TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products Page 12 Notice – New Agricultural & Veterinary Chemical Products Avian Influenza Virus H7N1 Page 15 [NOBILIS (R) INFLUENZA H7N1 (INACTIVATED) VACCINE] Sulfuryl fluoride Page 18 [Profume Gas Fumigant]

pyrasulfotole Page 21 [PRECEPT SELECTIVE HERBICIDE]

Other Notices Application Summaries Page 25 Licensing of Veterinary Chemical Manufacturers Page 27 Amendments to the MRL Standard Page 30

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: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No Entries” 2. AGRICULTURAL PRODUCTS

BASED ON NEW ACTIVE CONSTITUENTS:

Product Name: Bion Plant Activator Seed Treatment Active Constituent/s: 500 g/L acibenzolar-s-methyl Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For suppression of Fusarium Wilt and Black Root Rot of cotton by activating the plant’s natural resistance mechanisms. Date of Registration: 19 July 2007 Label Approval No: 60556/1/0507 3. AGRICULTURAL PRODUCTS

BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Family Protection Aerogard Odourless Low Irritant* Great For Kids 12 Months & Over Insect Repellent Active Constituent/s: 95 g/kg picaridin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For repelling mosquitoes, flies, sandflies, and other annoying and biting insects

Date of Registration: 19 July 2007 Label Approval No: 61364/150g/0607, 61364/250g/0607 Product Name: Richgro Permethrin Ant, Spider And Roach Killer Active Constituent/s: 30 g/L permethrin (25:75) Applicant Name: A Richards Pty Ltd T/A Richgro Garden Products Applicant ACN: 008 734 852 Summary of Use: For indoor and outdoor use for control of ants, spiders and cockroaches in and around the home and garden. Date of Registration: 20 July 2007 Label Approval No: 61917/250ML/0507, 61917/500ML-1L/0507 Product Name: Killmaster Zero Pest Strip Active Constituent/s: 186 g/kg dichlorvos Applicant Name: Barmac Industries Pty Ltd Applicant ACN: 009 674 953 Summary of Use: For the control of various flying and crawling insects. Date of Registration: 23 July 2007 Label Approval No: 59750/65g/1006 Product Name: Akodelthrin Insecticide Active Constituent/s: 27.5 g/L deltamethrin Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 279 109 Summary of Use: For the control of Heliothis (helicoverpa spp) and other specified pests on cotton and various other crops. Date of Registration: 23 July 2007 Label Approval No: 62031/20/0607, 62031/110/0607, 62031/200/0607, 62031/1000/0607, 62031/20000/0607 Product Name: Akodim Herbicide Active Constituent/s: 240 g/L clethodim Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 279 109 Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-fruit bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans. Date of Registration: 23 July 2007 Label Approval No: 62065/1/0607, 62065/5/0607, 62065/10/0607, 62065/20/0607, 62065/60/0607, 62065/200/0607, 62065/0607 Product Name: TWA Woodcare Diffusible Wood Preservitive No-Rot Gel Injection Grade Active Constituent/s: 111 g/L boron present as disodium octaborate tetrahydrate, 13.2 g/L benzalkonium chloride Applicant Name: Preschem Pty Ltd

Applicant ACN: 006 867 929 Summary of Use: For treatment of timber against decay and insects. Date of Registration: 25 July 2007 Label Approval No: 61856/300mL/0407 Product Name: Glutachem Sanitiser Active Constituent/s: 150 g/L glutaraldehyde, 120 g/L quaternary ammonium compound. Applicant Name: Chemetall (Australasia) Pty Ltd Applicant ACN: 074 869 015 Summary of Use: Sanitiser for the control of bacteria, fungi and viruses for poultry, pigs, or related industry. Date of Registration: 26 July 2007 Label Approval No: 61656/25-200L/0507 Product Name: Country Phospot 600 Systemic Fungicide Active Constituent/s: 600 g/L phosphorous acid present as mono-di potassium phosphite Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: A systemic fungicide for the control of root and crown diseases in avocado, citrus, ornamentals and pineapple caused by phytophthora fungi. Also for the control of downy mildew in grapes, poppies and cucurbits. Date of Registration: 27 July 2007 Label Approval No: 61449/5L/0207, 61449/10L/0207, 61449/20L/0207, 61449/110L/0207, 61449/200L/0207, 61449/1000L/0207 Product Name: Brunnings Rose Spray Active Constituent/s: 4.8 g/L tau-fluvalinate, 2.2 g/L myclobutanil Applicant Name: Brunnings Garden Products Pty Ltd Applicant ACN: 050 655 760 Summary of Use: For the control of black spot and various insects on roses and other ornamentals. Date of Registration: 27 July 2007 Label Approval No: 60945/200/0507, 60945/500/0507 Product Name: Chemetall Paraformaldehyde Disinfectant Active Constituent/s: 900 g/kg formaldehyde Applicant Name: Chemetall (Australasia) Pty Ltd Applicant ACN: 074 869 015 Summary of Use: For disinfection of poultry houses. Date of Registration: 27 July 2007 Label Approval No: 61655/25kg/0307

