To obtain approval to import or manufacture a pesticide · 5. Please make sure that you obtain all...

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

To obtain approval to import or manufacture a pesticide

APPLICATION FORM Pesticides

www.epa.govt.nz

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

Grandevo

Date

August 2017

mailto:[email protected]

2

Application Form Approval to import or manufacture a pesticide

May 2015 EPA0316

Completing this application form

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

(HSNO) Act 1996. It only covers the import or manufacture of pesticides to be released in New

Zealand under section 28 of the HSNO Act. If you wish to make an application for another type of

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

(such as emergency, special emergency or containment), a different form will have to be used. All

forms are available on our website.

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

Authority (EPA) as early in the application process as possible. An Applications Advisor can assist

you with any questions you have during the preparation of your application including advising on

any consultation requirements.

3. Before submitting this application, you may make an informal Status of Substance (SOS) advice

request to the EPA. Further information on this process is available on our website. Please note

that this is not mandatory and an SOS request is only informal advice.

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

the substances and their uses are of a similar nature.

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

have used or provided in this application form, if you are not the owner of such data.

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

formally received and assessed. If a section is not relevant to your application, please provide a

comprehensive explanation why this does not apply. If you choose not to provide the specific

information, you will need to apply for a waiver under section 59(3)(a)(ii) of the HSNO Act. This

can be done by completing the section on the last page of this form.

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

referenced, and included with the application form when it is submitted.

8. Please add extra rows or tables where needed.

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

application fee (including GST) unless you are already an approved EPA customer. To be

recognised by the EPA as an “Approved customer”, you must have submitted more than one

application per month over the preceding six months, and have no history of delay in making

payments, at the time of presenting an application.

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: Nufarm Ltd

Contact Name:

Job Title:

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

Physical Address:

Phone (office and / or mobile):

Fax:

Email:

1.2. New Zealand agent or consultant (if applicable)

Company Name:

Contact Name:

Job Title:


Physical Address:


Fax:

Email:

1.3. Formal correspondence contact

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

Company Name: As above

Contact Name: As above

Job Title:


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May 2015 EPA0316

Physical Address:


Fax:

Email:

1.4. Invoice contact

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

identified here

Company Name:

Contact Name:

Job Title:


Physical Address:


Fax:

Email:

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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

Grandevo is a biological insecticide for the control of mealybug in grapes. It contains

300g/kg fermentation solids of Chromobacterium subtsugae strain PRAA-1T as a

wettable powder. Not less than 1000 Cabbage Looper Killing Units (CLKU)/mg

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 X 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?

X Yes ☐ No

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

☐ Yes X No

Does the product contain an ingredient originating from an organism (plant, animal, etc)?1

X Yes ☐ No

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

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May 2015 EPA0316

Does the formulated substance contain any nanomaterial?

☐ Yes X No

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): Chromobacterium subtsugae PRAA4-1T, cells and spent

fermentation media

Chemical name (IUPAC): Not applicable

Chemical name (CA): Not applicable

Molecular formula: Not applicable

Structural formula: Not applicable

Manufacturer development codes: MBI-203

CIPAC No: Not applicable

CAS No: Not applicable

EEC No (EINECS or ELINCS): Not applicable

Function:

For plant protection products

☐ Herbicide ☐ Microbial strain ☐ Fungicide

X Insecticide ☐ Semiochemical

(pheromone, attractant,

repellent etc.)

☐ Plant Extracts

☐ Other, eg plant growth regulators (specify):

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

describe the function:

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May 2015 EPA0316

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

Minimum purity of the active ingredient as manufactured: N/A

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 ☐ X ☐ ☐ ☐

Canada ☐ X ☐ ☐ ☐ Submitted to PMRA

Canada in Feb 2015

Europe ☐ X ☐ ☐ ☐

EU dossier submitted to

the Netherlands in Mar

2015

Japan ☐ ☐ ☐ ☐ ☐

New Zealand X ☐ ☐ ☐ ☐

USA ☐ ☐ X ☐ ☐ Registered 2012

Other

jurisdictions

(specify in

comments)

☐ X ☐ ☐ ☐ Mexico, Brazil and South

Africa

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

When restricted or not renewed, explanations should be provided:

3.3. Identity of the formulated substance

Formulated substance name: Grandevo

Manufacturer development codes: MBI-203 DF3

Unique names for public register: Grandevo

Active ingredient(s) and content (g/kg or L and % w/w): 300g/kg/30% (w/w) fermentation solids of

