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April 2014 EPA0316
Completing this application form
1. This form has been approved under section 28 of the Hazardous Substances and New Organisms
(HSNO) Act 1996. It only covers the import or manufacture of pesticides to be released in New
Zealand under section 28 of the HSNO Act. If you wish to make an application for another type of
substance (such as a veterinary medicine or industrial chemical) or for another type of application
(such as emergency, special emergency or containment), a different form will have to be used. All
forms are available on our website.
2. It is recommended that you contact an Applications Advisor at the Environmental Protection
Authority (EPA) as early in the application process as possible. An Applications Advisor can assist
you with any questions you have during the preparation of your application including advising on
any consultation requirements.
3. Before submitting this application, you may make an informal Status of Substance (SOS) advice
request to the EPA. Further information on this process is available on our website. Please note
that this is not mandatory and an SOS request is only informal advice.
4. This application form may be used to seek approvals for more than one hazardous substance, if
the substances and their uses are of a similar nature.
5. Please make sure that you obtain all appropriate permissions for the use of any data that you
have used or provided in this application form, if you are not the owner of such data.
6. Unless otherwise indicated, all sections of this form must be completed for the application to be
formally received and assessed. If a section is not relevant to your application, please provide a
comprehensive explanation why this does not apply. If you choose not to provide the specific
information, you will need to apply for a waiver under section 59(3)(a)(ii) of the HSNO Act. This
can be done by completing the section on the last page of this form.
7. Any extra material that does not fit in the application form must be clearly labelled, cross-
referenced, and included with the application form when it is submitted.
8. Please add extra rows or tables where needed.
9. You must sign the form (the EPA will accept electronically signed forms) and enclose the
application fee (including GST) unless you are already an approved EPA customer. To be
recognised by the EPA as an “Approved customer”, you must have submitted more than one
application per month over the preceding six months, and have no history of delay in making
payments, at the time of presenting an application.
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.
April 2014 EPA0316
Commercially sensitive information
12. Commercially sensitive information must be put in a confidential appendix to this form (also
available on our website) and be identified as confidential. If you consider any information to be
commercially sensitive, please show this in the relevant section of this form and cross reference to
where that information is located in the confidential section.
13. Any information you supply to the EPA prior to formal lodgement of your application will not be
publicly released. Following formal lodgement of your application any information in the body of
this application form and any non-confidential appendices will become publicly available.
14. Once you have formally lodged your application with the EPA, any information you have supplied
to the EPA about your application is subject to the Official Information Act 1982 (OIA). If a request
is made for the release of information that you consider to be confidential, your view will be
considered in a manner consistent with the OIA and with section 57 of the HSNO Act. You may be
required to provide further justification for your claim of confidentiality.
Definitions
Active ingredient Component of a formulated substance responsible for the pesticidal effect
CAS Number Chemical Abstracts Service number. This is a unique identifier for a chemical
substance
CIPAC Number Collaborative International Pesticides Analytical Council. The CIPAC code
number system is a simple approach for an unambiguous coding of active
ingredients and variants used in the area/field of pesticides
Hazardous substance
Any substance with one or more of the following intrinsic properties:
Explosiveness
Flammability
A capacity to oxidise
Corrosiveness
Toxicity (including chronic toxicity)
Ecotoxicity, with or without bioaccumulation, or
which on contact with air or water (other than air or water where the
temperature or pressure has been artificially increased or decreased)
generates a substance with any one or more of the properties specified in this
definition
EINECS European INventory of Existing Commercial chemical Substances
ELINCS European List of Notified Chemical Substances
IUPAC International Union of Pure and Applied Chemistry. The world authority on
chemical nomenclature
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
April 2014 EPA0316
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)
April 2014 EPA0316
1. Applicant details
1.1. Applicant
Company Name: Kaken Pharmaceutical Co., Ltd.