Product Name: United Farmers Metsulfuron WG Herbicide Active Constituent/s: 600 g/kg metsulfuron methyl Applicant Name: United Farmers Cooperative Company Ltd Applicant ACN: C100 5555 Summary of Use: For the control of broadleaf weeds in native pastures and winter cereal crops, also in commercial and industrial areas. Date of Registration: 27 July 2007 Label Approval No: 60719/0706, 60719/200-500g/0706, 60719/1-2kg/0706 Product Name: Chemetall Formaldehyde 37/7 Active Constituent/s: 400 g/L formaldehyde Applicant Name: Chemetall (Australasia) Pty Ltd Applicant ACN: 074 869 015 Summary of Use: For disinfecting poultry houses. Date of Registration: 27 July 2007 Label Approval No: 61653/200L/0207 Product Name: Dow Agrosciences IPA 300 Herbicide Active Constituent/s: 300 g/L 2,4-D present as the isopropylamine salt Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops. Date of Registration: 31 July 2007 Label Approval No: 61109/20L/0407, 61109/100L/0407, 61109/110L/0407, 61109/1000L/0407, 61109/0407 Product Name: Ignite Herbicide Active Constituent/s: 200 g/L glufosinate-ammonium Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For non-residual control of broadleaf and grass weeds in various situations. Date of Registration: 1 August 2007 Label Approval No: 61549/20/0207, 61549/0207 Product Name: Kenso Agcare Traktion 400 WG Herbicide Active Constituent/s: 400 g/kg tralkoxydim Applicant Name: Kenso Corporation (M) Sdn Bhd Summary of Use: For the control of wild oats and annual ryegrass and suppression of annual phalaris in wheat, barley, rye and triticale. Date of Registration: 1 August 2007

Label Approval No: 61784/15/0207, 61784/0207 Product Name: B'sure Insect Repellent Active Constituent/s: 40 g/kg n-octyl bicycloheptene dicarboximide, 20 g/kg di-n-propyl isocinchomeronate, 190 g/kg diethyltoluamide Applicant Name: Millbrook Investments Ltd Summary of Use: For protection against mosquitoes, sandflies, flies, ticks and leeches. Date of Registration: 2 August 2007 Label Approval No: 61416/100/1206, 61416/125/1206 Product Name: Infruta Sulphur Dioxide Pads Active Constituent/s: 980 g/kg sodium metabisulfite Applicant Name: E.E. Muir & Sons Pty Limited Applicant ACN: 004 524 387 Summary of Use: Dual release sulphur dioxide pads for the control of botrytis in packaged grapes. Date of Registration: 2 August 2007 Label Approval No: 59866/7/1006, 59866/500/1006 Product Name: Statesman 720 Herbicide Active Constituent/s: 720 g/L 2,4-D present as the dimethylethanolamine salt and dimethylamine salt Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 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, sugar cane peanuts and non-agricultural areas. Date of Registration: 2 August 2007 Label Approval No: 61116/20/0707, 61116/100/0707, 61116/110/0707, 61116/1000/0707, 61116/0707 Product Name: Rentokil Bromakil Kills Rats And Mice! Active Constituent/s: 0.05 g/kg bromadiolone Applicant Name: Rentokil Initial Pty Ltd Applicant ACN: 000 034 597 Summary of Use: Bromadiolone block baits for rat control around industrial, commericial, and domestic buildings. Date of Registration: 3 August 2007 Label Approval No: 61668/140/0407 Product Name: Grazon Extra Herbicide Active Constituent/s: 8 g/L aminopyralid present as hexyloxypropylamine salt, 100 g/L picloram present as the hexyloxypropylamine

salt, 300 g/L triclopyr present as the butoxyethyl ester. Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: For the control of a range of environmental and noxious woody and herbaceous weeds in agricultural non-crop areas, commercial and industrial areas, forests, pastures, rights-of-way and fallow. Date of Registration: 03 August 2007 Label Approval No: 60830/1/0407, 60830/5/0407, 60830/20/0407, 60830/0407 Product Name: Kristle Pool Oxidiser Active Constituent/s: 372 g/kg chlorine present as sodium dichloroisocyanurate Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For crystal clear swimming pool water. Date of Registration: 3 August 2007 Label Approval No: 61771/400G/0507, 61771/1-5KG/0507, 61771/6-20KG/0507 Product Name: Rygel Procanoil Vegetable Oil Concentrate Active Constituent/s: 835 g/L vegetable oil (emulsifiable) Applicant Name: Rygel Australia Pty Ltd Applicant ACN: 106 839 007 Summary of Use: To enhance the performance of agricultural and horticultural sprays by increasing droplet deposition and retention. Date of Registration: 3 August 2007 Label Approval No: 61759/5L/0207, 61759/20L/0207, 61759/200L/0207 Product Name: Agri Dyne, Iodine Based Disinfectant Active Constituent/s: 16 g/L iodine Applicant Name: Tasman Chemicals Pty Ltd Applicant ACN: 005 072 659 Summary of Use: Disinfectant for use in the poultry industry. Date of Registration: 03 August 2007 Label Approval No: 61947/5L/0507, 61947/20L/0507, 61947/25L/0507, 61947/110L/0507, 61947/200L/0507 Product Name: H20 Pool Chemicals Lithium Hypochlorite Active Constituent/s: 350 g/kg chlorine present as lithium hypochlorite Applicant Name: Kleenco Australia Pty Limited Applicant ACN: 003 131 539 Summary of Use: For the control of bacteria and algae in swimming pools and spas. Date of Registration: 3 August 2007