Chromobacterium subtsugae strain PRAA4-1T

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May 2015 EPA0316

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): Dark brown powder

pH: 7.95

Density: 0.36g/ml

Vapour pressure: N/A

Boiling/melting point: N/A

Solubility in water: N/A

Water/Octanol partitioning co-efficient: N/A

3.5. Regulatory status of the formulated substance

Jurisdiction

Regulatory status

Comment* Never

approved Pending Approved Restricted

Not

renewed

Australia ☐ X ☐ ☐ ☐

Canada ☐ X ☐ ☐ ☐ Submitted to PMRA

Canada in Feb 2015

Europe ☐ X ☐ ☐ ☐

EU dossier submitted to

the Netherlands in Mar

2015

Japan ☐ ☐ ☐ ☐ ☐

New Zealand X ☐ ☐ ☐ ☐

USA ☐ ☐ X ☐ ☐ Registered 2012

Other

jurisdictions

(specify in

comments)

☐ X ☐ ☐ ☐ Mexico, Brazil and South

Africa

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

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May 2015 EPA0316

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

Medicines Act?

X 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

Formulation to be submitted directly by the supplier.

4. Life cycle of the substance

Manufacturing

Will your formulated substance be manufactured in New Zealand?

☐ Yes X No

Importation

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

X Sea X Air

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

☐ Bulk Containers X Packaged ready for sale

If your formulated substance will be imported in bulk containers, please describe these containers:

Will repackaging of your formulated substance be carried out in New Zealand?

☐ Yes X No

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

☐ Yes X No

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

substance:

Transport

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May 2015 EPA0316

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

X Road X Sea X Rail ☐ Air

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

Grandevo will be imported into New Zealand primarily by sea. Occasionally it may be

necessary to bring it in by air. After clearance by customs Grandevo will be

transported by truck to a Nufarm Limited warehouse where it will be stored until

dispatched to rural retailers or end users. Transportation between the North and

South Island will be by sea. Transportation to retail stores will be carried out by

specialist chemical transport companies.

UN Number: Not dangerous goods

UN Transport Hazard Classes: N/A

UN Packing Group Number (UN Model Regulations2): N/A

Marine Pollutant? (IMDG Code3): No

Packaging

Pack sizes: 9 or 10kg

Type of packaging: Plastic lined paper or foil bags

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

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:

From the border this product is transported to the warehouse and stored prior to distribution to the

retailers.

The storage area in the warehouse has prominent signage to denote the substances being held.

Product is despatched to retail outlets to be stored on shelves for sale to the commercial end-user.

Warehouse storage

2 UN Model Regulations mean Model Regulations annexed to the most recently revised edition of the Recommendations on the Transport of Dangerous Goods published by the UN 3 IMDG Code means that International Maritime Dangerous Goods code, as amended

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May 2015 EPA0316

Provide details of how the formulated substance will be stored: The storage area in the

warehouse has prominent signage to denote the substances being held.

Containment of spillages: Wear appropriate protective clothing and prevent material from

entering waterways. Contain liquid spills and absorb with inert material. Sweep up

solids without creating dust. Wash area with water and detergent, absorb further inert

material and dispose of waste safely in an approved landfill.

Decontamination of areas, personnel, vehicles and buildings: As above

Disposal

Disposal of damaged packaging, contaminated absorbents and other materials: Dispose of waste

safely in an approved landfill.

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

container is unlikely to be disposed of until empty. Containers should be triple rinsed

and if appropriate recycled through the Agrecovery container recycling scheme.

The product label and Safety Data Sheet (SDS) recommend:

That the substance be disposed of only by using according to the label or at an

approved landfill. Do not burn.

That the packaging is to be disposed of by ensuring the container is completely

empty and triple rinsed. Empty containers can be recycled, otherwise buried in

a landfill.

Further information is supplied in the SDS stating:

TO avoid disposal, all attempt should be made to utilise the product completely in

accordance with it’s registered use. dilute unusable product according to the label and

pour onto fallow land. Prevent the product from entering natural water sources.

Methods other than controlled incineration for disposal: The empty container can be recycled

through the Agrecovery container recycling scheme.

