bw, OECD 423

guideline)

Subclass 6.1Acute toxicity (dermal)

No

Data on a closely similar

substance (LD50 >5,000 mg/kg

bw, OECD 402 guideline)

Subclass 6.1 Acute toxicity (inhalation)

No


substance (LD50 >5 mg/L air,

OECD 436 guideline)

Subclass 6.1 Aspiration hazard

No

Mixture rules (no components

classified as an aspiration

hazard). No evidence of

aspiration hazard.

Subclass 6.3/8.2 Skin irritancy/corrosion

6.3B


substance (mean Draize score of

2 for erythema, OECD 404

guideline)

Subclass 6.4/8.3 Eye irritancy/corrosion

6.4A


substance (mean Draize score of

2 for conjunctival redness, OECD

405 guideline)

Subclass 6.5A Respiratory sensitisation

No


substance (not a contact

sensitiser).

As the skin sensitisation study

indicates GF-3308 is not a skin

sensitiser, it can be considered

as negative for respiratory

sensitisation.

Subclass 6.5B Contact sensitisation

No


substance (Stimulation Indices

<15%, OECD 429 guideline)

Subclass 6.6 Mutagenicity

No Mixture rules (no component

classified as mutagenic)

Subclass 6.7 Carcinogenicity


classified as carcinogenic)

Subclass 6.8 Reproductive or developmental

toxicity

No

Mixture rules (no component

classified as a reproductive or

developmental hazard)


toxicity (known, presumed or suspected)

No

Mixture rules (no component


developmental hazard)


toxicity (via lactation)



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developmental hazard via

lactation)

Subclass 6.9 Target organ systemic toxicity5

6.9B (oral)

6.9B

(inhalation)

Mixture rules

6.9B (oral) classification

triggered by a solvent (a

reaction mass of N,N-

Dimethyloctan-1-amide and N,N-

Dimethyldecan-1-amide)

6.9B (inhalation) classification

triggered by an emulsifier (eo/po

block copolymer, CAS 9038-95-

3)

Subclass 9.1 Aquatic ecotoxicity

9.1A

Substance data (LC50 of

0.078 mg/L for rainbow trout,

OECD 203 guideline and EC50 of

0.048 mg/L for Daphnia, OECD

202 guideline)

Subclass 9.2 Soil ecotoxicity

No

Substance data (no effects in

earthworms at the highest tested

concentration of 972 mg/kg soil,

OECD 222 guideline)

Subclass 9.3 Terrestrial vertebrate ecotoxicity

No

Substance data (LD50

>2,000 mg/kg bw for northern

bobwhite)

Subclass 9.4 Terrestrial invertebrate

ecotoxicity

No

Substance data (contact LD50 of

53.4 μg/bee and oral LD50 of

>205.6 μg/bee)

Fenpicoxamid and GF-3308 have been extensively tested using internationally accepted

standard protocols (OECD, US EPA, EC guidelines and others as appropriate). The proposed

HSNO classification is based on a comprehensive data pack, which includes 194 studies

containing 23,900+ pages and has been assembled to comply with EPA data requirements

as outlined on EPA website. Please note: a separate data pack containing the Residue and

Efficacy & Crop Safety dossiers, which includes 34 studies (7,600+ pages) has been

submitted to the Ministry for Primary Industries for registration under the Agricultural

Compounds and Veterinary Medicines Act.

With this application the following studies are included in our data package for

fenpicoxamid and its metabolites to address identification, physical – chemical

properties, toxicology, transport in environment and ecotoxicology:

5 Identify classification for single and/or repeat dose target organ toxicity for oral, dermal or inhalation routes.

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Guidance/Hazardous-Substances-Data-Requirements.pdf



May 2015 EPA0316

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• Product identity and composition, description of materials used to produce the

product, description of production process, discussion of formation of impurities,

preliminary analysis, and enforcement analytical method

• Determination of colour, physical state, odour, melting point and decomposition

temperature

• Determination of colour, odour, physical state, oxidizing and reducing action,

explodability, pH and bulk density

• Determination of surface tension, flammability, explosive properties, relative self-

ignition temperature for solids and oxidising properties

• Relative density

• Dissociation constant

• Octanol-water partition coefficient

• Water solubility

• Organic solvent solubility

• Vapour pressure

• Particle size distribution

• Acute oral toxicity in rats (for fenpicoxamid and its relevant metabolite)

• Acute dermal toxicity in rats

• Acute inhalation toxicity in rats

• Acute skin irritation in rabbits

• Acute eye irritation in rabbits

• Acute skin sensitisation in mice

• Bacterial reverse mutation in Salmonella typhimurium (for a relevant metabolite)

• Mutation test in hamster ovary & hypoxanthine-guaninephosphoribosyl transferase

• Mammalian-microsome reverse mutation assay

• Mouse peripheral blood micronucleus test

• 28-day dietary toxicity in rats

• 28-day dietary toxicity in mice

• 28-day dietary toxicity in dogs

• 90-day dietary toxicity in rats

• 90-day dietary toxicity in mice

• 90-day dietary toxicity in dogs

• Developmental toxicity in rats

• Developmental toxicity in rabbits

• 2-generation dietary reproduction study in rats

May 2015 EPA0316

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• 1-year dietary toxicity in dogs

• 18-month dietary oncogenicity in mice

• 2-year dietary oncogenicity in rat

• Pharmacokinetics and metabolism in rats

• Tissue distribution in rats

• Elimination of radioactivity in bile, urine and faeces

• In-vitro chromosomal aberration assay

• In-vitro comparative metabolism study

• In-vitro cytotoxicity irradiation assay with artificial sunlight

• In-vivo DNA synthesis test in mouse liver cells

• Equilibrium adsorption of soil photodegradates (for fenpicoxamid and its soil

metabolites)

• Hydrolysis (for fenpicoxamid and its metabolite)

• Aqueous photolysis

• Soil photolysis

• Photochemical oxidation rate

• Ready biodegradability (CO2 evolution)

• Aerobic mineralisation in water

• Aerobic aquatic-sediment degradation

• Anaerobic aquatic-sediment degradation

• Aerobic degradation in soil

• Anaerobic soil and aerobic aquatic degradation

• Aerobic degradation in soil (for soil metabolites)

• Anaerobic degradation in soil

• Soil dissipation (for fenpicoxamid and its soil metabolites)

• Field soil degradation kinetics (for fenpicoxamid and its soil metabolites)

• Bioconcentration study in zebra fish

• Acute toxicity to common carp

• Acute toxicity to rainbow trout (for fenpicoxamid and its aquatic metabolites)

• Acute toxicity to fathead minnow

• Acute toxicity to Daphnia magna (for fenpicoxamid and its aquatic metabolites)

• Growth inhibition in green algae Pseudokirchneriella subcapitata (for fenpicoxamid

and its aquatic metabolites)

• Early life-stage toxicity with fathead minnow

• Full life-cycle toxicity with Daphnia magna

May 2015 EPA0316

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• Daphnia indoor microcosm study (for fenpicoxamid and its aquatic metabolite)

• Effects on earthworms (for fenpicoxamid and its soil metabolites)

• Effects on predatory mite Hypoaspis aculeifer (for fenpicoxamid and its soil

metabolites)

• Effects on a springtail Folsomia candida (for fenpicoxamid and its soil metabolites)

• Effects on soil microflora (for fenpicoxamid and its soil metabolites)

• Non-target plants study on seedling emergence (for a soil metabolite)

• Non-target plants study on vegetative vigour (for relevant metabolites)

• Acute oral toxicity with northern bobwhite

• Reproduction toxicity with northern bobwhite

• Acute contact and oral toxicity in bees (for fenpicoxamid and its relevant

metabolites)

• Bee larval toxicity study

• Effects on predatory mite Typhlodromus pyri

• Effects on parasitic wasp Aphidius rhopalosiphi

• Activated sludge respiration study

• Effects on freshwater midge Chironomus riparius

The following studies are included in our data package for GF-3308 to address physical –

chemical properties, toxicology and ecotoxicology:

• Determination of colour, physical state, odour, oxidizing and reducing action,

flammability, pH, viscosity and density

• Determination of surface tension, explosive properties, auto-ignition temperature,

oxidising properties and kinematic viscosity

• Storage stability study

• Acute oral toxicity in rats (similar formulation)

• Acute dermal toxicity in rats (similar formulation)

• Acute inhalation tox in rats (similar formulation)

• Acute skin irritation in rabbits (similar formulation)

• Acute eye irritation in rabbits (similar formulation)

• Acute skin sensitisation in mice (similar formulation)

• Dermal absorption study

• Eye irritation potential (EpiOcular Tissue Model)

• Skin Irritation potential (EpiDerm Tissue Model)

• Acute toxicity to rainbow trout

May 2015 EPA0316

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• Acute toxicity to Daphnia magna

• Growth inhibition test with green algae Pseudokirchneriella subcapitata

• Indoor aquatic microcosm study with Daphnia magna

• Effects on earthworms

• Effects on predatory mite Hypoaspis aculeifer

• Effects on springtail Folsomia candida

• Effects on soil microflora

• Non-target plants study on seedling emergence

• Non-target plants study on vegetative vigour

• Acute oral toxicity with northern bobwhite

• Acute contact and oral effects on honey bees

• Brood development of the honey bee, semi-field tunnel study

• Effects on the adult honey bee, 10-day chronic test

• Effects on the predatory mite Typhlodromus pyri

• Effects on the parasitic wasp Aphidius rhopalosiphi

• Effects on the rove beetle Aleochara bilineata

• Effects on the parasitic wasp Aphidius rhopalosiphi, aged residue test

May 2015 EPA0316

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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.

