TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products Page 10 Notice – New Agricultural & Veterinary Chemical Products Hydrocortisone Aceponate Page 13 [CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS]

Other Notices Reconsideration of Approvals and Registrations Page 17 Related to Sodium Fluoroacetate New and Amended Application Forms Page 19 Application Summaries Page 20 Notice of Appointment of Approved Analyst Page 23 Operational Notice – Label Claims for Efficacy against Pests Page 24 and Diseases which are Exotic to Australia Licensing of Veterinary Chemical Manufacturers Page 25 Amendments to the MRL Standard Page 28

NOTICE OF REGISTRATION OF AGRICULTURAL AND 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. AGRICULTURAL CHEMICAL PRODUCTS 1. RESTRICTED PRODUCT: Product Name: Pigout Feral Pig Bait Active Constituent/s: 0.3 g/kg sodium fluoroacetate. Each bait contains 72 mg of sodium fluoroacetate. Applicant Name: Animal Control Technologies (Australia) Pty Ltd Applicant ACN: 068 652 693 Summary of Use: Solid bait for the reduction of feral pig populations. Date of Registration: 21 December 2007 Label Approval No: 61293/3.75/0108, 61293/8/0108, 61293/12.5/0108, 61293/16/0108, 61293/25/0108 2. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS: Product Name: Precept Selective Herbicide Active Constituent/s: 25 g/L pyrasulfotole, 125 g/L MCPA present as 2-ethyl hexyl ester Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: Herbicide for the post-emergent broadleaf weeds in wheat, barley, oats, cereal rye and triticale. Date of Registration: 18 December 2007 Label Approval No: 60897/1107, 60897/20/1107, 60897/110/1107 Product Name: Cooee Timbertreat Active Constituent/s: 73 g/L lanolin, 2.5 g/L potassium sorbate, 2.5 g/L sodium propionate, 9 g/L benzalkonium chloride Applicant Name: Cooee Products Pty Ltd Applicant ACN: 084 747 160 Summary of Use: Remedial timber surface treatment that enhances the performance of timber from protection against decay,

termites and water ingress. For use with timber or wood used for internal floor, internal laminated beams and interior joinery that are inside, above ground and protected from wetting. Date of Registration: 15 January 2008 Label Approval No: 58162/1/0807, 58162/4/0807, 58162/10/0807, 58162/15/0807. 3. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS: Product Name: Rhodia Glyphosate Potassium Express Herbicide Active Constituent/s: 517 g/L glyphosate present as the potassium salt Applicant Name: Rhodia Australia Pty Limited Applicant ACN: 050 029 000 Summary of Use: For non-selective control of many annual and perennial weeds. Date of Registration: 10 December 2007 Label Approval No: 62173/0907, 62173/5L/0907, 62173/10L/0907, 62173/20L/0907, 62173/110L/0907, 62173/200L/0907, 62173/1000L/0907 Product Name: Conquest Powersurge Spray Adjuvant Active Constituent/s: 210 g/L non-ionic surfactant, 598 g/L paraffinic oil Applicant Name: Conquest Agrochemicals Pty Ltd Applicant ACN: 098 814 932 Summary of Use: To improve the wetting and spreading of herbicides and to enhance the penetrating properties of herbicides through waxy leaf surfaces. Date of Registration: 10 December 2007 Label Approval No: 61812/20L/0707, 61812/110L/0707, 61812/220L/0707 Product Name: Sumitomo Samurai Systemic Insecticide Active Constituent/s: 500 g/kg clothianidin Applicant Name: Sumitomo Chemical Australia Pty Limited. Applicant ACN: 081 096 255 Summary of Use: Control of mealy bug, woolly aphid and codling moth in apples and pears, and green peach aphid and oriental fruit moth in peaches and nectarines. Date of Registration: 10 December 2007 Label Approval No: 60687/1207, 60687/2.5kg/1207

Product Name: Sumitomo Shield Systemic Insecticide Active Constituent/s: 200 g/L clothianidin Applicant Name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of Use: For control of aphids and mirids on cotton and rust thrips and weevil borers on bananas. Date of Registration: 11 December 2007 Label Approval No: 60689/5L/1207, 60689/20L/1207, 60689/1207 Product Name: Gringo Insecticide/Miticide Active Constituent/s: 80 g/L bifenthrin Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: For the control of apples dumpling bug and plague thrips in apples, scab moth and flower thrips in bananas, two spotted mites in pears and several pests in ornamentals. Date of Registration: 12 December 2007 Label Approval No: 62075/0907, 62075/1L/0907, 62075/5L/0907, 62075/20L/0907 Product Name: Osmose Determite Reseal Active Constituent/s: 5 g/L bifenthrin Applicant Name: Osmose Australia Pty Ltd Applicant ACN: 088 260 575 Summary of Use: A ready to use product for the protection of framing timber which have been cut, sawn or notched against termites, furniture beetles and European House borer. Date of Registration: 12 December 2007 Label Approval No: 61870/500mL/1107 Product Name: Premium Quality Brilliant Pool Shock And Sanitiser Active Constituent/s: 504 g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Premium Quality Pool Products Pty Limited Applicant ACN: 002 446 648 Summary of Use: For the control of algae and bacteria in outdoor swimming pools. Date of Registration: 12 December 2007 Label Approval No: 62399/300g/1107, 62399/500g/1107, 62399/1kg/1107, 62399/2kg/1107, 62399/4kg/1107, 62399/10kg/1107, 62399/20kg/1107 Product Name: Aquasheen Spa Lithium Hypochlorite Active Constituent/s: 350 g/kg chlorine present as lithium hypochlorite Applicant Name: Premium Quality Pool Products Pty Limited

Applicant ACN: 002 446 648 Summary of Use: For the control of algae and bacteria in swimming spools and spas. Date of Registration: 12 December 2007 Label Approval No: 62324/500/1007, 62324/1/1007, 62324/2/1007 Product Name: Starycide Insect Growth Regulator Active Constituent/s: 48 g/L triflumuron Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of silverfish, immature fleas and cockroaches. Date of Registration: 13 December 2007 Label Approval No: 61251/1L/1207, 61251/1207 Product Name: Iprodione 250 Turf Fungicide Active Constituent/s: 250 g/L iprodione Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For the control of certain fungal diseases in turf and ornamental. Date of Registration: 13 December 2007 Label Approval No: 62516/5/1007, 62516/1007. Product Name: Chemforce Diuron 900WG Herbicide Active Constituent/s: 900 g/kg diuron Applicant Name: Frank Vanderkley & Paul Richards T/A Chemforce Australia Summary of Use: For the control of a wide range of weeds in various crops and industrial areas. Date of Registration: 14 December 2007 Label Approval No: 62426/10/1007, 62426/15/1007, 62426/1007 Product Name: United Farmers Bolster Spray Tank Adjuvant Active Constituent/s: 838 g/L petroleum oil Applicant Name: United Farmers Co-Operative Company Ltd Applicant ACN: 014 213 492 Summary of Use: For use in combination with selective herbicides to improve their wetting and penetrating properties through waxy leaf surfaces. Date of Registration: 17 December 2007 Label Approval No: 62040/20L/0607, 62040/110L/0607, 62040/205L/0607 Product Name: X-Pand Herbicide Active Constituent/s: 610 g/kg isoxaben, 40 g/kg florasulam

Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: Herbicide for early post-emergent control of certain broadleaf weeds in barley, triticale and wheat. Date of Registration: 17 December 2007 Label Approval No: 61235/1.25/0907 Product Name: United Farmers Platnum Spray Tank Adjuvant Active Constituent/s: 704 g/L ethyl and methyl esters of fatty acids derived from refined canola Applicant Name: United Farmers Co-Operative Company Ltd Summary of Use: To enhance the penetrating properties of herbicides and pyrethroid insecticides. Date of Registration: 17 December 2007 Label Approval No: 62041/20L/0607, 62041/110L/0607, 62041/205L/0607 Product Name: Protoxin Phosphine Fumigation Tablets Active Constituent/s: 330 g/kg phosphine (PH3) present as aluminium phosphide. Applicant Name: Proterra Pty Ltd Applicant ACN: 120 507 182 Summary of Use: Aluminium phosphide tablets that liberate phosphine gas for the control of pests which infest stored food commodities. Date of Registration: 18 December 2007 Label Approval No: 61675/300g-20kg/0307, 61675/0307. Product Name: United Farmers Assist Spray Tank Adjuvant Active Constituent/s: 859 g/L petroleum oil Applicant Name: United Farmers Co-Operative Company Ltd Summary of Use: For use in conjunction with knockdown or non-selective herbicides. Date of Registration: 18 December 2007 Label Approval No: 62039/20L/0607, 62039/110L/0607, 62039/205L/0607, 62039/1000L/0607 Product Name: Richgro Rogor Insecticide Active Constituent/s: 100 g/L dimethoate Applicant Name: A Richards Pty Ltd T/A Richgro Garden Products Applicant ACN: 008 734 852 Summary of Use: For the control of fruit fly, aphids, thrips, leaf miners, bean fly and certain other insect pests on fruit trees, vegetables, potatoes and ornamentals. Date of Registration: 18 December 2007 Label Approval No: 61916/250/1007

Product Name: Aquasheen Stabilised Pool Chlorine Active Constituent/s: 560 g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Premium Quality Pool Products Pty Limited Applicant ACN: 002 446 648 Summary of Use: For the control of algae and bacteria in outdoor swimming pools and to increase the longevity of chlorine in outdoor pools. Date of Registration: 18 December 2007 Label Approval No: 62501/1/1107, 62501/2/1107, 62501/4/1107, 62501/10/1107, 62501/20/1107, 62501/50/1107 Product Name: Gesaprim Granules Herbicide Active Constituent/s: 900 g/kg atrazine Applicant Name: Syngenta Crop Protection Pty Limited. Applicant ACN: 002 933 717 Summary of Use: For the selective control of annual grass and broadleaf weeds in a variety of crops and situations. Date of Registration: 20 December 2007 Label Approval No: 61892/10/0507 Product Name: Dairymaster Morning Alka-Master Low Foaming Liquid Alkali Detergent For The Cleaning Of Dairy Milking Equipment Active Constituent/s: 400 g/L sodium hydroxide Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: Low foaming alkali dairy detergent for the cleaning of dairy milking equipment. Date of Registration: 20 December 2007 Label Approval No: 62145/110L/0807, 62145/200L/0807, 62145/1000L/0807 Product Name: Rentokil Mouse Killer Box Active Constituent/s: 0 1 g/kg bromadiolone Applicant Name: Rentokil Initial Pty Ltd Applicant ACN: 000 034 597 Summary of Use: Ready-to-use rodenticide for control of mice in the home. Date of Registration: 20 December 2007 Label Approval No: 61181/1/0807, 61181/40/0807 Product Name: Legion 200SC Insecticide Active Constituent/s: 200 g/L fipronil Applicant Name: Crop Care Australasia Pty Ltd

Applicant ACN: 061 362 347 Summary of Use: For the control of various insect pests in bananas, Brassica’s, cotton, wine, grapevines, mushrooms, pasture, potatoes, sorghum, and sugarcane. Date of Registration: 21 December 2007 Label Approval No: 62236/0707, 62236/2.5L/0707, 62236/5L/0707, 62236/10L/0707, 62236/20L/07 Product Name: Melpat Spray Grade Ammonium Sulphate Herbicide Adjuvant Active Constituent/s: 980 g/kg ammonium sulphate Applicant Name: Melpat International Pty Ltd Applicant ACN: 066 067 507 Summary of Use: For the use as herbicide adjuvant to be used with glyphosate based herbicides to minimise antagonism when tank mixing with flowable herbicides, and to improve performance under adverse environmental conditions. Date of Registration: 21 December 2007 Label Approval No: 61740/25/1107 Product Name: Osmose Determite Ultra Low Odour Timber Framing Insecticide RTU Active Constituent/s: 5 g/L bifenthrin Applicant Name: Osmose Australia Pty Ltd Applicant ACN: 088 260 575 Summary of Use: A ready to use product for the protection of timber and timber based products from damage by borers and termites. Date of Registration: 4 January 2008 Label Approval No: 61546/200L/1107, 61546/1000L/1107, 61546/BULK/1107 Product Name: 4Farmers Haloxyfop 520 Herbicide Active Constituent/s: 520 g/L Haloxyfop present as the haloxyfop-R methyl ester. Applicant Name: 4 Farmers Pty Ltd Applicant ACN: 067 443 485 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, medi and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruits, pyrethrum, tropical fruit and nut crops. Date of Registration: 7 January 2008 Label Approval No: 61558/1-10L/0707, 61558/20-1000L/0707, 61558/0707 Product Name: Decoy 400 Herbicide Active Constituent/s: 400 g/L fluroxypyr as

the methyl heptyl ester Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, pastures, sugarcane and winter cereals. Date of Registration: 9 January 2008 Label Approval No: 61720/1007, 61720/1L/1007, 61720/5L/1007, 61720/20L/1007, 61720/10L/1007, 61720/60L/1007, 61720/110L/1007, 61720/200L/1007, 61720/500L/1007, 61720/1000L/1007 Product Name: Mortein Rat Kill Active Constituent/s: 0.05 g/kg brodifacoum, 0.04 g/kg fipronil Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: To kill fleas and ticks on mice and rats prior to control of these specified rodents in household situations. Date of Registration: 9 January 2008 Label Approval No: 58661/20g/0606, 58661/40g/0606, 58661/80g/0606 Product Name: Dairy Chem Alkali Powder Detergent Active Constituent/s: 10 g/kg nonyl phenol ethoxylate, 800 g/kg sodium hydroxide Applicant Name: Jaegar Australia Pty Limited Applicant ACN: 005 286 224 Summary of Use: For the removal of soils and is suitable for in place cleaning of pasteurizers, evaporators, holding vats in dairy factories and for cleaning systems on dairy farms. Date of Registration: 9 January 2008 Label Approval No: 60622/10KG/1107 Product Name: Innova Iprodione 500 Aquaflo Fungicide Active Constituent/s: 500 g/L iprodione Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For the control of certain fungal diseases in various crops and situations. Date of Registration: 10 January 2008 Label Approval No: 62463/10-20/0108 Product Name: Fire-Up 510 Herbicide Active Constituent/s: 510 g/L glyphosate present as the isopropylamine salt. Applicant Name: Agvantage Pty Ltd

