APPLICATION FORM Pesticides To obtain approval to import or manufacture a pesticide Send to Environmental Protection Authority preferably by email ( [email protected]) or alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany application; see our fees and charges schedule for details. This form should also be used for Antifouling paints ☐ Fumigants ☐ Plant protection products ☒ Timber treatments ☐ Vertebrate Toxic Agents ☐ Name of the substance to be approved GF-3308 Date December 2018 www.epa.govt.nz
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To obtain approval to import or manufacture a pesticide · Application Form Approval to import or manufacture a pesticide Commercially sensitive information 12. The EPA strongly advises
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APPLICATION FORM Pesticides
To obtain approval to import or manufacture a pesticide
Send to Environmental Protection Authority preferably by email ([email protected]) or alternatively by post (Private Bag 63002, Wellington 6140)
Payment must accompany application; see our fees and charges schedule for details.
Application Form Approval to import or manufacture a pesticide
Completing this application form
1. This form has been approved under section 28 of the Hazardous Substances and New Organisms
(HSNO) Act 1996. It only covers the import or manufacture of pesticides to be released in New
Zealand under section 28 of the HSNO Act. If you wish to make an application for another type of
substance (such as a veterinary medicine or industrial chemical) or for another type of application
(such as emergency, special emergency or containment), a different form will have to be used. All
forms are available on our website.
2. It is recommended that you contact an Applications Advisor at the Environmental Protection
Authority (EPA) as early in the application process as possible. An Applications Advisor can assist
you with any questions you have during the preparation of your application including advising on
any consultation requirements.
3. Before submitting this application, you may make an informal Status of Substance (SOS) advice
request to the EPA. Further information on this process is available on our website. Please note
that this is not mandatory and an SOS request is only informal advice.
4. This application form may be used to seek approvals for more than one hazardous substance, if
the substances and their uses are of a similar nature.
5. Please make sure that you obtain all appropriate permissions for the use of any data that you
have used or provided in this application form, if you are not the owner of such data.
6. Unless otherwise indicated, all sections of this form must be completed for the application to be
formally received and assessed. If a section is not relevant to your application, please provide a
comprehensive explanation why this does not apply. If you choose not to provide the specific
information, you will need to apply for a waiver under section 59(3)(a)(ii) of the HSNO Act. This
can be done by completing the section on the last page of this form.
7. Any extra material that does not fit in the application form must be clearly labelled, cross-
referenced, and included with the application form when it is submitted.
8. Please add extra rows or tables where needed.
9. You must sign the form (the EPA will accept electronically signed forms) and enclose the
application fee (including GST) unless you are already an approved EPA customer. To be
recognised by the EPA as an “Approved customer”, you must have submitted more than one
application per month over the preceding six months, and have no history of delay in making
payments, at the time of presenting an application.
10. Information about application fees is available on the EPA website. If you wish to claim a fee
reduction for a reduced-risk-formulated product the appropriate justification must be submitted at
the pre-lodgement stage for consideration.
11. All application communications from the EPA will be provided electronically, unless you
specifically request otherwise.
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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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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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1. Applicant details
1.1. Applicant
Company Name: Dow AgroSciences (NZ) Ltd.
Contact Name: Emilia Cieslak
Job Title: Regulatory Manager
Postal Address (provide only if not the same as the physical):
Physical Address: 89 Paritutu Rd, New Plymouth, 4310
Application Form Approval to import or manufacture a pesticide
2. Information about the substance
2.1. Purpose statement or executive summary of the application for the public register
No more than 1,100 characters including the description of the formulated substance to be approved, e.g.
Soluble Concentrate 350-400 g active ingredient/L
To import or manufacture for release GF-3308, an emulsifiable concentrate fungicide
containing 50 g a.i./L fenpicoxamid for the control of Septoria tritici in wheat.
2.2. Type of application
Tick the box(es) that best describe your application
Has ‘Status of Substance (SOS) Advice’ been obtained from the EPA?
☐ Yes ☒ No
If yes, show the SOS reference number:
If yes, is the formulation of the substance different to that submitted at the SOS stage?
(In either case, please provide the composition to the EPA. This may be provided as part of the confidential
appendix)
☐ Yes ☐ No
Is the product a new active ingredient to New Zealand?
☒ Yes ☐ No
Does the product contain any viable new organisms, including GMOs?
☐ Yes ☒ No
Does the product contain an ingredient originating from an organism (plant, animal, etc)?1
☒ Yes2 ☐ No
Does the formulated substance contain any nanomaterial?
☐ Yes ☒ No
1 If you tick ‘Yes’ and the product is being imported, then include a Biosecurity Clearance from the Ministry for Primary Industries New Zealand. If one has been provided with a previous application and is still valid, this may be referenced. 2 Applicant’s note: An application for the Biosecurity Clearance will be filed with the MPI along with the A1 application.
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3. Identity of the substance
Any commercially sensitive information may be provided in the confidential appendix of this form
Provide details on the active ingredient(s) as well as the mixture in this section
3.1. Identity of the active ingredient(s)
Active ingredient (Common Name): Fenpicoxamid
Chemical name (IUPAC): (3S,6S,7R,8R)-8-benzyl-3-{[(4-methoxy-3-{[(2-
Manufacturer development codes: XDE-777, XR-777, X772777
CIPAC No: Not available
CAS No: 517875-34-2
EEC No (EINECS or ELINCS): Not available
Function:
For plant protection products
☐ Herbicide ☐ Microbial strain ☒ Fungicide
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☐ Insecticide ☐ Semiochemical
(pheromone, attractant,
repellent etc.)
☐ Plant Extracts
☐ Other, e.g. plant growth regulators (specify):
For timber treatments, Vertebrate Toxic Agents (VTA), anti-fouling paints or fumigants, please
describe the function:
N/A
FAO Specification (including year of publication): ☐ Yes Year: ☒ No
Minimum purity of the active ingredient as manufactured (g/kg): 750 g/kg
Note: Any impurities must be provided to the EPA. A certificate of analysis may be included in the
confidential appendix.
3.2. Regulatory status of the active ingredient(s)
Jurisdiction
Regulatory status
Comment*
Never
approved
Pending
Approved
Restricted
Not
renewed
Australia ☒ ☐ ☐ ☐ ☐
Canada ☒ ☐ ☐ ☐ ☐
Europe ☐ ☐ ☒ ☐ ☐
Japan ☒ ☐ ☐ ☐ ☐
New Zealand ☒ ☐ ☐ ☐ ☐
USA ☒ ☐ ☐ ☐ ☐
Other
jurisdictions
(specify in
comments)
☐
☐
☐
☐
☐
Approved in Guatemala,
Panama and Ecuador
*For instance, specify here under which regulation(s) or directive(s).