IDENTIFICATION OF RISKS AND COSTS

• Physical hazards

GF-3308 is proposed to be classified as a flammable liquid of low hazard (3.1D). Under

some circumstances, e.g. presence of a sources of ignition, it may increase the fire risk.

• Human health

GF-3308 is proposed to be classified as a 6.1E (low acute toxicity), 6.3B (mildly irritating

to the skin), 6.4A (mildly irritating to the eye) and 6.9B (target organ toxicant) substance.

Human exposure to GF-3308 can occur at any stage of the product life cycle (manufacture

and packaging, importation, transport and storage, use and disposal).

• Environment

GF-3308 is highly toxic in the aquatic environment (proposed classification 9.1A). In terms

of the product life cycle, the most relevant hazard can be identified for the application of

May 2015 EPA0316

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the substance in the field. GF-3308 is not proposed to be used for the control of any

pathogens in the aquatic environment. The only relevant exposure route for aquatic

organisms is via accidental spills or off-target movement (such as spray drift).

• Risks to society and the market economy

There are not expected to be any significant adverse impacts on the social environment

with the controlled use of GF-3308, apart from the potential health and environmental

effects discussed above. It is argued in this application that GF-3308 brings significant

benefits to the New Zealand agricultural sector.

IDENTIFICATION OF BENEFITS The following benefits have been identified for GF-3308:

• Access to a novel active ingredient for the New Zealand farmers

• Access to a state-of-the-art patented formulation for the New Zealand farmers

• Control of the key fungal disease of high economic significance

• Yield loss prevention

• New, unique mode-of-action against Septoria tritici in wheat

• A significant contribution to the future robust fungicide resistant management

strategy in wheat for New Zealand, the need for which is becoming more urgent

in the face of the reported instances of resistance in the Septoria pathogen in New

Zealand and in other wheat producing countries

• Low application rates

• Desirable toxicological and ecotoxicological profile

May 2015 EPA0316

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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.

ASSESSMENT OF RISKS AND COSTS

• Physical hazards

GF-3308 is a flammable liquid of the lowest hazard under HSNO (3.1D). For comparison,

eucalyptus oil is also classified 3.1D under HSNO. In addition to containing the HSNO

classification, the label and the SDS will state the hazard and instruct the user to avoid

sources of ignition. Given the use pattern, the low hazard and highly regulated transport,

use and storage of agrichemicals the likelihood of GF-3308 exposure to a source of ignition

is negligible and therefore the risk is low.

• Human health

There are a number of HSNO hazard classes triggered for GF-3308: the lowest level of

acute toxicity (6.1E), mild irritation to the skin (6.3B), mild irritation to the eye (6.4A)

and low target organ toxicity (6.9B), oral and inhalation. It is useful to put the hazard

classification in the context of commonplace substances carrying the same or similar

HSNO hazard classification:

GF-3308 For comparison

6.1E

Acutely toxic (via ingestion)

LD50 2,000 – 5,000 mg/kg bw/day

Eucalyptus oil (6.1D)

LD50 46 – 460 mg/kg bw/day

Common salt (sodium chloride) (6.1E)

LD50 3,000 mg/kg bw/day

6.3B

Mildly irritating to the skin Eucalyptus oil (6.3A)

6.4A

Mildly irritating to the eye

Eucalyptus oil (6.4A)

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Acetic acid >80% aqueous solution

(vinegar) (8.3A) (corrosive to the eye)

6.9B (oral and inhalation)

Harmful to human target organs or

systems (when ingested or inhaled)

Vitamin A (6.9A (oral))

Acetic acid >80% aqueous solution

(vinegar) (6.9B (inhalation))

It should also be noted that all human health hazard classes are triggered solely by co-

formulants (fenpicoxamid does not trigger any toxicity classification). GF-3308 is a state-

of-the-art, patented emulsifiable concentrate based on a three-way organic solvent

system. Based on the understanding of how fenpicoxamid’s activity and redistribution

across the plant surface is influenced by the formulation composition, GF-3308 has been

designed to minimise fenpicoxamid application rate and optimise the product’s

performance and storage stability. The necessary excipients in GF-3308, which contribute

to its hazard classification include the following materials: a reaction mass of N,N-

Dimethyloctan-1-amide and N,N-Dimethyldecan-1-amide (no CAS number available),

cyclohexanone (CAS 108-94-1), ethoxylated tridecyl alcohol (CAS 78330-21-9),

dodecylbenzenesulfonic acid calcium salt (CAS 84989-14-0) and eo/po block copolymer

(CAS 9038-95-3).

Manufacturing, packaging and labelling may be done either overseas or in the company

owned pesticide manufacturing plant in New Plymouth or other suitable contractor facility.

The risks during manufacture are managed mainly by establishing an adequate

containment system, which prevents the escape of GF-3308, contamination of the facility,

excludes unauthorised people and unwanted organisms from the facility, prevents

unintended release of the substances, controls the effects of any accidental release,

manages waste disposal and establishes procedures to inspect and monitor the

containment facility. The potential for human exposure for people handling GF-3308 during

its manufacture, packaging and labelling is reduced to a negligible level by implementing

such a containment system coupled with the compulsory use of appropriate personal

protective equipment as well as training and qualification requirements for staff on

handling hazardous substances and following established Standard Operating Procedures.

During transport and storage of GF-3308, only one scenario can be identified for human

exposure to the substance: isolated incidents where spillage occurs. HSNO controls (the

label, SDS and packaging) and adherence to the Land Transport Rule 45001, Civil Aviation

Act 1990 and Maritime Transport Act 1994 will apply to manage those risks, which are

therefore considered negligible.

Disposal of GF-3308 is most likely to be achieved through the use as a foliar spray. Unused

product and packaging will be acceptable for collection by Agrecovery, the Rural Recycling

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Programme, which is an industry stewardship scheme. Alternatively, empty packaging

should be crushed or punctured and buried in a suitably approved landfill. The end users

disposing of the substance will have the necessary knowledge (e.g. via information

provided on the label and SDS) to manage the risk adequately.

The most relevant exposure scenario is identified for the end users of GF-3308, who handle

and apply the product on farm. Each triggered hazard class will be discussed separately in

the following paragraphs.

Acute toxicity (6.1E) GF-3308 has been classified as 6.1E based on the data available for a closely similar

formulation, a study conducted in compliance with the OECD 423 guideline. The acute oral

median lethal dose (LD50) for a closely similar substance in Wistar rats was found to be

between 2,000 and 5,000 mg/kg body weight. This is equivalent to 140 - 350 g

(approximately 138 – 344 mL) of GF-3308 for a person weighing 70 kg. The likelihood of

a person ingesting a fraction of this amount through normal use is improbable. To reduce

the risk of any incidental ingestion, the label will also contain standard precautions: DO

NOT eat, drink or smoke while using. Avoid inhalation of product or spray mist. Remove

protective clothing immediately after handling this product and wash hands and face before

meals and after work.

Eye and skin irritation (6.3B and 6.4A) GF-3308 has been classified as 6.3B based on the data available for a closely similar

formulation, a study conducted in compliance with the OECD 404 guideline. Very slight to

well-defined erythema and very slight oedema were observed in the exposed rabbits. The

mean dermal irritation scores at 24, 48 and 72 h post-patch removal were 2.00, 2.00, 2.00

for erythema and 1.00, 1.00, 1.00 for oedema for the three tested rabbits respectively.

Recovery was complete in all rabbits by day 7 post patch removal.