Applicant ACN: 097 970 280 Summary of Use: For use in the control of a wide range of annual and perennial weeds in agricultural situations. Date of Registration: 10 January 2008 Label Approval No: 60312/20L/1007, 60312/110L/1007, 60312/200L/1007, 60312/1000L/1007, 60312/1007 Product Name: DuPont Compatriot Xtruded Herbicide Active Constituent/s: 67 g/kg hexazinone, 533 g/kg diuron Applicant Name: Du Pont (Australia) Ltd Applicant ACN: 000 716 469 Summary of Use: For use in sugar cane to control various weeds. Date of Registration: 10 January 2008 Label Approval No: 61794/2/1007, 61794/10/1007, 61794/10B/1007, 61794/10P/1007, 61794/12/1007 Product Name: Nowra Chemical Manufacturers Pool Chlorine Active Constituent/s: 700 g/kg available chlorine (Cl) present as calcium hypochlorite. Applicant Name: Nowra Chemical Manufacturers Pty Ltd Applicant ACN: 001 505 988 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 14 January 2008 Label Approval No: 62524/4/1107, 62524/10/1107, 62524/20/1107 Product Name: Omega Chemicals Low Residue Granular Chlorine 70% Active Constituent/s: 700 g/kg available chlorine (Cl) present as calcium hypochlorite. Applicant Name: Chemprod Nominees Pty Limited T/A Omega Chemicals Applicant ACN: 005 032 744 Summary of Use: Controls algae and bacteria in swimming pools. Date of Registration: 14 January 2008 Label Approval No: 62322/10-40kg/1007 Product Name: Iproval Aquaflo Fungicide Active Constituent/s: 500 g/L iprodione Applicant Name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of Use: For the control of certain fungal diseases in various crops and situations. Date of Registration: 14 January 2008 Label Approval No: 61321/5L/1007, 61321/20L/1007, 61321/1007.

Product Name: Clark Rubber Filtrite 12.5% Liquid Pool Chlorine Active Constituent/s: 125 g/L available chlorine (Cl) present as sodium hypochlorite. Applicant Name: Clark Rubber Franchising Pty Ltd Applicant ACN: 065 708 723 Summary of Use: For the control of algae and bacteria in swimming pools and spas. Date of Registration: 14 January 2008 Label Approval No: 62466/10/1107, 62466/15/1107, 62466/20/1107 Product Name: Protech Crack And Crevice Residual Insecticide Active Constituent/s: 1.5 g/kg cyphenothrin, 1.5 g/kg tetramethrin Applicant Name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of Use: For the control of flying (flies and mosquitoes) and crawling (cockroaches) insects in the home. Date of Registration: 14 January 2008 Label Approval No: 62274/416g/1107 Product Name: Nowra Chemical Manufacturers Stabilised Chlorine For Pools Active Constituent/s: 560 g/kg available chlorine (Cl) present as sodium dichloroisocyanurate. Applicant Name: Nowra Chemical Manufacturers Pty Ltd Applicant ACN: 001 505 988 Summary of Use: For the control of algae and bacteria in outdoor swimming pools. Date of Registration: 14 January 2008 Label Approval No: 62526/10/1107 Product Name: Chemag Bromox MA Selective Herbicide Active Constituent/s: 200 g/L bromoxynil present as the n-octanoyl ester, 200 g/L MCPA present as the ethyl hexyl ester Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Use: For the control of weeds in wheats, oats, barley, cereal rye, triticale, linseed, grass pastures and turf. Date of Registration: 15 January 2008 Label Approval No: 61593/5L/1007, 61593/20L/1007, 61593/110L1007, 61593/200L/1007, 61593/1000L/1007. 61593/1007. Product Name: Homeguard GT Granular Termiticide Active Constituent/s: 1 g/kg bifenthrin Applicant Name: FMC Australasia Pty Ltd

Applicant ACN: 095 326 891 Summary of Use: For the protection of perimeter cavities and construction voids from concealed termite entry. Date of Registration: 15 January 2008 Label Approval No: 61588/15KG/0108 Product Name: Macspred Glyphosate Bi Dri Herbicide Active Constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt. Applicant Name: Macspred Pty Ltd Applicant ACN: 011 029 495 Summary of Use: For the control of annual, perennial and aquatic weeds in forestry, pasture, designated aquatic situations, commercial, industrial and public service areas. Date of Registration: 15 January 2008 Label Approval No: 61952/500g/0607, 61952/5kg/0607, 61952/10kg/0607, 61952/0607 Product Name: Country Imidacloprid 200 SC Termiticide Active Constituent/s: 200 g/L imidacloprid. Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For control of subterranean termites as a barrier treatment or in reticulation systems in existing buildings, as a barrier treatment around new buildings and wooden structures and for treatment of termite nests in wall cavities, poles and trees. Date of Registration: 16 January 2008 Label Approval No: 60576/1L/0607, 60576/2.5L/0607, 60576/5L/0607, 60576/10L/0607 Product Name: Jockey Stayer Seed Treatment Fungicide Active Constituent/s: 167 g/L fluquinconazole Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: A seed treatment product for the control and suppression of various diseases in wheat, barley and canola. Date of Registration: 18 January 2008 Label Approval No: 62522/10/1107, 62522/100/1107, 62522/200/1107, 62522/1000/1107, 62522/1107 4.VARIATIONS Product Name: Atlantis Selective Herbicide

Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: Variation of registration and label approval to extend the use to include control of barley grass. Date of Variation: 19 December 2007 Label Approval No: 54252/5A/1107, 54252/10A/1107, 54252/A/1107, 54252/5B/1107, 54252/10B/1107, 54252/B/1107 Product Name: MaximXL Fungicide Seed Treatment. Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Variation: Variation of product registration and label approval to extend use to control damping off/root rot complex caused by Pythium and Fusarium in maize, sweet corn and sorghum and the addition of 1L and 5L pack sizes. Date of Variation: 19 December 2007 Label Approval No: 53572/1/1007, 53572/5/1007, 53572/115/1007, 53572/1000/1007 5. RESTRICTED PRODUCT VARIATION Product Name: Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: “No entries”

NOTICE OF REGISTRATION OF AGRICULTURAL AND 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.

VETERINARY CHEMICAL PRODUCTS

1. RESTRICTED PRODUCT: Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No Entries” 2. VETERINARY PRODUCTS BASED

ON NEW ACTIVE CONSTITUENTS: Product Name: Lifetide SW 5 Injectable Plasmid Encoding Porcine GHRH Active Constituent/s: 2.5 mg/mL synthetic porcine GHRH encoding plasmid. Applicant Name: VGX Animal Health, Inc. Summary of Use: A synthetic porcine GHRH-encoding plasmid injected into sows by or under the direction of a veterinary surgeon to increase the number of piglets weaned. Date of Registration: 4 January 2008 Label Approval No: 59865/2ML/0108, 59865/10ML/0108, 59865/20ML/0108, 59865/50ML/0108, 59865/100ML/0108, 59865/0108 3. VETERINARY PRODUCTS BASED

ON EXISTING ACTIVE CONSTITUENTS:

Reissue of 62059 Product Name: NV Joint Guard Powder For Cats Active Constituent/s: Each 2.5g contains 400 mg chondroitin sulfate, 500 mg glucosamine hydrochloride Applicant Name: Nature Vet Pty Limted Applicant ACN: 002 692 426 Summary of Use: Oral powder product for use in cats where long term use may help to reduce non-infectious joint inflammation.