Label Approval No: 61175/1/0507, 61175/2/0507, 61175/5/0507 Product Name: Sureguard Moth Balls Lavender Active Constituent/s: 990 g/kg naphthalene Applicant Name: Pental Products Pty Ltd Applicant ACN: 103 213 467 Summary of Use: Lavender scented naphthalene tablets contained in a plastic device for protecting clothes from moths and silverfish. Date of Registration: 6 August 2007 Label Approval No: 62053/27/0607 Product Name: Chlorofume Soil Fumigant Active Constituent/s: 985 g/kg chloropicrin Applicant Name: R & R Fumigation Services Pty Ltd Applicant ACN: 058 234 987 Summary of Use: Registration of a soil fumigant use against soil borne pests. Date of Registration: 6 August 2007 Label Approval No: 62101/100/0707 Product Name: Farmoz Chief 250 SC Seed Dressing Fungicide Active Constituent/s: 250 g/L iprodione Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: For control of brown leaf spot and the suppression of hypocotyl rot, in the first four weeks after emergence in lupins and for the control of hypocotyl rot in potatoes. Date of Registration: 07 August 2007 Label Approval No: 61084/5/0607, 61084/20/0607 Product Name: Poolgard Multi-Chlor Pool Sanitiser Active Constituent/s: 800 g/kg chlorine present as trichloroisocyanuric acid, 3 g/kg copper present as copper sulfate pentahydrate Applicant Name: Poolgard Pty Ltd Applicant ACN: 118 467 226 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 7 August 2007 Label Approval No: 61047/2kg/0507, 61047/4kg/0507, 61047/10kg/0507 Product Name: Poolgard Multi-Shoc Pool Oxidiser Active Constituent/s: 800 g/kg chlorine present as trichloroisocyanuric acid, 3 g/kg copper present as copper sulfate pentahydrate Applicant Name: Poolgard Pty Ltd Applicant ACN: 118 467 226 Summary of Use: For the control of algae and bacteria in swimming pools.

Date of Registration: 7 August 2007 Label Approval No: 61048/450g/0507 Product Name: Qhemag Whack 900 WG Fungicide Active Constituent/s: 900 g/kg chlorothalonil Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 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. Date of Registration: 07 August 2007 Label Approval No: 61278/1/0707, 61278/5/0707, 61278/10/0707, 61278/15/0707, 61278/20/0707, 61278/5B/0707, 61278/10B/0707, 61278/0707 Product Name: Superway Dicamba-M Selective Herbicide Active Constituent/s: 80 g/L dicamba present as the dimethylamine salt, 340 g/L MCPA present as the dimethylamine salt Applicant Name: Superway Garden Ag & Pest Products Pty Ltd Applicant ACN: 056 553 274 Summary of Use: For the control of certain broadleaf weeds in winter cereals, pastures, turf and non-crop areas. Date of Registration: 7 August 2007 Label Approval No: 61938/1L/0407, 61938/2.5L/0407, 61938/5L/0407, 61938/10L/0407, 61938/20L/0407, 61938/200L/0407, 61938/1000L/0407, 61938/0407 Product Name: Growers Oxysept Broad Spectrum Disinfectant Active Constituent/s: 308 g/L hydrogen peroxide, 65 g/L peroxyacetic acid Applicant Name: Ecolab Pty Ltd Applicant ACN: 000 449 990 Summary of Use: A broad spectrum disinfectant for use on hard non-porous surfaces on poultry pig, dairy and vegetable farms. Date of Registration: 7 August 2007 Label Approval No: 59890/5L/0807, 59890/10L/0807, 59890/20L/0807 Product Name: Snailem Slug And Snail Pellets Active Constituent/s: 15 g/kg metaldehyde Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For the control of snails and slugs. Date of Registration: 08 August 2007 Label Approval No: 62063/25kg/0507,

62063/150kg/0507, 62063/150kgB/0507, 62063/500kg/0507, 62063/BULK/0507 Product Name: Ratsnip Rodenticide Blocks Active Constituent/s: 0.05 g/kg difenacoum Applicant Name: Sorex Ltd Summary of Use: Bait blocks for the control of rats in domestic, rural, commerical and agricultural buildings. Date of Registration: 8 August 2007 Label Approval No: 61442/3/1106, 61442/10/1106 Product Name: Halox 520 Herbicide Active Constituent/s: 520 g/L haloxyfop present as the haloxyfop-r methyl ester Applicant Name: eChem (Australia) Pty Limited Applicant ACN: 089 133 095 Summary of Use: For the pre-emergence control of a wide range of annual and perennial grass weeds in grain, legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, banana, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops. Date of Registration: 8 August 2007 Label Approval No: 61953/250mL/0607, 61953/1L/0607, 61953/5L/0607, 61953/10L/0607, 61953/20L/0607, 61953/0607 Product Name: Farmoz Amigan WG Herbicide Active Constituent/s: 400 g/kg ametryn, 250 g/kg terbutryn Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: For the control of certain weeds in sugar cane. Date of Registration: 8 August 2007 Label Approval No: 61151/15/0707 Product Name: Innova 2,4-D IPA 300 Herbicide Active Constituent/s: 300 g/L 2,4-D present as the isopropylamine salt Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Use: For control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops and pastures. Date of Registration: 9 August 2007 Label Approval No: 61679/20-1000/0707 Product Name: Chemag Rebellion 450 Herbicide Active Constituent/s: 450 g/L glyphosate present as the monoethanolamine salt Applicant Name: Imtrade Australia Pty Ltd