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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)

Metho

d 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

Wine

grapes

Grandev

o/MBI-

203 DF3

F Mealybug WP 300g/kg

Direct

ed

spray

Pre and

post

flowering

1-4 per

croppin

g

season

1 week 0.075-

0.102

300 -

2000

0.3-

1.5kg

as/ha

Nil

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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)


treatment

PHI

(days)

(l)

Remarks

(m)

Type

(d-f)

Conc of

as

(i)

Metho

d 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

Greenhou

se fruiting

vegetable

s

Grandev

o/MBI-

203 DF3

G

Whiteflies,

army worm,

loopers,

tomato

fruitworm,

aphids,

mites,

psyllids,

thrips

WP 300g/kg Foliar

spray

All growth

stages as

required

according

to

presence

of pests

All year

round

1-4 per

croppin

g

season

7 days 0.075-

0.102

300-

4000

0.225

4.0

Nil

Citrus Whitefly WP 300g/kg Foliar

spray

As

required

1-6 per

croppin

7-14 days 0.075-

0.102

500-

3000

0.375-

3.06

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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)


treatment

PHI

(days)

(l)

Remarks

(m)

Type

(d-f)

Conc of

as

(i)

Metho

d 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

g

season

* This will vary by target area (eg bunchline spraying or full canopy), canopy density and row spacings

(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the

use situation should be described (eg fumigation of a structure)

(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)

(c) eg biting and suckling insects, soil born insects, foliar fungi, weeds

(d) eg wettable powder (WP), emulsifiable concentrate (EC), granule (GR)

(e) GCPF Codes - GIFAP Technical Monograph No 2, 1989

(f) All abbreviations used must be explained

(g) Method, eg high volume spraying, low volume spraying, spreading, dusting, drench

(h) Kind, eg overall, broadcast, aerial spraying, row, individual plant, between the plants -

type of equipment used must be described

(i) g/kg or g/l

(j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997,

Blackwell, ISBN 3-8263-3152-4), including where relevant, season at time of application

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

use must be provided

(l) PHI - minimum pre-harvest interval

(m) Remarks may include: extent of use, economic importance and restrictions

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

paints or fumigants)

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May 2015 EPA0316

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

User

(a)

Area of Use

(b)

Pest or group of

pests controlled

(c)

Application

Application rate per

treatment

(f)

Remarks

(g)

Method

(d)

Number

min max

(e)

Interval between

applications - days

(minimum)

(a) Professional/non professional

(b) Domestic/commercial/industrial

(c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds

(d) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench

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

must be provided

(f) g/kg and g/l or others

(g) Remarks may include; extent of use, economic importance and restrictions

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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.

Hazard Class/Subclass

Formulated

substance

classification

Justification

Examples 3.1C

6.1D

Flashpoint = 46 deg C (closed cup)

Calculated LD50 = 1250 mg/kg (mixture

rules)

Class 1 Explosiveness N/A Grandevo has no ingredients with

explosive properties

Class 2, 3 & 4 Flammability N/A Grandevo has no ingredients with

flammable properties

Class 5 Oxidisers/Organic Peroxides N/A Grandevo has no ingredients with

oxidising properties

Subclass 8.1 Metallic corrosiveness N/A Grandevo has no ingredients which

exhibit corrosiveness to metal

Subclass 6.1 Acute toxicity (oral) No Acute oral LD50>5000mg/kg bw in

female rats

Subclass 6.1Acute toxicity (dermal) No Acute dermal LD50>5050mg/kg bw

in rats

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

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

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May 2015 EPA0316

Subclass 6.1 Acute toxicity (inhalation) No Acute inhalation LC50 >5.11mg/L in

rats

Subclass 6.1 Aspiration hazard N/A Not applicable (not a liquid)

Subclass 6.3/8.2 Skin irritancy/corrosion No Non irritating (Toxicity Category IV)

Subclass 6.4/8.3 Eye irritancy/corrosion No

Mean scores for conjunctival

erythema/redness and conjunctival

chemosis were below 2 therefore

does not require classification as an

eye irritant under the Hazardous

Substance Classification Regulations.

Subclass 6.5A Respiratory sensitisation ND Not an OECD registration

requirement for microbial pesticides

Subclass 6.5B Contact sensitisation No

None of the ingredients in the

formulation are classified as skin

sensitisers

Subclass 6.6 Mutagenicity No

The genotoxicity of the heat-killed

sterile active substance was

assessed in studies of bacterial

mutagenicity, mammalian cell

mutagenicity and mammalian cell

clastogenicity in vitro. No evidence

of mutagenicity or clastogenicity was

seen in these studies. There is no

evidence of mutagenicity with the

other ingredients

Subclass 6.7 Carcinogenicity N/A Not an OECD registration

requirement for microbial pesticides.