Date of Registration: 6 December 2007 Label Approval No: 62059/100G/1207 Product Name: Hill's Prescription Diet C/D Multicare Feline (Tinned) Applicant Name: Hill's Pet Nutrition Inc Summary of Use: A complete pet diet which is intended to assist in the nutritional management of cats suffering from Feline Lower Urinary Tract Disease (FLUTD) caused by struvite uroliths or urethral plugs, oxalate uroliths of feline idiopathic cystitis (FIC). Date of Registration: 12 December 2007 Label Approval No: 62037/156g/1007 Product Name: Fortekor Flavour 20mg Tablets For Dogs Active Constituent/s: Each tablet contains 20 mg benazepril hydrochloride Applicant Name: Novartis Animal Health Australasia Pty Limited Applicant ACN: 076 745 198 Summary of Use: For the treatment of heart failure in dogs due to mitral regurgitation and dilated cardiomyopathy Date of Registration: 13 December 2007 Label Approval No: 61192/28/0907, 61192/0907 Product Name: Veanavite Veanalyte Electroguard Active Constituent/s: Each 30 gram measure contains 12 g dextrose, 10.20 g ispaghula husk, 0.81 g potassium chloride, 0.27 g magnesium hydroxide, 2.16 g sodium bicarbonate, 1.38 g sodium chloride, 0.84 g sodium citrate. Applicant Name: QAF Feeds Pty Ltd Applicant ACN: 004 356 763 Summary of Use: An oral electrolyte powder to aid in the prevention of dehydration and scouring in calves. Date of Registration: 14 December 2007 Label Approval No: 59836/0.5/0707, 59836/1.5/0707, 59836/2.0/0707, 59836/5.0/0707, 59836/15/0707, 59836/20/0707 Product Name: Fortekor Flavour 5mg Tablets For Dogs And Cats Active Constituent/s: Each tablet contains 5 mg benazepril hydrochloride. Applicant Name: Novartis Animal Health Australasia Pty Limited Applicant ACN: 076 745 198 Summary of Use: For the treatment of heart failure in dogs due to mitral regurgitation and dilated cardiomyopathy, and for the treatment of hypertropic cardiomyopathy and chronic renal insufficiency in cats. Date of Registration: 14 December 2007

Label Approval No: 61193/0907, 61193/28/0907 Product Name: Rufus & Coco Inner Balance Soluble Probiotic To Maintain Gut Health & Aid Recovery. Also Useful During Periods Of Stress Powder Suitable For Puppies, Kittens, Animals & Birds Active Constituent/s: Each gram contains 180 Million CFU as: bifidobacterium bifidum, enterococcus faecium, lactobacillus delbrueckii subspecies bulgaricus, lactobacillus acidophilus, lactobacillus plantarum, lactobacillus rhamnosus, streptococcus salivarius subspecies thermophilus. Applicant Name: Rufus & Coco Pty Ltd Applicant ACN: 123 213 070 Summary of Use: Use to maintain gut health and aid recovery and during periods of stress, in puppies, kittens, animals and birds. Date of Registration: 19 December 2007 Label Approval No: 62259/100g/1107 Product Name: Agvantage Pty Ltd Active Constituent/s: 400 g/L sodium hydroxide Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: Low foaming alkali dairy detergent for the cleaning of dairy milking equipment. Date of Registration: 20 December 2007 Label Approval No: 62145/110L/0807, 62145/200L/0807, 62145/1000L/0807 Product Name: Coopers Diazinon Sheep Blowfly Dressing And Cattle, Goat And Pig Spray Active Constituent/s: 200 g/L diazinon Applicant Name: Schering-Plough Pty Limited Applicant ACN: 000 235 245 Summary of Use: A dressing for control of blowfly strike on struck sheep and as a wound dressing and for the control of lice and buffalo fly on cattle, lice on goats, lice and mange on pigs. Date of Registration: 24 December 2007 Label Approval No: 62353/5/1007, 62353/20/1007 Product Name: Nuflor Pig Premix Active Constituent/s: 40 g/kg florfenicol Applicant Name: Schering-Plough Pty Limited Applicant ACN: 000 235 245 Summary of Use: For the treatment of swine respiratory disease associated with Actinobacullus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp and Streptococcus suis Type 2 Date of Registration: 7 January 2008

Label Approval No: 60369/5kg/1207, 60369/25kg/1207 Product Name: Rufus & Coco Odour Fender Improves Digestion, Reduces Faecal Odour & Loose Bowel Motion Powder Suitable For Dogs Active Constituent/s: 718.8 g/kg sodium bentonite, 7.2 g/kg digestive enzymes (with lipase, protease & amylase). Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: To improve digestion and reduce faecal odour and loose bowel motions in dogs. Date of Registration: 9 January 2008 Label Approval No: 62201/400g/1107 Product Name: Zinjet Blowfly And Lice Jetting Fluid For Sheep Active Constituent/s: 16 g/L ivermectin Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: For treatment of, and protection against, blowfly strike on sheep for up to 12 weeks and treatment of biting lice on long woolled sheep. Date of Registration: 14 January 2008 Label Approval No: 61696/5L/0807, 61696/10L/0807 Product Name: Nobivac Bb/Pi Active Constituent/s: Each single dose vial contains at least 0.05 ug purified inactivated Bordetella bronchiseptica antigen, 106 TCID50 inactivated canine parainfluenza virus. Applicant Name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of Use: For the immunisation of dogs against Bordetella bronchiseptica and Canine parainfluenza virus. Date of Registration: 17 January 2008 Label Approval No: 62433/1D/1107, 62433/10D/1107, 62433/1107 4.VARIATIONS Product Name: Pestigard Vaccine Applicant Name: Pfizer Animal Health A Div Of Pfizer Aust Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation of label approval to change the time interval between the primary and secondary vaccinations from 4-6 weeks to 6 months. Date of Variation: 12 December 2007 Label Approval: No: 53867/1/1007, 53867/2/1007, 53867/3/1007, 53867/4/1007, 53867/1007 Product Name: Pestigard Vaccine

Applicant Name: Pfizer Animal Health A Div Of Pfizer Aust Pty Ltd Applicant ACN: 008 422 348 Summary of Variation: Variation to extend the use of the product in pregnant cows. Date of Variation: 12 December 2007 Label Approval No: 53867/1/1007, 53867/2/1007, 53867/3/1007, 53867/4/1007, 53867/1007 Product Name: Alamycin LA 300 Oxytetracycline Injectable Solution Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Variation: Approval of variation to include Export Slaughter Intervals. Date of Variation: 20 December 2007 Label Approval No: 53087/100ML/1007, 53087/250ML/1007, 53087/500ML/1007, 53087/1007 5. RESTRICTED PRODUCT

VARIATION Product Name: Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: “No entries”

NOTICE

Hydrocortisone aceponate

in the product: CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Virbac (Australia) Pty Limited for the approval of a new active constituent, hydrocortisone aceponate and for the registration of a new product containing hydrocortisone aceponate. The product is CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS. The product is for use on dogs. 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 active constituent approval and registration of product should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice. Particulars of Active Constituent

IUPAC Name: [(8S,9S,10R,11S,13S,14S,17R)-17-(2-acetyloxyacetyl)-11-hydroxy-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[α]phenanthren-17-yl]propanoate

CA Name: 21-(acetyloxy)-11 beta-hydroxy-17 alpha-(propionyloxy)-4-pregnene-3,20-dione

Manufacturer’s Code: HC63 M CAS No: 74050-20-7 Molecular Formula: C26H36O7Molecular Weight: 460.56 Structure:

O

CH3HO

H CH3O CH3

O

OO

CH3

H

H

H

O

Chemical Family: Corticosteroid Mode of Action: Immunosuppression and inhibition of prostaglandin and

leukotriene production.