Contact Name: Kenichiro Takei
Job Title: Director & General Manager, Agrochemicals & Animal Health Products,
Planning & Coordination Department
Postal Address (provide only if not the same as the physical): the same as the physical
Physical Address: 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo 113-8650, Japan
Phone (office and / or mobile): +81 3 5977 5032
Fax: +81 3 5977 5136
Email: [email protected]
1.2. New Zealand agent or consultant (if applicable)
Company Name: Eurofins Agroscience Services Pty Ltd
Contact Name: Kathryn Adams
Job Title: Regulatory Leader
Postal Address (provide only if not the same as the physical): 50 Leewood Drive (PO Box 972) Orange
NSW 2800 Australia
Physical Address: 50 Leewood Drive, Orange NSW 2800, Australia
Phone (office and / or mobile): +61 2 6362 4539
Fax: +61 2 6362 7844
Email: [email protected]
1.3. Formal correspondence contact
All formal correspondence will be sent to the contact person for the application identified here
Company Name: Eurofins Agroscience Services Pty Ltd
Contact Name: Kathryn Adams
April 2014 EPA0316
Job Title: Regulatory Leader
Postal Address (provide only if not the same as the physical): 50 Leewood Drive (PO Box 972) Orange
NSW 2800 Australia
Physical Address: 50 Leewood Drive, Orange NSW 2800, Australia
Phone (office and / or mobile): +61 2 6362 4539
Fax: +61 2 6362 7844
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
Company Name:
Contact Name:
Job Title:
Postal Address (provide only if not the same as the physical):
Physical Address:
Phone (office and / or mobile):
Fax:
Email:
April 2014 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
This application is to seek approval to import ESTEEMTM (POLYOXIN D ZINC SALT 5SC
FUNGICIDE), containing 5% w/w Polyoxin D zinc salt in the form of supension
concentrate for disease control in apples and grapes.
The formulation will be imported from Japan in bulk containers, repacked and relabeled
in New Zealand for retail distribution.
The formulation has the hazardous classification of 6.3B. The use of protective clothing
will minimize any adverse effects to the skin.
Polyoxin D zinc salt and it formulations have been widely used in many countries over
several dacades. It has a non-toxic, fungal-specific mode of action, which acts against
fungi by inhibiting chitin growth in the cell walls. This unique mode of action will make it
a very useful and sustainable product for combatting diseases in food crops.
Polyoxin D zinc salt is produced using a naturally occurring microorganism, and is
classified as a biochemical pesticide in the U.S.A. It rapidly degrades in the environment.
In addition, several confirmatory studies, its non-toxic mode of action, and the long-term
use history demonstrate the low risk to human health and the environment. This resulted
in establishing a tolerance exemption for all food commodities, and approval of the post-
harvest use in the U.S.A.
2.2. Type of application
Tick the box(es) that best describe your application
Has ‘Status of Substance (SOS) Advice’ been obtained from the EPA?
☐ Yes ☒ No
If yes, show the SOS reference number:
If yes, is the formulation of the substance different to that submitted at the SOS stage?
(In either case, please provide the composition as part of the confidential appendix)
Apri
☐ Yes
Is the pro
☒ Yes
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☐ Yes
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il 2014 EPA03
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April 2014 EPA0316
Manufacturer development codes: PSB
CIPAC No: not yet allocated
CAS No: 146659-78-1
EEC No (EINECS or ELINCS): not yet allocated
Function: fungicide
For plant protection products
☐ Herbicide ☐ Microbial strain ☒ Fungicide
☐ Insecticide ☐ Semiochemical
(pheromone, attractant,
repellent etc.)
☐ Plant Extracts
☐ Other, eg plant growth regulators (specify):
For timber treatments, Vertebrate Toxic Agents (VTA), anti-fouling paints or fumigants, please
describe the function:
FAO Specification (including year of publication): ☐ Yes Year: ☐ No
Minimum purity of the active ingredient as manufactured (g/kg): Please see the attached
Confidential Appendix EPA0319.
Note: Any impurities must be specified in the confidential appendix.
3.2. Regulatory status of the active ingredient(s)
Jurisdiction
Regulatory status
Comment* Never
approvedPending Approved Restricted
Not
renewed
Australia ☐ ☐ ☐ ☐ ☐
Canada ☐ ☒ ☐ ☐ ☐
Submitted an application for Import MRL in Sept 2014 as non-conventional pesticide.
Europe ☐ ☐ ☐ ☐ ☐
Japan ☐ ☐ ☒ ☐ ☐ For over 40years
April 2014 EPA0316
New Zealand ☐ ☐ ☐ ☐ ☐
USA ☐ ☐ ☒ ☐ ☐
EPA Reg Number: 68173-1
For over 16years.
Classified as biochemical pesticide.
Tolerance exemption has been established.