When restricted or not renewed, explanations should be provided:
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3.3. Identity of the formulated substance
Formulated substance name: GF-3308
Manufacturer development codes: GF-3308
Unique names for public register: GF-3308
Active ingredient(s) and content (g/kg or L and % w/w): 50 g/L; 4.92% (w/w)
3.4. Physical and chemical properties of the formulated substance
Provide as much information as possible on the physical and chemical properties of the substance
(at 20°C and 1 atmosphere unless otherwise stated)
Appearance (colour, odour, physical state and form): Clear light yellow liquid with a fruity odour
pH: 4.35 at 20.0 °C
Density: 1.016 g/mL
Vapour pressure: No data for the formulated product, 2.0 × 10-7 Pa (1.5 × 10-9 mmHg) at
25 °C for fenpicoxamid
Boiling/melting point: No data for the formulated product, fenpicoxamid decomposes before
boiling, melting point for fenpicoxamid is 158.3 ºC
Solubility in water: Excellent solubility in water, GF-3308 is to be sprayed after diluting in
water
Water/Octanol partitioning co-efficient: No data for the formulated product, log10 Pow = 4.4 ±
0.2 at pH 7 (Pow = 26,800 – 9,400) for fenpicoxamid
3.5. Regulatory status of the formulated substance
Jurisdiction
Regulatory status
Comment*
Never
approved
Pending
Approved
Restricted
Not
renewed
Australia ☒ ☐ ☐ ☐ ☐
Canada ☒ ☐ ☐ ☐ ☐
Europe ☐ ☒ ☐ ☐ ☐
Japan ☒ ☐ ☐ ☐ ☐
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New Zealand ☒ ☐ ☐ ☐ ☐
USA ☒ ☐ ☐ ☐ ☐
Other
jurisdictions
(specify in
comments)
☒
☐
☐
☐
☐
*For instance, specify here under which regulation(s) or directive(s).
Has an application been made for an approval under the Agricultural Compounds and Veterinary
Medicines Act?
☒ Yes ☐ No
3.6. Composition details of the formulated substance
Full composition details for the substance must be provided to the EPA. These may be included in the
confidential appendix The full formulation composition is provided in the Confidential Appendix
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4. Life cycle of the substance
Manufacturing
Will your formulated substance be manufactured in New Zealand?
☒ Yes ☐ No
Importation
Will your formulated substance be imported into New Zealand by air and/or sea?
☒ Sea ☒ Air
Will your formulated substance be imported in bulk containers or packaged ready for sale?
☒ Bulk Containers ☒ Packaged ready for sale
If your formulated substance will be imported in bulk containers, please describe these containers:
100 kg drums with a HDPE liner
Will repackaging of your formulated substance be carried out in New Zealand?
☒ Yes ☐ No
Will relabelling of your formulated product be carried out in New Zealand?
☒ Yes ☐ No
Please provide any additional relevant information relating to the importation of your formulated
substance:
Transport
Will your formulated substance be transported by road, rail, air and/or sea within New Zealand?
☒ Road ☒ Sea ☒ Rail ☒ Air
Please provide any additional information relating to transport of your formulated substance:
GF-3308 will primarily be imported by sea fright packed, labelled and ready for sale. In
some instances it may also be imported in bulk packs, in which case the final packaging
and labelling will take place in New Zealand. Upon customs clearance, GF-3308 will be
transported to a Dow AgroSciences (NZ) Ltd. warehouse designed for the secure storage
of agricultural compounds. In the future, GF-3308 may be formulated in New Zealand.
Bulk distribution will occur by way of designated trucks and rail wagons designed for the
transportation of hazardous goods. Transportation will comply with the UNRTG
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Application Form Approval to import or manufacture a pesticide
requirements for dangerous goods for marine transport. Distribution will involve
transport by road and sea using dedicated chemical transport companies to retail farm
supply distributors.
UN Number: 3082
UN Transport Hazard Classes: 9
UN Packing Group Number (UN Model Regulations3): III
Marine Pollutant? (IMDG Code4): No
Packaging
Pack sizes: 15 L
Type of packaging: fluorinated high density polyethylene (F-HDPE) drums
Type of closure (consider opening size, type of cap, child resistant packaging): induction,
compression or vented 63 mm caps
Please provide any additional information relating to the packaging of your formulated substance:
Storage
Provide details of how the substance will be stored, and the facilities it will be stored in:
The proposed label storage directions include the following:
• Store in the original container tightly closed and in a locked, dry, cool, well-
ventilated area, away from foodstuffs. Storage must be generally in accordance
with the New Zealand Standard for the Management of Agrichemicals (NZS
8409).
• Stores containing more than 100 L of GF-3308 (or substances of the same hazard
class) require containment, emergency response plans and are subject to
signage. See the Hazardous Substances Emergency Management Regulations
and the New Zealand Standard for the Management of Agrichemicals (NZS 8409)
for further information.
3 UN Model Regulations mean Model Regulations annexed to the most recently revised edition of the Recommendations on the Transport of Dangerous Goods published by the UN 4 IMDG Code means that International Maritime Dangerous Goods code, as amended
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Warehouse storage
Provide details of how the formulated substance will be stored: During the distribution phase of
the product’s life cycle, GF-3308 will be stored in suitably approved facilities. The plant
warehouses are under the control of the personnel qualified and experienced in handling
agricultural chemicals. Appropriate procedures and SOPs apply to a variety of plant
protection products. When collected from the Dow AgroSciences site, the substance is
to be stored by distributors, who also have dedicated pesticide storage facilities, until
sold to farmers.
Containment of spillages: Accidental spillage can be absorbed with material such as sand,
soil or sawdust. Spilled product should be collected and placed in a sealable container
for appropriate disposal.
Decontamination of areas, personnel, vehicles and buildings: Spill residues may be cleaned
using water and detergent. The wash water should also be contained and absorbed for
disposal.
Disposal
Disposal of damaged packaging, contaminated absorbents and other materials: The same as for
GF-3308 and its packaging below.
Detailed instructions for safe disposal of the formulated substance and its packaging: The following
disposal direction are proposed for the product label:
• Dispose of the product only by using according to the label, via Agrecovery, the
the Rural Recycling Programme, which is an industry stewardship scheme, or at
an approved landfill.