Applicant ACN: 090 151 134 Summary of Use: For the control of various annual & perennial weeds in a wide range of agricultural situations. Date of Registration: 9 August 2007 Label Approval No: 59997/5/1106, 59997/20/1106, 59997/110/1106, 59997/200/1106, 59997/500/1106, 59997/800/1106, 59997/1000/1106, 59997/Bulk/1106, 59997/1106 Product Name: Splash Pool Sanitiser Active Constituent/s: 660 g/kg available chlorine (Cl) present as trichloroisocyanurate. Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 10 August 2007 Label Approval No: 61770/1-2kg/0307, 61770/4-5kg/0307, 61770/10-20kg/0307 Product Name: Farmoz Citadel Fungicide Active Constituent/s: 250 g/L triadimenol Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: For the control of ring spot on brassica vegetables, powdery mildew on cucurbits, grapevines and pawpaws, pineapple disease of sugarcane and for the control of various diseases in turf. Date of Registration: 10 August 2007 Label Approval No: 61368/1M/0707, 61368/1MLL/0707, 61368/5M/0707, 61368/5MLL/0707, 61368/10M/0707, 61368/10MLL/0707, 61368/0707 Product Name: Splash Tabs Pool Sanitiser Active Constituent/s: 5.8 g/kg boric acid, 68 g/kg sodium tetraborate pentahydrate, 650 g/kg chlorine present as trichloroisocyanuric acid Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 10 August 2007 Label Approval No: 61768/1-2kg/0407, 61768/8-20kg/0407 Product Name: Cresgard Disinfectant Active Constituent/s: 770 g/L cresol Applicant Name: Chemetall (Australasia) Pty Ltd Applicant ACN: 074 869 015 Summary of Use: For sanitising poultry sheds and poultry litter. Date of Registration: 10 August 2007 Label Approval No: 61654/25-200L/0407

Product Name: Blitzem! Wasp Killer & Nest Destroyer Active Constituent/s: 1.3g/kg d-allethrin, 1.2 g/kg d-phenothrin Applicant Name: Yates Australia A Div Of Orica Australia Pty Ltd Applicant ACN: 004 117 828 Summary of Use: For the control of wasps and wasp nests around the home and in the home garden. Date of Registration: 13 August 2007 Label Approval No: 61018/350g/0207 Product Name: Express Liquid Acid Dairy Detergent Active Constituent/s: 472 g/L nitric acid, 158 g/L phosphoric acid Applicant Name: Klen International Pty Ltd Applicant ACN: 009 067 556 Summary of Use: Low foaming acidic detergent for use in the dairy industry. Date of Registration: 13 August 2007 Label Approval No: 60787/5L/1206, 60787/15L/1206, 60787/120L/1206, 60787/200L/1206, 60787/1000L/1206 Product Name: Faudel Fungicide Active Constituent/s: 720 g/L chlorothalonil Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 179 109 Summary of Use: For the control of fungus diseases on almonds, bananas, cucurbits, grapes, oramentals, peanuts, stone fruits, tobacco and vegetables. Date of Registration: 13 August 2007 Label Approval No: 62030/1L/0507, 62030/5L/0507, 62030/20L/0507¸62030/0507 Product Name: Splash Step 3 Algaecide Active Constituent/s: 460 g/L poly(oxyethylene (dimethylimino) ethylene (dimethylimino) ethylene dichloride Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For the control of algae in swimming pools. Date of Registration: 13 August 2007 Label Approval No: 61765/500-1000mL/0307, 61765/2-20L/0307 Product Name: Generex Sugarhex Herbicide Active Constituent/s: 132 g/kg hexazinone, 468 g/kg diuron Applicant Name: Generex Australia Pty Limited Applicant ACN: 063 490 120 Summary of Use: For the control of a wide range of annual and perennial grasses, broadleaf weeds and vines in established sugar cane.

Date of Registration: 13 August 2007 Label Approval No: 62012/10kg/0707 Product Name: Power Chlor Tabs Pool Sanitiser Active Constituent/s: 650 g/kg available chlorine (Cl) present as trichloroisocyanuric acid Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 13 August 2007 Label Approval No: 61788/1-2kg/0307, 61788/8-20kg/0307 Product Name: Mortein Energy Ball Shake To Activate Kills Fast Fly Killer Odourless Household Protection Active Constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 14 August 2007 Label Approval No: 60745/250g/1006, 60745/350g/1006 Product Name: Pea Beu Insect Killer Fast Kill Rapid Kill Household Insecticide Active Constituent/s: 0.7 g/kg esbiothrin, 0.6 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 14 August 2007 Label Approval No: 60750/250g/1006, 60750/350g/1006 Product Name: Pea Beu Insect Killer Fast Kill Lemon Fresh Household Insecticide Active Constituent/s: 0.7 g/kg esbiothrin, 0.6 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 14 August 2007 Label Approval No: 60749/250g/1006, 60749/350g/1006 Product Name: Pea Beu Insect Killer Fast Kill Pine Fresh Household Insecticide Active Constituent/s: 0.7 g/kg esbiothrin, 0.6 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited

Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 14 August 2007 Label Approval No: 60748/250g/1006, 60748/350g/1006 Product Name: Mortein Energy Ball Shake To Activate Kills Fast Fly Killer Pine Household Protection Active Constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 14 August 2007 Label Approval No: 60747/250g/1006, 60747/350g/1006 Product Name: Mortein Energy Ball Shake To Activate Kills Fast Fly Killer Lemon Household Protection Active Constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: For control of most flying and crawling insect pests in the home. Date of Registration: 15 August 2007 Label Approval No: 60746/250g/1006, 60746/350g/1006 Product Name: Vivus Max Helicoverpa Biocontrol Active Constituent/s: 5 x 109 polyhedral inclusion bodies of the nucleo-polyhedrovirus of helicoverpa armigera per millilitre Applicant Name: Ag Biotech Australia Pty Ltd Applicant ACN: 098 975 403 Summary of Use: For the biocontrol of Helicoverpa spp in various crops. Date of Registration: 15 August 2007 Label Approval No: 60905/1/0407, 60905/5/0407, 60905/10/0407, 60905/20/0407 Product Name: Crop Care Cadre Herbicide Active Constituent/s: 240 g/L imazapic present as the ammonium salt Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For the pre-emergence control of certain annual grass and broadleaf weeds in fallow situations, sugarcane and peanuts and early post-emergence control of certain annual grass and broadleaf weeds in peanuts and sugarcane.

