APVMA Gazette no. 2, 29 January 2013

No. APVMA 2, Tuesday, 29 January 2013

Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The

Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette. A reference to Agvet

Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 2, Tuesday, 29 January 2013 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2013

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any

process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

The Manager, Public Affairs

The Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

The APVMA Gazette is published in electronic format only and is available from the APVMA website,

www.apvma.gov.au/publications/gazette/.

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4871

For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

mailto:[email protected]

http://www.apvma.gov.au/

http://www.apvma.gov.au/publications/gazette/


CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 10

Notice – New Agricultural Active Constituent 14 Flonicamid ............................................................................................................................................................................ 14

Notice – Revision To Existing APVMA Standard For Active Constituents 17 Thiacloprid ............................................................................................................................................................................ 17

Other Notices 20 Continued suspension of products containing 2,4-D ethyl, butyl and isobutyl esters and all associated label approvals ..... 20 Addendum to the Record of Approved Active Constituents .................................................................................................. 27 Application Summaries ......................................................................................................................................................... 28


Notice of Registrations – Agricultural Chemical Products

NOTICE OF REGISTRATIONS

Agricultural Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

1. RESTRICTED PRODUCT

Product Name: Rainbow Bifenthrin 100 EC Insecticide And Miticide

Active Constituent/s: 100g/L bifenthrin

Applicant Name: Shandong Rainbow International Co., Ltd.

Applicant ACN: N/A

Summary of Use: For use as an insecticide and miticide when installing chemical soil barriers for new building work, post-construction management of subterranean termites and the control of a large range of other urban pests

Date of Registration: 15 January 2013

Label Approval No: 68183/57730

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Antagonist Pro Residual Ant Insecticide


Applicant Name: Sundew Solutions Pty Ltd

Applicant ACN: 135 400 261

Summary of Use: For control of a range of ant species in external urban areas



Product Name: Astral 250EC Insecticide/Miticide


Applicant Name: Crop Care Australasia Pty Ltd


Summary of Use: For control of insect pests and mites in a range of broadacre and horticultural crops



Product Name: CPPU 10 Plant Growth Regulator

Active Constituent/s: 10g/L forchlorfenuron

Applicant Name: Ronic International Pty Limited


Summary of Use: For increasing berry size in table grapes





Product Name: FMC Trifluralin 480 Selective Herbicide

Active Constituent/s: 480g/L trifluralin

Applicant Name: FMC Australasia Pty Ltd


Summary of Use: For the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops



Product Name: Albatross 200SC Insecticide

Active Constituent/s: 200g/L fipronil

Applicant Name: Farmoz Pty Limited


Summary of Use: For the control of various insect pests in brassicas, cotton, wine grapes, potatoes and sugarcane



Product Name: FMC 2,4-D LV Ester 680 Herbicide

Active Constituent/s: 680g/L 2,4-D present as the ethylhexyl ester



Summary of Use: For selective control of various weeds in crops, pastures and non-agricultural areas



Product Name: Novaguard Lambda 250 CS Insecticide

Active Constituent/s: 250g/L lambda-cyhalothrin

Applicant Name: Novaguard Pty Ltd


Summary of Use: For the control of certain insect pests in cotton, barley, wheat and various field crops



Product Name: Apparent Propyzamide 500 SC Herbicide

Active Constituent/s: 500g/L propyzamide

Applicant Name: Apparent Pty. Ltd.


Summary of Use: For the control of certain grasses and broad leaf weeds in lettuce, sports turf, home lawns and legumes seed crops and pastures



Product Name: Barmac Delta Force Pest Strips

Active Constituent/s: 186g/kg Dichlorvos (an anticholinesterase compound)

Applicant Name: Barmac Pty Ltd


Summary of Use: For the control of flying and crawling insects





Product Name: Fury 120 EW General Household Insecticide

Active Constituent/s: 80g/L bifenthrin, 40g/L alpha-cypermethrin



Summary of Use: For control of a range of urban pests including ants, clothes moths, cockroaches, flies, fleas, papernest wasps and spiders



Product Name: Smart Tralkoxydim WG Herbicide

Active Constituent/s: 400g/kg tralkoxydim

Applicant Name: Crop Smart Pty Ltd


Summary of Use: For the control of wild oats and annual ryegrass and suppression of annual phalaris in wheat, barley, rye and triticale.