Subclass 6.8 Reproductive or developmental

toxicity N/A

Not an OECD registration


Testing not required by US EPA if no

significant infectivity, toxicity or

pathogenicity observed.


toxicity (known, presumed or suspected) N/A




toxicity (via lactation) N/A



Subclass 6.9 Target organ systemic toxicity4 N/A

No an OECD registration


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

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May 2015 EPA0316

Published literature data do not

indicate any adverse effects

associated with exposure to

Chromobacterium subtsugae.

Routine monitoring of workers

involved in the manufacture and

formulation of the product and in

product application has not revealed

any adverse effects resulting from

exposure. Target organ toxicity is

considered unlikely.

Subclass 9.1 Aquatic ecotoxicity 9.1D

Multiple tests were conducted on

various fish species with no toxicity

observed. The acute toxicity test

gave an LC50 result of >100mg/L

for rainbow trout.

The acute toxicity test for Daphnia

magna gave a 48hr EC50 result of

17.8mg/L.

The algal growth rate test gave a

72hr EC50 result of 88.1mg/L

The 9.1D classification is based on

the crustacean and algae EC50

results.

Subclass 9.2 Soil ecotoxicity No Juvenile earthworm EC50>

100mg/kg

Subclass 9.3 Terrestrial vertebrate ecotoxicity No

Avian oral pathogenicity and toxicity

study in Northern bobwhite using

the TGAI only showed no evidence

of pathogenicity or treatment related

effects on body weight or feed

consumption. The no observed

effect dosage was approx. 4.0x1011

CFU/kg bw per day for 5 days. It is

expected that this test represents

the worst-case toxicity scenario so

no further studies with the

formulated product were considered

necessary. The data for rats

supports this assumption.

Subclass 9.4 Terrestrial invertebrate

ecotoxicity No

Contact and oral 48hr LD50 values

estimated to be >100µg a.s./bee

This proposed classification of Grandevo is based on studies of both the active ingredient Chromobacterium subtsugae and the finished product generated for the registration of Grandevo in the EU and USA. A worksheet showing more detailed rationale behind this classification is provided in the confidential appendices.

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A summary of the reports used in classifying the product as well as the reports themselves are provided in the confidential appendices.

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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, Costs and Benefits The risks associated with the different stages of the lifecycle of the product are identified in the table below:

Lifecycle stage Risk

Manufacturing and Packaging

Not applicable as manufacturing will not take place in New Zealand.

Transport An incident leading to spillage of Grandevo could occur during the transportation of the product. This could lead to human and environmental exposure.

Storage

An incident leading to spillage of Grandevo could occur during the storage of the product. This could lead to human exposure. Environmental exposure is unlikely as storage areas would be bunded.

Use

Incidents leading to human and environmental exposure to the product are most likely to occur at the use stage from spillage of the wettable powder or diluted product and spray drift of the diluted product.

Disposal Disposal of the product or packaging could result in limited human and environmental exposure.

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Identification of Costs No new or additional costs are likely to be associated with this product as there are already similar agrichemicals in use with the same use patterns. The costs associated with the risks identified above are primarily related to clean up of spills. As per the label, medical advice should be sought if product is swallowed or if eye contact occurs. Relevant medical costs would apply. Identification of Benefits:

Addition of a novel bio-insecticide to the New Zealand market

Will fill a gap in the current insect control options for wine growers

A new bioinsecticide for organic growers

Reduced reliance on older synthetic chemistry

Resistance Management Tool

Financial benefits to growers and the economy

Low toxicity risk

Low ecotoxicity risk

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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.