• DO NOT burn.
• Triple rinse empty containers and add rinsate to spray tank.
• Triple rinsed containers containing the Agrecovery logo on the label, which are
free of all residues (liquid and dry) and have an intact legible label should be
taken to an Agrecovery container collection site.
• Otherwise crush and bury in a suitably approved landfill.
• DO NOT burn empty containers.
• Dispose of equipment cleaning water onto ground away from edible crops.
• DO NOT dispose of this product, spray mix or equipment cleaning water down
drains or sewers.
Methods other than controlled incineration for disposal: As described above.
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5. Intended uses of the formulated substance
The information you provide here will be used by the EPA to assess the risks posed by the substance and the controls assigned to manage these risks. You
must outline either all the proposed uses of the product or the worst-case scenario for each application method (considering both the application rate and the
frequency). Please use table 5.1 for plant protection products or table 5.2 for all other types of pesticides. Explanatory notes are below each table.
5.1. Intended uses for plant protection products
You must outline either all the proposed uses of the product or the worst case scenario for each application method (considering both the application rate and frequency)
Crop
and/or
situation
(a)
Product
Code
F G
or I
(b)
Pest or
group of
pests
controlled
(c)
Formulation
Application
Application rate per
treatment
PHI
(days)
(l)
Remarks
(m)
Type
(d-f)
Conc of
as
(i)
Method
kind
(f-h)
Growth
stage
and
season
(j)
Numbe
r
min
max
(k)
Interval
between
application
s (min)
Kg
as/hL
min
max
Water
L/ha min
max
Kg
as/ha
min
max
Wheat
GF-3308
F
Septoria
tritici
EC
Fenpico
xamid,
50 g/L
Ground
broadca
st
GS30 –
GS69
1 or 2
14 days
0.0375
– 0.1
kg/hL
100 –
200
L/ha
0.075
– 0.1
kg
a.i./ha
Not
require
d when
used as
Does not
require a
separate
adjuvant
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Crop
and/or
situation
(a)
Product
Code
F G
or I
(b)
Pest or
group of
pests
controlled
(c)
Formulation
Application
Application rate per
treatment
PHI
(days)
(l)
Remarks
(m)
Type
(d-f)
Conc of
as
(i)
Method
kind
(f-h)
Growth
stage
and
season
(j)
Numbe
r
min
max
(k)
Interval
between
application
s (min)
Kg
as/hL
min
max
Water
L/ha min
max
Kg
as/ha
min
max
directe
d
Wheat
GF-3308
F
Septoria
tritici
EC
Fenpico
xamid,
50 g/L
Aerial
broadca
st
GS30 –
GS69
1 or 2
14 days
0.075
– 0.2
kg/hL
50 –
100
L/ha
0.075
– 0.1
kg
a.i./ha
Not
require
d when
used as
directe
d
Does not
require a
separate
adjuvant
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(a) For crops, the EU and Codex classifications (both) should be used; where relevant, the
use situation should be described (eg fumigation of a structure)
(b) Outdoor or field use (F), glasshouse application (G) or indoor application (I)
(c) eg biting and suckling insects, soil born insects, foliar fungi, weeds
dodecylbenzenesulfonic acid calcium salt (CAS 84989-14-0) and eo/po block copolymer
(CAS 9038-95-3).
Manufacturing, packaging and labelling may be done either overseas or in the company
owned pesticide manufacturing plant in New Plymouth or other suitable contractor facility.
The risks during manufacture are managed mainly by establishing an adequate
containment system, which prevents the escape of GF-3308, contamination of the facility,
excludes unauthorised people and unwanted organisms from the facility, prevents
unintended release of the substances, controls the effects of any accidental release,
manages waste disposal and establishes procedures to inspect and monitor the
containment facility. The potential for human exposure for people handling GF-3308 during
its manufacture, packaging and labelling is reduced to a negligible level by implementing
such a containment system coupled with the compulsory use of appropriate personal
protective equipment as well as training and qualification requirements for staff on
handling hazardous substances and following established Standard Operating Procedures.
During transport and storage of GF-3308, only one scenario can be identified for human
exposure to the substance: isolated incidents where spillage occurs. HSNO controls (the
label, SDS and packaging) and adherence to the Land Transport Rule 45001, Civil Aviation
Act 1990 and Maritime Transport Act 1994 will apply to manage those risks, which are
therefore considered negligible.
Disposal of GF-3308 is most likely to be achieved through the use as a foliar spray. Unused
product and packaging will be acceptable for collection by Agrecovery, the Rural Recycling
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Programme, which is an industry stewardship scheme. Alternatively, empty packaging
should be crushed or punctured and buried in a suitably approved landfill. The end users
disposing of the substance will have the necessary knowledge (e.g. via information
provided on the label and SDS) to manage the risk adequately.
The most relevant exposure scenario is identified for the end users of GF-3308, who handle
and apply the product on farm. Each triggered hazard class will be discussed separately in
the following paragraphs.
Acute toxicity (6.1E) GF-3308 has been classified as 6.1E based on the data available for a closely similar
formulation, a study conducted in compliance with the OECD 423 guideline. The acute oral
median lethal dose (LD50) for a closely similar substance in Wistar rats was found to be
between 2,000 and 5,000 mg/kg body weight. This is equivalent to 140 - 350 g
(approximately 138 – 344 mL) of GF-3308 for a person weighing 70 kg. The likelihood of
a person ingesting a fraction of this amount through normal use is improbable. To reduce
the risk of any incidental ingestion, the label will also contain standard precautions: DO
NOT eat, drink or smoke while using. Avoid inhalation of product or spray mist. Remove
protective clothing immediately after handling this product and wash hands and face before
meals and after work.
Eye and skin irritation (6.3B and 6.4A) GF-3308 has been classified as 6.3B based on the data available for a closely similar
formulation, a study conducted in compliance with the OECD 404 guideline. Very slight to
well-defined erythema and very slight oedema were observed in the exposed rabbits. The
mean dermal irritation scores at 24, 48 and 72 h post-patch removal were 2.00, 2.00, 2.00
for erythema and 1.00, 1.00, 1.00 for oedema for the three tested rabbits respectively.
Recovery was complete in all rabbits by day 7 post patch removal.