Summary of the APVMA’s Evaluation of Hydrocortisone Aceponate Active Constituent

The Chemistry Section of the APVMA has evaluated the chemistry aspects of hydrocortisone aceponate 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, it is proposed that the following APVMA Active Constituent Standard be established for hydrocortisone aceponate active constituent:

Constituent Specification Level Hydrocortisone aceponate

Hydrocortisone aceponate Not less than 985 g/kg (anhydrous, solvent free basis)

Other compounds of toxicological significance are not expected to occur in hydrocortisone aceponate as a result of the raw materials and the synthetic route used. The Office of Chemical Safety in the Commonwealth Department of Health and Aging has considered the toxicological aspects of hydrocortisone aceponate, and advised that there are no toxicological objections to the approval of this chemical. Since hydrocortisone aceponate is not intended for use in food production, an Acceptable Daily Intake (ADI) and an Acute Reference Dose (ARfD) are not considered necessary. The National Drugs and Poisons Schedule Committee (NDPSC) has included hydrocortisone aceponate into Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The APVMA accepts the findings and recommendations of its advisers on these criteria. The APVMA is satisfied that the proposed importation and use of hydrocortisone aceponate active constituent would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use. Particulars of Application Proposed product name: CORTAVANCE CUTANEOUS SPRAY

SOLUTION FOR DOGS Applicant company: Virbac (Australia) Pty Limited Signal heading: Schedule 4 Prescription Animal Remedy Statement of claims: For topical use as an aid in the reduction of

dermatological signs in localised lesions associated with flea allergy dermatitis and for the symptomatic relief of inflammatory and pruritic skin conditions when used under veterinary direction.

Pack sizes: 76ml Withholding period: Not applicable. Summary of the APVMA’s evaluation of hydrocortisone aceponate in CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS 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 hydrocortisone aceponate in CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS 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 Commonwealth Department of Health and Aging assessed the human toxicological aspects of this application. The product will be formulated in France. Hydrocortisone aceponate has low acute oral, dermal and inhalation toxicity, low skin irritant, moderate eye irritant and unlikely to be a skin senstitiser. OCS advised the APVMA that there are no toxicological objections to the registration of the product and recommended safety directions with respect to eyes. The APVMA accepts the findings and recommendations of the OCS evaluation.

(ii) The APVMA is satisfied that the proposed use of hydrocortisone aceponate in CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS will not be an undue hazard to the safety of people using anything containing its residues. The OCS determined that because the product is for use in companion animals only, hydrocortisone aceponate is unlikely to enter the food chain.

(iii) The APVMA is satisfied that the proposed use of the hydrocortisone aceponate in

CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS is not likely to be harmful to human beings if used according to the product label directions. The National Drugs and Poisons Scheduling Committee (NDPSC) has examined the active constituent and placed it in Schedule 4 Prescription Animal Remedy of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The appropriate Signal Heading is on the product label. First Aid and Safety Directions for hydrocortisone aceponate have been recommended by the Office of Chemical Safety in the Commonwealth Department of Health and Aging and have been included on the label. The APVMA accepts the findings and recommendations of its advisers on this criterion.

(iv) The APVMA is satisfied that the proposed use of hydrocortisone aceponate in

CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS is not likely to have an unintended effect that is harmful to animals, plants or the environment. The Department of the Environment, Water, Heritage and the Arts (DEWHA) has assessed data in support of product registration. In considering the proposed use pattern and the relatively low amount proposed for use, DEWHA has advised that this will not result in a significant environmental hazard.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(v) The APVMA is satisfied that the proposed use of hydrocortisone aceponate in

CORTAVANCE CUTANEOUS SPRAY SOLUTION FOR DOGS would not adversely affect trade between Australia and places outside Australia as is for use in dogs only.

(vi) In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to

determine that it is satisfied that the data from trials supporting the efficacy of the products demonstrate that the product is safe and effective for the proposed uses.

Written submissions on the APVMA’s proposal to grant the application for approval of the active constituent and the applications for registration of the products should be addressed to:

Karina Tyson Acting Senior Product Evaluator Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4729 Fax: (02) 6210 4741 Email: karina.tyson@apvma.gov.au

NOTICE

RECONSIDERATION OF APPROVALS AND REGISTRATIONS RELATED TO SODIUM FLUOROACETATE

The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, has reconsidered registrations of all products containing sodium fluoroacetate and the approvals of all associated product labels listed in Table 1. The use of sodium fluoroacetate, commonly known as 1080, was pioneered in Australia in the early 1950s as a rabbit poison in Tasmania. Products containing 1080 are now widely used in Australia for vertebrate pest control (rabbits, foxes, wild dogs and feral pigs) in agricultural production as well as biodiversity conservation. Following the finalisation of its reconsideration of 1080, the APVMA is satisfied that the conditions to which label approvals are currently subject can be varied to ensure that the requirements for continued label approval will be complied with. Therefore the APVMA has varied the conditions of label approval for the labels listed in Table 1. The APVMA is satisfied that the labels of products listed in Table 1 have been varied and that the products meet the prescribed requirements for continued registration. On this basis the APVMA is satisfied that continued registration of the products in accordance with their instructions for use:

• would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and

• would not be likely to have an effect that is harmful to human beings; and • would not be likely to have an unintended effect that is harmful to animals, plants or

things or to the environment; and • would not unduly prejudice trade or commerce between Australia and places outside

Australia; and therefore has affirmed the product registrations. Table 1: Products registrations that have been affirmed and label approval

numbers varied as an outcome of the review

Product number

Product name Registrant Varied label approval numbers

40573 FOXOFF FOX BAIT Animal Control Technologies (Australia) Pty Ltd

40573/0801

46434 FOXOFF ECONOBAIT Animal Control Technologies (Australia) Pty Ltd

46434/1205

49384 DOGGONE WILD DOG BAIT Animal Control Technologies (Australia) Pty Ltd

49384/0904

50304 RABBAIT 1080 OAT BAIT Animal Control Technologies (Australia) Pty Ltd

50304/0999

42458 1080 BAITS Department of Primary Industries and Water

Ψ

49350 1080 OATS RABBIT BAIT Department of Natural Resource and Environment

49350/01

49351 1080 CARROTS RABBIT BAIT Department of Sustainability and Environment

49351/01

49354 1080 PREDATOR BAIT Department of Sustainability and Environment

49354/01

49355 1080 FOX BAIT Department of Sustainability and Environment

49355/01

42498 1080 CONCENTRATE (RED) Agricultural Protection Board of Western Australia

42498/0403

42499 1080 CONCENTRATE (BLACK) Agricultural Protection Board of Western Australia