RISKS AND COSTS - ASSESSMENT

The potentially significant risks and costs with toxic hazardous properties and the possible adverse effects on human health and the environment have been considered. Human Health Risks: Grandevo has been assessed as having no human health risks. Studies show low toxicity by the oral, dermal and inhalation routes, and it was not a skin irritant or skin sensitiser. Mild eye irritation was observed however the irritation was transient and not significant enough to trigger classification as an eye irritant. There is no evidence of genotoxicity in in vitro studies conducted with the active substance. Published literature data do not indicate any adverse effects associated with exposure to Chromobacterium subtsugae. Routine monitoring of workers involved the manufacture and formulation of the product and from product application has not revealed any adverse effects resulting from exposure. Based on the active substance data, classification of the co-formulants published literature data and routine monitoring of workers exposed to the product, Grandevo is not classified for chronic health effects. While the active substance is defined as spent culture medium containing the bacteria, the formulation process of the product involves a step which kills the bacteria. The product Grandevo therefore does not contain viable bacterial cells. Additional studies have been conducted to investigate the potential for infection/pathogenicity and the potential for skin and respiratory sensitisation. These studies show that Chromobacterium subtsugae PRAAT-1T does not have any potential for effects following inhalation, intravenous and subcutaneous exposure. Based on the available data is it concluded that the product does not trigger any of the HSNO toxicity classifications. Despite the low level of toxicity, in common with other products containing biological material, the label and SDS will require people handling the product to wear appropriate protective equipment such as eye protection, waterproof gloves, boots, hat and cotton overalls when dealing with spillage and during use. Further information on human health risks is given in the confidential appendices. Biological and Physical Environment Risks:

Grandevo triggers the following HSNO classification:

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9.1D – toxic to aquatic organisms. The potentially significant risks to the environment would relate to the contamination of:

Water. This may occur from spillage into drains and waterways, spray drift or run-off from any washings as a result of cleaning up/containment of any spillage.

Transportation: A transport accident resulting in the spillage of this particular substance is considered improbable. The possibility of adverse environmental effects occurring as a result of any spillage is very unlikely if the proposed controls are in place. Drivers and emergency workers attending the spill should be trained in emergency management procedures to contain a spill and prevent it from reaching sensitive environments eg waterways. The magnitude of any effect is considered to be minimal as any effects will be acute and localised and the size of the individual containers will limit the amount released (assuming not all packages are damaged). The resultant risk is thus considered insignificant.

Storage: As above, a spillage in the storage facility is considered unlikely. Storage facilities will be bunded and warehouse staff attending the spill should be trained in emergency management procedures to contain a spill and prevent it from reaching sensitive environments eg waterways. Relevant HSNO controls should ensure that any effects of any spillage from storage facilities are minimal. The resultant risk is thus considered insignificant.

Use: Grandevo is a bio-insecticide for use in vineyards. It consists of non-viable bacteria and spent culture medium. It will be applied as a directed spray in sufficient water to get good penetration of the canopy and coverage of the trunk, branches, leaves and bunches of grapevines. Worker Exposure: Any worker exposure would be through contact with the wettable powder due to incorrect mixing practices (ie not wearing gloves and eye protection) or spray drift during application. Bystander Exposure: Bystander exposure is only likely to occur from spray drift. For the active substance Chromobacterium subtsugae PRAAT-1T, violacein is used as a marker compound and has shown activity against target species. Violacein-producing bacteria are known to be environmentally ubiquitous and has been isolated from soil, water and various edible crop species. Environmental levels of violacein resulting from the proposed use of Grandevo are shown to be minimal compared to the naturally occurring background levels. Based on this it can be concluded that there is a natural background level of exposure for operators, bystanders and workers. Data which clearly demonstrate the low toxicity of Grandevo, coupled with evidence of this natural background level of exposure to violacein do not raise any concerns for operator, bystander or worker safety. The resultant risk is thus considered insignificant. Based on the low acute toxicity of Grandevo, the risk to operators, bystanders and workers from the proposed use is considered to be acceptable if the product is used in accordance with labelling instructions. Environmental Exposure: Environmental exposure could occur through spillages during preparation of the spray mix or from spray drift. Users should be trained in emergency management procedures to contain a spill and prevent the product from entering sensitive environments such as waterways. The magnitude of any effect is considered to be minimal as any effects would be acute and localised and the size of the

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individual containers will limit the amount released. The resultant risk is thus considered insignificant. Application of Grandevo on commercial properties will be by directed spray application equipment. It is recognised that spray drift can occur but it is also noted that Grandevo is diluted prior to use. At this level of dilution it is expected that the magnitude of any effects on aquatic species in nearby ditches and drains due to spray drift or run off would be minimal due to the small quantities of active being applied over a hectare. The low aquatic toxicity of Grandevo and the natural background level of Chromobacterium already present in the environment indicates that the use of the product poses an insignificant risk to aquatic organisms when Grandevo is used in accordance with GAP. Disposal: Situations where there is a need to dispose of Grandevo could occur following spillage during transport, storage or end use. The need to dispose of a significant amount of the substance, such as through a major spill, is considered very unlikely.