GF-3308 has been classified as 6.4A based on the data available for a closely similar
formulation, a study conducted in compliance with the OECD 405 guideline. Corneal
opacity, conjunctival redness and conjunctival chemosis were observed in the tested
rabbits. The mean of the eye irritation scores observed at 24, 48 and 72 h post instillation
were 0.67, 1.00, 1.00 for corneal opacity, 0.00, 0.00, 0.00 for area of corneal opacity,
0.00, 0.00, 0.00 for iris effects, 2.00, 2.00, 2.00 for conjunctival redness, 1.00, 1.00, 1.00
for conjunctival chemosis and 0.00, 0.00, 0.00 for discharge for the three rabbits
respectively. Recovery for all symptoms in all rabbits occurred by day 7.
To manage the risk of skin and eye irritation, appropriate (and standard) statement will be
added to the product label: Causes mild skin irritation and eye irritation. Avoid contact with
the skin and eyes. When opening the container, preparing the product for use and applying
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the product, wear eye protection, cotton overalls buttoned to the neck and wrist (or
equivalent clothing) and chemical resistant gloves.
These recommendations are consistent with good practice and existing industry standards.
With such measures in place the risk of skin and eye irritation is low.
Target organ toxicity (6.9B) GF-3308 has been classified as 6.9B based on mixture rules. Two co-formulants, a reaction
mass of N,N-Dimethyloctan-1-amide and N,N-Dimethyldecan-1-amide and eo/po block
copolymer (CAS 9038-95-3) are classified 6.9B (oral) and 6.9B (inhalation) respectively.
Adverse effects from ingesting GF-3308 are only likely to occur if undiluted GF-3308 is
consumed for prolonged periods of time at high doses, which is improbable through the
normal use. Eo/po block copolymer is present in GF-3308 at a concentration <5% and will
be further diluted, in the tank mix at least 25 times (up to 200 times) therefore the
exposure through inhaling the spray mist is very low.
To manage the risks, the same measures as for acute oral classification apply. To address
the inhalation risk the label will contain the following statement: Avoid inhalation of product
or spray mist. This is good practice regardless of the agrichemical product classification
and is part of the established industry standards.
The dietary risk assessment for consumers is out of scope of the EPA evaluation, other
than setting the TELs, however, for completeness it is noted that exposure through the
diet will be evaluated by the Ministry of Primary Industries based on the comprehensive
residue dossier. Under the Food Act Dow AgroSciences has proposed a domestic MRL
(Maximum Residue Level) of 0.2 mg/kg fenpicoxamid in wheat grain (it will be 0.6 mg/kg
in the EU). This value is based on the highest residue level (0.13 mg/kg fenpicoxamid)
found in any grain sample tested after the most intensive label treatment was applied to
wheat in New Zealand (2 applications at the max proposed label rate (100 g a.i./ha), at
the latest application timing (GS69) and with the shortest allowed application interval (2
weeks)).
The EFSA set the Acceptable Daily Intake (ADI) (the amount that can be ingested on a
daily basis over a lifetime without an appreciable health risk) at 0.05 mg/kg fenpicoxamid
and the Acute Reference Dose (ARfD) (the amount that can be ingested over a short period
of time, usually during one meal or one day, without an appreciable health risk) at
1.8 mg/kg fenpicoxamid. These values are based on the lowest toxicity endpoints and
include a safety factor of 100. Assuming the highest allowed fenpicoxamid residue in grain
(i.e. the proposed MRL of 0.2 mg/kg), ADI and ARfD correspond to 250 g and 9 kg of wheat
grain respectively (this also assumes no residue decay through storage or preparation).
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Please also note that an MRL represents an exaggerated worst case scenario. The residue
found in wheat grain in New Zealand trials resulting from the most intensive label use
pattern ranged from <LOQ (limit of quantification) to 0.13 mg/kg fenpicoxamid.
The Joint FAO/WHO Meeting on Pesticide Residues established the same ADI and no ARfD
due to low toxicity. Dow AgroSciences expects the NZ EPA to establish the ADE (Acceptable Daily Exposure)
value in line with the European and JMPR ADI. Considering all the above points, the risk to human health from the controlled use of GF-
3308 is therefore considered low.
• Environment
The only environmental hazard associated with GF-3308 and triggered by the active
ingredient is its high aquatic toxicity. The formulation endpoints supporting the 9.1A
classification are the LC50 of 0.078 mg/L in rainbow trout (from a study conducted
according to the OECD 203 guideline) and the EC50 of 0.048 mg/L for Daphnia (from a
study conducted according to the OECD 202 guideline). For comparison, copper hydroxide,
a fungicide certified for use in organic fruit and vegetables, is also classified 9.1A based on
the endpoints of LC50 of 0.023 mg/L in fathead minnow and LC50 of 0.0065 mg/L in
Daphnia6. The registered minimum application rate of copper hydroxide in stone fruit for
example is 1.9 kg/ha7; no maximum rate is stated nor prescribed by the EPA controls (see
HSR000739 approval).
Laboratory and field studies have been conducted to determine the fate of fenpicoxamid
in the environment. Fenpicoxamid degrades rapidly in the environment to UK-2A8 which
then degrades rapidly to pesticidally non-active compounds (the laboratory hydrolysis DT50
for fenpicoxamid at pH 7 is 0.9 days, the laboratory photolysis DT50 for fenpicoxamid at
pH 7 is 3.1 days, soil aerobic laboratory DT50 is 1.9 days for fenpicoxamid and 2.3 days for
UK-2A). Dissipation of Inatreq occurs primarily through microbial degradation in the soil
and hydrolysis and photolysis in water. Laboratory studies have demonstrated an average
Koc of 53,173 mL/g for fenpicoxamid and 10,040 mL/g for UK-2A indicating that they are
strongly adsorbed to soil.
6 EPA’s Chemical Classification and Information Database (CCID) 7 Refer to HORTCARE Copper Hydroxide 300 label (ACVM registration number P008704) or ChampION++ label (ACVM registration number P009228). 8 UK-2A is a natural substance produced by fermentation of Actinomyces bacteria isolated from a soil sample. Fenpicoxamid is manufactured from UK-2A through a single post-fermentation manufacturing step. See the Benefits section for more information.
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Manufacturing, packaging and labelling may be done either overseas or in the company
owned pesticide manufacturing plant in New Plymouth or other suitable contractor facility.