Post-harvest use has been approved.
Other
jurisdictions
(specify in
comments)
☐ ☐ ☒ ☐ ☐
Taiwan for over 28 years
Korea for over 24 years
Mexico for over 6 year
Tolerance exemption has been established in these countries.
*For instance, specify here under which regulation(s) or directive(s).
When restricted or not renewed, explanations should be provided:
ESTEEMTM
3.3. Identity of the formulated substance
Formulated substance name: POLYOXIN D ZINC SALT 5SC FUNGICIDE
Manufacturer development codes: KPP-209SC
Unique names for public register: ESTEEMTM
Active ingredient(s) and content (g/kg or L and % w/w):
Polyoxin D zinc salt, 50 a.i. g/kg, 5.0 % (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 or form): Dark Brown Liquid
pH: 7.01 (25°C, 1% aqueous mixture)
Density: 1.05 (22°C)
Vapour pressure: Please see Confidential Appendix [2.09W TGAI].
Boiling/melting point: Please see Confidential Appendix [2.01 TGAI].
April 2014 EPA0316
Solubility in water: Please see Confidential Appendix [2.01 TGAI].
Water/octanol partitioning co-efficient: Please see Confidential Appendix [2.09W TGAI].
3.5. Regulatory status of the formulated substance
Jurisdiction
Regulatory status
Comment* Never
approvedPending Approved Restricted
Not
renewed
Australia ☐ ☐ ☐ ☐ ☐
Canada ☐ ☒ ☐ ☐ ☐
Submitted an application for Import MRL in Aug 2014 as non-conventional pesticide.
Europe ☐ ☐ ☐ ☐ ☐
Japan ☐ ☐ ☐ ☐ ☐
New Zealand ☐ ☐ ☐ ☐ ☐
USA ☐ ☐ ☒ ☐ ☐
EPA Registration Number:68173-4
(For post-harvest use:
68173-5)
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 MPI has assigned “Reg Number P009155” for the
anticipated application for ACVM registration.
3.6. Composition details of the formulated substance
Full composition details for the substance must be provided in the confidential appendix
Please see the attached confidential appendix [1.2 5SC] (5SC Confidential Statement of Formula).
April 2014 EPA0316
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:
The formulated substance will be imported into New Zealand in 200 to 1000 litre bulk containers.
Will repackaging of your formulated substance be carried out in New Zealand?
☒ Yes ☐ No
Will relabelling of your formulated product be carried out in New Zealand?
☒ Yes ☐ No
Please provide any additional relevant information relating to the importation of your formulated
substance:
Not applicable
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:
Not applicable
UN Number: Not regulated
UN Transport Hazard Classes: Not regulated
April 2014 EPA0316
UN Packing Group Number (UN Model Regulations2): Not regulated
Marine Pollutant? (IMDG Code3): Not regulated
Packaging
Pack sizes: 1, 5, 10 and 20 Litres
Type of packaging: UN approved HDPE jerry cans
Type of closure (consider opening size, type of cap, child resistant packaging): Screw type caps
with tamper evident ring seals attached to caps.
Please provide any additional information relating to the packaging of your formulated substance: Not
applicable
Storage
Provide details of how the substance will be stored, and the facilities it will be stored in:
Store in original container, tightly closed and in a dry, cool area away from foodstuffs.
Store in accordance with NZS 8409 Management of Agrichemicals.
Warehouse storage
Provide details of how the formulated substance will be stored: A designated locked store for
pesticidal substances.
Containment of spillages: The warehouse is bunded to contain spillages and has a site
certification program under the HSNO legislation. The spillage is mixed with inert
absorbent material (such as sand, sawdust, earth, vermiculite or other dr inert material).
Spillage to prevented from entering drains, waterways and around local vegetation.
Decontamination of areas, personnel, vehicles and buildings: The use of a detergent and water
to clean contaminated articles or sites. Liquid contaminated waste is contained and
placed in a spill drum within the warehouse.
Disposal
Disposal of damaged packaging, contaminated absorbents and other materials: To be stored in a
sealed receptacle for disposal at an appropriate landfill. The contaminated liquid waste is
also retained for appropriate disposal to the local Council waste dumping facility,
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
April 2014 EPA0316
according to the local Council by-laws.
Detailed instructions for safe disposal of the formulated substance and its packaging: The substance
is retained in its original packaging, sealed, and stored security until completely used.