Date of Registration: 15 August 2007 Label Approval No: 62122/1L/0707, 62122/5L/0707, 62122/20L/0707, 62122/0707 Product Name: Bioguard Lite Pool Shock Active Constituent/s: 100 g/kg sodium tetraborate pentahydrate, 372 g/kg chlorine (CI) present as sodium dichloroisocyanurate Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For superb soft and sparkling clear pool water. Date of Registration: 15 August 2007 Label Approval No: 62070/450G/0607, 62070/10-20KG/0607 Product Name: Virogard Sanitiser Active Constituent/s: 100 g/L quaternary ammonium compound Applicant Name: Chemetall (Australasia) Pty Ltd Applicant ACN: 074 869 015 Summary of Use: For sanitizing poultry sheds, animal pens and farm equipment. Date of Registration: 15 August 2007 Label Approval No: 61658/25-200L/0507 Product Name: Farmoz Gem Fungicide Active Constituent/s: 500 g/L fluazinam. Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Use: For control of club root in broccoli, brussels sprouts, cabbage, cauliflower and kohl rabi; pre-bud burst suppression of phomopsis cane and leaf blight in grapevines and white root rot in apples. Date of Registration: 16 August 2007 Label Approval No: 61450/1M/0807, 61450/1MLL/0807, 61450/5M/0807, 61450/5MLL/0807, 61450/0807 Product Name: Genie Algaecide Active Constituent/s: 460 g/L poly(oxyethylene (dimethyliminio) ethylene (dimethylimino) Applicant Name: Chemtura Australia Pty Ltd Applicant ACN: 005 225 507 Summary of Use: For the control of algae in swimming pools. Date of Registration: 17 August 2007 Label Approval No: 61766/500-1000mL/0307, 61766/2-20L/0307 Product Name: Allfire 2,4-D LV Ester 600 Herbicide Active Constituent/s: 600 g/L 2,4-D as the ethyl hexyl ester Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280

Summary of Use: A low volatile herbicide for selective control of various broadleaf weeds in crops, pastures and non-agricultural areas. Date of Registration: 17 August 2007 Label Approval No: 60282/20L/0207, 60282/110L/0207, 60282/110L/0207, 60282/1000L/0207, 60282/0207 4.VARIATIONS Product Name: Transit Herbicide Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Variation: Update of label to reflect closely similar reference product. Date of Variation: 31 July 2007 Label Approval No: 54040/1L/0607, 54040/5L/0607, 54040/10L/0607, 54040/20L/0607, 54040/0607 Product Name: Tilt Xtra Fungicide Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Variation: Extension of use to include the control of net form net blotch and reduce the rate for the control of spot form net blotch on barley. Date of Variation: 01 August 2007 Label Approval No: 58167/20/0607, 58167/100/0607, 58167/110/0607 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: Duvaxyn R Equine Rotavirus Vaccine (Inactivated) Active Constituent/s: Contains equine rotavirus (RP ≥ 1.0), grown in tissue culture, chemically inactivated and added to an oil adjuvant Applicant Name: Fort Dodge Australia Pty Limited Applicant ACN: 000 074 902 Summary of Use: For the immunization of mares to stimulate the production of antibodies in colostrums and milk against equine rotavirus, as an aid in the management of rotavirus enteritis. Date of Registration: 24 July 2007 Label Approval No: 56501/10mL/0607, 56501/100/0607, 56501/0607 3. VETERINARY PRODUCTS BASED

ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Fort Dodge Fortaclav 50 mg Tablets For Dogs And Cats Active Constituent/s: Each tablets contains 40 mg amoxycillin (as trihydrate), 10 mg clavulanic acid (as potassium clavulanate) Applicant Name: Norbrook Laboratories Australia Pty Limited

Applicant ACN: 080 972 596 Summary of Use: For the treatment of bacterial infections that are sensitive to amoxycilllin and clavulanic acid in dogs and cats Date of Registration: 19 July 2007 Label Approval No: 61023/100T/0706, 61023/250T/0706, 61023/500T/0706, 61023/50C/0706, 61023/250C/0706, 61023/0706 Product Name: Fort Dodge Fortaclav 250 mg Tablets For Dogs And Cats Active Constituent/s: Each tablet contains 200 mg amoxycillin (as trihydrate), 50 mg clavulanic acid (as potassium clavulanate) Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: For the treatment of bacterial infections that are sensitive to amoxyicillin and clavulanic acid in dogs and cats. Date of Registration: 19 July 2007 Label Approval No: 61024/100T/0706, 61024/250T/0706, 61024/50C/0706, 61024/250C/0706, 61024/0706 Product Name: Fort Dodge Fortaclav 500 mg Tablets For Dogs And Calves Active Constituent/s: Each tablet contains 400 mg amoxycillin (as amoxycillin trihydrate), 100 mg clavulanic acid (as potassium clavulanate) Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: For the treatment of bacterial infections that are sensitive to amoxicillin and clavulanic acid in dogs and calves Date of Registration: 19 July 2007 Label Approval No: 61025/100T/0706, 61025/250T/0706, 61025/100C/0706 61025/250C/0706, 61025/500C/0706, 610250706 Product Name: Advance Arthri-Care Active Constituent/s: Each chew contains 500 mg stabilised green-lipped mussel powder Applicant Name: Effem Foods Pty Ltd T/A Masterfoods Australia & NZ Applicant ACN: 008 454 313 Summary of Use: May help in the relief of arthritic symptoms in dogs. Date of Registration: 23 July 2007 Label Approval No: 61946/21/0407 Product Name: Troy Applyte Oral Rehydration Gel For Horses Active Constituent/s: 260 g/L glucose, 23.17 g/L phosphate as sodium phosphate dodecahydrate, 63.96 g/L chloride as sodium chloride and potassium chloride, 30.36 g/L