GF-3308 has been classified as 6.4A based on the data available for a closely similar

formulation, a study conducted in compliance with the OECD 405 guideline. Corneal

opacity, conjunctival redness and conjunctival chemosis were observed in the tested

rabbits. The mean of the eye irritation scores observed at 24, 48 and 72 h post instillation

were 0.67, 1.00, 1.00 for corneal opacity, 0.00, 0.00, 0.00 for area of corneal opacity,

0.00, 0.00, 0.00 for iris effects, 2.00, 2.00, 2.00 for conjunctival redness, 1.00, 1.00, 1.00

for conjunctival chemosis and 0.00, 0.00, 0.00 for discharge for the three rabbits

respectively. Recovery for all symptoms in all rabbits occurred by day 7.

To manage the risk of skin and eye irritation, appropriate (and standard) statement will be

added to the product label: Causes mild skin irritation and eye irritation. Avoid contact with

the skin and eyes. When opening the container, preparing the product for use and applying

May 2015 EPA0316

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the product, wear eye protection, cotton overalls buttoned to the neck and wrist (or

equivalent clothing) and chemical resistant gloves.

These recommendations are consistent with good practice and existing industry standards.

With such measures in place the risk of skin and eye irritation is low.

Target organ toxicity (6.9B) GF-3308 has been classified as 6.9B based on mixture rules. Two co-formulants, a reaction

mass of N,N-Dimethyloctan-1-amide and N,N-Dimethyldecan-1-amide and eo/po block

copolymer (CAS 9038-95-3) are classified 6.9B (oral) and 6.9B (inhalation) respectively.

Adverse effects from ingesting GF-3308 are only likely to occur if undiluted GF-3308 is

consumed for prolonged periods of time at high doses, which is improbable through the

normal use. Eo/po block copolymer is present in GF-3308 at a concentration <5% and will

be further diluted, in the tank mix at least 25 times (up to 200 times) therefore the

exposure through inhaling the spray mist is very low.

To manage the risks, the same measures as for acute oral classification apply. To address

the inhalation risk the label will contain the following statement: Avoid inhalation of product

or spray mist. This is good practice regardless of the agrichemical product classification

and is part of the established industry standards.

The dietary risk assessment for consumers is out of scope of the EPA evaluation, other

than setting the TELs, however, for completeness it is noted that exposure through the

diet will be evaluated by the Ministry of Primary Industries based on the comprehensive

residue dossier. Under the Food Act Dow AgroSciences has proposed a domestic MRL

(Maximum Residue Level) of 0.2 mg/kg fenpicoxamid in wheat grain (it will be 0.6 mg/kg

in the EU). This value is based on the highest residue level (0.13 mg/kg fenpicoxamid)

found in any grain sample tested after the most intensive label treatment was applied to

wheat in New Zealand (2 applications at the max proposed label rate (100 g a.i./ha), at

the latest application timing (GS69) and with the shortest allowed application interval (2

weeks)).

The EFSA set the Acceptable Daily Intake (ADI) (the amount that can be ingested on a

daily basis over a lifetime without an appreciable health risk) at 0.05 mg/kg fenpicoxamid

and the Acute Reference Dose (ARfD) (the amount that can be ingested over a short period

of time, usually during one meal or one day, without an appreciable health risk) at

1.8 mg/kg fenpicoxamid. These values are based on the lowest toxicity endpoints and

include a safety factor of 100. Assuming the highest allowed fenpicoxamid residue in grain

(i.e. the proposed MRL of 0.2 mg/kg), ADI and ARfD correspond to 250 g and 9 kg of wheat

grain respectively (this also assumes no residue decay through storage or preparation).

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Please also note that an MRL represents an exaggerated worst case scenario. The residue

found in wheat grain in New Zealand trials resulting from the most intensive label use

pattern ranged from <LOQ (limit of quantification) to 0.13 mg/kg fenpicoxamid.

The Joint FAO/WHO Meeting on Pesticide Residues established the same ADI and no ARfD

due to low toxicity. Dow AgroSciences expects the NZ EPA to establish the ADE (Acceptable Daily Exposure)

value in line with the European and JMPR ADI. Considering all the above points, the risk to human health from the controlled use of GF-

3308 is therefore considered low.

• Environment

The only environmental hazard associated with GF-3308 and triggered by the active

ingredient is its high aquatic toxicity. The formulation endpoints supporting the 9.1A

classification are the LC50 of 0.078 mg/L in rainbow trout (from a study conducted

according to the OECD 203 guideline) and the EC50 of 0.048 mg/L for Daphnia (from a

study conducted according to the OECD 202 guideline). For comparison, copper hydroxide,

a fungicide certified for use in organic fruit and vegetables, is also classified 9.1A based on

the endpoints of LC50 of 0.023 mg/L in fathead minnow and LC50 of 0.0065 mg/L in

Daphnia6. The registered minimum application rate of copper hydroxide in stone fruit for

example is 1.9 kg/ha7; no maximum rate is stated nor prescribed by the EPA controls (see

HSR000739 approval).

Laboratory and field studies have been conducted to determine the fate of fenpicoxamid

in the environment. Fenpicoxamid degrades rapidly in the environment to UK-2A8 which

then degrades rapidly to pesticidally non-active compounds (the laboratory hydrolysis DT50

for fenpicoxamid at pH 7 is 0.9 days, the laboratory photolysis DT50 for fenpicoxamid at

pH 7 is 3.1 days, soil aerobic laboratory DT50 is 1.9 days for fenpicoxamid and 2.3 days for

UK-2A). Dissipation of Inatreq occurs primarily through microbial degradation in the soil

and hydrolysis and photolysis in water. Laboratory studies have demonstrated an average

Koc of 53,173 mL/g for fenpicoxamid and 10,040 mL/g for UK-2A indicating that they are

strongly adsorbed to soil.

6 EPA’s Chemical Classification and Information Database (CCID) 7 Refer to HORTCARE Copper Hydroxide 300 label (ACVM registration number P008704) or ChampION++ label (ACVM registration number P009228). 8 UK-2A is a natural substance produced by fermentation of Actinomyces bacteria isolated from a soil sample. Fenpicoxamid is manufactured from UK-2A through a single post-fermentation manufacturing step. See the Benefits section for more information.

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Manufacturing, packaging and labelling may be done either overseas or in the company

owned pesticide manufacturing plant in New Plymouth or other suitable contractor facility.

The risks during manufacture are managed mainly by establishing an adequate

containment system, which prevents the escape of GF-3308, contamination of the facility,

excludes unauthorised people and unwanted organisms from the facility, prevents

unintended release of the substances, controls the effects of any accidental release,

manages waste disposal and establishes procedures to inspect and monitor the

containment facility. The risk of contamination of waterways, groundwater, soil or

neighbouring properties is negligible with such a containment system in place.

During transport and storage of GF-3308, only one scenario can be identified for

environmental exposure to the substance: isolated incidents where spillage occurs. HSNO

controls (the label, SDS and packaging) and adherence to the Land Transport Rule 45001,

Civil Aviation Act 1990 and Maritime Transport Act 1994 will apply to manage those risks,

which are therefore considered negligible.

Disposal of GF-3308 is most likely to be achieved through the use as a foliar spray. Unused

product and packaging will be acceptable for collection by Agrecovery, the Rural Recycling

Programme, which is an industry stewardship scheme. Alternatively, the empty packaging

should be crushed or punctured and buried in a suitably approved landfill. The draft label

contains the following statements: Dispose of equipment cleaning water onto ground away

from edible crops. DO NOT dispose of this product, spray mix or equipment cleaning water

down drains or sewers. Cleaning water should be discharged onto a designated disposal

area, or onto unused land away from desirable plants and water sources. The end users

disposing of the substance will have the necessary knowledge (e.g. via information

provided on the label and SDS) to manage the risk adequately.

The highest risk for a water body contamination is associated with the application of GF-

3308 in the field. The label will prohibit uses directly into or onto water and a corresponding

HSNO control is expected to be imposed. The draft label contains the following statements:

Very toxic to aquatic organisms. DO NOT apply directly into or onto water. No person may

apply the substance in a manner that results in adverse effects to a water body.

The most likely exposure route would be via accidental spills or off-target movement such

as spray drift.

Spray drift For any substance applied as a spray treatment, the potential for off-target drift will always

be present. Off-target drift can be minimised using drift reduction techniques. The most

common of these include:

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a) Specifying acceptable wind speed: Best practice advice is to spray only when the

wind is between 3 and 20 km/h, but for some types of products the upper limit

may be reduced. Spraying in calm conditions is not recommended as the direction

of the drift can be unpredictable in apparently still air.