Product Name: ACP Mancozeb 750 WG Fungicide

Active Constituent/s: 750g/kg mancozeb

Applicant Name: Australis Crop Protection Pty Ltd


Summary of Use: For the control of certain fungus diseases of fruit, field crop, tobacco, turf, vegetables and ornamentals



Product Name: Novaguard Propiconazole 250 EC Fungicide

Active Constituent/s: 250g/L propiconazole



Summary of Use: For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugarcane, wheat and other crops



Product Name: Pacific Clethodim 240 EC Selective Herbicide

Active Constituent/s: 240g/L clethodim

Applicant Name: Pacific Agriscience Pty Ltd


Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans



Product Name: Sirdar Glyphosate 360 Weed Killer

Active Constituent/s: 360g/L glyphosate present as the isopropylamine salt

Applicant Name: John Danks & Son Pty Ltd


Summary of Use: For control of annual and perennial weeds in residential areas





Product Name: Amgrow Weedkiller Ready To Use

Active Constituent/s: 7.2g/L glyphosate present as the isopropylamine salt

Applicant Name: Amgrow Pty Ltd


Summary of Use: For non-selective weed control in home garden situations



Product Name: Imtrade Top Cat Rodenticide Wax Blocks

Active Constituent/s: 0.05g/kg brodifacoum

Applicant Name: Imtrade Australia Pty Ltd


Summary of Use: For the control of rats and mice in damp or dry situations in and around industrial, commercial, agricultural and domestic buildings, exterior and interior of buildings and structures



Product Name: Novaguard Trifluralin 480 Herbicide

Active Constituent/s: 480g/L trifluralin



Summary of Use: For the control of annual grasses and certain broadleaf weeds in certain horticultural and agricultural crops



Product Name: Ospray LVE 600 MCPA Herbicide

Active Constituent/s: 600g/L MCPA present as the ethyl hexyl ester

Applicant Name: Ospray Pty Ltd


Summary of Use: For the selective control of certain broadleaf weeds in cereals and grass pastures



Product Name: Wellfarm Metsulfuron-methyl 600 WG Herbicide

Active Constituent/s: 600g/L metsulfuron-methyl

Applicant Name: Wellfarm Proprietary Limited


Summary of Use: For selective control of many annual and broadleaf weeds and plants in a range of situations



Product Name: KDPC Marker Dye Blue

Active Constituent/s: 90g/L sulphonate aromatic acid dye

Applicant Name: KD Plant Care Pty Ltd


Summary of Use: For use as a spray marker dye and foam marker colouring agent





Product Name: Accensi Glyphosate 450 SSD Herbicide

Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt

Applicant Name: Accensi Pty Ltd


Summary of Use: For non-selective control of various annual and perennial weeds



Product Name: EzyCrop Imidacloprid 600 Seed Treatment Insecticide

Active Constituent/s: 600g/L imidacloprid

Applicant Name: EzyCrop Pty Ltd


Summary of Use: For the control of various insect pests in a range of crops and the protection of spread of barley yellow dwarf virus in cereal crops



Product Name: Agro-Essence Haloxyfop 520 Herbicide

Active Constituent/s: 520g/L haloxyfop present as the haloxyfop-R-methyl ester

Applicant Name: Agro-Alliance (Australia) Pty Ltd


Summary of Use: For the post-emergent control of a wide range of annual and perennial grass weeds in grain legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops



3. VARIATIONS

Product Name: Rainbow Glyphosate 450 Herbicide

Applicant Name: Shandong Rainbow International Co., Ltd.

Applicant ACN: N/A

Summary of Variation: To remove the use of the product in aquatic situations

Date of Variation: 11 January 2013


Product Name: Pool Algaecide Salt Pool Protector

Applicant Name: Biolab Australia Pty Ltd


Summary of Variation: To change the product name from BIOGUARD PROTECTOR ALGAE INHIBITOR SALT POOL ALGAECIDE to POOL ALGAECIDE SALT POOL PROTECTOR





Product Name: Dalapon 740 SP Systemic Grasskiller

Applicant Name: Agricrop Pty Ltd


Summary of Variation: To change the product name from AGRICROP PROPON SYSTEMIC GRASSKILLER to DALAPON 740 SP SYSTEMIC GRASSKILLER



Product Name: Lannate-L Insecticide

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Variation: To include additional uses of adzuki beans, rapeseed, lettuce and armyworms in sweetcorn



Product Name: Ravensdown Diuron 900 WG Herbicide

Applicant Name: Ravensdown Fertiliser Co-Operative Limited


Summary of Variation: To change the product name from UNITED FARMERS DIURON 900 WG HERBICIDE to RAVENSDOWN DIURON 900 WG HERBICIDE



Product Name: Fipforce Aqua Termiticide & Insecticide

Applicant Name: Sherwood Chemicals Public Company Limited

Applicant ACN: N/A

Summary of Variation: To change the product name from 'FIPFORCE AQUA TERMITICIDE' to 'FIPFORCE AQUA TERMITICIDE & INSECTICIDE', to extend the use to include control of nuisance and nesting ants, to instigate a pack size range and to update the label particulars




Notice of Registrations – Veterinary Chemical Products

Veterinary Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals

Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following

products, with effect from the dates shown.

4. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Renal With Tuna Feline

Active Constituent/s: N/A

Applicant Name: Royal Canin Australia Pty Ltd


Summary of Use: To support renal function in cats with chronic or temporary renal insufficiency under veterinary supervision



Product Name: Mastylo Tylosin Injection

Active Constituent/s: 200mg/mL tylosin

Applicant Name: Pfizer Animal Health Australia Pty Ltd


Summary of Use: For treatment of organisms sensitive to tylosin in cattle and pigs



Product Name: Colix Injection

Active Constituent/s: flunixin meglumine equivalent to 50mg/mL flunixin

Applicant Name: Randlab Australia Pty Ltd


Summary of Use: For use in horses, cows, pigs and dogs as an anti-inflammatory agent with analgesic and anti-pyretic activity



Product Name: Elanco Cyrex Liquid Sheep Blowfly and Lice Treatment

Active Constituent/s: 12.5g/L spinosad, 500g/L cyromazine

Applicant Name: Elanco Animal A Div of Eli Lilly Aust Pty Ltd


Summary of Use: For the control of body lice on sheep with long wool and for treatment and prevention of blowfly strike



5. VARIATIONS

Product Name: Sensitivity Control SC 21 Canine

Applicant Name: Royal Canin Australia Pty Ltd


Summary of Variation: To change name from 'SENSITIVITY CONTROL SC 24 BLUE WHITING & TAPIOCA CANINE' to 'SENSITIVITY CONTROL SC 21 CANINE' and variation to label approval





Product Name: Aristopet Animal Health Bouquet Flea & Tick Rinse Concentrate for Dogs, Cats, Puppies, Kittens & Caged Birds

Applicant Name: Beaphar Australia Pty Ltd


Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR BOUQUET FLEA & TICK RINSE CONCENTRATE FOR DOGS, CATS, PUPPIES, KITTENS & CAGED BIRDS to ARISTOPET ANIMAL HEALTH BOUQUET FLEA & TICK RINSE CONCENTRATE FOR DOGS, CATS, PUPPIES, KITTENS & CAGED BIRDS



Product Name: Aristopet Animal Health All Wormer Paste for Cats & Kittens



Summary of Variation: Variation of registered particulars and RLP to change name from BEAPHAR ALL WORMER PASTE FOR CATS & KITTENS to ARISTOPET ANIMAL HEALTH ALL WORMER PASTE FOR CATS AND KITTENS



Product Name: Aristopet Animal Health Bouquet Flea & Tick Shampoo for Dogs, Cats, Puppies & Kittens



Summary of Variation: Variation of registered particulars & RLP to change product name from BEAPHAR BOUQUET FLEA & TICK SHAMPOO FOR DOGS, CATS, PUPPIES & KITTENS to ARISTOPET ANIMAL HEALTH BOUQUET FLEA & TICK SHAMPOO FOR DOGS, CATS, PUPPIES & KITTENS


Label Approval No: 47224.57090

Product Name: Aristopet Animal Health Heartworm Tablets 400mg for Dogs



Summary of Variation: Variation of registered particulars and RLP to change name from BEAPHAR HEARTWORM TABLETS 400MG FOR DOGS to ARISTOPET ANIMAL HEALTH TABLETS 400MG FOR DOGS



Product Name: Aristopet Animal Health Fly Repellent Spray



Summary of Variation: Variation of registered partiiculars and RLP to change product name from BEAPHAR FLY REPELLENT SPRAY FOR DOGS AND HORSES to ARISTOPET ANIMAL HEALTH FLY REPELLENT SPRAY FOR DOGS AND HORSES



Product Name: Aristopet Animal Health All Wormer for Large Dogs



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR ALL WORMER FOR LARGE DOGS to ARISTOPET ANIMAL HEALTH ALL WORMER FOR LARGE DOGS





Product Name: Aristopet Animal Health Multi-Wormer for Dogs, Cats, Puppies and Kittens



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR MULTI-WORMER FOR DOGS, CATS, PUPPIES AND KITTENS to ARISTOPET ANIMAL HEALTH MULTI-WORMER FOR DOGS, CATS, PUPPIES AND KITTENS



Product Name: Aristopet Animal Health All Wormer for Dogs and Puppies



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR ALL WORMER FOR DOGS AND PUPPIES to ARISTOPET ANIMAL HEALTH ALL WORMER FOR DOGS AND PUPPIES



Product Name: Aristopet Animal Health Flea Powder for Dogs, Cats, Puppies, & Kittens



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR FLEA POWDER FOR DOGS, CATS, PUPPIES, & KITTENS to ARISTOPET ANIMAL HEALTH FLEA POWDER FOR DOGS, CATS, PUPPIES, & KITTENS



Product Name: Aristopet Animal Health Heartworm Tablets 200mg for Dogs



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR HEARTWORM TABLETS 200MG FOR DOGS to ARISTOPET ANIMAL HEALTH HEARTWORM TABLETS 200MG FOR DOGS



Product Name: Aristopet Animal Health Flea & Tick Shampoo for Dogs, Cats, Puppies and Kittens



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR FLEA & TICK SHAMPOO FOR DOGS, CATS, PUPPIES AND KITTENS to ARISTOPET ANIMAL HEALTH FLEA & TICK SHAMPOO FOR DOGS, CATS, PUPPIES AND KITTENS



Product Name: Aristopet Animal Health Cat & Kitten All Wormer Tablets



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR CAT & KITTEN ALL WORMER TABLETS to ARISTOPET ANIMAL HEALTH CAT & KITTEN ALL WORMER TABLETS