Methods other than controlled incineration for disposal: Triple rinse empty container and add
rinsate to the spray tank. If recycling, discard cap and deliver clean container to an
Agrecovery depot. Alternatively crush and bury in a suitable landfill. Dispose of product
only by using according to this label, or at an approved disposal facility.
5. Intended uses of the formulated substance The information you provide here will be used by the EPA to assess the risks posed by the substance and the controls assigned to manage these risks. You must outline either all the proposed uses of the product or the worst-case scenario for each application method (considering both the application rate and the frequency). Please use table 5.1 for plant protection products or table 5.2 for all other types of pesticides. Explanatory notes are below each table.
5.1. Intended uses for plant protection products You must outline either all the proposed uses of the product or the worst case scenario for each application method (considering both the application rate and frequency)
Crop
and/or
situation
(a)
Product
Code
F G or
I (b)
Pest or
group of
pests
controlled
(c)
Formulation Application Application rate per treatment
PHI
(days)
(l)
Remarks
(m) Type
(d-f)
Conc of
as
(i)
Method kind
(f-h)
Growth
stage and
season
(j)
Number
min max
(k)
Interval
between
application
s (min)
g as/hL
min max
Water
L/ha
min max
g as/ha
min max
APPLES ESTEEMTM
(POLYOXIN D ZINC SALT 5SC FUNGICIDE
Field Powdery
mildew SC 50 g/kg
LV spray
HV spray
broad cast
BBCH74-
BBCH89 1-6 7-14 days 2.5-5.0
400-
2000 20 -50 0 days
GRAPES Field
Powdery
mildew
Gray mold
SC 50 g/kg
LV spray
HV spray
broad cast
BBCH71-
BBCH89 1-6 7-14 days 2.5-5.0
400-
2000 20 -50 0 days
April 2014 EPA0316
April 2014 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
5.2. Intended use for pesticides not used as plant protection products (eg timber treatments, Vertebrate Toxic Agents (VTA), anti-fouling paints or fumigants)
You must outline either all the proposed uses of the product or the worst case scenario for each application method (considering both the application rate and frequency)
User
(a)
Area of Use
(b)
Pest or group of
pests controlled
(c)
Application
Application rate per
treatment
(f)
Remarks
(g)
Method
(d)
Number
min max
(e)
Interval between
applications - days
(minimum)
April 2014 EPA0316
(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
18
Application Form Approval to import or manufacture a pesticide
April 2014 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)
Polyoxin D Zinc Salt Technical (Technical Grade Active Ingredient)
Class 1 Explosiveness No -
Class 2, 3 & 4 Flammability No -
Class 5 Oxidisers/Organic Peroxides No -
Subclass 8.1 Metallic corrosiveness No -
Subclass 6.1 Acute toxicity (oral) No
Rat LD50 (male) : > 15000 mg/kg bw
Rat LD50 (female) : 10000-15000 mg/kg bw
Subclass 6.1Acute toxicity (dermal) No Rat LD50 (male) : > 2000 mg/kg bw
Rat LD50 (female) : > 2000 mg/kg bw
Subclass 6.1 Acute toxicity (inhalation) 6.1D Rat LC50 (male) : > 2.44mg/L
Rat LC50 (female) : 2.17mg/L
Subclass 6.1 Aspiration hazard No -
April 2014 EPA0316
Subclass 6.3/8.2 Skin irritancy/corrosion 6.3B Slight irritation (Draize)
Subclass 6.4/8.3 Eye irritancy/corrosion 6.4A Slight to moderate irritation (Draize)
Subclass 6.5A Respiratory sensitisation No -
Subclass 6.5B Contact sensitisation No Negative (Mouse LLNA)
Subclass 6.6 Mutagenicity No Negative (Micronucleus test, Ames test)
Subclass 6.7 Carcinogenicity No
Mouse NOEL (male, 24months) :
3591 mg/kg/day
Mouse NOEL (female, 24months) :
4177 mg/kg/day
Rat NOEL (male, 24months) :
2058.7 mg/kg/day
Rat NOEL (female, 24months) :
2469.8 mg/kg/day
Subclass 6.8 Reproductive or developmental toxicity
(Prenatal Developmental Toxicity) No
Rabbit NOEL Foetal : >800mg/kg/day
Rat NOAEL Foetal : 1000mg/kg/day
Subclass 6.8 Reproductive or developmental toxicity
(Reproductive Toxicity) No Rat NOALE : 1% in diet (HDT)
Subclass 6.9 Target organ systemic toxicity4 No -