The risks during manufacture are managed mainly by establishing an adequate
containment system, which prevents the escape of GF-3308, contamination of the facility,
excludes unauthorised people and unwanted organisms from the facility, prevents
unintended release of the substances, controls the effects of any accidental release,
manages waste disposal and establishes procedures to inspect and monitor the
containment facility. The risk of contamination of waterways, groundwater, soil or
neighbouring properties is negligible with such a containment system in place.
During transport and storage of GF-3308, only one scenario can be identified for
environmental exposure to the substance: isolated incidents where spillage occurs. HSNO
controls (the label, SDS and packaging) and adherence to the Land Transport Rule 45001,
Civil Aviation Act 1990 and Maritime Transport Act 1994 will apply to manage those risks,
which are therefore considered negligible.
Disposal of GF-3308 is most likely to be achieved through the use as a foliar spray. Unused
product and packaging will be acceptable for collection by Agrecovery, the Rural Recycling
Programme, which is an industry stewardship scheme. Alternatively, the empty packaging
should be crushed or punctured and buried in a suitably approved landfill. The draft label
contains the following statements: Dispose of equipment cleaning water onto ground away
from edible crops. DO NOT dispose of this product, spray mix or equipment cleaning water
down drains or sewers. Cleaning water should be discharged onto a designated disposal
area, or onto unused land away from desirable plants and water sources. The end users
disposing of the substance will have the necessary knowledge (e.g. via information
provided on the label and SDS) to manage the risk adequately.
The highest risk for a water body contamination is associated with the application of GF-
3308 in the field. The label will prohibit uses directly into or onto water and a corresponding
HSNO control is expected to be imposed. The draft label contains the following statements:
Very toxic to aquatic organisms. DO NOT apply directly into or onto water. No person may
apply the substance in a manner that results in adverse effects to a water body.
The most likely exposure route would be via accidental spills or off-target movement such
as spray drift.
Spray drift For any substance applied as a spray treatment, the potential for off-target drift will always
be present. Off-target drift can be minimised using drift reduction techniques. The most
common of these include:
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a) Specifying acceptable wind speed: Best practice advice is to spray only when the
wind is between 3 and 20 km/h, but for some types of products the upper limit
may be reduced. Spraying in calm conditions is not recommended as the direction
of the drift can be unpredictable in apparently still air.
GF-3308 draft label contains the following statement: DO NOT apply when wind
speeds are less than 3 km/h or more than 20 km/h as measured at the application
site.
b) Avoiding application during inversion conditions. These occur mainly at night or
early morning.
GF-3308 draft label contains the following statement: Avoid strong winds or
inversion conditions that may result in drift from the target area. Techniques to
minimise drift should be employed at all times.
c) Specifying the spray quality in accordance with ASAE (S-572) or BCPC
specifications. Higher quality (very coarse to extra coarse) spray reduces drift, but
may negatively impact efficacy for some products.
GF-3308 will be recommended to be applied with a medium quality spray in
alignment with other registered cereal fungicides.
d) Limiting the application rates.
The maximum label application rate is 2 L/ha (100 g a.i./ha). Specifying the minimum downwind buffer zones is the most common risk mitigation
measure to manage spray drift. In case of GF-3308, the risk to aquatic organisms having
the lowest endpoints, will determine the necessary buffer zones (if any). The EPA does not
publish their risk assessment methodology in sufficient detail for Dow AgroSciences to
predict the buffer zone calculations. We await the Staff Report to add mandatory buffer
zones, if applicable, to the product label as per the corresponding HSNO control.
It is appropriate that EPA use the same modelling input parameters, such as equipment
configuration (e.g. boom length, number of nozzles, release height, etc.) or climatic
conditions as for GF-2687, also a foliar plant protection product for use in cereals and
approved to be applied by broadcast ground and aerial application methods in 2016 (see
the Staff Report for the APP202336 application).
An important risk mitigation measure will also be the compulsory qualification
requirements as set out in the EPA Hazardous Substances (Hazardous Property Controls)
Notice 2017 (e.g. Rural Contractors New Zealand’s Registered Chemical Applicator
Accreditation with relevant strand or GROWSAFE® Registered Chemical Applicator
Certificate with relevant strand or National Certificate in Agrichemical Application with
relevant strand, etc.).
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The safety of aerial applications is an area of particular, and in our view undue, concern.
It should be emphasised that the aerial applicators undertake extensive training and are
required to achieve a significant level of understanding of the risks involved. The following
table summarises training requirements within the agricultural aerial industry:
Requirement
Scope and Comments
Provider
Compulsory pilot training (Part 137 certificate)
Commercial
Pilot Licence
(CPL)
Undergo training provided by a Part 61 qualified
flying instructor. Minimum 200 hours fixed wing
or 150 hours helicopter
Civil Aviation
Authority of NZ
Agricultural
rating
Grade 2
Undergo a course of instruction in Agricultural
flying provided by a qualified E Category
instructor operating under the authority of either
a Part 137 or Part 141 organisation authorised to
conduct the training.
Undergo a flight and ground assessment by an
Agricultural Flight Examiner. Successful
graduation leads to the issue of a Grade 2
agricultural rating.
Prerequisite is to hold a Pilot Chemical Rating
issued under Subpart P of Part 61.
Civil Aviation
Authority of NZ
Agricultural
rating
Grade 1
Undergo assessment for issue of a Grade 1
agricultural rating by demonstrating competency
to an Agricultural Flight Examiner.
Prerequisite is to hold a Pilot Chemical Rating
issued under Subpart P of Part 61 and to have
conducted 1,000 hours of productive agricultural
flight operations under direct supervision.
Civil Aviation
Authority of NZ
Chemical rating
To be eligible for issue of a Pilot Chemical Rating
issued under Subpart P of Part 61 of the CARs a
pilot must:
• Be the holder of at least a private pilot
licence in the appropriate category of
aircraft, and • Successfully complete a training course in
agricultural chemical application, with
assessment, conducted under the
authority of either a Part 137 or Part 141
that is authorised to conduct the training
Civil Aviation
Authority of NZ
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Optional accreditation/certification
AIRCARE™
Accreditation for companies who can
demonstrate to an independent auditor that
they have the requisite system in place,
understand and apply best practice.
Serves as evidence that best practice is used
every time the pilots undertake an agricultural
operation. Accreditation terms vary from 1-3
years depending on merit as determined by
audit.
NZAAA under
the auspices of
Aviation New
Zealand
GROWSAFE
certification
Understanding of NZS8409 Management of
Agrichemicals standard which defines best
practice. Following the standard means all
relevant legislation is complied with.