GF-3308 draft label contains the following statement: DO NOT apply when wind

speeds are less than 3 km/h or more than 20 km/h as measured at the application

site.

b) Avoiding application during inversion conditions. These occur mainly at night or

early morning.

GF-3308 draft label contains the following statement: Avoid strong winds or

inversion conditions that may result in drift from the target area. Techniques to

minimise drift should be employed at all times.

c) Specifying the spray quality in accordance with ASAE (S-572) or BCPC

specifications. Higher quality (very coarse to extra coarse) spray reduces drift, but

may negatively impact efficacy for some products.

GF-3308 will be recommended to be applied with a medium quality spray in

alignment with other registered cereal fungicides.

d) Limiting the application rates.

The maximum label application rate is 2 L/ha (100 g a.i./ha). Specifying the minimum downwind buffer zones is the most common risk mitigation

measure to manage spray drift. In case of GF-3308, the risk to aquatic organisms having

the lowest endpoints, will determine the necessary buffer zones (if any). The EPA does not

publish their risk assessment methodology in sufficient detail for Dow AgroSciences to

predict the buffer zone calculations. We await the Staff Report to add mandatory buffer

zones, if applicable, to the product label as per the corresponding HSNO control.

It is appropriate that EPA use the same modelling input parameters, such as equipment

configuration (e.g. boom length, number of nozzles, release height, etc.) or climatic

conditions as for GF-2687, also a foliar plant protection product for use in cereals and

approved to be applied by broadcast ground and aerial application methods in 2016 (see

the Staff Report for the APP202336 application).

An important risk mitigation measure will also be the compulsory qualification

requirements as set out in the EPA Hazardous Substances (Hazardous Property Controls)

Notice 2017 (e.g. Rural Contractors New Zealand’s Registered Chemical Applicator

Accreditation with relevant strand or GROWSAFE® Registered Chemical Applicator

Certificate with relevant strand or National Certificate in Agrichemical Application with

relevant strand, etc.).

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The safety of aerial applications is an area of particular, and in our view undue, concern.

It should be emphasised that the aerial applicators undertake extensive training and are

required to achieve a significant level of understanding of the risks involved. The following

table summarises training requirements within the agricultural aerial industry:

Requirement

Scope and Comments

Provider

Compulsory pilot training (Part 137 certificate)

Commercial

Pilot Licence

(CPL)

Undergo training provided by a Part 61 qualified

flying instructor. Minimum 200 hours fixed wing

or 150 hours helicopter

Civil Aviation

Authority of NZ

Agricultural

rating

Grade 2

Undergo a course of instruction in Agricultural

flying provided by a qualified E Category

instructor operating under the authority of either

a Part 137 or Part 141 organisation authorised to

conduct the training.

Undergo a flight and ground assessment by an

Agricultural Flight Examiner. Successful

graduation leads to the issue of a Grade 2

agricultural rating.

Prerequisite is to hold a Pilot Chemical Rating

issued under Subpart P of Part 61.

Civil Aviation

Authority of NZ

Agricultural

rating

Grade 1

Undergo assessment for issue of a Grade 1

agricultural rating by demonstrating competency

to an Agricultural Flight Examiner.

Prerequisite is to hold a Pilot Chemical Rating

issued under Subpart P of Part 61 and to have

conducted 1,000 hours of productive agricultural

flight operations under direct supervision.

Civil Aviation

Authority of NZ

Chemical rating

To be eligible for issue of a Pilot Chemical Rating

issued under Subpart P of Part 61 of the CARs a

pilot must:

• Be the holder of at least a private pilot

licence in the appropriate category of

aircraft, and • Successfully complete a training course in

agricultural chemical application, with

assessment, conducted under the

authority of either a Part 137 or Part 141

that is authorised to conduct the training

Civil Aviation

Authority of NZ

May 2015 EPA0316

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Optional accreditation/certification

AIRCARE™

Accreditation for companies who can

demonstrate to an independent auditor that

they have the requisite system in place,

understand and apply best practice.

Serves as evidence that best practice is used

every time the pilots undertake an agricultural

operation. Accreditation terms vary from 1-3

years depending on merit as determined by

audit.

NZAAA under

the auspices of

Aviation New

Zealand

GROWSAFE

certification

Understanding of NZS8409 Management of

Agrichemicals standard which defines best

practice. Following the standard means all

relevant legislation is complied with.

New Zealand

Agrichemical

Education Trust

Additional training and comments

Aviation New Zealand annual conference and the weekly and monthly newsletters are

used to provide updates, trends, issues and solutions.

Pilot Chemical Rating refresher courses; wire collision avoidance; and cockpit resource

management courses are run in conjunction with each annual conference as well as on

an as-required basis.

The majority of agricultural pilots are ‘grown’ from within the industry. The normal

career pattern is to start as a trainee loader/driver where chemical handling is learned

under supervision then an Agrichemical Handlers Certification is gained on completion of a course once sufficient experience is gained. This handlers’ certificate and

demonstrated experience is a prerequisite to complete the Pilot Chemical Rating. Once

the person has demonstrated the right ‘fit’ for the industry they will undergo pilot

training followed by Grade 2 then Grade 1 qualification. The whole process takes a

number of years and there are only 2-3 new pilots entering the industry each year.

The practices of the aerial industry have markedly improved over the last two decades due

to the introduction of rigorous protocols for the site-specific risk assessment that any aerial

applicator has to undertake and document. Unfortunately, there is no comprehensive

database of the adverse effects resulting from aerial applications in New Zealand, however,

the New Zealand Agricultural Aviation Association were able to obtain data from the

insurance claims statistics. In the 90s there were about 25 insurance claims annually

resulting from adverse effects caused by aerial spraying. Between 2007 and 2015 such

claims have averaged at 0.6/annum and in this time there were only 2 major incidents,

neither of which resulted from spray drift. New Zealand Agricultural Aviation Association

have confirmed this trend has been sustained up to date. The aerial applicators Dow

AgroSciences spoke to argue that there is no need for any tighter regulation as they can

only be insured up to $250,000 and therefore are personally liable for significant damage

to non-target crops and one significant non-insured claim would put them out of business.

May 2015 EPA0316

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It is possible to remain dissatisfied on the basis that this data does not stretch far enough

to provide evidence of the protection of the wider environment other than non-target crops,

however, it seems reasonable to assume that good application practice, as evidenced in

the insurance statistics, is applied equally to all non-target areas irrespective of what is

located downwind. Furthermore MPI (ACVMG) operates an adverse effect reporting scheme

in New Zealand, which should capture significant spray drift incidents. No reportable spray

drift incidents for its products have been brought to the attention of Dow AgroSciences for

at least the last 10 years. Dow AgroSciences is not aware of any data or information, as

reports of adverse effects, which would constitute evidence supporting the need to tighten

controls for aerial application.

We acknowledge the fact that the aerial application of GF-3308 will only be used

occasionally and most likely only when it is impractical to use ground equipment. However,

there can be situations when aerial spraying will be indispensable, e.g. when the ground

is too soft and muddy after heavy rainfall; in conditions, which also favour the development

of fungal diseases, and it is important to have such an option available to farmers when

needed. In recent years it seems to have become necessary to produce extensive

arguments and even specific data in support of aerial application. Dow AgroSciences does

not agree this is warranted. Aerial application is managed by its own, significantly stricter

controls (such as significantly longer buffer zones in comparison to ground application). If

through risk assessment practical risk management measures can be identified for aerial

application, there should be no reason to restrict access to such a well-established

technology in New Zealand.

ASSESSMENT OF BENEFITS Dow AgroSciences is a global, agricultural research and development agrichemical

company present in 130 countries around the world and employing more than 2000

discovery and field research scientists. We are one of a very few companies that work on

discovering innovative agricultural molecules globally.

Since its birth in the late 1930s, the synthetic agrichemical chemistry has achieved

remarkable progress through R&D investment. There is a consistent trend in developing

more target specific chemistries that are efficacious at significantly lower rates and offer

steadily improving toxicological and ecotoxicological profiles, i.e. “greener” agrichemicals.

For example, in the last six decades the vertebrate selectivity ratios of insecticides (i.e. a

relative measure of toxicity to targeted insects versus non-target vertebrates) has

increased by five orders of magnitude, when at the same time field rates dropped

May 2015 EPA0316

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approximately 100 times9. A similar trend in average application rates is reported in a more

recent review10.

Period of introduction Average rate: g/ha

Dithicarbamates 1943-67 2500

Morpholines 1968-2003 590

Triazoles 1976-2002 140

Strobilurins 1996-2007 490

SDHIs 2000s 100

Table. Chronology and application rate ranges of main fungicide groups10.