Subclass 9.1 Aquatic ecotoxicity No Carp LC50 (96hrs) : >100 mg/L
Subclass 9.2 Soil ecotoxicity No Earthworm EC50 :
>1000 mg/kg soil dry weight
Subclass 9.3 Terrestrial vertebrate ecotoxicity No Avian LD50 (acute oral) :
> 2150 mg/kg bw
Subclass 9.4 Terrestrial invertebrate ecotoxicity No Bee LD50 (acute contact) :
> 100 µg / bee
ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) (Formulated substance)
Class 1 Explosiveness No -
Class 2, 3 & 4 Flammability No No flash, sample reached 232°C
Class 5 Oxidisers/Organic Peroxides No Stable at RT to oxidization and reduction
Subclass 8.1 Metallic corrosiveness No -
Subclass 6.1 Acute toxicity (oral) No Rat LD50 : > 5000 mg/kg bw
Subclass 6.1Acute toxicity (dermal) No Rat LD50 : > 5050 mg/kg bw
April 2014 EPA0316
Subclass 6.1 Acute toxicity (inhalation) No Rat LC50 : > 2.20 mg/L
Subclass 6.1 Aspiration hazard No -
Subclass 6.3/8.2 Skin irritancy/corrosion 6.3B Very slight erythema observed at 24hrs after application only. No effects observed at 1hr, 48hrs, and 72hrs.
Subclass 6.4/8.3 Eye irritancy/corrosion No No adverse effect
Subclass 6.5A Respiratory sensitisation No -
Subclass 6.5B Contact sensitisation No -
Subclass 6.6 Mutagenicity No -
Subclass 6.7 Carcinogenicity No -
Subclass 6.8 Reproductive or developmental toxicity No -
Subclass 6.9 Target organ systemic toxicity5 No -
Subclass 9.1 Aquatic ecotoxicity No -
Subclass 9.2 Soil ecotoxicity No No adverse effect (soil microorganisms: N/C transformation test)
Subclass 9.3 Terrestrial vertebrate ecotoxicity No -
Subclass 9.4 Terrestrial invertebrate ecotoxicity No -
1 identify classification for single and/or repeat dose target organ toxicity for oral, dermal or inhalation routes
5 identify classification for single and/or repeat dose target organ toxicity for oral, dermal or inhalation routes
April 2014 EPA0316
7. Risks, costs and benefits
These are the positive and adverse effects referred to in the HSNO Act. It is easier to regard risks and costs as
being adverse (or negative) and benefits as being positive. In considering risks, cost and benefits, it is
important to look at both the likelihood of occurrence (probability) and the potential magnitude of the
consequences, and to look at distribution effects (who bears the costs, benefits and risks).
You will need to consider the effects on the environment and human health and welfare, including any social
effects.
In each section below, set out the information under the following three sub-headings: Costs and benefits which can be stated in monetary (dollar) terms
Non-monetary risks and costs
Non-monetary benefits.
You must fully complete this section, referencing supporting material. You will need to provide a description of
where the information in the application has been sourced from, e.g. from; in-house research, independent
research, technical literature, community or other consultation, and provide that information with this application.
7.1. Identify all of the potential risks, costs and benefits of the substance(s)
Identification is the first step in assessing risks, costs and benefits. It is important to think about the source of the risk, i.e. the way in which the risk is created (the exposure pathway), and then the consequences and likelihood of exposure.
You should try to think as widely as possible about every potential risk, cost and benefit and give a brief description.
ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) provides an opportunity for controlling powdery mildew and gray mold, major diseases of apples and grapes that causes losses throughout the growing season. There are no other products registered in New Zealand which contain the same active ingredient nor to our knowledge the same mode of action.
Powdery mildew and gray mold causes serious problems for many horticultural crops, especially when it covers the leaves of the plant and as a result the plant doesn’t produce fruit which means a reduced return for the grower. The cost of treatment is significantly less than the potential yield loss.