potassium as potassium chloride, 2.93 g/L magnesium as magnesium sulfate heptahydrate, 11.59 g/L sulphate as magnesium sulphate heptahydrate, 40.45 g/L sodium as sodium chloride and sodium phosphate dodecahydrate. Applicant Name: Troy Laboratories Pty Ltd Applicant ACN: 000 283 769 Summary of Use: An oral electrolyte rehydration solution for horses containing sodium, potassium, magnesium, chloride, sulphate, phosphate and glucose. Date of Registration: 24 July 2007 Label Approval No: 61378/250ML/0607 Product Name: Fort Dodge Carprogesic Injection Active Constituent/s: 50 mg/mL carprofen Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: A non-steroidal anti-inflammatory injection for use in cats, horses and dogs. Date of Registration: 30 July 2007 Label Approval No: 61505/20ML/1206, 61505/1206 Product Name: Fowl Pox Vaccine #2 Active Constituent/s: Fowl Pox virus, living, strain FPV-085a 10⁵∙⁶⁰ TCID₅₀ per mL when reconstituted to 2.5 mL Applicant Name: Intervet Australia Pty Limited Applicant ACN: 008 467 034 Summary of Use: For use in prevention of Fowl Pox disease in chickens older than 4 weeks of age. Date of Registration: 30 July 2007 Label Approval No: 60345/1/0207, 60345/5x1/0207, 60345/0207 Product Name: Exelpet Ezy-Dose Monthly Heartwormer + Intestinal All-Wormer For Dogs Active Constituent/s: Each chew contains 60 ug ivermectin, 543mg oxantel embonate, 143 mg pyrantel embonate, 50 mg praziquantel Applicant Name: Exelpet Products A Div Of Effem Foods Pty Ltd Applicant ACN: 008 454 313 Summary of Use: For the control of gastrointestinal worm species and prevention of heartworm infection in dogs. Date of Registration: 30 July 2007 Label Approval No: 61997/4/0507 Product Name: Draxxin Injectable Solution Active Constituent/s: 100 mg/mL tulathromycin Applicant Name: Pfizer Animal Health A Div of Pfizer Australia Pty Ltd Applicant ACN: 008 422 348

Summary of Use: For the treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida sensitive to tulathromycin; Treatment of swine resiratory disease associated with Pasteurella multocida and Mycoplasma hyopneumoniae sensitive to tulathromycin. Date of Registration: 2 August 2007 Label Approval No: 60018/50 mL/0507, 60018/100 mL/0507, 60018/0507 Product Name: Betavite Electrolyte, B Group And Vitamin E Concentrate For Horses Active Constituent/s: 68.1 g/kg bicarbonate, 35.3 g/kg calcium, 240 g/kg chloride, 135 g/kg potassium, 22.2 g/kg magnesium, 94.4 g/kg sodium, 13.5 g/kg phosphorus, 43 g/kg sulfate, 2.85 g/kg zinc, 7 g/kg choline, 8.8 g/kg inositol, 380 mg/kg folic acid, 14 mg/kg vitamin B12, 10.5 g/kg niacin supplement, 4.7 g/kg vitamin B5 calcium salt = calcium pantothenate, 3.4 g/kg vitamin B2, 2.94 g/kg vitamin B1, 158 mg/kg vitamin B6, 26 g/kg vitamin E Applicant Name: Birch International Pty Limited Applicant ACN: 095 043 244 Summary of Use: An electrolyte, B-group and Vitamin E concentrate for use in horses to supplement the diet, to help maintain electrolyte balance and to aid in recovery following strenuous exercise. Date of Registration: 13 August 2007 Label Approval No: 59571/2kg/0307, 59571/5kg/0307, 59571/16kg/0307 4.VARIATIONS Product Name: Elanco AF1304 Elancoban G Monensin sodium Premix Applicant Name: Elanco Animal Health A Div Of Eli Lilly Australia Applicant ACN: 000 233 992 Summary of Variation: Extension of use to include uses in feedlot cattle, pasture cattle, dairy cows and goats. Date of Variation: 24 July 2007 Label Approval No: 36787/25kg/0107 Product Name: Elanco AF0050 Tylan 50 Tylosin Phosphate Premix Applicant Name: Elanco Animal Health A Div of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of Variation: Extend the use to include poultry as an aid in the control of necrotic enteritis associated with susceptible strains of Clostridium perfringens. Date of Variation: 24 July 2007 Label Approval No: 36791/20/1106