Figure. Number of pesticides falling into different safety classifications as a function of the

decade in which they were introduced10. (The World Health Organization (WHO) classifies

pesticides into four main safety categories: Class I: Extremely (Ia) and highly (Ib)

hazardous, Class II: Moderately hazardous, Class III: Slightly hazardous, U: Unlikely to be

hazardous).

Our innovation efforts continue to generate novel solutions for farmers, the newest of

which is fenpicoxamid; a fungicide for the control of Septoria tritici, which causes Septoria

leaf blotch, also known as speckled leaf blotch; one of the major diseases in wheat, which

results in significant loss of yield.

9 Sparks, T. C. (2013) “Insecticide discovery: An evaluation and analysis”, Pesticide Biochemistry and Physiology, Vol. 107, p. 8 -17. 10 Phillips McDougall (2018) “Evolution of the Crop Protection Industry since 1960”

May 2015 EPA0316

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Speckled leaf blotch has become increasingly damaging to the New Zealand cereal

production in the last few years.

Figure: Snippets from the New Zealand online media.

http://www.stuff.co.nz/business/9942251/Fungicide-resistance-in-wheat-is-a-shock

https://agrihq.co.nz/section/arable/view/cereal-killer-on-the-rampage

Septoria infection causes lesions on leaves, which decrease the photosynthetic area. The

leaves turn yellow and die before dropping off. When this affects the top three leaves of

the wheat plant (so-called flag leaf, flag minus 1 and flag minus 2 leaves), the plant

becomes severely malnourished and the grain yield is reduced.

Septoria pathogen overwinters as mycelium, pycnidia and pseudothecia on crop debris

(e.g. stubble) or soil. It can be spread by contact, wind or rain and has multiple infection

cycles in one season. These factors together mean that, while there is some variability in

susceptibility among different wheat varieties, all crops have the potential to be infected

in warm moist conditions.

Independent trials conducted in Canterbury in the 2017/18 season, as well as trials

conducted in many European countries, demonstrate that GF-3308 provides very high level

of control against Septoria blotch and is equal to the market standard currently registered



https://agrihq.co.nz/section/arable/view/cereal-killer-on-the-rampage

39

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,. May2015 EPA0316

40

May 2015 EPA0316


Figure. Results of the New Zealand efficacy trials in wheat: Control of Septoria leaf blotch

on the flag minus 2 leaf.

These results demonstrate:

• The dose response (i.e. confirm the correct rates have been selected for the label)

• Efficacy of GF-3308 alone comparable to the market standard (81.5 – 97.7% control

v 85.0 – 99.0% control).

• Efficacy of GF-3308 with the tank mix partner comparable to the market standard

(90.1 – 99.7% control v 85.0 – 99.0% control).

New Zealand grows the highest yielding wheat in the world (up to almost 17 t/ha11) with

an average of approximately 9 t/ha. Losses of yield due to Septoria leaf blotch have been

reported at 2 – 3 t/ha and in extreme cases, 7 t/ha. Dow AgroSciences trials in 2017/18

11 Field, E. (2017) “NZ couple breaks Guinness World Record for wheat yield” The Weekly Times

May 2015 EPA0316

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showed control of Septoria leaf blotch with GF-3308 increased average yield from 9.7 t/ha

in untreated plots up to 12.4 t/ha, i.e. a gain of 2.7 t/ha or an increase in yield of 27%

compared to untreated. High yields not only improve the profitability of the farm but also

extract the best value from the land allocated to agriculture. It is estimated that 43,250 ha

of wheat were grown in 2018 yielding approximately 377,150 tonnes of wheat grain12. If

the yield was reduced by 30%, extra 18,500 ha would have to be cultivated to produce

the same amount of grain.

Figure. Results of the New Zealand efficacy trials in wheat: Grain yield.

Fenpicoxamid not only provides excellent efficacy against a common pathogen of economic

importance. One of its main benefits is its fit in a robust resistance management strategy

for cereal fungicides. This is because fenpicoxamid has a unique mode of action. It is the

12 “New Zealand survey of cereal areas and volumes: July 1, 2018” Arable Industry Marketing Initiative with Foundation for Arable Research.

May 2015 EPA0316

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first molecule in the picolinamides group of Quinone inside Inhibitor fungicides (FRAC13

mode of action group 21). Binding to complex III (the bc1 complex) at the Qi site (the

inner mitochondrial membrane), fenpicoxamid inhibits mitochondrial respiration in fungi

by blocking electron transfer in the respiratory chain. Inhibition of fungal mitochondrial

respiration results in a reduction in the amount of ATP (adenosintriphosphate) produced.

As ATP is the main chemical energy carrier that drives the vital functions of cells, the key

biochemical processes are disrupted, growth is inhibited and the fungus dies.

Fungicide treatments currently available in New Zealand include:

• Triazoles, e.g. epoxiconazole, tebuconazole, propiconazole, prothioconazole (Group

3 fungicides),

• Succinate-dehydrogenase inhibitors (SDHIs), e.g. isopyrazam, fluxapyroxad

(Group 7 fungicides) and

• Strobilurins, e.g. azoxystrobin, picoxystrobin, pyraclostrobin (Group 11 fungicides).

Development of resistance is a major concern in cereal production globally as well as in

New Zealand. While triazoles still show reasonable activity against Septoria in New

Zealand, reduced sensitivity has been widely reported13. Resistance to strobilurins, which

until recently had been the most effective in controlling Septoria, has been confirmed in

New Zealand. In Europe resistance to SDHIs is evident in the Septoria pathogen population

and this group of fungicides, while still very effective in New Zealand, is considered

moderate to high risk of resistance14. A new mode of action, which fenpicoxamid offers,

will become a crucial component of the resistance management toolbox. The need for a

robust resistance management strategy for cereal fungicides in New Zealand is universally

recognised in the industry. It will extend the lifespan of all fungicides increasing the viability

of the wheat industry. It is important to note that wheat in New Zealand is grown primarily

for animal feed. Unlike pasture or forage brassicas it can be stored for long periods of time

providing milk and meat producers with a flexible stock food. Therefore, benefits for the

wheat growers translate also into benefits for dairy, beef and lamb farmers.

While Dow AgroSciences does not agree synthetic molecules are inherently more

(eco)toxic, some users or members of the public may find fenpicoxamid’s natural origin an

important attribute. Fenpicoxamid is derived from a natural substance, UK-2A, produced

by fermentation of Actinomyces bacteria isolated from a soil sample collected at the Osaka

City University, Japan. Fenpicoxamid is synthesized from UK-2A through a single post-

fermentation chemical modification, which is required to enhance stability and performance

13 Fungicide Resistance Action Committee. FRAC is a Specialist Technical Group of CropLife International, who recommends resistance management strategies. They classify fungicides into distinctive groups based on their mode of action. A FRAC fungicide group is the most basic piece of information in any resistance management strategy, which involves alternating products with different modes of action and using other than chemical control methods. 14 The Foundation for Arable Research, “Issue 7 Cereal Disease Management (Revised 2016)”

May 2015 EPA0316

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(note, fenpicoxamid is devitalised and contains no viable microorganisms). Once in the

plant or fungal tissue, fenpicoxamid is converted back into UK-2A, its main metabolite.

GF-3308 is an emulsifiable concentrate containing 50 g/L fenpicoxamid, whose

redistribution across the plant surface is highly influenced by the formulation type. Based

on this understanding GF-3308’s performance has been optimized through specific,

patented formulation design to minimise fenpicoxamid application rate, maximise its

activity against Septoria, improve storage stability, rainfastness, ease of application and

overall product performance.

Fenpicoxamid has very low mammalian toxicity with no HSNO hazard classes triggered.

The HSNO classification for the formulated product, does not include any significant

hazards, which would require risk management measures outside of good industry

practice. Fenpicoxamid also degrades quickly in the environment and has very low toxicity

to non-target organisms with the exception of fish and aquatic crustaceans. However, with

the proposed use pattern, fenpicoxamid and GF-3308 pose low risk to the aquatic

environment.