Non-monetary risks and costs
There are few non-monetary risks or costs associated with the use of ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) as a foliar spray application. The main identifiable risk, and this applies to the product as such, is the user of the product who may be exposed to the concentrated product or diluted product. However, as the product has low toxicity, these risks are very low, especially if the user follows the label instructions and uses appropriate safety equipment when handling.
The product will only be used by growers experienced in the handling and application of agricultural pesticides using calibrated equipment designed to deliver accurately to the target plant. This will minimise any environmental impact. Although treated produce will enter the human and animal food chain, this does not present a risk to the purchaser. This is because ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) rapidly degrades in the environment and what is remaining is anticipated practically non-toxic.
There is some risk involved in transport of the product through spills resulting from storage and transport accidents. This risk is diminished by the small pack size being registered (1 to 20 L), its low toxicity and the way the product is packed.
Polyoxin D zinc salt and its formulations has been sold in Japan for over 40 years, the United States (U.S.A.) for more than 16 years, and Taiwan, Korea and Mexico for over 28, 24 and 6 years respectively.
April 2014 EPA0316
The manufacturer has not been presented with or advised of significant non-monetary costs associated with it’s use over that time.
Non-monetary benefits
Polyoxin D zinc salt and its formulations have been widely used as a fungicide for the control of several diseases on a range of horticultural food crops in several countries for many years, and this history supports its well-established efficacy for the disease control based on GAPs.
One of the major benefits is that Polyoxin D zinc salt has a unique, non-toxic, fungal-specific mode of action, which acts against fungi by inhibiting chitin growth in the cell walls. The combination use of unrelated mode of action fungicides will minimise the risk of disease resistance developing and assist in the long term effectiveness of all fungicides.
Another major benefit is its safety over current fungicides for both the environment and human health. Polyoxin D zinc salt is derived from Streptomyces carcaoi var. asoensis, a soil-bone bacterium isolated in Japan. This naturally occurring characteristic and the non-toxic mode of action resulted in classifying it as a biochemical pesticide, which is considered to have low risk to the environment, in the U.S.A. Its safety to the environment is also supported by the long-term international use history, its rapid degradation in the environment, and a number of dedicated ecotoxicology studies.
Furthermore, the toxicity studies, its non-toxic mode of action, and the long-term international use history demonstrate low risk to humans, both applicators and consumers. This resulted in establishing a tolerance exemption for all food commodities and approval of the post-harvest use in the U.S.A.
With the low risk, it will also provide an opportunity for disease control at pre-harvest period in New Zealand, which is still difficult by using current fungicides.
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 benefits
Saving of resources and broad control of diseases presents a significant benefit to the grower. One of the
major benefits is the use of the new active ingredient of a unique mode of action. It will make ESTEEMTM
(POLYOXIN D ZINC SALT 5SC FUNGICIDE) a very useful and sustainable product for combatting diseases in
food crops. Another major benefit is its safety over current fungicides for both human health and the
environment. It will also provide an opportunity for disease control at pre-harvest period in New
Zealand, which is still difficult by using current fungicides.
23
Application Form Approval to import or manufacture a pesticide
April 2014 EPA0316
Assessment of risks to workers (and general public in the case of consuming food treated with the product), with controls in place
Lifecycle
Activity
Associated Source
of Risk
Related hazard /
adverse
experience
Likelihood of adverse experience Significance of adverse event Level of
risk
Transport –
maritime
and land
based
Transport or
handling incident
during importation,
transportation or
loading/unloading,
resulting in spillage
and subsequent
exposure of people
or the environment
6.3B Skin
irritancy/corrosion
Highly improbable: Product will be
transported in compliance with the
appropriate legislation; small pack size:
relatively limited quantity of the substance
being imported.
Minor - storage and transport are the
only routes for an adverse event with
any possibility of significance.
However, it is highly improbable that
any worker would be involved in
transport of the material on a
sufficiently frequent basis and that the
combined necessary event of accident
or spillage would result in exposure.
Insignificant
Storage Incident during
storage at the
importer’s or
retailer’s facilities or
at the end user’s
site resulting in
spillage and
subsequent
exposure of people
or the environment
6.3B Skin
irritancy/corrosion
Highly improbable: Product will be
contained in the measure pack inside a
sealed pouch within a shipper. Significant
force would be required to damage the
packaging.
Minor – storage and transport are the
only routes for an adverse event with
any possibility of significance.