New Zealand
Agrichemical
Education Trust
Additional training and comments
Aviation New Zealand annual conference and the weekly and monthly newsletters are
used to provide updates, trends, issues and solutions.
Pilot Chemical Rating refresher courses; wire collision avoidance; and cockpit resource
management courses are run in conjunction with each annual conference as well as on
an as-required basis.
The majority of agricultural pilots are ‘grown’ from within the industry. The normal
career pattern is to start as a trainee loader/driver where chemical handling is learned
under supervision then an Agrichemical Handlers Certification is gained on completion of a course once sufficient experience is gained. This handlers’ certificate and
demonstrated experience is a prerequisite to complete the Pilot Chemical Rating. Once
the person has demonstrated the right ‘fit’ for the industry they will undergo pilot
training followed by Grade 2 then Grade 1 qualification. The whole process takes a
number of years and there are only 2-3 new pilots entering the industry each year.
The practices of the aerial industry have markedly improved over the last two decades due
to the introduction of rigorous protocols for the site-specific risk assessment that any aerial
applicator has to undertake and document. Unfortunately, there is no comprehensive
database of the adverse effects resulting from aerial applications in New Zealand, however,
the New Zealand Agricultural Aviation Association were able to obtain data from the
insurance claims statistics. In the 90s there were about 25 insurance claims annually
resulting from adverse effects caused by aerial spraying. Between 2007 and 2015 such
claims have averaged at 0.6/annum and in this time there were only 2 major incidents,
neither of which resulted from spray drift. New Zealand Agricultural Aviation Association
have confirmed this trend has been sustained up to date. The aerial applicators Dow
AgroSciences spoke to argue that there is no need for any tighter regulation as they can
only be insured up to $250,000 and therefore are personally liable for significant damage
to non-target crops and one significant non-insured claim would put them out of business.
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It is possible to remain dissatisfied on the basis that this data does not stretch far enough
to provide evidence of the protection of the wider environment other than non-target crops,
however, it seems reasonable to assume that good application practice, as evidenced in
the insurance statistics, is applied equally to all non-target areas irrespective of what is
located downwind. Furthermore MPI (ACVMG) operates an adverse effect reporting scheme
in New Zealand, which should capture significant spray drift incidents. No reportable spray
drift incidents for its products have been brought to the attention of Dow AgroSciences for
at least the last 10 years. Dow AgroSciences is not aware of any data or information, as
reports of adverse effects, which would constitute evidence supporting the need to tighten
controls for aerial application.
We acknowledge the fact that the aerial application of GF-3308 will only be used
occasionally and most likely only when it is impractical to use ground equipment. However,
there can be situations when aerial spraying will be indispensable, e.g. when the ground
is too soft and muddy after heavy rainfall; in conditions, which also favour the development
of fungal diseases, and it is important to have such an option available to farmers when
needed. In recent years it seems to have become necessary to produce extensive
arguments and even specific data in support of aerial application. Dow AgroSciences does
not agree this is warranted. Aerial application is managed by its own, significantly stricter
controls (such as significantly longer buffer zones in comparison to ground application). If
through risk assessment practical risk management measures can be identified for aerial
application, there should be no reason to restrict access to such a well-established
technology in New Zealand.
ASSESSMENT OF BENEFITS Dow AgroSciences is a global, agricultural research and development agrichemical
company present in 130 countries around the world and employing more than 2000
discovery and field research scientists. We are one of a very few companies that work on
Since its birth in the late 1930s, the synthetic agrichemical chemistry has achieved
remarkable progress through R&D investment. There is a consistent trend in developing
more target specific chemistries that are efficacious at significantly lower rates and offer
steadily improving toxicological and ecotoxicological profiles, i.e. “greener” agrichemicals.
For example, in the last six decades the vertebrate selectivity ratios of insecticides (i.e. a
relative measure of toxicity to targeted insects versus non-target vertebrates) has
increased by five orders of magnitude, when at the same time field rates dropped
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approximately 100 times9. A similar trend in average application rates is reported in a more
recent review10.
Period of introduction Average rate: g/ha
Dithicarbamates 1943-67 2500
Morpholines 1968-2003 590
Triazoles 1976-2002 140
Strobilurins 1996-2007 490
SDHIs 2000s 100
Table. Chronology and application rate ranges of main fungicide groups10.
Figure. Number of pesticides falling into different safety classifications as a function of the
decade in which they were introduced10. (The World Health Organization (WHO) classifies
pesticides into four main safety categories: Class I: Extremely (Ia) and highly (Ib)
hazardous, Class II: Moderately hazardous, Class III: Slightly hazardous, U: Unlikely to be
hazardous).
Our innovation efforts continue to generate novel solutions for farmers, the newest of
which is fenpicoxamid; a fungicide for the control of Septoria tritici, which causes Septoria
leaf blotch, also known as speckled leaf blotch; one of the major diseases in wheat, which
results in significant loss of yield.
9 Sparks, T. C. (2013) “Insecticide discovery: An evaluation and analysis”, Pesticide Biochemistry and Physiology, Vol. 107, p. 8 -17. 10 Phillips McDougall (2018) “Evolution of the Crop Protection Industry since 1960”
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Speckled leaf blotch has become increasingly damaging to the New Zealand cereal
production in the last few years.
Figure: Snippets from the New Zealand online media.
Application Form Approval to import or manufacrure a pesUcide
-specifically Adexar®, which is a fluxapyroxad + epoxiconazole fungicide from BASF. The
complete efficacy and crop safety dossier has been submitted to the MPIto support the
product's registration in New Zealand under the ACVM Act. A high-level summary showing
the control of the Septoria pathogen on the three critical wheat leaves is presented below.
% control of Septoria on FLAG leaf
Based on AUAPC (5 of 5 trials)
80
100 20 N 20 ;,:l
-.20
- --2
.0
-- 20 .
-r-
20
...7 ...... !195 997
% control of Septoria on FLAG -1 (leaf 2)
Based on AUAPC (5 of 5 trials)
100
80 . •
20
0
Figure. Results of the New Zealand efficacy trials in wheat: Control of Septoria leaf blotch on the flag and the flag minus 1leaves.
40
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Figure. Results of the New Zealand efficacy trials in wheat: Control of Septoria leaf blotch
on the flag minus 2 leaf.
These results demonstrate:
• The dose response (i.e. confirm the correct rates have been selected for the label)
• Efficacy of GF-3308 alone comparable to the market standard (81.5 – 97.7% control
v 85.0 – 99.0% control).