Product Name: Aristopet Animal Health Heart Shield Chewable for Dogs



Summary of Variation: Variation of registered particulars and RLP to change product name from BEAPHAR HEART SHIELD CHEWABLE FOR DOGS to ARISTOPET ANIMAL HEALTH HEART SHIELD CHEWABLE FOR DOGS



Product Name: Aristopet Animal Health Worming Syrup for Puppies & Kittens



Summary of Variation: Variation of registered particulars and RLP to change name from BEAPHAR WORMING SYRUP FOR PUPPIES & KITTENS to ARISTOPET ANIMAL HEALTH WORMING SYRUP FOR PUPPIES & KITTENS



6. LISTED PRODUCT VARIATION

Product Name: Aristopet Animal Health Glucosamine Tablets for Dogs



Summary of Variation: Variation to listed particulars to change product name from BEAPHAR GLUCOSAMINE TABLETS FOR DOGS to ARISTOPET ANIMAL HEALTH GLUCOSAMINE TABLETS FOR DOGS.


Product No: 62736

Product Name: Aristopet Animal Health Joint Health Tablets for Dogs



Summary of Variation: Variation of listed particulars to change product name from BEAPHAR JOINT HEALTH TABLETS FOR DOGS to ARISTOPET ANIMAL HEALTH JOINT HEALTH TABLETS FOR DOGS


Product No: 63721


Notice – New Agricultural Active Constituent—Flonicamid

NOTICE – NEW AGRICULTURAL ACTIVE CONSTITUENT

Flonicamid

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Ishihara Sangyo

Kaisha Ltd for the approval of a new active constituent, flonicamid.

Flonicamid is a pyridinecarboxamide compound, with novel systemic insecticidal properties. It has selective activity

against hemipterous pests, such as aphids and whiteflies, and thysanopterous pests and is under development as a

foliar, selective aphicide.

Common Name: Flonicamid

IUPAC Name: N-cyanomethyl-4-(trifluoromethyl)nicotinamide

CAS Name: N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridincarboxamide

CAS Registry Number: 158062-67-0

Manufacturer’s Codes: IKI-220

Minimum Purity: 960 g/kg

Molecular Formula: C9H6F3N3O

Molecular Weight: 229.2

Structure:

Chemical Family:

pyridinecarboxamide compounds

Mode of Action: insecticide

SUMMARY OF THE APVMA’S EVALUATION OF FLONICAMID ACTIVE CONSTITUENT

The Pesticides Program of the APVMA has evaluated the chemistry aspects of Flonicamid active constituent

(manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be

acceptable.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active

Constituent Standard be established for Flonicamid active constituent:

N

CF3

CONHCH2CN



Constituent Specification

Flonicamid Flonicamid: 960 g/kg minimum

Other compounds of toxicological significance are not expected to occur in the flonicamid Technical Grade Active

Constituent (TGAC).

The Office of Chemical Safety (OCS) has completed a toxicological evaluation of flonicamid.

An Acute Reference Dose (ARfD) of 0.025 mg/kg bw has been set, based on a No-Observed Effect Level (NOEL) of 2.5

mg/kg bw/day in a rabbit developmental study for developmental toxicity, after applying a 100-fold safety factor.

The National Drugs and Poisons Scheduling Committee (NDPSC) have considered flonicamid to be appropriate for

inclusion in Schedule 6 (six) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

The OCS has indicated that there are no objections on toxicological grounds to the approval of the active constituent

flonicamid.

The APVMA accepts the findings and recommendations of its advisers on these criteria.

The APVMA is satisfied that the proposed importation and use of flonicamid would not be an undue toxicological hazard

to the safety of people exposed to it during its handling and use.

MAKING A SUBMISSION

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of Flonicamid should be granted. Submissions should relate only to matters

that the APVMA is required by legislation to consider in deciding whether to grant the approval. These grounds include

chemistry and manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments

received outside these grounds cannot be considered by the APVMA.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post. A summary of relevant

comments and the APVMA’s response will be published on the APVMA website.

When making a submission please include a:

contact name

company or group name (if relevant)

postal address

email address (if available)

the date you made the submission.

All personal and sensitive1 material contained in submissions will be treated confidentially.

1 A full definition of ‘Sensitive’ is contained in the Agvet Code.

http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1



Written submissions on the APVMA’s proposal to grant approval for Flonicamid that relate to the grounds for approval

should be sent by email to [email protected], or by mail to:

Manager, Pesticides Chemistry Evaluation Section

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Enquiries:

Phone: +61 2 6210 4936

Fax: +61 2 6210 4840





Notice – Revision To Existing APVMA Standard For Active Constituents—Thiacloprid

NOTICE – REVISION TO EXISTING APVMA STANDARD FOR ACTIVE CONSTITUENTS

Thiacloprid

The Australian Pesticides and Veterinary Medicines Authority (APVMA) invites comment on proposed changes to the

current standard for the active constituent thiacloprid. The purpose of the change is to update the standard in accordance

with the FAO standard published in 2010.