However, it is highly improbable that
any worker would be involved in
transport of the material on a
sufficiently frequent basis and that the
combined necessary event of accident
or spillage would result in exposure.
Insignificant
April 2014 EPA0316
Use Handling of the
substance during use or
an incident during use
resulting in spillage or
leaching and subsequent
exposure of users or the
environment
6.3B Skin
irritancy/corrosion
Highly improbable: use on commercial
farms by staff trained in the use and
management of chemicals;
Product is contained in measure packs
so splashes and spills only likely for
diluted spray solution;
Workers will wear protective clothing as
specified in default controls.
Minor Insignificant
Disposal Disposal of the
substance or containers,
resulting in release of
the substance and
subsequent exposure of
people or the
environment
6.3B Skin
irritancy/corrosion
Highly improbable : disposal of
product won’t be required under normal
conditions of use; disposal (as directed
on product label) of substance and its
packaging will be carried out in
accordance with the requirements of the
HSNO Act and other relevant legislation,
such as the HSE Act
Minor Insignificant
Consumpti
on of food
treated
with
product
Incidents occurring from
exposure to treated
produce
6.3B Skin
irritancy/corrosion
Highly improbable: Skin
irritancy/corrosion not possible from
eating treated produce.
Minor Insignificant
April 2014 EPA0316
Assessment of risks to general public / community
With the controlled use of ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) there are not
expected to be any adverse impacts on the social environment. Transport accidents involving a
vehicle carrying the product may occur but any effects to a community, apart from those discussed
above, are improbable. Consequently, the Applicant considers that this aspect of potential risk
need not be considered further.
Assessment of economic risks
None identified
Assessment of effect of the substance being unavailable
There are other substances available for the treatment of fungi for the nominated crops on the
ESTEEMTM (POLYOXIN D ZINC SALT 5SC FUNGICIDE) label. On this basis, the likely effect of this
product not being available is a reduction in consumer choice and a slight increase in the risk of
fungicide resistance development due to fewer modes of action being available.
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.
As this substance is a fungicidal compound for use in agriculture, the effect on the Maori
population in general is going to be no greater than currently approved substances.
Controls are in place to protect all peoples from risk through the use of agricultural
compounds. Food crops/sources should be sprayed as required and native fauna and
flora are not likely to be exposed if standard application methods are used. HSNO
controls suggest avoiding all water ways - this contol should mitigate the risk.
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
No international obligations have been identified.
April 2014 EPA0316
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
ESTEEMTM (POLIOXIN D ZINC SALT 5SC FUNGICIDE) will be manufacutured by Kaken
Phamaceutical Co., Ltd. and will be imported from Japan in bulk containers by Zelam Limited. The
substance will be repacked and relabeled in New Zealand for retail distribution by Zelam Limited.
Within New Zealand, distribution will be handled by Zelam Limited and regional distributors.
Use will be handled by purchasers, who in many cases, and particularly during the early stages of
its introduction to the market, will be supervised by staff from the distributor. Users are expected
to be commercial growers of apples and grapes. Members of the public will not be involved with
the use of this product.
All product containers sold will have a batch number on the label in order to ensure that quality
problems can always be checked with the manufacturer's records.
The product label will contain information on the management of risk, in particular human handling
safety directions and first aid directions, storage and spill management instructions and
environmental concerns.
Overall, the product will be managed by application of appropriate controls:
Default Applicant comments/
proposed variation
Control Regulation Heading
T1 11-27
Limiting exposure to toxic
substances; setting values for
acceptable daily exposure
(ADE)/reference dose (RfD),
potential daily exposure (PDE),
tolerable exposure limit (TEL);
prohibition on use of
substances in excess of TEL
The safety of Polyoxin D zinc salt
and ESTEEMTM (POLYOXIN D ZINC
SALT 5SC FUNGICIDE) for human
health is well established.
Tolerance exemptions have been
established in several countries.
Public exposure to ESTEEMTM
(POLYOXIN D ZINC SALT 5SC
FUNGICIDE) is not considered likely
when it is used in accordance with
the proposed label. It is proposed
that ADEs, RfDs, PDEs, and TELs
not be set.
April 2014 EPA0316
T2 29-30
Controlling exposure in places
of work and other "use"
situations; setting of workplace
exposure standards (WES)
OSH WES values have not been set
for any of the components in
ESTEEMTM (POLYOXIN D ZINC SALT
5SC FUNGICIDE). The U.S.A do not
quote standards for any of these
components. Proposal is that WES
not be set.