Product Name: Elanco AF 0091 Tylan 100 Tylosin Phosphate Premix Applicant Name: Elanco Animal Health A Div of Eli Lilly Australia Pty Ltd Applicant ACN: 000 233 992 Summary of Variation: Include an additional use in cattle for the reduction in the incidence of liver abcess. Date of Variation: 25 July 2007 Label Approval No: 36790/20/1206 Product Name: Elanco AF1300 Tylan Tylosin Tartrate Soluble Applicant Name: Elanco Animal Health A Div of Eli Lilly Australia Pty Ltd Applicant ACN: 000 233 992 Summary of Variation: Extension of use to include the prevention and control of ileitis associated with susceptible strains of Lawsonia intracellularis in pigs. Date of Variation: 25 July 2007 Label Approval No: 40217/100g/0307, 40217/1kg/0307, 40217/55kg/0307 5. RESTRICTED PRODUCT

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

NOTICE

AVIAN INFLUENZA VIRUS H7N1

[in the product: NOBILIS (R) INFLUENZA H7N1 (INACTIVATED) VACCINE]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Commonwealth Department of Agriculture Fisheries and Forestry, for the approval of a new active constituent, Avian influenza virus H7N1 Strain A/CK/Italy/473/99. The APVMA also has before it an application from the same applicant, for the registration of a new product, NOBILIS (R) INFLUENZA H7N1 (INACTIVATED) VACCINE (‘the product’) containing the above new active constituent. The product is for the immunisation of chickens against avian influenza type A, subtype H7 serotype to reduce mortality, clinical signs and/or lesions due to this disease. 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 APVMA should grant the applications for approval of this active constituent and the application for the registration of the product. Submissions should state the grounds on which the submissions are based. Such grounds should relate only to matters outlined below that the Agvet Code requires APVMA to take into account in deciding whether to grant the approval of the new active constituent and registration of the product containing that active constituent. The APVMA must receive comment within 28 days of the date of this Gazette. Particulars of the Active ConstituentCommon name: Avian influenza virus H7N1 Strain/serotype: Strain A/CK/Italy/473/99 Identity and purity: Carried out by the OIE Reference Laboratory for Newcastle Disease and Avian Influenza, Sterility: As per European Pharmacopoeia Extraneous agents: As per European Pharmacopoeia Mycoplasma: As per European Pharmacopoeia Mode of action: Inducing immunological responses Gene technology: Not applicable Applicant name: Department of Agriculture Fisheries and Forestry

Edmund Barton Building Blackall Street, Barton ACT 2601

Summary of use: This active is to be incorporated in a vaccine for the immunisation of healthy chickens as an aid in the control of avian influenza type A, subtype H7NI; and to reduce mortality, clinical signs and/or lesions due to the disease.

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Particulars of the Product Product name NOBILIS (R) INFLUENZA H7N1 (INACTIVATED) VACCINE Name of Applicant Department of Agriculture Fisheries and Forestry Edmund Barton Building Blackall Street, Barton ACT 2601 Active constituent Avian influenza virus H7N1 Strain A/CK/Italy/473/99 Adjuvant Liquid light paraffin Pharmaceutical form Emulsion for injection Target species Chicken. Indications for use For the immunisation of healthy chickens as an aid in the control of avian influenza type A, subtype H7NI. Directions for use For chickens up to the age of 6 weeks a dose of 0.25 mL is recommended. It is recommended to vaccinate chickens at 8-10 days of age. Laying hens and breeders should receive a second vaccination of 0.5mL, 6-10 weeks after first vaccination. The vaccine is to be administered subcutaneously in the lower back part of the neck or intramuscularly into the breast. Caution This vaccine has not been tested in other species. The level of efficacy for other species may differ from that observed in chickens. User safety information This product contains mineral oil. Extreme caution should be used when administering oil emulsion vaccine to avoid accidental self-injection. Accidental self-injection may cause inflammatory reaction, severe pain and swelling that require correct medical management. Seek medical attention as soon as possible in the event of accidental self-injection. Incompatibilities Do not mix with any other medicinal product. Withholding periods Nil.

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Conditions of supply and use The product can only be released on the authority of the Chief Veterinary Officer (CVO) in the relevant State or Territory. The product can only be used under the control of the CVO of the jurisdiction in accordance with a decision of the Consultative Committee on Exotic Animal Diseases (CCEAD). The product can only be used by authorised personnel or persons otherwise authorised under State/Territory legislation. The product must be used in accordance with the approved label directions/instructions or as specified by the CCEAD, or the CVO of the relevant jurisdiction. Summary of the APVMA’s Evaluation of the Active Constituent and the Product The chemistry and manufacturing aspects of Avian influenza virus H7N1 Strain A/CK/Italy/473/99 and the product, including starting materials, master seed organism (source, isolation, identification, testing), culture medium, vaccine production, storage, quality control and batch release analysis, have been evaluated and found to be acceptable. The APVMA is satisfied that the proposed use of Avian influenza virus H7N1 Strain A/CK/Italy/473/99 in the product for active immunisation of chickens against avian influenza type A, subtype H7NI to reduce mortality, clinical signs and/or lesions due to this disease would not be likely to have an effect that is harmful to human beings, environment or trade. In relation to its assessment of efficacy and safety in target animals the APVMA is satisfied that the data addressing the efficacy and safety of the product demonstrate that this product is likely to be effective under Australian conditions when used as directed according to the label instructions. Written submissions on the APVMA’s proposal to grant the application for approval of the active constituents Avian influenza virus H7N1 Strain A/CK/Italy/473/99, and the registration of the product should be addressed in writing to: Linden Moffatt Acting Manager, Vaccines and Antibiotics Veterinary Medicines Program The Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4736 Fax: (02) 6210 4741 email: linden.moffatt@apvma.gov.au