GF-3308 is not designed to replace any existing product but complement a resistance

management strategy, however, a hazard comparison with its major competitors in the

marketplace is presented in the table below:

HSNO classification GF- 3308

Adexar Aviator Xpro

Seguris Flexi

Proline Comet Elatus Plus

3.1 Flammable liquid 3.1D 3.1D

6.1 Acutely toxic 6.1E 6.1D 6.1E 6.1D 6.1D 6.1D

6.3 Irritating to the skin 6.3B 6.3B 6.3A

6.4 Irritating to the eye 6.4A 6.4A 6.4A 6.4A 6.4A 6.4A

8.3 Corrosive to the eye 8.3A

6.5 Contact sensitiser 6.5B 6.5B

6.7 Carcinogenic 6.7B 6.7B

6.8 Reproductive /developmental toxicant

6.8B 6.8B

6.9 Harmful to human target organs or systems

6.9B 6.9B 6.9B 6.9B 6.9B 6.9A 6.9B

9.1 Ecotoxic in the aquatic environment

9.1A 9.1A 9.1B 9.1A 9.1B 9.1A 9.1A

9.2 Ecotoxic in soil 9.2D 9.2C

9.3 Ecotoxic to terrestrial vertebrates

9.3C 9.3C 9.3C 9.3B 9.3C

May 2015 EPA0316

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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.

The following table summarises the initial risk assessment undertaken by Dow

AgroSciences:

Impacts Level of risk Comment Cultural

Medium

GF-3308 is toxic to aquatic organisms (fish and

crustaceans) and is proposed to be classified 9.1A. It

is expected a number of HSNO additional controls

(s77A controls) will be imposed on GF-3308 to

manage the risks to water bodies:

• The substance must not be applied onto or into

water.

• No person may apply the substance in a

manner that results in adverse effects to a

water body.

• A maximum application rate control

• A buffer zone control. Label advice will be provided to comply with EPA

controls (awaiting the Staff Report).

Health &

Wellbeing

Low

Health risks to end users associated with the identified

hazards (the lowest level of acute toxicity (6.1E), mild

irritation to the skin (6.3B), mild irritation to the eye

(6.4A) and low target organ toxicity (6.9B), oral and

inhalation), will be managed by appropriate label

recommendations with regards to safe transport,

handling, storage and application, e.g. protective

clothing, handling and spraying precautions, etc.. All

required measures are consistent with the well-

established standard industry practices, with which

applicators are already familiar.

May 2015 EPA0316

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The use of agricultural chemicals like GF-3308 is often

considered as negatively impacting the balance of

nature. The use of GF-3308 will be limited to

commercial wheat production where the benefits to

farmers, including Māori farmers, and the New

Zealand economy significantly outweigh the risks.

Environment Medium See cultural impacts.

Economy

No risk

The applicant is unable to identify any economic risk

resulting from the use of GF-3308. It is argued in this

application that this product will bring significant

benefits to the New Zealand cereal production and the

associated industries (e.g. dairy). Please refer to the

benefits section of this application.

Treaty

Principles

No risk

The applicant is unable to identify any pathway, by

which the Treaty Principles could be violated by the

application of GF-3308 when appropriate risk

management measures (as imposed by the HSNO

controls) are applied to minimise health,

environmental and cultural impacts.

Dow AgroSciences undertook a pre-application Māori consultation. We were grateful to be

given an opportunity to present GF-3308 to the Ngāi Tahu HSNO Komiti at one of their

meetings. Prior to the meeting an application summary was provided. Many questions were

addressed during the meeting; one regarding the choice of the test species for the

bioconcentration study was responded to via e-mail after the meeting (summarised in the

following paragraphs). No written comment was provided to Dow AgroSciences by the

Komiti.

The application summary was also distributed for input and comment by the EPA within Te

Herenga, the extensive National Māori Network. Te Herenga is a forum for kaitiaki and

environmental resource managers to come together and discuss important environmental

issues. Dow AgroSciences also reached out via personal communication to Ngāti Whātua

Ōrākei and Te Rūnanga-Ā-Iwi O Ngāpuhi, who made submissions for our previous

application in 2015, to bring the consultation to their attention. No comments were

received within the 3-week consultation period.

While no questions or comments were made in writing, Dow AgroSciences would like to

explain their position on a number of issues often raised for pesticide applications as well

May 2015 EPA0316

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as those discussed at the Ngāi Tahu HSNO Komiti meeting and in the subsequent

communication.

Data provided to the EPA in confidence

On many previous occasions the confidential appendices have been accused of being a

“blanket concealment for any data deemed commercially sensitive”. In many cases the

applicants were criticised for withholding the formulation composition or the identity of the

impurities. Usually, such information cannot be provided as it is a trade secret. Disclosing

some composition related information can also generate commercial prejudice (e.g.

addresses of manufacturing plants, suppliers of ingredients, etc.).

A joint CropLife America and European Crop Protection Association report15 shows that the

cost of developing and registering new pest and disease prevention products (i.e. a novel

formulation containing one new active ingredient) was estimated at about 290 million USD,

with the cost of generating the toxicology and ecotoxicology component alone constituting

about 1/3 of this sum. It is understandable then that the R&D companies invest

considerable efforts in guarding the proprietary information.

However, no information is withheld from the EPA whose role is to impartially assess

the data, characterise the risks and impose controls.

Nevertheless, Dow AgroSciences understands the concerns and confusion resulting from

the unspecified contents of the confidential dossiers and therefore a general list of the

studies provided to EPA can be found in Section 6 of this application form (and more

information can be provided on request).

Also, study summaries for all submitted studies will be included in the public Staff Report.

Dow AgroSciences believes it would be better to conduct the consultation after the Staff

Report is released but the legislation places it pre-lodgement when it is impossible for the

Staff Report to be available.

Lastly, it is Dow AgroSciences’ belief that the Māori consultation is not undertaken with an

aim that the Māori conduct a comprehensive pre-submission data evaluation and risk

assessment but to identify all potential risks that will be carefully assessed by the EPA

during their evaluation, and the results of which will be published as the Staff Report. With

this in mind, Dow AgroSciences believe that sufficient information is provided.

15 Phillips McDougall (2016) “The Cost of New Agrichemical Product Discovery, Development & Registration in 1995, 2000, 2005-8 and 2010 to 2014. R&D expenditure in 2014 and expectations for 2019” A Consultancy Study for Crop Life America and the European Crop Protection Association.

May 2015 EPA0316

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Formulation composition undisclosed

As noted above, the formulation composition and the impurity profile for fenpicoxamid, as

well as other chemistry and manufacturing information (e.g. manufacturing methods,

addresses of manufacturing sites, etc.) are provided to the EPA in confidence and usually

constitute a trade secret.

However, since GF-3308 is protected by a US patent, the formulation design is disclosed

in the patent documentation. Section 7.2 above explains that the necessary excipients in

GF-3308, which contribute to its hazard classification include the following materials: a

reaction mass of N,N-Dimethyloctan-1-amide and N,N-Dimethyldecan-1-amide,

cyclohexanone (CAS 108-94-1), ethoxylated tridecyl alcohol (CAS 78330-21-9),

dodecylbenzenesulfonic acid calcium salt (CAS 84989-14-0) and eo/po block copolymer

(CAS 9038-95-3).

It should also be emphasised that the hazards of GF-3308 are fully disclosed and discussed,

and the HSNO classification is proposed for the substance including all of its ingredients

and their impurities. The technical grade active ingredient as well as the formulation do

not contain any other components of toxicological significance that would override the

hazards determined for the active ingredient or the formulation. In fact, the toxicity of all

of the impurities present in the active ingredient is accounted for during the testing of the

active ingredient and the formulation. Where no formulation data is available, such as for

non-acute hazards, the classification is based on mixture rules according to the EPA

Thresholds and Classifications User Guide, again taking into account all of the components

and their impurities.

Data on native species

The ecotoxicological data package has been put together according to the EPA

requirements as published on their website. There is no requirement to test any New

Zealand native species, neither are there any guidelines available on what species should

be tested and what protocols should be followed. More importantly, however, Dow

AgroSciences believe that such testing is unnecessary as the risk can be adequately

characterised based on the endpoints established for the internationally accepted indicator

species according to the internationally accepted guidelines (such as OECD, OPPTS). This

is the approach used in other countries with advanced regulatory systems. The indicator

species used in these protocols have been confirmed to be suitable based on decades of

research and are used in all countries to estimate the risk for their native species. For

regulatory purposes the species tested need to meet a number of conditions such as to be

easily cultured in laboratory conditions, have sensitivity to known toxicants and have been

demonstrated to allow derivation of repeatable/reproducible results irrespective of the test

facility. The ecotoxicological testing also employs a tiered approach, i.e. when toxicity is

https://www.epa.govt.nz/assets/Uploads/Documents/Hazardous-Substances/Guidance/thresholds-classification-guidance.pdf



May 2015 EPA0316

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indicated in one species at trigger doses, further species have to be tested and therefore

the hazards are always adequately investigated. The OECD countries accept these tests

and consider the indicator test species used as surrogates sufficiently representative to

extrapolate to other organisms for the purposes of classification and risk assessment to

account for entire ecosystems.