DESCRIPTION OF THE CHANGE TO THE APVMA STANDARD FOR THIACLOPRID ACTIVE CONSTITUENT

Change to sections:

1. (Description) from:

The material shall consist of thiacloprid together with related manufacturing impurities and shall be a yellow

powder, free from visible extraneous matter and added modifying agents.

to:

The material shall consist of thiacloprid together with related manufacturing impurities, in the form of a white to

light brown coloured crystalline powder, free from visible extraneous matter and added modifying agents.

6.1 (Composition) from:

Active constituent: 985 g/kg minimum

to:

Active constituent: 975 g/kg minimum

This revision is to fall in line with the 2010 FAO standard for content thiacloprid available at

www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Specs/Thiacloprid_2010.pdf

PARTICULARS OF THE ACTIVE CONSTITUENT:

Common Name: thiacloprid

IUPAC Name: (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide

CAS Name: (Z)-[3-[(6-chloro-3-pyridinyl)methyl]-2-thiazolidinylidene]cyanamide

CAS Registry Number: 111988-49-9

Current APVMA Minimum

published Purity:

985 g/kg

Revised APVMA Minimum

Purity:

975 g/kg

Molecular Formula: C10H9ClN4S

Molecular Weight: 252.7

http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Specs/Thiacloprid_2010.pdf



THE PROPOSED REVISED STANDARD WILL BE AS FOLLOWS:

Version 2—Standard for thiacloprid active constituent

1. Description: The material shall consist of thiacloprid together with related manufacturing impurities, in the form of a

white to light brown coloured crystalline powder, free from visible extraneous matter and added modifying agents.

2. Common Name: thiacloprid

3. Chemical Name (IUPAC): (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide

4. CAS Number: 111988-49-9

5. Identity test: identity of the active constituent must be established by one or more of the following methods:

spectroscopic tests (IR spectrum, NMR, mass spectra), Chromatography (HPLC or GC retention time with reference

compound) or any other suitable test method.

6. Composition

6.1 Active constituent: 975 g/kg minimum

7. Analytical methods

The analytical method used for the determination of the active constituent and toxicological significant impurities

must be validated in accordance with the APVMA guidelines for the validation of analytical methods.

The APVMA guidelines on validation of analytical methods state that “Analytical methods described in CIPAC

handbooks and AOAC International Manual, and in recognized pharmacopoeias [BP, BP (Vet), Ph Eur and

USP] for a particular active constituent or formulation are regarded as validated and do not require revalidation.

However, the suitability of these methods must be verified under actual conditions of use i.e., the selectivity and

accuracy of the method should be demonstrated for the published method when applied to the relevant sample

matrix and laboratory conditions.

When a CIPAC or AOAC method is used for the assay of an active constituent in a bulk active constituent, there

is no matrix. The registrants need to check the specificity of the method to ensure there is no interference from

impurities or degradation products. However, determination of accuracy of the method is not required as there is

no matrix effect. However, when a CIPAC or AOAC method is used for the assay of an active constituent in a

formulated product, determination of both specificity and accuracy is required as the matrix is relevant in

formulated products (formulated products have different composition and quantities of excipients).

Refer to Guidelines for the Validation of Analytical Methods for Active Constituent, Agricultural And Veterinary

Chemical Products (PDF, 164kb).

Unless the scope of the collaborative method (CIPAC and AOAC) also includes toxicological significant

impurities in the active constituent, validation data for impurities are required.

AOAC: Association of Official Analytical Chemists (The Official Methods of Analysis)

CIPAC: Collaborative International Pesticides Analytical Council

MAKING A SUBMISSION

The APVMA invites any person to submit a relevant written submission as to whether the proposed amendment to the

APVMA standard should be granted. Submissions should relate only to matters that the APVMA is required by

http://www.apvma.gov.au/publications/guidelines/docs/gl_69_analytical_methods.pdf

http://www.apvma.gov.au/publications/guidelines/docs/gl_69_analytical_methods.pdf



legislation to consider in deciding whether to publish the intended revision. These grounds include chemistry and

manufacture, and toxicity. Submissions should state the grounds on which they are based. Comments received

outside these grounds cannot be considered by the APVMA.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include a:

contact name

company or Group name (if relevant)

email or postal address

the date you made the submission.

All personal and confidential commercial information (CCI)2 material contained in submissions will be treated

confidentially.

Written submissions on the APVMA’s proposal to revise the APVMA standard for thiacloprid that relate to the grounds for

approval can be sent by email to: [email protected], or by mail to

Manager, Pesticides Chemistry Evaluation Section


PO Box 6182

KINGSTON ACT 2609

Enquiries:

Phone: +61 2 6210 4936

Fax: +61 2 6210 4840


2 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.



http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1


Other Notices – Continued suspension of products containing 2,4-D ethyl, butyl and isobutyl esters and all associated label approvals

OTHER NOTICES

Continued suspension of products containing 2,4-D ethyl, butyl and isobutyl esters and all associated label approvals

The APVMA has extended the period of suspension of the registrations and label approvals of products containing 2,4-D

ethyl, butyl and isobutyl esters (referred to as 2,4-D HVE hereafter) identified in the table below. The decisions to

suspend the registrations and label approvals were made under subsections 41(1) and 41(3) of the Agricultural and

Veterinary Chemicals Code Act 1994 (Agvet Code).

Table 1: Product registrations and label approvals suspended

APVMA Approval

No.

Product Name Registrant Label Approval No.

31209 Nufarm Estercide 800 Herbicide Nufarm Australia Limited 31209/0705, 31209/0902,

31209/0998, 31209/0498,

31209/1197, 31209/01

51110 CHEMAG ESTER 800 HERBICIDE IMTRADE AUSTRALIA PTY LTD 51110/0805, 51110/0998

52322 SIPCAM SIESTER 800 HERBICIDE SIPCAM PACIFIC AUSTRALIA

PTY LTD

52322/1005, 52322/0805,

52322/0103, 52322/0200

52591 4FARMERS 2,4-D ESTER 800

HERBICIDE

4FARMERS PTY LTD 52591/0805, 52591/0300

53169 DISTRIBUTION 2,4-D ESTER 800

HERBICIDE

GROW CHOICE PTY LIMITED 53169/0600, 53169/0304,

53169/0805

53699 UNITED FARMERS ESTER 800

HERBICIDE

UNITED FARMERS CO-

OPERATIVE COMPANY

PTY LTD

53699/0206, 53699/0503,

53699/0301, 53699/0905

54595 HALLEY 2,4-D ESTER 800 HERBICIDE HALLEY INTERNATIONAL

ENTERPRISE (AUSTRALIA)

PTY LTD

54595/0805, 54595/0903,

54595/0901

54925 CONQUEST ESTER 800 SELECTIVE

HERBICIDE

CONQUEST CROP

PROTECTION PTY LTD

54925/0805, 54925/0302,

54925/0102

54954 KENSO AGCARE KEN-ESTER 800

HERBICIDE

KENSO CORPORATION (M)

SDN. BHD.

54954/0805, 54954/1201

55079 WSD 2,4-D ESTER 800 HERBICIDE REBOP HOLDINGS PTY LTD

T/A WESTERN STOCK

DISTRIBUTORS

55079/0905, 55079/1201

56764 CROP CARE ESTER 800 SELECTIVE

HERBICIDE

CROP CARE AUSTRALASIA

PTY LTD

56764/0705, 56764/0203

56895 ROTAM 2,4-D ESTER 800 HERBICIDE ROTAM AUSTRALASIA PTY LTD 56895/0805, 56895/0403

58919 CROWN 2,4-D ETHYL ESTER 800

SELECTIVE HERBICIDE

CORONA INDUSTRIES PTY LTD 58919/0805, 58919/0105



APVMA Approval

No.

Product Name Registrant Label Approval No.

59653 GENFARM 2,4-D ESTER 800 EC

HERBICIDE

GENFARM CROP PROTECTION

PTY LTD

59653/0605

60523 DOW AGROSCIENCES ESTER 800

HERBICIDE

DOW AGROSCIENCES

AUSTRALIA LIMITED

60523/1105

The suspensions are in effect until 31 January 2014.

REASONS

The APVMA has decided that the continued use of, or other dealings with products containing 2,4-D HVE in accordance

with current label instructions may be likely to have an unintended effect that is harmful to animals, plants or things or to

the environment. In addition, the APVMA has decided that the instructions on currently approved labels for the products

may no longer be adequate.

Since 26 September 2006, registrations of products containing 2,4-D HVE and associated label approvals have been

suspended primarily because of concerns about damage to non-target crops and vegetation from HVE vapour drift. The

APVMA has issued instructions for dealing with and using suspended products during the spray window between 1 May

and 31 August. Application of 2,4-D HVE only within this spray window would minimise the risk of unintended harmful

effects to native vegetation and susceptible crops.

INSTRUCTIONS FOR POSSESSING, HAVING CUSODY OF, USING OR DEALING WITH SUSPENDED PRODUCTS

OR PRODUCT CONTAINING THE SUSPENDED LABELS

Subsections 45A(5) and 55(3) of the Agvet Code cease to apply in respect of the products identified in the table above.

During the period of suspension, a person may not possess, have custody of, use or deal with any of the products other

than in accordance with:

the instructions set out at the end of this Notice; and

a permit issued by the APVMA (PER13339).

WARNING

From 1 February 2013 a person may only possess, have custody of, use or otherwise deal with the products identified

above in accordance with any permit issued by the APVMA and the instructions set out at the end of this Notice (see

Attachment 1).

Depending on further information that may be received and assessed for the ongoing review of 2,4-D products, the

APVMA may cancel any permit(s) and issue replacement permit(s) at any time prior to the expiry dates on the permits.

Before using, supplying or otherwise dealing with products containing 2,4-D HVE, suppliers and users need to be

satisfied that the instructions set out at the end of this Notice continue to apply, and that their activities are authorised by

a permit. Current permits are available at www.apvma.gov.au/permits/search.php

Failure to comply with the instructions set out at the end of this Notice attracts a penalty under section 55(4) of the Agvet

Code. The penalty is 300 penalty units ($33,000).

http://www.apvma.gov.au/permits/search.php



ATTACHMENT:

ATTACHMENT 1: Instructions for using or dealing with suspended products.

APVMA CONTACT

For any queries or further information about this matter, please contact:

Manager, Chemical Review


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4749

Fax: +61 2 6210 4776


ATTACHMENT 1:INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING, OR DEALING WITH

SUSPENDED PRODUCTS, OR PRODUCTS CONTAINING THE SUSPENDED LABELS.

Possession and custody

A person may possess, have custody of, use, or otherwise deal with the product, or product containing a suspended

label only in accordance with these instructions.

Supply

Product may only be supplied, if a copy of the instructions contained in this notice is securely affixed to the container.

Use

These instructions apply to the use of products containing 2,4-D ethyl, butyl or isobutyl ester during the period of

suspension in all states and territories.

READ THESE INSTRUCTIONS before using or otherwise handling the product.

When using or otherwise handling the product, follow these instructions.

Other than as specified below, the products must be used in accordance with the instructions on the label attached to the

container. Where the below instructions are inconsistent with the label instructions, the instructions in this notice (below)

must be followed.

In all states and territories the following are new DIRECTIONS FOR USE:

RESTRAINTS:

This is a PHENOXY HERBICIDE that can cause severe damage to native vegetation and susceptible crops such as

cotton, grapes, tomatoes, oilseed crops and ornamentals.

DO NOT apply this product between 1 September and 30 April, unless authorised by an APVMA permit. Use of the

product may only occur between 1 May and 31 August.




DO NOT apply this product by air.

DO NOT apply this product

in aquatic situations

to sugar cane

to rights of way

as a harvest aid/salvage spray

DO NOT apply more than 800 g ae/ha (1L of this product per ha) (ae=acid equivalent)

DO NOT apply if crop or weeds are stressed due to dry or excessively moist conditions.

DO NOT use unless wind speed is more than 3 kilometres per hour and less than 15 kilometres per hour as measured at

the application site.

DO NOT apply with smaller than Coarse spray droplets according to the ASAE S572 definition for standard nozzles.

DO NOT use if rain is likely within 6 hours.

DIRECTIONS FOR USE - FIELD CROPS AND PASTURES

Situation & Crop

Weeds State Rate Withholding Period (days)

Critical Comments

Wheat, Barley Refer ro Weed Table on product label

Vic only 180-700mL/ha 7

CROP STAGES: ALL CEREALS Apply at tillered to boot stages. (Vic only) (DC 30-39) Apply when the first node can be felt at the base of the tiller and before swelling of the head can be felt in a tiller. (NSW only) Apply from mid-tillering to before boot stage. (Qld only) Apply from completion of tillering to early jointing stage. (SA only) Apply from the 5 leaf stage up to jointing stage (Zadoks 15-33). Apply only at 6 leaf stage for cranbrook and jacup wheats (Zadoks 16) to avoid possible damage (WA only).

Qld, NSW only

350-700mL/ha

SA only 200-700mL/ha

WA only 700mL/ha

Triticale Qld, NSW only

350-700mL/ha

SA only 200-700mL/ha

Vic, NSW only

180-700mL/ha

Cereal Rye Qld, NSW only

350-700mL/ha

Vic only 180-700mL/ha



Situation & Crop

Weeds State Rate Withholding Period (days)

Critical Comments

Pastures - Direct Drilling or Surface Sowing

Charlock, Clover, Medics, Mustards, Paterson’s Curse, Saffron, Slender, Variegated and Spear Thistles, Turnip Weed, Wild Radish, Wild Turnip, Capeweed, Wireweed, Storksbill / Erodium, Flatweed, Horehound (seedlings), Skeleton Weed, Nodding or Star Thistles

Qld, WA, Vic NSW only

700mL-1L/ha

7 Apply to young, actively growing weeds. SOWING: Do not sow pasture seeds for at least 21 days after application. If soil moisture is dry, delay sowing for at least 30 days.

All of the above plus grasses

As above plus other herbicide such as glyphosate

Improved Pasture containing Clover

Refer Weed Table Qld, NSW, SA only

350-700mL/ha 7 Clover must be well covered by the grass or extensive damage may result.

Pastures - non legumes,

Refer Weed Table NOTE: the following weeds may not be controlled at these rates Apple of Sodom Black Knapweed Buffalo Burr Colocynth Galvanised Burr Hard Head / Russian Knapweed Nut Grass St Johns Wort Sand Mustard /Sand Rocket Silverleaf Nightshade Thistle - Golden - Nodding - Soldier - Stemless Wild Sage Wild Teasel

Qld, Vic, NSW, SA, WA only

700mL-1L/ha Control of most perennial weeds, but due to the rooting habits of most species control may take a number of years. Damage may result to legumes in pasture.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THESE INSTRUCTIONS UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.



WITHHOLDING PERIOD: PASTURE, CEREAL CROPS - DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 7 DAYS AFTER APPLICATION.

ADDITIONAL INSTRUCTIONS Buffer zones

Use only Coarse to Very Coarse spray quality according to ASAE S572 definition for standard nozzles, and a buffer zone

of 100 m between field edges and downwind water bodies, native vegetation and sensitive crops.

Permissible Dates of Application of 2,4-D High Volatile Esters

Application of 2,4-D ethyl ester, butyl ester or isobutyl ester must only take place during a spray window between 1 May

and 31 August.

Victoria, Western Australia, Tasmania and Queensland currently have mechanisms whereby the use of specific

chemicals (including 2,4-D) is restricted to geographical areas and/or time zones due to the higher risk for adverse off-

target crop or environmental effects. These state restrictions on 2,4-D use may place additional requirements on users

within this spray window between 1 May and 31 August, for example, length of the spray window and spray equipment.

Users must consult their local authority or department of agriculture to ensure they meet state requirements.

Application of 2,4-D only within this spray window will minimise the risk of unintended harmful effects to native vegetation

and susceptible crops. Avoid spraying upwind of nearby susceptible crops.

RECORD KEEPING REQUIREMENTS

Within 24 hours of completing a 2,4-D ethyl, butyl or isobutyl ester application all users must make and keep a record of

each application. The details required in a 2,4-D ester spray record must contain at least the information set out below. It

is recommended and considered good practice, that the grower collects from any person acting on his or her behalf a

copy of the 2,4-D ester spray record. (For convenience, a 2,4-D record-keeping form can be obtained from the Australian

Pesticides and Veterinary Medicines Authority website.)

General:

Name and address of farm owner (or grower if grower is not owner)

Name and address of person who applied 2,4-D

Date of application

Whether neighbours have been notified Y/N (this is not a mandatory requirement)

Map of farm with treated field or paddock outlined on map and field number or name indicated

Area of field or paddock sprayed with 2,4-D

Crop/situation and Pest Details:

Name of crop/situation Major types of pests present Pest stage of growth

Weather Conditions at Application Site:

Conditions at time of application (showers, overcast, partly cloudy, clear sky, inversion conditions)

Temperature and humidity at time of application

Wind speed and direction at beginning of application

Wind consistency (gusty/steady breeze, direction steady/variable)

Whether wind direction changed during application and to where

Whether wind speed changed during application and to what

Application Details:

Sprayer pressure used Equipment and type of nozzles used

Speed of ground application equipment

Product name or unique APVMA approval number

Amount of 2,4-D product applied per hectare

Total volume of spray mixture applied per hectare

Any additives used in mixture and rate of use

Time at beginning of application Time at end of application



A statement saying the information on this record is accurate and correct, followed by the signature of the user.

Warning

These products are unregistered and labels are not approved during the period of suspension. A person must not

possess with the intent to supply, or deal with any of these products during this period except in accordance with the

instructions contained in this notice. A failure to comply with them will result in an offence against the Agvet Codes and

the APVMA will take appropriate compliance action.


Other Notices – Addendum to the Record of Approved Active Constituents

Addendum to the Record of Approved Active Constituents

The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the

APVMA website, www.apvma.gov.au

APPROVED SINCE GAZETTE NO. 1, 15 JANUARY 2013

For use in agricultural and/or veterinary chemical products:

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

Alpha-cypermethrin AIMCO KR

AUSTRALIA PTY LTD

AIMCO PESTICIDES LIMITED

B 1/1 MIDC INDUSTRIAL AREA,

LOTE PARSHURAM, PB NO. 9, VILLAGE

AWASHI

DISTRICT RATANGIRI 415 707

MAHARASHTRA

INDIA

68290

APVMA CONTACT

For further information please contact:

Application Management and Enquiries


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721



Other Notices – Application Summaries

Application Summaries

The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are published in

weekly instalments using the date the application was accepted for assessment. If an application summary has been

amended, the APVMA will publish the amended version on the website and list it separately in the APVMA Gazette Notice

for Application Summaries.

As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.

A summary will be removed from the website 28 days after the application has been finalised. Therefore, some summaries

published in this notice may have already been removed prior to the Gazette being published.

APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO. 1, 15 JANUARY 2013

Application No. Name

56704 NOT AVAILABLE

57056 NOT AVAILABLE

57238 NOT AVAILABLE

57675 CONCENTRATE ADVANCE ROUNDUP WEEDKILLER

57728 CAMPBELL MAGNATE 500EC FUNGICIDE

58207 MACSPRED CLOMAC HERBICIDE

58232 TITAN FLUMETSULAM 800 WG HERBICIDE

58336 RAINBOW DIFENOCONAZOLE 250 EC FUNGICIDE

58446 FARMALINX LAUNCHER PH INDICATOR AND BUFFERING ADJUVANT

57059 DEAD SURE DRIFT REDUCTION TECHNOLOGY SPRAY ADJUVANT

56876 FLUENSULFONE 480EC NEMATICIDE

APVMA CONTACT

For further information please contact:

Application Management and Enquiries Team (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721


Documents

APVMA Gazette no. 2, 29 January 2013