• Efficacy of GF-3308 with the tank mix partner comparable to the market standard
(90.1 – 99.7% control v 85.0 – 99.0% control).
New Zealand grows the highest yielding wheat in the world (up to almost 17 t/ha11) with
an average of approximately 9 t/ha. Losses of yield due to Septoria leaf blotch have been
reported at 2 – 3 t/ha and in extreme cases, 7 t/ha. Dow AgroSciences trials in 2017/18
11 Field, E. (2017) “NZ couple breaks Guinness World Record for wheat yield” The Weekly Times
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showed control of Septoria leaf blotch with GF-3308 increased average yield from 9.7 t/ha
in untreated plots up to 12.4 t/ha, i.e. a gain of 2.7 t/ha or an increase in yield of 27%
compared to untreated. High yields not only improve the profitability of the farm but also
extract the best value from the land allocated to agriculture. It is estimated that 43,250 ha
of wheat were grown in 2018 yielding approximately 377,150 tonnes of wheat grain12. If
the yield was reduced by 30%, extra 18,500 ha would have to be cultivated to produce
the same amount of grain.
Figure. Results of the New Zealand efficacy trials in wheat: Grain yield.
Fenpicoxamid not only provides excellent efficacy against a common pathogen of economic
importance. One of its main benefits is its fit in a robust resistance management strategy
for cereal fungicides. This is because fenpicoxamid has a unique mode of action. It is the
12 “New Zealand survey of cereal areas and volumes: July 1, 2018” Arable Industry Marketing Initiative with Foundation for Arable Research.
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first molecule in the picolinamides group of Quinone inside Inhibitor fungicides (FRAC13
mode of action group 21). Binding to complex III (the bc1 complex) at the Qi site (the
inner mitochondrial membrane), fenpicoxamid inhibits mitochondrial respiration in fungi
by blocking electron transfer in the respiratory chain. Inhibition of fungal mitochondrial
respiration results in a reduction in the amount of ATP (adenosintriphosphate) produced.
As ATP is the main chemical energy carrier that drives the vital functions of cells, the key
biochemical processes are disrupted, growth is inhibited and the fungus dies.
Fungicide treatments currently available in New Zealand include:
• Triazoles, e.g. epoxiconazole, tebuconazole, propiconazole, prothioconazole (Group
3 fungicides),
• Succinate-dehydrogenase inhibitors (SDHIs), e.g. isopyrazam, fluxapyroxad
(Group 7 fungicides) and
• Strobilurins, e.g. azoxystrobin, picoxystrobin, pyraclostrobin (Group 11 fungicides).
Development of resistance is a major concern in cereal production globally as well as in
New Zealand. While triazoles still show reasonable activity against Septoria in New
Zealand, reduced sensitivity has been widely reported13. Resistance to strobilurins, which
until recently had been the most effective in controlling Septoria, has been confirmed in
New Zealand. In Europe resistance to SDHIs is evident in the Septoria pathogen population
and this group of fungicides, while still very effective in New Zealand, is considered
moderate to high risk of resistance14. A new mode of action, which fenpicoxamid offers,
will become a crucial component of the resistance management toolbox. The need for a
robust resistance management strategy for cereal fungicides in New Zealand is universally
recognised in the industry. It will extend the lifespan of all fungicides increasing the viability
of the wheat industry. It is important to note that wheat in New Zealand is grown primarily
for animal feed. Unlike pasture or forage brassicas it can be stored for long periods of time
providing milk and meat producers with a flexible stock food. Therefore, benefits for the
wheat growers translate also into benefits for dairy, beef and lamb farmers.
While Dow AgroSciences does not agree synthetic molecules are inherently more
(eco)toxic, some users or members of the public may find fenpicoxamid’s natural origin an
important attribute. Fenpicoxamid is derived from a natural substance, UK-2A, produced
by fermentation of Actinomyces bacteria isolated from a soil sample collected at the Osaka
City University, Japan. Fenpicoxamid is synthesized from UK-2A through a single post-
fermentation chemical modification, which is required to enhance stability and performance
13 Fungicide Resistance Action Committee. FRAC is a Specialist Technical Group of CropLife International, who recommends resistance management strategies. They classify fungicides into distinctive groups based on their mode of action. A FRAC fungicide group is the most basic piece of information in any resistance management strategy, which involves alternating products with different modes of action and using other than chemical control methods. 14 The Foundation for Arable Research, “Issue 7 Cereal Disease Management (Revised 2016)”
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(note, fenpicoxamid is devitalised and contains no viable microorganisms). Once in the
plant or fungal tissue, fenpicoxamid is converted back into UK-2A, its main metabolite.
GF-3308 is an emulsifiable concentrate containing 50 g/L fenpicoxamid, whose
redistribution across the plant surface is highly influenced by the formulation type. Based
on this understanding GF-3308’s performance has been optimized through specific,
patented formulation design to minimise fenpicoxamid application rate, maximise its
activity against Septoria, improve storage stability, rainfastness, ease of application and
overall product performance.
Fenpicoxamid has very low mammalian toxicity with no HSNO hazard classes triggered.
The HSNO classification for the formulated product, does not include any significant
hazards, which would require risk management measures outside of good industry
practice. Fenpicoxamid also degrades quickly in the environment and has very low toxicity
to non-target organisms with the exception of fish and aquatic crustaceans. However, with
the proposed use pattern, fenpicoxamid and GF-3308 pose low risk to the aquatic
environment.
GF-3308 is not designed to replace any existing product but complement a resistance
management strategy, however, a hazard comparison with its major competitors in the
marketplace is presented in the table below:
HSNO classification GF- 3308
Adexar Aviator Xpro
Seguris Flexi
Proline Comet Elatus Plus
3.1 Flammable liquid 3.1D 3.1D
6.1 Acutely toxic 6.1E 6.1D 6.1E 6.1D 6.1D 6.1D
6.3 Irritating to the skin 6.3B 6.3B 6.3A
6.4 Irritating to the eye 6.4A 6.4A 6.4A 6.4A 6.4A 6.4A
8.3 Corrosive to the eye 8.3A
6.5 Contact sensitiser 6.5B 6.5B
6.7 Carcinogenic 6.7B 6.7B
6.8 Reproductive /developmental toxicant
6.8B 6.8B
6.9 Harmful to human target organs or systems
6.9B 6.9B 6.9B 6.9B 6.9B 6.9A 6.9B
9.1 Ecotoxic in the aquatic environment
9.1A 9.1A 9.1B 9.1A 9.1B 9.1A 9.1A
9.2 Ecotoxic in soil 9.2D 9.2C
9.3 Ecotoxic to terrestrial vertebrates
9.3C 9.3C 9.3C 9.3B 9.3C
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7.3. Provide an assessment of any risks, costs and benefits which arise from the kaitiaki
relationship of Māori and their culture to the environment
Please note that consultation with Māori may be appropriate for this application. Please refer to the EPA
policy ‘Engaging with Māori for applications to the EPA’ which can be found on the EPA website
(www.epa.govt.nz) or contact the EPA for advice.