The requirement to generate country specific ecotoxicological data for each hazardous

substance would add considerably to the costs of bringing new products and uses to the

very small New Zealand market, beyond what its size can support. If the costs become

prohibitive for no justifiable scientific reason, innovative products will not come to New

Zealand depriving farmers of newer, safer to use products and potentially putting them at

a competitive disadvantage in export markets. Moreover, it would be contradictory to the

global efforts to minimise vertebrate and invertebrate testing and would create an

unnecessary differentiation of New Zealand among the OECD countries, which could be

regarded as a barrier to trade.

This issue has been extensively discussed in the series of workshops EPA hosted in 2015

– 2017 and in which Dow AgroSciences participated. It is our understanding that the

consensus was reached not to introduce additional data requirements in New Zealand.

Bioconcentration factor in longfin eel

During the Māori consultation a specific question regarding the choice of the test species

was raised and we would like to include it in this discussion for the benefit of all public

submitters.

The BCF (bioconcentration factor) for fenpicoxamid is reported to be <5 L/kg. This value

comes from a GLP study in zebrafish conducted according to the OECD guideline 305. The

question was whether, or actually why no BCF factor was experimentally established in

longfin eel, which is more relevant to New Zealand.

Zebrafish was tested because it is one of the recommended species for the OECD 305 fish

BCF study and the laboratory, which ran the test has considerable experience working with

this species. Longfin eel is not a recognized OECD or US EPA fish species and Dow

AgroSciences is not aware of any reputable laboratory, which could run such a test or a

regulator, which would accept such a study to satisfy the bioconcentration data

requirement. The list of recommended species includes those that can be cultured in the

lab and the control and reference toxicant testing results meet established validity criteria,

which are not available for the eel.

Bioaccumulation potential is a function of the lipid content, which is much higher in eel

than in zebrafish so the <5 L/kg endpoint is likely to be underestimated for the eel.

However, the OECD 305 study also produces an endpoint normalized to the lipid content,

May 2015 EPA0316

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which in the zebrafish study is reported to be <2.6 L/kg on a 5% lipid-corrected basis. This

value can be used to estimate a BCF in a species with a higher or lower lipid content. Using

the conservative value of 30% fat content for the eel (source, see p. 8), a BCF for it can

be calculated to be <15.6 L/kg. Please note that this is a non-definite endpoint (<), since

there were no detected residues in the study, and the <15.6 L/kg value has a limited

meaning.

The trigger to consider a substance bioaccumulative is >1,000 L/kg in US and >2,000 in

EU (and >5000 for very bioaccumulative in both US and EU). It is understood the NZ EPA

follows the European EFSA. Both, the measured BCF in zebrafish and the estimated BCF in

longfin eel, are very low, even if one assumes the worst case values (i.e. without the “<”).

The aquatic DT50 of fenpicoxamid is less than 24 hours. Therefore, owing to its fast

degradation in the aquatic environment and the very low BCF values, fenpicoxamid is

highly unlikely to bioaccumulate in any aquatic species.

Draft label not provided

The draft label is subject to both the pending HSNO controls and the ongoing MPI review.

These can result in important label amendments. Some sections are not even in a draft

form and await the EPA Staff Report to be released (e.g. buffer zones). We believe there

is little value in focusing the consultation on a document so far from the final. Importantly,

EPA does not review label content (while there can be HSNO additional controls dictating

some compulsory label wording). The subject of the EPA evaluation is the use pattern,

which is discussed in this form in great detail (see Section 5.1 of this application form).

Many draft label statements addressing the risks to human health and the environment

are also quoted in this form.

The detailed risk assessment

This document does not attempt to provide a comprehensive risk assessment for GF-3308.

The EPA does not publish guidelines on the risk assessment methodologies they use in

sufficient detail to allow applicants pre-empt the conclusions from the New Zealand risk

assessment. It would also be an unnecessary duplication of a substantial piece of work,

which EPA will undertake independently regardless of the level of risk assessment

presented by the applicant. The comprehensive New Zealand specific risk assessment for

GF-3308 will be published by EPA as the Staff Report.

Dow AgroSciences have made all possible efforts to provide a review of potential risks and

risk management (lifecycle controls) as comprehensive as possible and have based this

document on all the data available (and submitted to the EPA) as well as drawing from the

competent EFSA conclusions, which are publically available.

https://www.es.govt.nz/Document%20Library/Research%20and%20reports/Surface%20water%20quality%20reports/fish_surveys_in_non-wadeable_systems.pdf

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Risks to taonga species

Dow AgroSciences supports the EPA in incorporating the taonga species in its risk

assessment as long as it maintains high scientific rigour and is equally applied to all

pesticides in the New Zealand market.

Dow AgroSciences do not agree that imposing unprecedented and limiting controls on

novel, low hazard pesticides benefits the farmers or, indeed, the environment or human

health, when much higher hazard products that are already in the marketplace do not

attract the same limiting controls. The labels for new products, which are a result of a

modern, significantly more rigorous risk assessment and more stringent risk management

controls, while at the same time 30, 40 year old formulations have hardly any restrictions,

misleads the users and the general public into assuming that the older products are safer

and additionally makes them easier to use. This has the perverse outcome of users

preferentially selecting the older products with less stringent controls (but higher hazards

and risks). This coupled with the unavoidable premium associated with state-of-the-art

products stands in the way of adopting new, better technologies, tools and approaches

which benefit people, the environment and the economy.

There are about 1,500 pesticides registered for use in New Zealand. While there is no

statistics, Dow AgroSciences estimates there is less than 20 agricultural chemicals

approved with standard buffer zones and less than 10 with buffer zones for the protection

of endangered species. While we accept, it is unfeasible to roll out new methodologies and

requirements uniformly across the market, the gap between old and new in New Zealand

is truly extreme and more effort should be devoted to the implementation of new

restrictions more uniformly, in stages, allowing at least an appreciable percentage of

existing products to catch up (via reassessments) before the next level of conservatism is

imposed on novel products.

Tank mixing

In recent years some of the public submitters have raised concerns about toxic and

ecotoxic effects of tank mixes, i.e. when two or more agrichemicals are applied in one

spray treatment.

GF-3308 has sufficient efficacy to control Septoria on its own, however, to prevent the

development of resistance it will be recommended to be applied with a tank mix partner –

a suitable wheat fungicide with a different mode of action, e.g. prothioconazole.

In general, tank mixing is used in agriculture to broaden the spectrum of activity (e.g.

control both Septoria leaf blotch and powdery mildew), to prevent the development of

resistance in the target pest by targeting multiple sites, to increase the efficiency of crop

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protection treatments (one pass instead of two or more) or to apply a required combination

of actives, which are unstable in each other’s presence to allow a practical shelf life and

have to be mixed together immediately before the application.

Like in other countries, tank mixing is a standard agricultural practice in New Zealand and

a good practice too. It allows farmers to simultaneously treat multiple pests and crop

conditions in the most economical and efficient way. It reduces the time and resources

needed (water, fuel, adjuvant) as well as minimises operator exposure (which is a function

of the exposure time), vehicle emissions, soil compaction and crop injury.

The design of a spray program depends on many factors such as weeds, pests and diseases

present, environmental conditions, crop variety, farmer’s economic decisions, etc. and

therefore the sheer number of combinations would be unfeasible to evaluate.

The NZ EPA approves individual substances. Any tank mix partner will have its own HSNO

approval and controls. The users must ensure compliance with the strictest controls

applicable to any substances in the tank mix. If an aquatic buffer zone for a product A is

20 m and for a product B it is 50 m, a 50 m buffer zone applies to the A+B tank mix; if

the withholding period for a product A is 3 weeks and for a product B it is 1 week, the

withholding period for the A+B tank mix is 3 weeks and so on. If there are multiple products

applied at the same time, the applicator may have to navigate a long list of restrictions.

However, adding tank mix specific recommendations on all labels would hardly reduce this

complexity.

It is acknowledged that there may be some uncertainty with respect to

synergistic/antagonistic effects, additive toxicity or the “cocktail” effect. However, true

synergy is rare. Additive toxicity can be suspected when multiple chemicals with the same

mode of action are used. For tank mixtures usually one component, which drives the

toxicity can be identified. In such cases considering mixture effects does not result in

markedly stricter mitigation measures than considering the driver alone. The benefit of

such minor potential distinctions is not outweighed by the drastically increased complexity

of labels or in the risk assessment.