Situations may arise where the end user needs to dispose of old or surplus stock. This can be done via a specialised chemical disposal company such as Agrecovery.

The key HSNO default controls in preventing/managing disposal related risks are the disposal controls, describing how the substance should be safely disposed of (SDS and labelling recommendations), the ecotoxic property controls, the identification controls and emergency management controls.

With these controls in place, it is considered unlikely that the disposal of Grandevo would result in adverse effects to the environment. In the event of an exposure, the magnitude of effect is considered to be minimal as the effects will be acute and localised due to the likely small volumes involved. The resultant risk is thus considered insignificant. Any incorrect disposal has the potential to cause adverse environmental risks. The assessment of the risks to the environment after HSNO controls are imposed are summarised in the table below.

Assessment of Environmental Risks with controls in place

Lifecycle stage

Event Potential effect

Likelihood of Adverse

Effects

Magnitude Risk

Transport

Accident during transport and handling - on ship, at port, in land vehicle, to and from storage.

Death of aquatic organisms

Unlikely Minimal Insignificant

Storage Spillage


Very unlikely Minimal Insignificant

Use Spillage when opening container, measuring and pouring into spray tank



Run off from the active ingredients entering waterways after application.



Disposal Inappropriate disposal



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Further information on the environmental effects of Grandevo is given in the confidential appendices. Biological and Physical Environment Costs: The costs associated with the risks identified above are primarily related to clean up of spills. Users would incur costs for the materials used to contain the spills and the disposal costs. As per the label, medical advice should be sought if product is swallowed or if eye contact occurs. Relevant medical costs would apply. Costs incurred due to lost time injuries are unlikely to the low toxicity of the product. None of these costs would be different or greater than costs associated with similar agrichemicals already in use. Overall the risks and costs to the biological and physical environment arising from the import and use of Grandevo are considered to be insignificant.

BENEFITS - ASSESSMENT

Benefit Explanation

Addition of a novel new bio-insecticide to the New Zealand market

The introduction of the new bioinsecticide Grandevo will give growers more choice in insect control options, particularly close to harvest. Other than the organophosphate insecticide chlorpyriphos (which requires specific approval from the Sustainable Winegrowers NZ National Co-ordinator), no conventional insecticides are registered for the control of mealybug after the start of flowering. Due to it’s nil withholding period, Grandevo can be applied post flowering between capfall and pre-bunch closure.

Insect control

Mealybugs are a major pest in New Zealand vineyards and are the main vector of leafroll 3 virus. This incurable disease reduces the lifespan of grapevines and reduces fruit quality and yield. Mealybugs can have 2-3 generations per season and numbers can increase significantly from bunch closure. Grandevo will fit well into spray programmes to control mealybug during this crucial time when limited chemical options are available.

New bioinsecticide for organic growers

Organic wine growers have no organic certified products

registered to control mealybug other than mineral oils. The

introduction of Grandevo will add another option and help

improve crop yield.

Reduced reliance on older synthetic chemistry

The availability of a new bioinsecticide such as Grandevo will reduce reliance on the older more hazardous chemical chlorpyrifos after the start of flowering.

Resistance Management

The introduction of this new bioinsecticide will offer growers another option for resistance management. The active ingredient has never been used for insect control in New Zealand therefore Grandevo will be a valuable resistance management tool for growers.

Financial benefits to growers and the economy

Use of Grandevo will result in reduced crop losses and damage due to mealybug and the virus it spreads and will

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increase yields for growers which will have flow on effects for the New Zealand economy.

Low toxicity Grandevo poses no significant risks to human health and will be safer for growers and spray contractors to apply than the synthetic chemical options currently available.

Low ecotoxicity risk

Grandevo poses a low ecotoxicity threat as the product is

based on a dead cells of a microbe already present in the

soil. Studies have shown no adverse effects to fish, soil

organisms, terrestrial vertebrates and invertebrates and

only minor effects on crustaceans and algae which can be

adequately managed with label controls.

Effects on aquatic species in nearby ditches and drains

due to run off is expected to be minimal as the use rate of

the product is unlikely to result in concentrations high

enough to cause damage to aquatic crustaceans and

algae.

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.