42499/0403

42500 1080 IMPREGNATED OATS (WILD DOG CONTROL)

Agricultural Protection Board of Western Australia

42500/1002

42501 "ONE SHOT" 1080 IMPREGNATED OATS

Agricultural Protection Board of Western Australia

42501/1002

42538 1080 IMPREGNATED OATS (FOX CONTROL)

Agricultural Protection Board of Western Australia

42538/0802

52954 1080 READY-TO-LAY RABBIT OAT BAIT

Agricultural Protection Board of Western Australia

52954/0600

54616 1080 DRIED MEAT FOX BAITS Agricultural Protection Board of Western Australia

54616/1201

42450 1080 BAIT FOR THE CONTROL OF RABBITS

Animal and Plant Control Group

42450/0503

Ψ Label approval approved prior to the commencement of the agvet codes and hence does not have an approval number. The detailed reasons for these reconsiderations can be found in the APVMA Final Review Report and Regulatory Decision. Copies of the report or further information can be obtained from the APVMA website: www.apvma.gov.au or by request to the Chemical Review Contact Officer on (02) 6210 4700 or chemrev@apvma.gov.au.

NOTICE

New and amended application forms New application forms Until now, there has been an application form for application categories 3-7 and 10. The APVMA has replaced this single application from with three new application forms:

(1) Application form for ag categories 3 and 4 (2) Application form for ag and vet categories 5, 6 and 7 (3) Application form for ag and vet category 10

The reason for the new forms is that the previous form was not best suited for application categories 5, 6 and 7. These are applications for registration of products which are similar or closely similar to existing registered products, ie they are image products. Application categories 3, 4 and 10 are for registration of new products. Amended application forms The application forms for categories 1, 2, 3, 4, 5, 6, 7, 8, 10, 11, 12, 13, and 14 now have a question on page 1: “Can the APVMA disclose the formulation details to the applicant/registrant?” The reason for this amendment is to assist the APVMA to not inadvertently release commercially confidential information to the applicant or registrant. All application forms can be accessed via the Manual of Requirements and Guidelines (MORAG) on the APVMA website at http://www.apvma.gov.au/industry/MORAG.shtml Contact: Martin Holmes Program Manager, Veterinary Medicines Tel: (02) 6210 4725 Fax: (02) 6210 4741 Email: martin.holmes@apvma.gov.au

NOTICE

Application Summaries The APVMA publishes complete application summaries on the APVMA website (http://www.apvma.gov.au/data_protection/appl_summaries.shtml). 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, 1st January 2008

Application No Name 37342 NOT AVAILABLE 39816 BIOTIS ALPHA 100 INSECTICIDE 41582 BOOST PLUS RUMENSIN 41649 MARINE BLUE AUSTRALIA SPF 30+ SUNSCREEN LOTION WITH INSECT REPELLENT

41651 AUSCARE INDUSTRIAL FORMULA SUNSET BY WORKSENSE SPF30+ SUNSCREEN WITH INSECT REPELLENT

41673 NOT AVAILABLE 41676 COOPERS STRIKE INSECT GROWTH REGULATOR FOR SHEEP DIPPING AND JETTING 41696 SUN SURE SPF30+ SUNSCREEN WITH INSECT REPELLENT 41697 SEA & SKI PROTECTION PLUS SPF30+ WITH INSECT REPELLENT 41836 NOT AVAILABLE 41936 IMPACT MASTA 41982 HEMPEL'S ANTIFOULING OLYMPIC 86951 41983 RENTOKIL IGR 300 GRAIN PROTECTANT 41985 HEMPEL'S ANTIFOULING OLYMPIC 86901 42126 NOT AVAILABLE 42295 RENTOKIL ALPHA RAPID RODENTICIDE 42409 ECO-BOR 100 42481 WSD APLHACYPER 100 EC INSECTICIDE 42552 GENERATION BLUE MAX BLOCK SINGLE-FEED RODENTICIDE 42589 Y-TEX AGRESSOR CATTLE EAR TAGS 42694 CHAMELEON JUMBO SWIMMING POOL TABLETS 42757 ISOMATE C/OFM TT PHEROMONE INSECT CONFUSION AGENT 42793 CAMPBELL IPRAL 250 LIQUID FUNGICIDE 42823 COUNTRY GLYPHOSATE 450 K-SALT HERBICIDE 42829 NOT AVAILABLE 43085 NOT AVAILABLE 43086 NOT AVAILABLE 43088 NOT AVAILABLE 43089 NOT AVAILABLE 43092 CHEMFORCE SIMAZINE 900WG HERBICIDE 43107 BEAT-A-BUG POSS OFF 43128 AGROREG CLOPYRALID 300 SL HERBICIDE 43159 NOT AVAILABLE 43160 UNITED FARMERS TRIADIMEFON 500 WG FUNGICIDE 43164 PROGIBB SG PLANT GROWTH REGULATOR 43176 RESFLOR INJECTABLE SOLUTION

43181 ROTAM IMAXI 350 SC INSECTICIDE 43195 MERIT INJECTABLE TREE INSECTICIDE 43208 TITAN ALPHA DUO 100 INSECTICIDE 43209 NOT AVAILABLE 43247 TITAN FLUROXYPER 200 EC HERBICIDE 43264 DEFENDER ROSEPRIDE FUNGICIDE, INSECTICIDE & MITICIDE 3 IN 1 PEST SPRAY 43268 CARBARYL 43284 GLYPHOSATE 43287 IQ SHOCK & SWIM 43298 BIGWET 1000 SURFACTANT 43315 NUFARM GRUNT 750WDG HERBICIDE 43331 NOT AVAILABLE 43332 NOT AVAILABLE 43333 NOT AVAILABLE 43354 YATES ZERO RAPID GLYPHOSATE WEEDSPRAY 43356 NOT AVAILABLE 43371 NUFARM AERO FUNGICIDE 43376 4FARMERS SULFOMETURON 750WDG HERBICIDE 43397 COUNTRY BIFENTHRIN 100 EC INSECTICIDE/MITICIDE 43404 CLODIN 240EC SELECTIVE HERBICIDE 43446 SICKLE 540 HERBICIDE 43448 NOT AVAILABLE 43449 RUMETRACE EZYMIN SHEEP COBALT PILLS 43466 IGA FATAL HIGH PERFORMANCE SURFACE SPRAY 43475 COUNTRY TRIADIMEFON 125 EC FUNGICIDE 43494 AGROREG PROMETRYN 900 WG HERBICIDE 43502 FLUAZIFOP-P-BUTYL 43506 FLUTRIAFOL 43511 COUNTRY PARAQUAT/DIQUAT 250 HERBICIDE 43521 AGROREG TRICLOPYR 600 EC HERBICIDE 43524 TALON MOUSE BAIT STATION 43539 TITAN BROMOXYNIL MA SELECTIVE HERBICIDE 43548 TERBACIL 43550 DIQUAT DIBROMIDE 43558 ACETAMIPRID 43568 EPOXICONAZOLE 43576 SUPERWAY WHITE ANT TERMINATOR TERMITE BAIT 43639 AGROREG CYANAZINE 900 WG HERBICIDE 43655 ACETAM 225 SL HERBICIDE 43668 DECCO POTATO STORAGE SPROUT INHIBITOR 43670 R & R METHYL BROMIDE 1000 FUMIGANT 43671 R & R METHYL BROMIDE 980 FUMIGANT 43675 NOT AVAILABLE 43682 NOT AVAILABLE 43685 NOT AVAILABLE 43750 OZCROP ATRAZINE 900 WG HERBICIDE 43753 OZCROP OXY 240 EC HERBICIDE 43757 NOT AVAILABLE 43766 TRIPICRIN 500-500 SOIL FUMIGANT 43772 TASK HERBICIDE 43773 NOT AVAILABLE 43846 DIMETHOMORPH