An example of the issues to consider include whether the substance poses any risk to native or valued
species, or waterways.
The following table summarises the initial risk assessment undertaken by Dow
AgroSciences:
Impacts Level of risk Comment Cultural
Medium
GF-3308 is toxic to aquatic organisms (fish and
crustaceans) and is proposed to be classified 9.1A. It
is expected a number of HSNO additional controls
(s77A controls) will be imposed on GF-3308 to
manage the risks to water bodies:
• The substance must not be applied onto or into
water.
• No person may apply the substance in a
manner that results in adverse effects to a
water body.
• A maximum application rate control
• A buffer zone control. Label advice will be provided to comply with EPA
controls (awaiting the Staff Report).
Health &
Wellbeing
Low
Health risks to end users associated with the identified
hazards (the lowest level of acute toxicity (6.1E), mild
irritation to the skin (6.3B), mild irritation to the eye
(6.4A) and low target organ toxicity (6.9B), oral and
inhalation), will be managed by appropriate label
recommendations with regards to safe transport,
handling, storage and application, e.g. protective
clothing, handling and spraying precautions, etc.. All
required measures are consistent with the well-
established standard industry practices, with which
applicators are already familiar.
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The use of agricultural chemicals like GF-3308 is often
considered as negatively impacting the balance of
nature. The use of GF-3308 will be limited to
commercial wheat production where the benefits to
farmers, including Māori farmers, and the New
Zealand economy significantly outweigh the risks.
Environment Medium See cultural impacts.
Economy
No risk
The applicant is unable to identify any economic risk
resulting from the use of GF-3308. It is argued in this
application that this product will bring significant
benefits to the New Zealand cereal production and the
associated industries (e.g. dairy). Please refer to the
benefits section of this application.
Treaty
Principles
No risk
The applicant is unable to identify any pathway, by
which the Treaty Principles could be violated by the
application of GF-3308 when appropriate risk
management measures (as imposed by the HSNO
controls) are applied to minimise health,
environmental and cultural impacts.
Dow AgroSciences undertook a pre-application Māori consultation. We were grateful to be
given an opportunity to present GF-3308 to the Ngāi Tahu HSNO Komiti at one of their
meetings. Prior to the meeting an application summary was provided. Many questions were
addressed during the meeting; one regarding the choice of the test species for the
bioconcentration study was responded to via e-mail after the meeting (summarised in the
following paragraphs). No written comment was provided to Dow AgroSciences by the
Komiti.
The application summary was also distributed for input and comment by the EPA within Te
Herenga, the extensive National Māori Network. Te Herenga is a forum for kaitiaki and
environmental resource managers to come together and discuss important environmental
issues. Dow AgroSciences also reached out via personal communication to Ngāti Whātua
Ōrākei and Te Rūnanga-Ā-Iwi O Ngāpuhi, who made submissions for our previous
application in 2015, to bring the consultation to their attention. No comments were
received within the 3-week consultation period.
While no questions or comments were made in writing, Dow AgroSciences would like to
explain their position on a number of issues often raised for pesticide applications as well
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as those discussed at the Ngāi Tahu HSNO Komiti meeting and in the subsequent
communication.
Data provided to the EPA in confidence
On many previous occasions the confidential appendices have been accused of being a
“blanket concealment for any data deemed commercially sensitive”. In many cases the
applicants were criticised for withholding the formulation composition or the identity of the
impurities. Usually, such information cannot be provided as it is a trade secret. Disclosing
some composition related information can also generate commercial prejudice (e.g.
addresses of manufacturing plants, suppliers of ingredients, etc.).
A joint CropLife America and European Crop Protection Association report15 shows that the
cost of developing and registering new pest and disease prevention products (i.e. a novel
formulation containing one new active ingredient) was estimated at about 290 million USD,
with the cost of generating the toxicology and ecotoxicology component alone constituting
about 1/3 of this sum. It is understandable then that the R&D companies invest
considerable efforts in guarding the proprietary information.
However, no information is withheld from the EPA whose role is to impartially assess
the data, characterise the risks and impose controls.
Nevertheless, Dow AgroSciences understands the concerns and confusion resulting from
the unspecified contents of the confidential dossiers and therefore a general list of the
studies provided to EPA can be found in Section 6 of this application form (and more
information can be provided on request).
Also, study summaries for all submitted studies will be included in the public Staff Report.
Dow AgroSciences believes it would be better to conduct the consultation after the Staff
Report is released but the legislation places it pre-lodgement when it is impossible for the
Staff Report to be available.
Lastly, it is Dow AgroSciences’ belief that the Māori consultation is not undertaken with an
aim that the Māori conduct a comprehensive pre-submission data evaluation and risk
assessment but to identify all potential risks that will be carefully assessed by the EPA
during their evaluation, and the results of which will be published as the Staff Report. With
this in mind, Dow AgroSciences believe that sufficient information is provided.
15 Phillips McDougall (2016) “The Cost of New Agrichemical Product Discovery, Development & Registration in 1995, 2000, 2005-8 and 2010 to 2014. R&D expenditure in 2014 and expectations for 2019” A Consultancy Study for Crop Life America and the European Crop Protection Association.
May 2015 EPA0316
47
Application Form Approval to import or manufacture a pesticide
Formulation composition undisclosed
As noted above, the formulation composition and the impurity profile for fenpicoxamid, as
well as other chemistry and manufacturing information (e.g. manufacturing methods,
addresses of manufacturing sites, etc.) are provided to the EPA in confidence and usually
constitute a trade secret.
However, since GF-3308 is protected by a US patent, the formulation design is disclosed
in the patent documentation. Section 7.2 above explains that the necessary excipients in
GF-3308, which contribute to its hazard classification include the following materials: a
reaction mass of N,N-Dimethyloctan-1-amide and N,N-Dimethyldecan-1-amide,