While no single tank mix partner can be nominated for GF-3308, prothioconazole is named

as an example of a suitable candidate. Fenpicoxamid, a quinone inside inhibitor, and

prothioconazole, a demethylation inhibitor, have different modes of action, which is the

whole point of a resistance management strategy. While mixtures of GF-3308 with a

prothioconazole product did show a slightly improved efficacy in our trials, the primary

purpose of tank mixing GF-3308 with prothioconazole is not the increased activity but

targeting two distinctive sites in the fungus cell simultaneously. Genetic mutations leading

to the development of resistance against both modes of action at the same time are

significantly less likely than to each one separately and therefore the risk of resistance

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development to either mode of action is significantly reduced. This way the future viability

of both fenpicoxamid and its tank mix partner is safeguarded.

With two different modes of action, the consideration of additive toxicity is not appropriate.

Dow AgroSciences is also not aware of any data showing synergy between fenpicoxamid

and prothioconazole (or any other triazole, SDHI or strobilurin).

The only proposed ecotoxicological hazard classification for GF-3308 is its aquatic toxicity,

9.1A. Prothioconazole products are classified either 9.1B (HSR101175, HSR101177,

HSR001661) or 9.1C (HSR101126). While, the endpoints, on the basis of which these

classifications were applied to prothioconazole products is not published on the EPA

website, the range to trigger a 9.1B classification is >1 but ≤10 mg/L and for the 9.1C

classification it is >10 but ≤100 mg/L (the endpoint for GF-3308 is 0.048 mg/L in Daphnia

and 0.078 mg/L in rainbow trout). Clearly, the aquatic toxicity will be driven by

fenpicoxamid, not prothioconazole. Therefore, any HSNO controls for GF-3308, like an

aquatic buffer zone, will be protective against prothioconazole.

Through technical training materials and user guides Dow AgroSciences will recommend

similar resistance management strategy as well as spectrum extension approach where

needed for fenpicoxamid in Europe. This does not trigger the tank mix evaluation under

the EU regulations.

While in some jurisdictions under specific circumstances tank mixing triggers additional

toxicological and ecotoxicological risk assessment, which is usually based on concentration

addition models to estimate mixture endpoints, Dow AgroSciences New Zealand is not

aware of any regulator who would apply these in the case presented here. Regulation has

its limits and it is globally recognised it is impossible to account for every possible scenario

in the field. In our opinion it would also be impossible to demonstrate that allocation of

resources in such a pursuit to account for as many scenarios as technically feasible, can

be justified.

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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

Dow AgroSciences cannot identify any impact on New Zealand’s international obligations,

which could result from the approval of GF-3308.

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

It is expected GF-3308 will trigger many default controls, similarly to other crop protection

products, e.g.:

• Hazardous Substance (Hazardous Property Controls) Notice 2017, HPC Notice Part

4 Clause 47 (Equipment for class 9 substances must be appropriate); Part 4 Clause

48 (Records of application of class 9 pesticides and plant growth regulators); Part

4 Subpart A (Site and storage controls for class 9 substances); Part 4 Subpart C

(Qualifications required for application of class 9 pesticides)

• Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001, Regs 11 –

26, Limiting exposure to toxic substances through the setting of TELs

• Hazardous Substances (Identification) Regulations 2001, Regs 6, 32 – 35, 36(1) –

(7), 9, 18, 20, 25, 26, 27, 29 – 31 (identification requirements, priority and

secondary identifiers)

• Hazardous Substances (Packaging) Regulations 2001, Regs 5, 6, 7(1), 8, 9, 19, 21

(packaging requirements)

• Hazardous Substances (Disposal) Regulations 2001, Reg 8 – 11 (disposal

requirements)

• Hazardous Substances (Emergency Management) Regulations 2001, Regs 6, 9 –

11, 8(e), 8(f), 12, 13, 15, 16, 18 – 20 (information requirements for suppliers)

• HSW (Hazardous Substance) Regulations Part 2 Labelling, signage, safety data

sheets and packaging, HSW Reg 2.1 - 2.4, 2.4 – 2.10, 2.11 – 2.14.

• HSW (Hazardous Substance) Regulations Part 3 General duties relating to risk

management, HSW Reg 3.1 – 3.3 (inventory and managing risks)

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• HSW (Hazardous Substance) Regulations Part 4 Certified handlers and supervision

and training of workers, HSW Reg 4.5 - 4.6 (Information, instruction, training and

supervision)

• HSW (Hazardous Substance) Regulations Part 5 Emergency Management, HSW Reg

5.6-5.13 (Emergency response plans)

• HSW (Hazardous Substance) Regulations Part 13 Class 6 and 8 substances, HSW

Reg 13.7 (Duty of PCBU to ensure equipment is appropriate); HSW Reg 13.8 (Duty

of PCBU to ensure personal protective equipment used); HSW Reg 13.14 - 13.16

(Transportation); HSW Reg 13.17 (Prohibition on use of substance in excess of

TELs); HSW Reg 13.18 (Duty of PCBU to ensure prescribed exposure standards for

class 6 substances not exceeded); HSW Reg 13.30 -33 (Secondary containment

requirements for pooling)

• HSW (Hazardous Substance) Regulations Part 16 Tank wagons and transportable

containers, HSW Part 16 (Requirements for tank wagons and transportable

containers)

The table below presents the proposed label statements designed to advise end users how

to manage the risks arising from the hazards identified for GF-3308:

Identified hazard Proposed management (label statements)

3.1D

Flammability COMBUSTIBLE LIQUID

Keep away from sources of ignition.

6.1E

Acute toxicity

6.3B

Mild irritation to the skin

6.4A

Mild irritation to the eye

6.9B

target organ toxicity,

oral and inhalation

Causes mild skin irritation and eye irritation. Avoid contact

with the skin and eyes. May be harmful if swallowed. May

cause damage to organs through prolonged or repeated

exposure. DO NOT eat, drink or smoke while using. Avoid

inhalation of product or spray mist. Remove protective

clothing immediately after handling this product and wash

hands and face before meals and after work.

When opening the container, preparing the product for use

and applying the product, wear eye protection, cotton overalls

buttoned to the neck and wrist (or equivalent clothing) and

chemical resistant gloves.

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9.1A

Ecotoxicity in the

aquatic environment

Very toxic to aquatic organisms. DO NOT apply directly into

or onto water. No person may apply the substance in a

manner that results in adverse effects to a water body.

Management of Spray Drift:

Persons applying this substance must not cause adverse

effects to any water body.

DO NOT apply when wind speeds are less than 3 km/h or

more than 20 km/h as measured at the application site.

Spraying equipment must be calibrated to deliver medium or

larger droplets as defined by the American Society of

Agricultural and Biological Engineers ASABE Standard (S572)

or the British Crop Production Council guideline.

These statements will be reviewed when the Staff Report is available.

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 risks, costs and benefits to the New Zealand agricultural industry and economy, the

environment, the Māori and the New Zealand’s international obligations have been

identified and assessed in detail in sections 7.2 – 7.4. The controls to manage the identified

risks have been proposed in section 7.5. It can be concluded from this analysis that the

benefits of a controlled use of GF-3308 significantly outweigh the risks.

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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:

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8.2. Statutory Declaration

I [full name], of [address], [occupation/position], being the applicant or

authorised to do so on behalf of the applicant, verify that the information contained in this application

for [substance name] is true and correct. I make this solemn declaration conscientiously

believing the same to be true and by virtue of the Oaths and Declarations Act 1957.

Signature

Declared at on this day of , 20 before me.

Witness signature [name] Barrister or Solicitor of the High Court of New Zealand

[or Justice of the Peace, Notary Public, or other person authorised to take a statutory declaration]

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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.

Please note the EPA strongly encourages

applicants to provide as much information

as possible in the main body of the

application form unless there is a genuine

argument that it is commercially sensitive.

☒ Yes ☐ No

Supplementary optional information attached:

• Copies of additional references ☒ Yes ☐ No

• Letter(s) of access ☐ Yes ☒ No Not applicable

• Relevant correspondence ☒ Yes ☐ No

• Draft label ☒ Yes ☐ No

• Draft Safety Data Sheet (SDS) ☐ Yes ☒ No Not available at this

stage

Administration

Are you an approved EPA customer? ☐ Yes ☐ No

If yes are you an:

Applicant: ☐

Agent: ☐

Not relevant anymore.

The initial lodgement

invoice 1168 has been

paid.

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:

• Cheque for application fee enclosed

☐ Yes ☐ No

☐ Payment to follow

☐ Yes ☐ No

☐ Payment to follow

Electronic signed copy of application e-

mailed to the EPA

☒ Yes

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Physical copy of signed statutory

declaration sent to the EPA, (rapid

assessment only)

☐ Yes Not applicable

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: