apvma gazette no. 17, 28 august 2012 · no. apvma 17, tuesday, 28 august 2012 agricultural and...

No. APVMA 17, Tuesday, 28 August 2012

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 17, Tuesday, 28 August 2012 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2012

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 a s required

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 publi sh details of applications

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

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information

about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.

Copies of the APVMA Gazette from November 1999 until July 2009 will remain available from the APVMA website.

APVMA CONTACTS

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

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CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 20

Notice – New Agricultural Active Constituent 23 Penthiopyrad ........................................................................................................................................................................ 23

Notice – New Agricultural Chemical Products 26 Penthiopyrad in the product DuPont™ Fontelis® Fungicide ................................................................................................ 26

Notice – New Veterinary Chemical Products 30 Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats ............ 30

Other Notices 33 Cancellation of Active Constituent Approvals at the Request of the Approval Holder .......................................................... 33 Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code ............................................................. 34 Addendum to the Record of Approved Active Constituents .................................................................................................. 40 Application Summaries ......................................................................................................................................................... 41


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: Homeguard Termiflex Termiticidal Adhesive & Sealant

Active Constituent/s: 2g/kg bifenthrin

Applicant Name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891

Summary of Use: For the management of subterranean termites (except Mastotermes darwiniensis)

Date of Registration: 17 August 2012

Label Approval No: 58471/50039

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Titan Terbutryn 500 SC Herbicide

Active Constituent/s: 500g/L terbutryn

Applicant Name: Titan Ag Pty Ltd


Summary of Use: For the control of certain early competing broadleaf weeds in wheat, barley, triticale, pastures, some varieties of oats and field peas



Product Name: Ratsak Professional All Weather Wax Blocks

Active Constituent/s: 0.05g/kg brodifacoum

Applicant Name: Duluxgroup (Australia) Pty Ltd


Summary of Use: For the control of rats and mice in and around agricultural, industrial, commercial and domestic buildings



Product Name: Coles Stabilised Granular Chlorine

Active Constituent/s: 560g/kg available (Cl) chlorine present as sodium dichloroisocyanurate

Applicant Name: Hy-Clor (Australia) Pty Ltd


Summary of Use: For use in swimming pools for the control of bacteria and algae





Product Name: Marque Stabilised Granular Chlorine

Active Constituent/s: 560g/kg available chlorine (Cl) present as sodium dichloroisocyanurate

Applicant Name: Hy-Clor (Australia) Pty Ltd


Summary of Use: For the control of algae and bacteria in swimming pools



Product Name: Ezycrop Triadimefon 500 WG Fungicide

Active Constituent/s: 500g/kg triadimefon

Applicant Name: Ezycrop Pty Ltd


Summary of Use: For the control of fungal diseases of wheat and barley



Product Name: Novaguard Imidacloprid 200 SC Insecticide

Active Constituent/s: 200g/L imidacloprid

Applicant Name: Novaguard Pty Ltd


Summary of Use: For the control of various insect pests of certain vegetables and turf



Product Name: AW Powerfen 100SC Termiticide And Insecticide

Active Constituent/s: 100g/L bifenthrin.

Applicant Name: Agri West Pty Limited


Summary of Use: For the control of a range of urban interior and exterior pests, for protection of structures from subterranean termite damage and for the control of termites



Product Name: Farmalinx Thundercat 700 WG Herbicide

Active Constituent/s: 700g/kg imazethapyr

Applicant Name: Farmalinx Pty Ltd


Summary of Use: For the control of certain weeds in Centrosema (Cavalcade), chickpeas, faba beans, field peas, lucerne, mung beans, peanuts, serradella, soybeans and subterranean clover





Product Name: Terminade Residual Termiticide

Active Constituent/s: 100g/L fipronil

Applicant Name: PCT Holdings Pty Ltd


Summary of Use: For the control of subterranean termites



Product Name: Kenso Agcare Ken-Mide 500 WG Herbicide

Active Constituent/s: 500g/kg propyzamide

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

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



Product Name: Proterra Metolachlor 960 Herbicide

Active Constituent/s: 960g/L metolachlor

Applicant Name: Proterra Pty Ltd


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



Product Name: Genfarm Epoxiconazole 125 Fungicide

Active Constituent/s: 125g/L epoxiconazole

Applicant Name: Landmark Operations Limited


Summary of Use: For the control of leaf rust, stripe rust and Septoria nodorum blotch of wheat and rust of barley



Product Name: Predator 300 Insecticide

Active Constituent/s: 300g/L chlorpyrifos (an anticholinesterase compound)

Applicant Name: Dow Agrosciences Australia Limited


Summary of Use: For the control of Helicoverpa spp., mites, aphids and other insect pests of cotton





Product Name: Superway Bifenthrin 100SC Water-Based Termiticide & Insecticide

Active Constituent/s: 100g/L bifenthrin

Applicant Name: Superway Garden Ag & Pest Products Pty Ltd


Summary of Use: For the pre and post-construction management of subterranean termites in accord with AS 3660 and for the control of termites and a range of interior and exterior urban pests



Product Name: Titan Azoxystrobin 250SC Fungicide

Active Constituent/s: 250g/L azoxystrobin



Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocadoes, mangoes, passionfruit and poppies



Product Name: Fasten Spray Adjuvant

Active Constituent/s: 700g/L ethyl and methyl esters of vegetable oil with 116g/L non-ionic surfactants

Applicant Name: Agrobest IP Pty Ltd


Summary of Use: To assist in the effectiveness of herbicides and other agricultural chemicals



Product Name: Yates Easy See Spray Dye Liquid Spray Marker Dye

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

Applicant Name: Duluxgroup (Australia) Pty Ltd


Summary of Use: For use with herbicide and pesticide spray solutions in the home garden



Product Name: Agrobest Ammonium Sulphate 417

Active Constituent/s: 417g/L ammonium sulphate



Summary of Use: For use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides and improve performance under adverse environmental conditions





Product Name: 4Farmers Tribenuron Methyl 750 Herbicide

Active Constituent/s: 750g/kg tribenuron methyl

Applicant Name: 4 Farmers Pty Ltd


Summary of Use: For the control of certain broadleaf weeds in fallow and pre-crop situations



Product Name: Repel Mosquito Coils

Active Constituent/s: 4g/kg d-allethrin

Applicant Name: Mayo Hardware Pty Ltd


Summary of Use: For the control of mosquitoes in the domestic environment



Product Name: AFA Upside Spray Oil Adjuvant

Active Constituent/s: 582g/L paraffinic oil, 120g/L nonyl phenol ethoxylate, 120g/L alcohol ethoxylate

Applicant Name: Agricultural Formulators Australia Pty Ltd


Summary of Use: For use as an adjuvant to improve the spreading and wetting of herbicides, insecticides, and defoliants on plant surfaces



Product Name: Atlas Flying Insect Killer Low Allergenic Odourless

Active Constituent/s: 2.09g/kg bioallethrin, 0.39g/kg bioresmethrin

Applicant Name: Pascoe's Pty Ltd


Summary of Use: For insect control in and around the home



Product Name: AFA Amsul Adjuvant

Active Constituent/s: 417g/L ammonium sulphate



Summary of Use: For use with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides and to improve performance under adverse environmental conditions





Product Name: Rainbow Chlorothalonil 900 WG Fungicide

Active Constituent/s: 900g/kg chlorothalonil

Applicant Name: Shandong Rainbow International Co., Ltd.

Applicant ACN: N/A

Summary of Use: For the control of fungal diseases on almonds, apricots, bananas, carrots, celery, cherries, faba beans, grapes, onions, peaches, peanuts, peas, plums, potatoes, tomatoes and vegetables



Product Name: FMC Glyphosate 540 K Herbicide

Active Constituent/s: 540g/L glyphosate present as the potassium salt



Summary of Use: For the control of many annual and perennial weeds



Product Name: Proterra Thidiazuron 500 Cotton Defoliant

Active Constituent/s: 500g/L thidiazuron



Summary of Use: For the defoliation of cotton prior to harvest



Product Name: Titan Epoxiconazole 125 SC Fungicide

Active Constituent/s: 125g/L epoxiconazole



Summary of Use: For the control of leaf rust and Septoria nodorum blotch of wheat and leaf rust of barley



Product Name: Woolworths Select Insect Bomb

Active Constituent/s: 0.77g/kg fenoxycarb, 10g/kg permethrin

Applicant Name: Woolworths Ltd


Summary of Use: For the control of insect infestations and prevention of reinfestations





Product Name: Black Flag Odourless Fly & Mosquito Killer

Active Constituent/s: 1.1g/kg esbiothrin, 0.5g/kg permethrin

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Use: For control of flies, mosquitoes, moths, cockroaches, ants, fleas, silverfish and spiders



Product Name: Enviromax Fipronil 100SC Termiticide & Insecticide

Active Constituent/s: 100g/L fipronil

Applicant Name: Enviromax Technologies Pty Ltd


Summary of Use: For control of subterranean termites around domestic and commercial structures



Product Name: Agrobest Wetter 1000

Active Constituent/s: 1000g/L nonionic alcohol ethoxylates



Summary of Use: For the improvement of spray coverage when using agricultural chemicals



Product Name: Mortein Naturgard Fly & Mosquito Killer Odourless

Active Constituent/s: 1.1g/kg esbiothrin, 0.5g/kg permethrin

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Use: For control of flies, mosquitoes, moths, cockroaches, ants, fleas, silverfish and spiders



Product Name: Agrobest Buffer 700 Surfactant

Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid



Summary of Use: For use as an acidifying and penetrating surfactant, which reduces alkaline hydrolysis of dimethoate, assists with uptake of foliar fertilisers and assists in management of spray droplet size





Product Name: Intercept 480SL Turf Growth Regulator

Active Constituent/s: 480g/L ethephon (an anti-cholinesterase compound)

Applicant Name: Greenshed Pty Limited


Summary of Use: For prevention of Poa annua seedhead emergence



Product Name: Imtrade Metakill Snail & Slug Bait

Active Constituent/s: 50g/kg metaldehyde

Applicant Name: Imtrade Australia Pty Ltd


Summary of Use: For use as a snail and slug bait



Product Name: Tebuhex 430 SC Fungicide

Active Constituent/s: 430g/L tebuconazole

Applicant Name: Hextar Chemicals Pty Ltd


Summary of Use: For the control of leaf spot and leaf speckle on bananas, rust, leaf spot and net blotch of peanuts, foliar diseases on cereal crops and other diseases on beans, peas, onions, pawpaw, pyrethrum, ryegrass and fescue seed crops



Product Name: Brunnings Bindii & Clover Kill

Active Constituent/s: 150g/L MCPA, 25g/L dicamba (both present as dimethylamine salt)

Applicant Name: Brunnings Garden Products Pty Ltd


Summary of Use: For selective control of broad leaf weeds in lawns



Product Name: Melpat Copper Sulphate Molluscicide

Active Constituent/s: 250g/kg copper (Cu) present as copper sulphate pentahydrate

Applicant Name: Melpat International Pty Ltd


Summary of Use: For the control of aquatic snails in rice paddies





Product Name: Omni Trichlor Blend Pool Sanitiser & Oxidiser

Active Constituent/s: 660g/kg available chlorine (Cl) present as trichloroisocyanuric acid

Applicant Name: Biolab Australia Pty Ltd


Summary of Use: For control of bacteria and algae in swimming pools



Product Name: Spalding Exocet 250 Herbicide

Active Constituent/s: 135g/L paraquat present as paraquat dichloride, 115g/L diquat present as diquat dibromide

Applicant Name: Spalding Holdings Pty. Ltd.


Summary of Use: For the control of a wide range of grasses and broadleaf weeds



Product Name: Ezycrop Chlorsulfuron 750 WG Herbicide

Active Constituent/s: 750g/kg chlorsulfuron



Summary of Use: For the control of Annual (Wimmera) Ryegrass and certain broadleaved weeds in wheat, barley, oats, cereal rye and triticale



Product Name: Crop Care Spark Herbicide

Active Constituent/s: 240g/L imazapic present as the ammonium salt

Applicant Name: Crop Care Australasia Pty Ltd


Summary of Use: For the control of certain annual grass and broadleaf weed in peanuts and sugarcane



Product Name: FMC Clopyralid 750 WG Herbicide

Active Constituent/s: 750g/kg clopyralid present as the potassium salt



Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land





Product Name: Searles Dead Grub Pro For Lawns

Active Constituent/s: 2g/kg bifenthrin

Applicant Name: J C & A T Searle Pty Ltd


Summary of Use: For control of lawn beetles and grubs in home garden



Product Name: Spalding Amine 625 Selective Herbicide

Active Constituent/s: 625g/L 2,4-D present as the dimethylamine and diethanolamine salts

Applicant Name: Spalding Holdings Pty. Ltd.


Summary of Use: For the control of broadleaf weeds in fallow before direct drilling or sowing of cereals and pastures; and in cereal crops, pastures, sugarcane, peanuts, and non-agricultural areas



Product Name: Sherwood Turf Care Selective Herbicide

Active Constituent/s: 300g/L MCPA present as the potassium salt, 15g/L diflufenican, 20g/L clopyralid present as the potassium salt

Applicant Name: Sherwood Chemicals Public Company Limited

Applicant ACN: N/A

Summary of Use: For the control of certain broadleaf weeds in turf



Product Name: Ezycrop Clopyralid 750 SG Herbicide.

Active Constituent/s: 750g/kg clopyralid present as the potassium salt



Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land



Product Name: Genfarm Azoxystrobin 500 WG Fungicide

Active Constituent/s: 500g/kg azoxystrobin

Applicant Name: Landmark Operations Limited


Summary of Use: For the control of various diseases of grapes, potatoes, tomatoes, cucurbits, avocados, mangoes, passionfruit and poppies





Product Name: Echem Acetamiprid 225 Insecticide

Active Constituent/s: 225g/L acetamiprid

Applicant Name: Echem (Aust) Pty Limited


Summary of Use: For the control of cotton aphid in cotton



Product Name: Spraytech Canola Oil Adjuvant

Active Constituent/s: 832g/L canola oil



Summary of Use: To increase droplet spread, chemical uptake and rainfastness; improve drift control and reduce foam generation; assist with odour and evaporation reduction



Product Name: FMC Wetter 1000

Active Constituent/s: 1000g/L nonyl phenol and alcohol ethoxylates



Summary of Use: For use to increase spray contact, coverage and penetration of herbicides, fungicides and insecticides



Product Name: FMC Methomyl 225 Insecticide

Active Constituent/s: 225g/L methomyl (an anti-cholinesterase compound)



Summary of Use: For the control of insect pests in various crops



Product Name: Fortune 500 EC (Agriculture) Insecticide

Active Constituent/s: 500g/L chlorpyrifos (an anticholinesterase compound)

Applicant Name: PCT Holdings Pty Ltd


Summary of Use: For post construction management of subterranean termites and other domestic insect pests and certain insect pests in crops and turf





Product Name: FMC Glyphosate 510 Herbicide

Active Constituent/s: 510g/L glyphosate present as the isopropylamine salt.



Summary of Use: For control of a wide range of annual and perennial weeds in a wide variety of situations



Product Name: AFA 700 Surfactant

Active Constituent/s: 350g/L soyal phospholipids, 350g/L propionic acid



Summary of Use: For use with herbicides



Product Name: Proterra Ethephon 720 Growth Regulator

Active Constituent/s: 720g/L ethephon (an anticholinesterase product)



Summary of Use: For accelerated boll opening, defoliation and pre-conditioning before defoliation of cotton



Product Name: AFA Wetter 1000 Surfactant

Active Constituent/s: 1000g/L nonyl phenol and alcohol ethoxylates



Summary of Use: To increase spray contact, coverage and penetration of herbicides, fungicides and insecticides



Product Name: FMC Clopyralid 300 Herbicide

Active Constituent/s: 300g/L clopyralid present as the triisopropanolamine salt



Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures, fallow land, forests and industrial situations





Product Name: FMC Triallate 500 Herbicide

Active Constituent/s: 500g/L tri-allate



Summary of Use: For the control of wild oats in wheat, triticale, chick peas, barley, peas, linseed, lupins, canola (rapeseed), faba beans and safflower



Product Name: Agro-Essence Diflufenican + MCPA 275 Herbicide

Active Constituent/s: 25g/L diflufenican, 250g/L MCPA present as the ethyl hexyl ester

Applicant Name: Agro-Alliance (Australia) Pty Ltd


Summary of Use: For the control of certain broadleaf weeds in winter cereal and clover



Product Name: Barflex 100SC Termiticide & Insecticide

Active Constituent/s: 100g/L bifenthrin

Applicant Name: Barmac Pty Ltd


Summary of Use: For the control of mosquitoes, biting midges, flies and termites



3. VARIATIONS

Product Name: Apparent Brush 'N' Wood Herbicide

Applicant Name: Apparent Pty. Ltd.


Summary of Variation: To change the product name from ‘APPARENT TRICLOPYR 300 + PICLORAM 100 HERBICIDE’ to ‘APPARENT BRUSH 'N' WOOD HERBICIDE’

Date of Variation: 8 August 2012


Product Name: Terbyne 750WG Herbicide

Applicant Name: Sipcam Pacific Australia Pty Limited


Summary of Variation: To extend the use to include pre-sowing and pre and post-emergence use in sorghum for the control and suppression of various broadleaf and grass weeds





Product Name: Smart Tri-Allate 500 EC Herbicide

Applicant Name: Crop Smart Pty Ltd


Summary of Variation: To approve an update in the withholding periods and safety directions



Product Name: Aquafresh By Lo-Chlor Pool Sanitiser

Applicant Name: M I International Pty Ltd T/A Lo-Chlor Chemicals


Summary of Variation: To change the product name from ‘LO-CHLOR AQUACADABRA POOL SANITISER’ to ‘AQUAFRESH BY LO-CHLOR POOL SANITISER’ and update RLP



Product Name: Affirm Insecticide

Applicant Name: Syngenta Crop Protection Pty Limited


Summary of Variation: To extend use to control of diamond back moth in canola



Product Name: Canopy Insecticide

Applicant Name: Caltex Australia Petroleum Pty Ltd


Summary of Variation: To extend use to suppression of silverleaf whitefly in cotton; green peach aphid and Helicoverpa spp. in pulse and oilseed crops



Product Name: Ospray Olympus Fungicide

Applicant Name: Ospray Pty Ltd


Summary of Variation: To add additional uses in wheat and barley



Product Name: Imtrade Eradicator 540 Herbicide

Applicant Name: Imtrade Australia Pty Ltd


Summary of Variation: To update the restraints and storage and disposal instructions





Product Name: Dupont Coragen Insecticide

Applicant Name: Du Pont (Australia) Ltd


Summary of Variation: To extend use to legume vegetables and sweet corn for control of lepidopteran species of insect pests and to include a surfactant recommendation for use in cucurbits



Product Name: Farmoz Colt Herbicide

Applicant Name: Farmoz Pty Limited


Summary of Variation: To approve a new product label


Label Approval No: 63316/54848(A)

Product Name: Rudducks Get Off My Garden Dog And Cat Repellent Gel Contains Natural Aromatic Oils

Applicant Name: Rudducks Pty Ltd


Summary of Variation: To change the product name from ‘GET OFF MY GARDEN DOG & CAT REPELLENT’ to ‘RUDDUCKS GET OFF MY GARDEN DOG AND CAT REPELLENT GEL CONTAINS NATURAL AROMATIC OILS’



Product Name: Rudducks Get Off My Garden Dog And Cat Repellent Spray Contains Natural Aromatic Oils

Applicant Name: Rudducks Pty Ltd


Summary of Variation: To change the product name from ‘NEW FORMULA WITH CITRINE FRAGRANCE GET OFF DOG & CAT REPELLENT’ to ‘RUDDUCKS GET OFF MY GARDEN DOG AND CAT REPELLENT SPRAY CONTAINS NATURAL AROMATIC OILS’



Product Name: Unitry 480 EC Selective Herbicide

Applicant Name: United Phosphorus Ltd.


Summary of Variation: To include a 5L pack size and extend uses to include additional states for various crops as well as a change the product name from ‘UNI-TRY TRIFLURALIN 480 EC SELECTIVE HERBICIDE’ to ‘UNITRY 480 EC SELECTIVE HERBICIDE ’



Product Name: Maxforce Complete Granular Insect Bait

Applicant Name: Bayer Cropscience Pty Ltd


Summary of Variation: To change the product name from 'MAXFORCE GRANULAR INSECT BAIT' to 'MAXFORCE COMPLETE GRANULAR INSECT BAIT'





Product Name: Novaguard Triadimefon 500 WG Fungicide

Applicant Name: Novaguard Pty Ltd


Summary of Variation: To change the product name from ‘NOVA AGRO TRIADIMEFON 500 WG FUNGICIDE’ to ‘NOVAGUARD TRIADIMEFON 500 WG FUNGICIDE’



Product Name: DuPont Altriset Termiticide

Applicant Name: Du Pont (Australia) Ltd


Summary of Variation: To add restraint statement relating to use in cavity walls; extend use to include control of Heterotermes ferox and Nasutitermes exitiosus in post construction and above ground areas of termite activity; extend protection period from 3 years to 4 years and revise critical comments associated with above ground use pattern



Product Name: Pool Sanitiser Salt Pool Sticks

Applicant Name: Biolab Australia Pty Ltd


Summary of Variation: To change the product name from 'BIOGUARD SALT POOL STICKS POOL SANITISER' to 'POOL SANITISER SALT POOL STICKS'




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: Profender Allwormer Flavour Tablets For Large Dogs

Active Constituent/s: 30mg emodepside, 150mg praziquantel

Applicant Name: Bayer Australia Ltd (Animal Health)


Summary of Use: For the treatment and control of roundworms, hookworms, whipworms and tapeworms in dogs



Product Name: Profender Allwormer Flavour Tablets For Medium Dogs







Product Name: Profender Allwormer Flavour Tablets For Small Dogs And Puppies







Product Name: Maximus Pour-On For Cattle

Active Constituent/s: 5g/L moxidectin

Applicant Name: Ancare Australia Pty Limited


Summary of Use: For the treatment and control of moxidectin sensitive internal and external parasites of cattle





Product Name: Southern Cross Gold OP Spray-On Off-Shears Sheep Lice Treatment

Active Constituent/s: 93.3g/L diazinon (an anticholinesterase compound)

Applicant Name: Agvantage Pty Ltd


Summary of Use: For off-shears control of OP susceptible and SP resistant strains of the sheep body louse (Bovicola ovis)



Product Name: Topon DX

Active Constituent/s: 20g/kg gamma oryzanol

Applicant Name: Rapidvite Industries Australasia Pty.Ltd.


Summary of Use: For stimulating the appetite of horses in training



Product Name: Neove Monensin 200 - Feed Additive Premix

Active Constituent/s: 200g/kg monensin (as monensin sodium)

Applicant Name: Neove Pharma Australia Pty Limited


Summary of Use: For use as a premix to improve feed efficiency, aid in the control of bloat in cattle and dairy cows; for increased milk production and, as an aid in reducing the severity of non-clinical ketosis in dairy cows; for increased weight gain, feed efficiency, reproductive performance in heifers; as an aid in the prevention of coccidiosis in chickens, cattle and goats



Product Name: Caninsulin Vetpen Insulin For Dogs And Cats

Active Constituent/s: 40IU/mL insulin

Applicant Name: Intervet Australia Pty Limited


Summary of Use: For the treatment of diabetes mellitus in dogs and cats



Product Name: Fli-Guard Spray On Sheep Blowfly Treatment

Active Constituent/s: 50g/L dicyclanil

Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd


Summary of Use: For the protection of sheep, either off-sheers or with any length wool, against flystrike for 18-24 weeks. For the protection of mulesing and marking wounds on sheep against fly strike during the healing process





5. VARIATIONS

Product Name: NV Natrozol Forte Powder - A Source Of Gamma Oryzanol For Horses

Applicant Name: Ceva Animal Health Pty Ltd


Summary of Variation: To change the product name from ‘NATROZOL FORTE POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’ to ‘NV NATROZOL FORTE POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’



Product Name: NV Natrozol Powder - A Source Of Gamma Oryzanol For Horses

Applicant Name: Ceva Animal Health Pty Ltd


Summary of Variation: To change the product name from ‘NATROZOL POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’ to ‘NV NATROZOL POWDER - A SOURCE OF GAMMA ORYZANOL FOR HORSES’



Product Name: Ensal Enteric Mixture

Applicant Name: Jurox Pty Limited


Summary of Variation: To change the product name from ‘VR ENSAL ENTERIC MIXTURE’ to ‘ENSAL ENTERIC MIXTURE’




Notice – New Agricultural Active Constituent— Penthiopyrad

NOTICE – NEW AGRICULTURAL ACTIVE CONSTITUENT

Penthiopyrad

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a

new active constituent, penthiopyrad.

Penthiopyrad is a fungicide which shows broad antifungal activity on a wide range of crops. It inhibits mitochondrial

function by disrupting complex II (succinate dehydrogenase) in the respiratory electron transport chain. Penthiopyrad is

used to control a range of pathogens including: grey mould, powdery mildew, tomato leaf mould, cucumber corynespora

leaf spot, rust, southern blight, apple and pear scab, apple blossom blight, peach and cherry brown rot. On cereals and

turf, penthiopyrad also has high activity against wheat septoria diseases, rust, brown patch, dollar spot, fairy rings,

anthracnose and snow mould.

Common Name: Penthiopyrad

IUPAC Name: (RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-

carboxamide

CAS Name: N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-

carboxamide

CAS Registry Number: 183675-82-3

Manufacturer’s Code: MTF-753

Minimum Purity: 976 g/kg

Molecular Formula: C16H20F3N3OS

Molecular Weight: 359.4

Structure:

Chemical Family:

Pyrazol Carboxamide

Mode of Action: Fungicide

SUMMARY OF THE APVMA’S EVALUATION OF PENTHIOPYRAD ACTIVE CONSTITUENT

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



Constituent Specification Level

Penthiopyrad Penthiopyrad Not less than 976 g/kg

Other compounds of toxicological significance are not expected to occur in penthiopyrad TGAC.

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

An Acceptable Daily Intake (ADI) of 0.1 mg/kg bw/d has been set, based on a No-Observed Effect Level (NOEL) of

11 mg/kg bw/d in a rat study, after applying a safety factor of 100. An Acute Reference Dose (ARfD) of 0.75 mg/kg bw

has been set based on a rabbit developmental toxicity study, after applying a safety factor of 100.

The National Drugs and Poisons Schedule Committee (NDPSC) has considered penthiopyrad to be appropriate for

inclusion in Schedule 5 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) with a 20% cut-

off exemption from poisons scheduling.

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

penthiopyrad TGAC.

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

The APVMA is satisfied that the proposed importation and use of penthiopyrad 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 sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of penthiopyrad 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 confidential commercial information (CCI)1 material contained in submissions will be treated

confidentially.

1 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



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

approval should be addressed in writing to:

Chemistry Manager

Pesticides Program

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4936

Fax: 02 6210 4840


Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 26

Notice – New Agricultural Chemical Products—Penthiopyrad in the product DuPont™ Fontelis® Fungicide

NOTICE – NEW AGRICULTURAL CHEMICAL PRODUCTS

Penthiopyrad in the product DuPont™ Fontelis® Fungicide

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

(Australia) Limited, for registration of a new product containing the active constituent penthiopyrad. The product

DuPont™ Fontelis® Fungicide The product is for use on a range of fruit and vegetable crops.

PARTICULARS OF THE APPLICATION

Proposed Product Name(s): DUPONT™ FONTELIS® FUNGICIDE

Applicant Company: DuPont (Australia) Limited

Name of Active Constituent: Penthiopyrad

Signal Heading: Schedule 5

Summary of Proposed Use: For the control of fungal diseases in strawberries, pome fruit, stone fruits,

tree nuts, bulb vegetables, brassica vegetables, cucurbit vegetables,

fruiting vegetables, leafy vegetables, and root and tuber vegetables.

Pack Sizes: 50-100mL, 150-250mL, 500mL, 1L, 3L and 5L

Withholding Period: HARVEST:

Strawberries, brassica vegetables, brassica leafy vegetables, fruiting

vegetables (other than cucurbits), stone fruit: Not required when used as

directed.

Cucurbit vegetables: Do not harvest for 1 day after application.

Onions, spring onions, shallots, leafy vegetables: Do not harvest for 3

days after application.

Root and tuber vegetables: Do not harvest for 7 days after application.

Tree nuts: Do not harvest for 14 days after application.

Pome fruit: Do not harvest for 28 days after application.

GRAZING:

Do not graze or cut for stock food.

SUMMARY OF THE APVMA’S EVALUATION OF DUPONT FONTELIS FUNGICDE IN ACCORDANCE WITH

SECTION 14(3)(E) AND (F) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET

CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental

safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE would not be an undue

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

The Office of Chemical Safety and Environmental Health (OCSEH) in the Department of Health and Ageing has

conducted a risk assessment on the product and concluded that it can be used safely.



The main occupational use of the product will be by farmers and their workers. Workers may be exposed to the

product when opening containers, mixing/loading, application, and cleaning up spills and equipment. The main

route of exposure to the product will be dermal with inhalation exposure from the spray also possible.

In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database

(PHED) Surrogate Exposure Guide was used to estimate exposure. Exposure to the product during mixing and

loading and both ground boom and air-blast application were at an acceptable level when a single layer of clothing

(cotton overalls or equivalent clothing) was worn with or without gloves.

Based on the risk assessment, a First Aid Instruction and Safety Directions have been recommended for the

product label.

(ii) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE will not be an undue

hazard to the safety of people using anything containing its residues.

The APVMA is satisfied that the proposed use of Dupont™ Fontelis® Fungicide will not be an undue hazard to the

safety of people using anything containing its residues. The product will be used as a foliar spray in a wide range of

fruit and vegetable crops, including strawberries, pome and stone fruit, tree nuts, leafy vegetables, bulb

vegetables, cucurbits, brassicas, root vegetables, and non-cucurbitaceous fruiting vegetables. The APVMA

Residues Section has evaluated the residues aspects of the proposed product and has recommended

amendments to the APVMA MRL Standard for penthiopyrad and for inclusion in the Food Standards Code. Dietary

exposure modelling has shown the expected chronic and acute dietary exposures to penthiopyrad are both below

the relevant health standards. Recommendations regarding withholding periods and protection statements for

livestock have been included on the label.

(iii) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE containing the active

constituent penthiopyrad is not likely to be harmful to human beings if used according to the product label.

The submitted studies on the active constituent in rats showed that it is extensively and rapidly absorbed by the

oral route (>83%) and excreted rapidly. The total absorbable dose in vitro for rat and human skin was 53% and

19% respectively. Penthiopyrad is of low acute oral, dermal and inhalational toxicity in rats. It was not a skin irritant

in rabbits but was considered a slight eye irritant in the same species. It was not a skin sensitiser in guinea pigs.

In repeat dose studies, liver toxicity was common in mice, rats and dogs, with thyroid toxicity also observed in mice

and rats. There were findings of an increased incidence of thyroid follicular epithelial adenomas in male rats, and

hepatocellular carcinomas in male mice. Overall, OCS considers that the weak induction of thyroid follicular

epithelial adenomas in male rats occurred via thyroid hormone perturbations and that the observed tumours are of

limited relevance to humans. Consequently, penthiopyrad is not considered to be a carcinogenic hazard to

humans.

Penthiopyrad was not a reproductive or developmental toxicant, and tested negative in vitro and in vivo in a battery

of mutagenicity and/or genotoxicity studies. Additionally, the available data was not considered to demonstrate a

neurotoxic or immunotoxic potential.

The product DuPont™ Fontelis® Fungicide is of low acute oral, dermal and inhalational toxicity in rats. It is not a

skin or eye irritant in rabbits nor a skin sensitiser in guinea pigs and mice.

Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human

health from the use of DuPont™ Fontelis® Fungicide when used in accordance with the label directions.



(iv) The APVMA is satisfied that the proposed use of DUPONT™ FONTELIS® FUNGICIDE containing the new active

constituent, penthiopyrad is not likely to have an unintended effect that is harmful to animals, plants or the

environment if used according to the product label directions.

The Department of Sustainability, Environment, Water, Population and Communities has assessed data in support

of the proposed use and has concluded that the risks to the environment from uses are acceptable provided that

the draft label is updated to meet current requirements.

Penthiopyrad is stable with minimal or no detectable degradation by abiotic processes (photolysis and hydrolysis).

It undergoes slow degradation by biotic processes in both soil and water under laboratory conditions. However,

under field conditions it dissipates more rapidly. Finally, penthiopyrad does not bio-accumulate in fish.

Penthiopyrad and the SC formulation are not toxic to birds, bees, earthworms, non-target arthropods or, plants and

did not affect the short-term respiration and nitrogen turnover in a soil. They are considered toxic to very toxic to

fish and aquatic invertebrates, and at worst toxic algae.

At the proposed rates, the major potential risk to the environment was penthiopyrad’s potential to accumulate in the

soil and the water compartment from multiple applications. With conservative modelling, acceptable risk to aquatic

organisms was found from run-off water entering environmental waters. Similarly the risk to water and sediment

dwelling organisms from spray drift was found to be acceptable if downwind no-spray zones are implemented.

The risk assessment determined that the chemical is unlikely to pose an environmental risk under the proposed

use patterns, provided the draft label is updated to meet current requirements.

The APVMA has considered the findings of the Department of Sustainability, Environment, Water, Population and

Communities and accepts these conclusions.

(v) The APVMA is considering whether the proposed use of DUPONT™ FONTELIS® FUNGICIDE would not

adversely affect trade between Australia and places outside Australia.

Export of treated produce containing finite (measurable) residues of penthiopyrad may pose a risk to Australian

trade in situations where (i) no residues tolerance (import tolerance) is established in the importing country or (ii)

where residues in Australian product are likely to exceed a residue tolerance (import tolerance) established in the

importing country.

The overall risk to export trade in animal commodities is considered to be low, as detectable residues of

penthiopyrad are not expected in meat, milk, eggs or offal, and MRLs have been recommended at the limit of

quantitation.

Detectable residues are expected in a number of commodities including tree nuts, strawberries, brassica

vegetables, leafy vegetables, bulb vegetables, fruiting vegetables and root vegetables. However, none of these are

significant export commodities, and the corresponding risk to trade is expected to be low.

Detectable residues are also expected in pome fruit and stone fruit, which are significant export commodities.

Of the export markets for pome and stone fruit, Australian fruit are expected to meet the current or forthcoming

standards of Canada, France and the UK, while New Zealand accepts Australian MRLs under the Trans-Tasman

mutual recognition agreement. Other export markets such as Hong Kong, Thailand, Singapore, Indonesia and

Papua New Guinea do not currently have either their own or Codex MRLs. There may therefore be some risk to

exports to these destinations.

Comment is sought from the relevant industry groups on the perceived level of risk and whether any industry-

initiated strategies are required to manage that risk.



(vi) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials

supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,

the product is effective for its proposed uses.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public

Consultation’ page, www.apvma.gov.au/consultation/public or by contacting the APVMA as indicated below.

MAKING A SUBMISSION

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written

submission as to whether the application for registration of DUPONT™ FONTELIS® FUNGICIDE should be granted.

Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding

whether to grant the application. These grounds include occupational health and safety, chemistry and manufacture,

residues, safety and first aid, environmental fate and toxicity, trade and efficacy. Submissions should state the

grounds on which they are based. Comments received outside these grounds cannot be considered by the APVMA.


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

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name


email or postal address



confidentially.

Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for

registration should be addressed in writing to:

Contact Officer

Pesticides Program


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4700

Fax: 02 6210 4776



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



Notice – New Veterinary Chemical Products—Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats

NOTICE – NEW VETERINARY CHEMICAL PRODUCTS

Dexmedetomidine hydrochloride in the product Dexdomitor Injectable Sedative and Analgesic for Dogs and Cats

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

Health, A division of Pfizer Australia Pty Ltd, for registration of a new product containing dexmedetomidine. The product

is DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR DOGS AND CATS. The product is to be used as a

sedative and analgesic in dogs and cats.

PARTICULARS OF THE ACTIVE CONSTITUENT

Common Name: Dexmedetomidine hydrochloride

CAS Name: 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride

Chemical Name: (S)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole hydrochloride

CAS Registry Number: 145108-58-3

Minimum Purity: 980 g/kg (dry basis)

Molecular Formula: C13H16N2.HCl

Molecular Weight: 236.7

Structure:

Chemical Family: imidazole

Mode of Action: alpha2 adrenoceptor agonist

SUMMARY OF THE APVMA’S EVALUATION OF DEXMEDETOMIDINE HYDROCHLORIDE ACTIVE CONSTITUENT

The Pharmaceutical Chemistry Section of the APVMA has evaluated the chemistry and manufacture aspects of

dexmedetomidine hydrochloride and is satisfied that all the data requirements (including physico-chemical properties,

spectral identification, manufacturing and quality control aspects, active constituent specification, stability data, batch

analysis data, analytical methods and packaging) necessary for the approval of this new active constituent have been

met.

PARTICULARS OF THE APPLICATION

Proposed Product Name(s): DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR

DOGS AND CATS

Applicant Company: Pfizer Animal Health, A division of Pfizer Australia Pty Ltd

Name of Active Constituent: Dexmedetomidine hydrochloride



Signal Heading: Prescription Animal Remedy - Schedule 4

Summary of Proposed Use: Sedative and analgesic for dogs and cats

Pack Sizes: 10mL

Withholding Period: N/A

SUMMARY OF THE APVMA’S EVALUATION OF DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC FOR

DOGS AND CATS IN ACCORDANCE WITH SECTION 14(3)(E) AND (F) OF THE AGRICULTURAL AND

VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND

VETERINARY CHEMICALS CODE ACT 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under

section 14(3)(e) of the Agvet Code, it proposes to determine that:

(vii) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS would not be an undue hazard to the safety of people exposed to it during its handling and

use.

The Office of Chemical Safety (OCS) in the Department of Health and Ageing has conducted a risk assessment on

the product and concluded that it can be used safely.

Based on the findings of the toxicological studies evaluated, dexmedetomidine hydrochloride has high intravenous

and subacute toxicity in mice, rats and dogs. It is unlikely to be a skin sensitiser. No studies on the skin and eye

irritation potential of dexmedetomidine were submitted with this application, however, medetomidine, the racemic

mixture of dexmedetomidine and levomedetomidine, was not a skin irritant or an eye irritant in guinea pigs or

rabbits, respectively. There was no data available on acute oral or inhalational toxicity; however, based on the use

pattern of the product, exposure via these routes is unlikely. The APVMA has considered and accepts the findings

and recommendations of the OCS evaluation.

(viii) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS will not be an undue hazard to the safety of people using anything containing its residues.

The product is for use in companion animals (dogs and cats) only. Dexmedetomidine hydrochloride is unlikely to

enter the food chain and therefore the determinations of an Acceptable Daily Intake (ADI) and Acute Reference

Dose (ARfD) are not considered necessary.

(ix) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS containing the active constituent dexmedetomidine is not likely to be harmful to human

beings if used according to the product label directions.

Dexmedetomidine is in schedule 4 of the SUSMP. Based on the toxicity profile of dexmedetomidine hydrochloride

and the use pattern of the product; it is proposed that a schedule for classification for this product remains

appropriate. The signal heading that corresponds to Schedule 4 and the First Aid instructions recommended by the

OCS will appear on the product label.