T4 7 Requirement for equipment
used to handle substances Covered by label.
T7 10
Restrictions on carriage of toxic
substances on passenger
service vehicles
Distribution/user management
practices
I1 6, 7, 32-35,
36(1)-(7)
Identification requirements,
duties of persons in charge,
accessibility, comprehensibility,
clarity and durability
Distribution/user management
practices
I9 18 Secondary identifiers for all
hazardous substances Covered by label and SDS.
I16 25 Secondary identifiers for toxic
substances Covered by label and SDS.
I19 29-31
Additional information
requirements, including
situations where substances
are in multiple packaging
Shipper labels, supply chain
I21 37-39, 47-
50
General documentation
requirements
Distribution/user management
practices
I28 46
Specific documentation
requirements for toxic
substances
Covered by label and SDS.
P1 5, 6, 7(1), 8 General packaging
requirements
Schedule 4 of packaging regulations
applies.
P3 9
Criteria that allow substances
to be packaged to a standard
not meeting Packing Group I, II
or III criteria
Combine P3 and P13. Schedule 4
of packing regulations applies.
April 2014 EPA0316
P13 19 Packaging requirements for
toxic substances (Class 6) Combine P3 and P13.
D4 8
Disposal requirements for class
6, 8 substances (toxics and
corrosives)
Covered by label.
D6 10 Disposal requirements for
packages Covered by label.
D7 11, 12
Information requirements for
manufacturers, importers and
suppliers, and persons in
charge
Covered by supply chain
management codes of practice,
label and SDS.
D8 13, 14
Documentation requirements
for manufacturers, importers
and suppliers and persons in
charge
Covered by supply chain
management codes of practice,
label and SDS.
EM1 6, 7, 9-11
Level 1 information
requirements for suppliers and
persons in charge
Covered by supply chain
management codes of practice,
label, and SDS.
EM6 8(e) Information required for toxic
substances Covered by label.
EM8 12-16, 18-
20
Level 2 information
requirements for suppliers and
persons in charge
Covered by supply chain
management codes of practice,
label, and SDS.
EM11 25-34
Level 3 emergency
management requirements:
duties of person in charge,
emergency response plans
Covered by supply chain
management codes of practice,
label, and SDS.
EM12 35-41
Level 3 emergency
management requirements:
secondary containment
Covered by supply chain
management codes of practice,
label, and SDS.
Variation of default controls
The product will be restricted to use within the commercial fruit and vegetable growing
sector and shall not be made available to the general public. This will be controlled
within the product distribution channels.
April 2014 EPA0316
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
There are no significant risks to human health and the environment associated with the
hazardous properties (skin irritation) in the importation, sale and use of ESTEEMTM
(POLYOXIN D ZINC SALT 5SC FUNGICIDE) by the proposed controls. The label will
include precautionary statements and personal protective equipment requirements that
are adequate to mitigate possible hazards associated with the product use.
There are however considerable advantages to the growers and consumers in terms of
containment of losses through the disease control with the unique mode of action and
the pre-harvest use, and its low risk to human health and the environment.
April 2014 EPA0316
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:
April 2014 EPA0316
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]
April 2014 EPA0316
9. Checklist This checklist is to be completed by the applicant
Application Comments/justifications
All sections of the application form
completed or you have requested an
information waiver under section 59 of the
HSNO Act
☒ Yes ☐ No
(If No, please discuss with an
advisor to enable your application
to be further processed)
Confidential data as part of the confidential
form
☒ Yes ☐ No
Supplementary optional information attached:
Copies of additional references ☒ Yes ☐ No Application #202334
Letter(s) of access ☐ Yes ☐ No
Relevant correspondence ☐ Yes ☐ No
Draft label ☒ Yes ☐ No Application #202334
Draft Safety Data Sheet (SDS) ☒ Yes ☐ No Application #202334
Administration
Are you an approved EPA customer? ☐ Yes ☒ No
If yes are you an:
Applicant: ☐
Agent: ☐
If you are not an approved customer,
payment of fee will be by:
Direct credit made to the EPA bank
account (preferred method of payment)
Date of direct credit:
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
Physical copy of signed statutory declaration
sent to the EPA, (rapid assessment only)
☐ Yes