Grandevo is a wettable powder bioinsecticide containing dead cells, metabolites and fermentation solids of the bacterium Chromobacterium subtsugae strain PRAA4-1T. This bacteria is already present in New Zealand and is commonly found in soil and water. It is intended for use in wine grapes for the control of mealybug. Grandevo will be applied as a directed spray in sufficient water to get good penetration of the canopy and coverage of the trunk, branches, leaves and bunches. The proposed HSNO classification is 9.1D (harmful to aquatic crustacea and algae). Studies have shown Grandevo to have low acute toxicity to human health. Studies have shown Grandevo to be safe to birds, fish and plants. Studies on Daphnia magna and algal growth indicated a low toxicity profile. Risks to valued species such as watercress have been considered and these will be negligible as Grandevo has no negative effects on plants and has a nil withholding period. Risks to native species such as birds, fish, and plants have been considered and these will be negligible. Risks to waterways have been considered and these will be negligible as the only likely affect is to be to aquatic crustacea and algae and only at rates much higher than the proposed application rate.

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An assessment of the risks and costs to human health and the biological and physical environment associated with Grandevo has determined that they are considered to be insignificant. The main benefits from the introduction of Grandevo are that it will provide growers with a unique, non-toxic new bioinsecticide and offer more choice in insect control options particularly close to harvest. Use of the product will result in increased yields in wine grapes which will have flow on effects to the New Zealand economy. The introduction of Grandevo also gives growers a safer bioinsecticide option to the synthetic chemicals currently relied on. This will benefit spray application staff as the health risks are much lower than with current chemical options. These benefits will benefit Maori growers and the wider community. Overall is it considered that the benefits derived from the introduction of Grandevo will outweigh any risks and we remain confident that any potential effects are unlikely to be significant to the outcomes of importance to Māori. The EPA policy – Engaging with Māori for Applications to the EPA notes that it is appropriate for applicants to engage with Māori for any application to be processed by the EPA that poses a significant impact (either positively or negatively) on outcomes of importance to Māori. The policy also notes that only Māori can determine whether an impact is significant to them or not. After undertaking our own assessment of the potential adverse and beneficial effects posed by this substance we asked the EPA to distribute an overview of this substance to its database of Māori resource managers for their comments. We received the following feedback from Pirirakau, a hapū of Ngati Ranginui Iwi in Tauranga Moana: Our hapū rohe (tribal area), is positioned amidst a highly productive agricultural and horticultural area. Our hapū rohe boundaries include two rivers, the Wairoa and Waipapa, the Kaimai ridge and the Tauranga inner harbour. As we are zoned rural our runoff and outfall to the harbour as the receiving environment lacks filtration systems. We are majorly concerned with agrichemical runoff which is difficult to manage as it is permitted for application without resource consent as opposed to point source discharge which is easier to manage. Our kaimoana (seafood) resources are depleting at a rapid rate and though we cannot determine that any individual agrichemical application contributes to the diminished ability to gather kaimoana which decreases our ability to exercise manaakitanga (providing care), although we are certain we can attribute the runoff of multiple agrichemical applications and their cumulative effects of runoff and drift to the detriment of our resources. We ask the applicant to consider and the EPA in their determinations of the proposed product Grandevo that the following be taken into account. The product label and information purports that it is harmful to aquatic environments. As a precautionary condition a buffer zone be applied and that the target application be permitted within an appropriate and substantial distance to any waterway or coastal area of New Zealand and/or any drain system or stormwater management outfall/outlet or leached to groundwater in proximity to these environs. This condition will prevent agrichemical trespass to aquatic environments. As kaitiaki (guardians) we must lead and take a strong position on appropriately managing the continual demands of land use practices which threaten our culture, our taonga (natural resources), water and its mauri (life supporting capacity) as agreed by the Crown and Tangata Māori through Article 2 of the Treaty of Waitangi to ensure the natural world is sustainably managed for future generations. In response to the concerns raised, we believe the risk to aquatic environments can be adequately managed without the use of buffer zones. Grandevo poses a low ecotoxicity threat as the product is based on the dead cells of a microbe. Studies have shown no adverse effects to fish, soil organisms, terrestrial vertebrates and invertebrates and only minor effects on crustaceans and algae which can be adequately managed with label controls.

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Effects on aquatic species in nearby ditches and drains due to run off is expected to be highly unlikely. Grandevo is applied as a directed spray to grapevines and the use rate of the product is unlikely to result in concentrations high enough to cause damage to aquatic crustaceans and algae. In a ready biodegradability study (provided in the confidential appendices) the active substance and product were shown to be inherently biodegradable with rapid degradation in the first few days. This indicates that the active components and any breakdown products are expected to be rapidly broken down in the environment and will not persist in the soil in any form. The non-degraded portion is likely to be the co-formulants which are inert and of no risk to the environment. The likelihood of enough product leaching into the groundwater to cause damage in the aquatic environment is unlikely.

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

international obligations

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

international obligations

There are no known international obligations that will be affected by this application

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

The default controls for Grandevo based on the proposed HSNO Classification are as follows:

Control Type Control

Ecotoxicity E1, E2, E6

Identification I1, I9, I11, I19, I21, I29

Packaging P1, P3, PS4

Disposal D5, D6, D7, D8

Emergency Management EM1, EM7, EM8, EM11, EM12, EM13

The product label has been written to take into account the relevant controls and precautions. The

relevant statements are below:

Grandevo

HAZARD CLASSIFICATION

9.1D

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This product must not be used for any purpose, or in any manner, contrary to this label unless authorised under appropriate legislation.

ECOTOXIC

Harmful to aquatic organisms. Avoid contamination of any water supply with product or empty container.

HANDLING PRECAUTIONS

STORAGE

Keep out of reach of children. Store in original container tightly closed and in a locked, dry, cool area away from foodstuffs. Storage must be in accordance with NZS 8409 Management of Agrichemicals.

Stores containing 10 000kg of Grandevo require signage and more than 10 000kg require emergency response plans.

PERSONAL PROTECTION

Avoid skin or eye contact and inhalation of spray mist. When handling wear eye protection, waterproof gloves, boots, hat and cotton overalls. Do not eat, drink or smoke while using. Remove protective clothing and wash hands and face thoroughly before meals and after work.

EQUIPMENT

Apply with well-maintained and calibrated equipment. DISPOSAL

Triple rinse empty container and add rinsate to the spray tank. Recycle empty container, otherwise crush and bury in a suitable landfill.

Dispose of product only by using according to the label, or at an appropriate landfill.

First Aid: If swallowed do NOT induce vomiting. For advice contact the National Poisons Centre 0800 POISON (0800 764 766) or a doctor immediately. If skin or hair contact occurs, remove contaminated clothing and flush skin and hair with running water. If splashed in eyes, flush with running water immediately for at least 15 minutes. If inhaled move the victim to fresh air immediately. Begin artificial respiration if breathing has stopped. Spillage: Wear appropriate protective clothing and prevent material from entering waterways. Contain liquid spills and absorb with inert material. Sweep up solids without creating dust. Wash area with water and detergent, absorb with further inert material and dispose of waste safely in an approved landfill.

The default controls will be managed using the following reference publications: Codes of Practice:

Product Labelling and Documentation Code for Agricultural Compounds & Veterinary Medicines (HSNO approval code HSNOCOP 9 Version 2.0) Agcarm.

Signage for Premises Storing Hazardous Substances and Dangerous Goods (HSNO CoP 2-1 09-04), NZCIC.

Preparation of Safety Data Sheets (ACoP SDS), NZCIC NZ Standards:

NZS 8409:2004: Management of Agrichemicals

NZS 5433:2012: Transport of Dangerous Goods on Land

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Other References:

United Nations Recommendations on the Transport of Dangerous Goods – Model Regulations

Land Transport Rule, Dangerous Goods 2005 Rule 45001/1

IMDG Code: International Maritime Dangerous Goods Code, 2008 Edition

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 of Grandevo have been identified and assessed in sections 7.2, 7.3 and

7.4. The risks to human health and the biological and physical environment, including Maori culture

and their relationship with the environment can be adequately managed through the controls that will

be put in place. The conclusion of this application is that the significant benefits of introducing

Grandevo 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

X 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.

X Yes ☐ No

Supplementary optional information attached:

Copies of additional references X Yes ☐ No Refer to confidential

appendices

Letter(s) of access ☐ Yes X No

Relevant correspondence ☐ Yes X No

Draft label X Yes ☐ No

Draft Safety Data Sheet (SDS) X Yes ☐ No

Administration

Are you an approved EPA customer? X Yes ☐ No

If yes are you an:

Applicant: ☐

Agent: ☐

If you are not an approved customer,

payment of fee will be by:

Direct credit made to the EPA bank

account (preferred method of payment)

Date of direct credit:

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

X Yes

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Physical copy of signed statutory

declaration sent to the EPA, (rapid

assessment only)

☐ Yes

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

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

organisation.

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

information I have provided in this application form is correct.

22 August 2017

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:

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