43878 RILEXINE 300 PALATABLE LIVER FLAVOURED CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS

43879 RILEXINE 600 PALATABLE LIVER FLAVOURED CEPHALEXIN ANTIBIOTIC TABLETS FOR DOGS

A change or correction has been made to the following summaries: Application No Product/Active Constituent Name

42031 MACSPRED GLYMAC DRI 700 HERBICIDE 41449 BOUNDARY HERBICIDE 41609 CHEMAG REGAL 800 WG INSECTICIDE 41304 CHEMAG RALLY 750 SG HERBICIDE 41005 CHEMAG MADDOG SELECTIVE HERBICIDE

Contact: Application Management and Enquiries Unit Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604

Ph: 6210 4701 Fax: 6210 4721

Notice of Appointment of Approved Analysts

Subsection 69G (2) of the Agricultural and Veterinary Chemicals

(Administration) Act 1992

Notice is hereby given that the persons described in Schedule 1 below were duly appointed on 11 December 2007, in accordance with subsection 69G (1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, as approved analysts for the purposes of the Agvet Codes.

Schedule 1

Appointment No. 075 Dr Robert Symons National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 076 Mr Gavin Stevenson National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 077 Ms Meg Croft National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 078 Dr Daniel Burke National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 079 Mrs Masooma Trout National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 080 Dr Michael Wu National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

Appointment No. 081 Mr David Saxby National Measurement Institute 1 Suakin Pl PYMBLE NSW 2073

APVMA Contact: Dr Joseph Morrall Regulatory, Strategy and Compliance Section Ph: (02) 6210 4801 Fax: (02) 6210 4813 E-mail: joseph.morrall@apvma.gov.au

OPERATIONAL NOTICE

Label claims for efficacy against pests and diseases which are exotic to Australia

The APVMA has published an Operational Notice which states that the APVMA will not grant approval of label claims for efficacy against pests and diseases which are exotic to Australia. The full text of the Operational Notice is on the APVMA website at http://www.apvma.gov.au/guidelines/downloads/op_notice_exotics.pdf Contact: Martin Holmes Program Manager, Veterinary Medicines Tel: (02) 6210 4725 Fax: (02) 6210 4741 Email: martin.holmes@apvma.gov.au

_____________________________________________________________________________________________________________ * Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer

NOTICE

Licensing of Veterinary Chemical Manufacturers _________________________________________________________________________ Pursuant to Part 8 of the Agricultural and Veterinary Chemical Codes scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has issued, amended or cancelled the manufacturing licences in respect of the following veterinary chemical manufacturers, with effect from the dates shown. For a comprehensive listing of all licensed manufacturers please see the APVMA’s web site: http://www.apvma.gov.au. _________________________________________________________________________ 1. NEW LICENCES: DR CHET’S PTY LTD ACN: 128 197 731 45 Aquila Street REDLAND BAY QLD 4165

Product Types:* Category 3: (Ectoparasiticides) Liquids and sprays Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply. Licence No: 3033 Full licence issued 10/12/07

2. CHANGES TO EXISTING LICENCES: MARS AUSTRALIA PTY LTD TRADING AS MARS PETCARE AUSTRALIA ACN: 008 454 313 Petcare Place WODONGA VIC 3690

Product Types:* Category 2: Palatable ingestable chews Category 4: Moist therapeutic pet foods Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, microbiological reduction treatment (heat), analysis and testing (physical, chemical and microbiological), storage and release for supply. Licence No: 2106 Amended licence issued 11/12/07, change of company name and extension of licence scope.

CUMBERLAND INDUSTRIES LTD TRADING AS FILPAC ACN: 002 534 670 59-65 Kurrajong Avenue MT DRUITT NSW 2770

Product Types:* Category 4: Premixes, supplements Step(s) of Manufacture: Formulation including blending, filling, packaging, labelling, strip, blister or sachet packaging, storage, and release for supply. Licence No: 4070 Amended licence issued 12/12/07, change of key personnel.

3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). KEITH JOHN AND JULIA ANNE CURTIN, TRADING AS SUMMERLAND SERUMS ABN: 53 763 618 329 192 Dalwood Road ALSTONVILLE NSW 2477

Licence No: 1025 Cancelled: 17/12/07 Reason for cancellation: s127 (1)(d)

MAGAR ENTERPRISES PTY LTD ACN: 008 970 643 Units 1 & 2 504 Marmion Street BOORAGOON WA 6154

Licence No: 4014 Cancelled: 19/12/07 Reason for cancellation: s127 (1)(f)

SYKES VET INTERNATIONAL PTY LTD ACN: 085 158 434 97/40 Popes Road KEYSBOROUGH VIC 3173

Licence No: 2122 Cancelled: 19/12/07 Reason for cancellation: s127 (1)(d) and (e)

4. LICENCE SUSPENSIONS: (The APVMA has suspended the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). NIL

5. REVOCATION OF LICENCE SUSPENSION: (The APVMA has revoked the suspension of the following licences under section 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). NIL

APVMA Contact: Kathryn Winterton _____________________________________________________________________________________________________________ * Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer

GMP Section Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Ph: (02) 6210 4804 Fax: (02) 6210 4813 Email: kathryn.winterton@apvma.gov.au

_____________________________________________________________________________________________________________ * Category 1: Immunobiologicals and sterile veterinary preparations Category 2: Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements Category 3: Ectoparasiticides Category 4: Premixes and supplements Category 5: Exempt Category 6: One-step manufacturer

AMENDMENT No. 8K

AMENDMENTS TO THE MRL STANDARD

The Australian Pesticides and Veterinary Medicines Authority (APVMA) sets maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. These MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. At the same time the APVMA is satisfied, from dietary exposure assessment, that the levels are not an undue hazard to human health. The MRL Standard lists MRLs of substances which may arise from the approved use of those substances or other substances, and provides the relevant residue definitions to which these MRLs apply. The evaluation process takes into account studies on chemistry, metabolism, analytical methodology, residues, good agricultural practice, toxicology and dietary exposure. From time to time the evaluation process results in amendments to the MRL Standard. It should be noted that relevant MRLs are referred to Food Standards Australia New Zealand for incorporation into Standard 1.4.2 of the Food Standards Code entitled “Maximum Residue Limits”. Note: ‘*’ denotes that the maximum residue limit (MRL) has been set at or about the limit

of analytical quantitation (see: Residue Guideline No.4, Maximum Residue Limit Proposals ‘At or about the Limit of Analytical Quantitation’, published in NRA Gazette No.9, p44, 5/9/95).