(x) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS is not likely to have an unintended effect that is harmful to animals, plants or the

environment if used according to the product label directions.



The Department of Sustainability, Environment, Water, Population and Communities (DSEWPAC), have

recommended to the APVMA that the use of the product in the proposed manner is not expected to have an

unintended effect that is harmful to the environment. The APVMA has considered these findings and accepts the

recommendations of DSEWPAC on this criterion.

(xi) The APVMA is satisfied that the proposed use of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS would not adversely affect trade between Australia and places outside Australia as the

product is for use in dogs and cats, which are not food-producing animals and do not produce any major Australian

export commodities.

(xii) In relation to its assessment of efficacy under section 14(3)(f), the APVMA is satisfied that data from trials

supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,

the product is effective for its proposed uses.

FURTHER INFORMATION

MAKING A SUBMISSION

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit a relevant written

submission as to whether the application for registration of DEXDOMITOR INJECTABLE SEDATIVE AND ANALGESIC

FOR DOGS AND CATS should be granted. Submissions should relate only to matters that the APVMA is required by

legislation to take into account in deciding whether to grant the application. These grounds include occupational health

and safety, chemistry and manufacture, residues, safety and first aid, environmental fate and toxicity, trade and

efficacy. Submissions should state the grounds on which they are based. Comments received outside these grounds

cannot be considered by the APVMA.


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

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name


email or postal address



confidentially.

Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds for

registration should be addressed in writing to:

Veterinary Medicines Program


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4700

Fax: 02 6210 4741





Other Notices – Cancellation of Active Constituent Approvals at the Request of the Approval Holder

OTHER NOTICES

Cancellation of Active Constituent Approvals at the Request of the Approval Holder

In accordance with Section 42 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code), if an

interested or approved person in relation to an approval or registration gives to the APVMA a written notice requesting

the APVMA to cancel the approval or registration, the APVMA must give written notice of its decision on the request to

the person(s) who made the request.

At the request of the approval holder, the APVMA has cancelled the approvals of the following active constituents:

Active No. Active Name Approval Holder Date of Effect

44450 ALDICARB MANUFACTURING

CONCENTRATE

BAYER CROPSCIENCE PTY LTD 14 August 2012

44025 ALDICARB MANUFACTURING

CONCENTRATE

BAYER CROPSCIENCE PTY LTD 14 August 2012

59053 IODOMETHANE ARYSTA LIFESCIENCE NORTH

AMERICA CORPORATION

14 August 2012

The following instructions set out how a person can deal with the cancelled actives.

SUPPLY

A person may supply or cause to be supplied active constituents manufactured prior to 14 August 2012 until

14 August 2014.

After 14 August 2014 it will be an offence against the Agvet Codes to have possession or custody of the active

constituents with the intention to supply the active constituents.

USE

Any person who possesses, has custody of, uses, or otherwise deals with the listed active constituents in accordance

with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have

custody of, use or otherwise deal with the active constituents after the approvals have been cancelled until

14 August 2014.

The supply and use of the active constituents must be in accordance with the conditions of approval, including any

conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the active constituents listed in the table in a manner that

contravenes the above instructions.

APVMA CONTACT

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

Chemical Review/AERP Contact Officer

Pesticides Program


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4749

Fax: 02 6210 4776


mailto:[email protected]


Other Notices – Variations to Standard 1.4.2 of the Australia New Zealand Foods Standards Code

Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code

The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which

have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and

veterinary chemical products as set out as in Standard 1.4.2 – Maximum Residue Limits of the Australia New Zealand

Food Standards Code. This notice pertains to proposal numbered 12O gazetted on 5 June 2012 (No. APVMA 11).

Submissions have been sought on these proposals and the APVMA has written separately to each person or

organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative

instrument, incorporated these variations to MRLs into Standard 1.4.2. A copy of the Amendment Instrument

(No. APVMA 8, 2012) accompanies this notice. For a complete and up-to-date version of Standard 1.4.2, including these

amendments together with their Explanatory Statement, please refer to the Federal Register of Legislative Instrument

available on the Comlaw website at http://www.comlaw.gov.au.

Based on dietary exposure assessments and current health standards, the APVMA and FSANZ are satisfied that these

MRLs are not harmful to public health. MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural

and veterinary chemicals that may legitimately occur in foods. By this means, Standard 1.4.2 permits the sale of treated

foods and protects public health by minimising residues in foods consistent with the effective control of pests and

diseases.

The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food

Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food

standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary

chemicals in food.

Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade

Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

The variations take effect as from the date of this notice.

This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.

For further information please contact:

Residues Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4837

Fax: 02 6210 4840


http://www.comlaw.gov.au/



Australia New Zealand Food Standards Code —

Standard 1.4.2 — Maximum Residue Limits Amendment Instrument No. APVMA 8, 2012

I, Rajumati Bhula, Program Manager, Pesticides Program and delegate of the Australian

Pesticides and Veterinary Medicines Authority, acting in accordance with my powers

under subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act

1992, make this instrument for the purposes of subsection 82(1)

of the Food Standards Australia New Zealand Act 1991.

Rajumati Bhula

Program Manager

Pesticides Program

Dated this twenty-first day of August 2012



Part 1 Preliminary

1 Name of Instrument

This Instrument is the Australia New Zealand Food Standards Code — Standard 1.4.2—Maximum Residue Limits Amendment Instrument No. APVMA 8, 2012.

2 Commencement

Pursuant to subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this Amendment Instrument commences on the day a copy of it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the

Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette No. APVMA

17 of

28 August 2012.

3 Object

The object of this Instrument is for the APVMA to make variations to Standard 1.4.2 — Maximum Residue Limits of the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation

In this Instrument: —

APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

Principal Instrument means Standard 1.4.2 — Maximum Residue Limits of the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that code. The whole of the Australia New Zealand Food Standard Code (including Standard 1.4.2) was further published in Gazette P 30 of 20 December 20004.

Part 2 Variations to Standard 1.4.2 — Maximum Residue Limits

5 Variations to Standard 1.4.2

The Schedule to this Instrument sets out the variations made to the Principal Instrument by this Amendment Instrument.

4 Note An amendment history from 20 December 2000 appears at the beginning of the Australia New

Zealand Food Standard Code.