‘T’ denotes that the MRL, residue definition or use is temporary to enable further

experimental work to be carried out in Australia or overseas, and will be reconsidered at some future date.

The MRL Standard is also accessible via the APVMA web page. http://www.apvma.gov.au/residues/mrl.shtml

TABLE 1: MAXIMUM RESIDUE LIMITS OF PESTICIDES,

AGRICULTURAL CHEMICALS, FEED ADDITIVES, VETERINARY MEDICINES AND ASSOCIATED SUBSTANCES IN FOOD COMMODITIES

Residues of substances which may occur in food commodities and for which the following maximum residue limits (MRLs) apply. COMPOUND FOOD MRL (mg/kg) Acibenzolar-S-methyl ADD:

FI 0327 Banana T0.02 GC 0080 Cereal grains T0.1 VC 0424 Cucumber T0.5 VL 0053 Leafy vegetables T0.5 FI 0345 Mango T0.5 VO 0448 Tomato T0.5

Bifenthrin ADD:

FI 0353 Pineapple T*0.01 Chlorpyrifos DELETE:

Vegetables [except asparagus; brassica vegetables; cassava; celery; leek; peppers, sweet [capsicums]; potato; taro; tomato] T*0.01

ADD:

Vegetables [except asparagus; brassica vegetables; cassava; celery; leek; peppers, sweet [capsicums]; potato; swede; sweet potato; taro; tomato] T*0.01

Closantel ADD:

MF 0812 Cattle fat T3 MO 1280 Cattle, Kidney T3 MO 1281 Cattle, liver T1

Cattle muscle T1

Clothianidin DELETE:

FP 0226 Apple T0.5 FI 0327 Banana T*0.02

SO 0691 Cotton seed T*0.02 MO 0105 Edible offal (Mammalian) T*0.02 MM 0095 Meat (mammalian)[in the fat] T*0.02

ML 0106 Milks T*0.01 FS 0245 Nectarine T2

FS 0247 Peach T2 FP 0230 Pear T0.5

ADD: FP 0226 Apple 0.5

FI 0327 Banana *0.02 SO 0691 Cotton seed *0.02 MO 0105 Edible offal (Mammalian) *0.02 PE 0112 Eggs *0.02 MM 0095 Meat (mammalian) *0.02

ML 0106 Milks *0.01 FS 0245 Nectarine 2

FS 0247 Peach 2 FP 0230 Pear 0.5 PO 0111 Poultry, Edible offal of *0.02 PM 0110 Poultry meat *0.02

Fipronil ADD: FI 0353 Pineapple T*0.01 Florfenicol ADD: Fish muscle T0.5 Fludioxonil DELETE: GC 0651 Sorghum T*0.05 ADD:

GC 0651 Sorghum *0.01 Glyphosate DELETE: SO 0088 Oilseed [except cotton seed and rape seed] *0.1 ADD: SO 0693 Linseed T5

SO 0088 Oilseed [except cotton seed, linseed and rape seed] T*0.1

Isoxaben ADD:

GC 0640 Barley *0.01 MO 0105 Edible offal (Mammalian) *0.01 PE 0112 Eggs *0.01 MM 0095 Meat (mammalian) *0.01 ML 0106 Milks *0.01 PO 0111 Poultry, Edible offal of *0.01 PM 0110 Poultry meat *0.01 GC 0653 Triticale *0.01 GC 0654 Wheat *0.01

Maldison DELETE: Vegetables [except beans (dry); cauliflower; chard; egg plant; garden pea; kale; kohlrabi; lentil (dry);

peppers, sweet; root and tuber vegetables; tomato; turnip, garden] 2

ADD:

VA 0388 Shallots T5 VA 0389 Spring Onion T5 Vegetables [except beans (dry); cauliflower; chard; egg plant; garden pea; kale; kohlrabi; lentil (dry);

peppers, sweet [capsicum]; root and tuber vegetables; shallots; spring onions; tomato; turnip] 2

Propiconazole ADD: VL 0502 Spinach T0.1 Pyrasulfotole ADD:

CM 0081 Bran, unprocessed of cereal grain 0.03 GC 0080 Cereal grains *0.02 MO 0105 Edible offal (Mammalian) 0.5 PE 0112 Eggs *0.01 MM 0095 Meat (mammalian) *0.01 ML 0106 Milks *0.01 PO 0111 Poultry, Edible offal of *0.01 PM 0110 Poultry meat *0.01

TABLE 3: RESIDUE DEFINITION Where MRL(s) are recommended, the following residue definitions are applicable. COMPOUND RESIDUE DELETE: Clothianidin {T} Commodities of plant origin: Clothianidin

{T} Commodities of animal origin: Sum of clothianidin, 2-chlorothiazol-5-ylmethylguanidine, 2-chlorothiazol-5-ylmethylurea, and the pyruvate derivative of N-(2-chlorothiazole-5-ylmethyl)-N’-methylguanidine expressed as clothianidin

ADD: Clothianidin Clothianidin DELETE: Pyrasulfotole {T} The sum of pyrasulfotole and (5-hydroxy-3-methyl-1H-

pyrazol-4-yl)[2-mesyl-4-(trifluoromethyl)phenyl]methanone, expressed as pyrasulfotole

ADD: Pyrasulfotole The sum of pyrasulfotole and (5-hydroxy-3-methyl-1H-

pyrazol-4-yl)[2-mesyl-4-(trifluoromethyl)phenyl]methanone, expressed as pyrasulfotole

TABLE 4: MAXIMUM RESIDUE LIMITS FOR PESTICIDES IN ANIMAL FEED

COMMODITIES Residues of substances which may occur in animal feed commodities and for which the following maximum residue limits (MRLs) apply. COMPOUND ANIMAL FEED COMMODITY MRL (mg/kg)

Fludioxonil DELETE: AF 0651 Sorghum forage (green) T*0.02 AS 0651 Sorghum straw and fodder, dry T*0.02 ADD: AF 0651 Sorghum forage (green) *0.01 AS 0651 Sorghum straw and fodder, dry *0.01

Glyphosate ADD:

Linseed meal T7 ADD: Isoxaben AS 0081 Straw and fodder (dry) of cereal grains 0.1 Cereal forage (fresh weight) *0.01 Propiconazole DELETE: AS 0081 Straw and fodder (dry) of cereal grains 5 ADD: AS 0645 Maize fodder T10

AS 0081 Straw and fodder (dry) of cereal grains [except maize] T5

Pyrasulfotole DELETE AS 0081 Fodder and straw of cereal grains T*0.02 AF 0081 Forage of cereal grains T0.5 ADD AS 0081 Straw and fodder (dry) of cereal grains *0.02 AF 0081 Forage of cereal grains 0.5 For further information please contact: Michelle Hemming Residues Contact Officer Australian Pesticides & Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4837 Fax: (02) 6210 4840 Email: michelle.hemming@apvma.gov.au