Schedule

Variations to Standard 1.4.2 — Maximum Residue Limits

1 Variations

(1) The Principal Instrument is varied by:

(a) omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

Linuron

Sum of linuron plus 3,4-dichloroaniline, expressed as linuron

Vegetables [except celeriac; celery; leek]

*0.05

Pirimicarb

Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue

(demethylformamido-pirimicarb), expressed as pirimicarb

Vegetables [except adzuki bean (dry); leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1

(b) inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

Chlorantraniliprole

Plant commodities and animal commodities other than milk: Chlorantraniliprole

Milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-

[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-

N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide,

expressed as chlorantraniliprole

Radish T0.05 Swede T0.05 Turnip, Garden T0.05

Chlorfenapyr

Chlorfenapyr

Onion, Welsh T1



Clofentezine

Clofentezine

Tomato T1

Cyprodinil

Cyprodinil

Lettuce, leaf T10

Difenoconazole

Difenoconazole

Celeriac T0.5

Fenbutatin oxide

Bis[tris(2-methyl-2-phenylpropyl)tin]-oxide

Nectarine 3 Tomato T2

Fludioxonil Commodities of animal origin: Sum of fludioxonil

and oxidisable metabolites, expressed as fludioxonil Commodities of plant origin: Fludioxonil

Lettuce, leaf T10

Haloxyfop

Sum of haloxyfop, its esters and conjugates, expressed as haloxyfop

Guar bean (dry) T2

Linuron

Sum of linuron plus 3,4-dichloroaniline, expressed as linuron

Parsnip T0.05 Vegetables [except celeriac; celery;

leek; parsnip] *0.05

Pirimicarb

Sum of pirimicarb, demethyl-pirimicarb and the N-formyl-(methylamino) analogue

(demethylformamido-pirimicarb), expressed as pirimicarb

Celeriac 0.1 Vegetables [except adzuki bean

(dry); celeriac; leafy vegetables; lupin (dry); mung bean (dry); onion, Welsh; shallot; soya bean (dry); spring onion; sweet corn (corn-on-the-cob)]

1

Prochloraz

Sum of prochloraz and its metabolites containing the 2,4,6-trichlorophenol moiety, expressed as

prochloraz

Litchi T2

Pyraclostrobin Commodities of plant origin: Pyraclostrobin

Commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-

1H-pyrazol-3-ol, expressed as pyraclostrobin

Litchi T2

Pyriproxyfen

Pyriproxyfen

Strawberry T0.5



(c) omitting from Schedule 1, under the entries for the following chemicals, the maximum residue limit for the food, substituting –

Ioxynil

Ioxynil

Leek T2

Iprodione

Iprodione

Garlic T10


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. 16, 14 AUGUST 2012

For use in agricultural and/or veterinary chemical products:

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

S-METOLACHLOR AGROGILL CHEMICALS PTY LTD

SHANDONG ZHONGNONG MINCHANG

CHEMICAL INDUSTRY CO., LTD

NO. 516 YONGXIN ROAD BINBEI TOWN BINZHOU SHANDONG CHINA CHINA

67054

BOSCALID AGROGILL CHEMICALS PTY LTD

NANTONG JIAHE CHEMICALS CO LTD QINGLONG PORT CHEMICAL PORT DISTRICT HAIMEN 226121 JIANGSU PROVINCE CHINA

67486

SULFOSULFURON AGROSHINE AUSTRALIA PTY LTD

ZHEJIANG BOSST CROPSCIENCE CO., LTD. NO. 1 FANGJIADAI RD HAIYAN ECONOMIC DEVELOPMENT ZONE HAIYAN, ZHEJIANG P.R CHINA

67328

TRICLOPYR BUTOXYETHYL ESTER

MAX(RUDONG) CHEMICALS CO., LTD

MAX(RUDONG) CHEMICALS CO., LTD YANGKOU CHEMICALS INDUSTRY PARK RUDONG COUNTY 226407 JIANGSU PROVINCE CHINA

67316

APVMA CONTACT


Application Management & Enquiries


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4701

Fax: 02 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.16, 14 AUGUST 2012

Application No. Name

50445 KENSO AGCARE CLETHO 240 EC SELECTIVE HERBICIDE

52867 GLYPHOSATE

53041 MELPAT MILDEX WG FUNGICIDE

54146 UNITED FARMERS DIURON 900 WG HERBICIDE

54527 FENOXAPROP-P-ETHYL

54556 CTC PREMIX 200

55378 LUNA PRIVILEGE FUNGICIDE

56734 SELOVIN LA LONG ACTING SELENIUM INJECTION FOR CATTLE

56910 NEOVAC VACCINE

56944 ROACH WIZZ

56976 SAFLUFENACIL

57049 GENFARM METOLACHLOR 960 HERBICIDE

57117 AGRITRADING GLYPHOSATE 700 SG HERBICIDE

57147 EQUIVAC EST EQUINE SALMONELLA TYPHIMURIUM VACCINE

57149 AUSAGRI GLYPHOSATE 450 HERBICIDE

57150 COUNTRY 2,4-D / PICLORAM HERBICIDE

57178 NOVAGUARD DIFLUFENICAN + MCPA SELECTIVE HERBICIDE

57179 SMART TRI-ALLATE 500 EC HERBICIDE

57219 EZYCROP TRIASULFURON 750 WG HERBICIDE

57224 EZYCROP CHLORPYRIFOS 500 INSECICIDE

57242 CROP CARE VIVANDO FUNGICIDE

57248 NOT AVAILABLE

57249 NOT AVAILABLE

57250 NOT AVAILABLE



Other Notices – Application Summaries

Application No. Name

57277 NOT AVAILABLE

55918 TORDON REGROWTHMASTER HERBICIDE

56141 ILIUM METHADONE INJECTION

56577 REVUS FUNGICIDE

56842 TERMATRIX TERMITE FOAM INSECTICIDE

56899 FMC BROMOXYNIL & MCPA HERBICIDE

56915 FMC TERBUTRYN MCPA HERBICIDE

56954 ERYVAC VACCINE

57104 LUCILURE SHEEP BLOWFLY ATTRACTANT

57106 FMC HALOXYFOP 520 HERBICIDE

57119 APPARENT DIFLUFENICAN 500 SC HERBICIDE

57123 TALON ANT KILLER GEL

57124 OPTIGARD ANT BAIT GEL

57151 EARTHCORE GLYPHOSATE 360 WEED KILLER

57167 CROP CARE SENTRY HERBICIDE

57172 WIPE-OUT DRY 700 SG HERBICIDE

57173 WONSTAR 250SC FUNGICIDE

57292 NOT AVAILABLE

57323 EZYCROP DICLOFOP-METHYL 375 EC HERBICIDE

57324 EZYCROP HALOXYFOP 520 HERBICIDE

57393 NUFARM ARCHER HERBICIDE

APVMA CONTACT


Application Management and Enquiries Team (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4701

Fax: 02 6210 4721


apvma gazette no. 17, 28 august 2012 · no. apvma 17, tuesday, 28 august 2012 agricultural and...

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