NOTICE

Sulfuryl fluoride

[in the product: Profume Gas Fumigant] The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Dow Agrosciences Australia Limited for registration of a new product containing the active constituent sulfuryl fluoride. The product is PROFUME GAS FUMIGANT. The product is for use in a range of non-food situations and on cereal grains, dried fruit and nuts, in accordance with the details outlined below under “Statement of claims”. 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 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 Application Proposed product name: PROFUME GAS FUMIGANT Applicant company: Dow Agrosciences Australia Limited Name of active constituent: Sulfuryl fluoride Signal heading: Schedule 6 Statement of claims: For the control of insects in buildings (commercial and residential), and non-residential structures including shipping containers and vehicles (excluding aircraft) and for the control of stored product pests in storage facilities such as silos or warehouses, in fumigation chambers, food handling and commodity processing facilities. Pack sizes: 56.7kg Withholding period: Do not release commodities for consumption for 24 hours

following fumigation. Summary of the APVMA’s evaluation of PROFUME GAS FUMIGANT 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 Profume Gas Fumigant 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) has conducted a risk assessment on Profume Gas Fumigant and concluded that it can be safely used in accordance with the recommended

safety instructions and precautions. The APVMA accepts the findings and recommendations of the OCS evaluation.

(ii) The APVMA is satisfied that the proposed use of Profume Gas Fumigant will not be an

undue hazard to the safety of people using anything containing its residues. Residues data were assessed by the APVMA and Maximum Residue Limits (MRLs) and

associated withholding periods (WHPs) are recommended for Profume Gas Fumigant when used on cereal grains, nuts and dried fruit.

Based on the data provided, the following residue definition for sulfuryl fluoride is considered appropriate: sulfuryl fluoride. The recommended withholding period for Profume Gas Fumigant is Do not release commodities for consumption for 24 hours following fumigation and will be included on the product label. The following MRLs are recommended for sulfuryl fluoride: cereal grains, 0.05 mg/kg; dried fruit, 0.07 mg/kg and tree nuts 7 mg/kg.

(iii) The APVMA is satisfied that the proposed use of the Profume Gas Fumigant is not likely

to be harmful to human beings if used according to the product label directions.

The Office of Chemical Safety (OCS) has conducted risk assessments on the products and concluded that they can be used safely when used in accordance with the prescribed safety directions. The APVMA accepts the findings and recommendations of the OCS evaluation. The active constituent (Sulfuryl fluoride) has been evaluated and will be approved at the same time as the product is registered. The OCS recommended Profume Gas Fumigant be included in schedule 6 of the Standard for the Uniform Scheduling of Drugs and Posions (SUSDP). The appropriate signal heading has been included on the label. First aid and safety directions for sulfuryl fluoride have been recommended by the OCS and have also been included on the label. The APVMA accepts the findings and recommendations of its advisors on this criteria.

(iv) The APVMA is satisfied that the proposed use of Profume gas fumigant is not likely to

have an unintended effect that is harmful to animals, plants or the environment. The Department of the Environment and Water Resources (DEWR) have assessed the environmental risk associated with Profume Gas Fumigant and considers that use according to the label directions is unlikely to have an unintended effect that is harmful to animals, plants or things, or to the environment. The APVMA accepts the findings and recommendations of its advisor on this criteria.

(v) The APVMA is satisfied that the proposed use of Profume Gas Fumigant would not

adversely affect trade between Australia and places outside Australia.

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

(i) The APVMA is satisfied the data from trials supporting the efficacy of Profume Gas Fumigant adequately demonstrates that under local conditions this product is effective for the proposed uses.

Public Release Summary A Public Release Summary of the evaluation is available on the APVMA website (www.apvma.gov.au) or by contacting Verity Scarlett on telephone (02) 6210 4748. Written submissions on the APVMA’s proposal to grant the application for registration are required within 28 days of the date of this notice and should be addressed in writing to: Laura Leis Pesticides Division Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4763 Fax: (02) 6210 4776

NOTICE

pyrasulfotole

in the product: PRECEPT SELECTIVE HERBICIDE

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Bayer CropSciences Pty Ltd for registration of a new product containing the active constituent pyrasulfotole in combination with another currently approved active MCPA. The product, PRECEPT SELECTIVE HERBICIDE, is for the post-emergence control of certain broadleaf weeds in wheat, barley, oats, cereal rye and triticale.

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 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 Application Proposed Product Name: PRECEPT SELECTIVE HERBICIDE Applicant Company: Bayer CropScience Pty Ltd. Active Constituents: Pyrasulfotole and MCPA Poisons Sheduling: Schedule 5 Statement of Claims: For the control of broadleaf weeds in wheat, barley, oats, cereal rye and triticale Pack sizes: 20L, 110L Withholding Period: Barley, wheat, oats, cereal rye and triticale: Harvest: Not required when used as directed.

Grazing/Stockfood: wheat, oats, cereal rye and triticale: Do not graze or cut for stockfood for 2 weeks after application. Barley: Do not graze or cut for stockfood for 4 weeks after application

Summary of the APVMA’s evaluation of PRECEPT SELECTIVE HERBICIDE 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 PRECEPT SELECTIVE HERBICIDE

would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Department of Health and Ageing, Office of Chemical Safety (Occupational Health and Safety) [OCS (OHS] section has conducted a risk assessment on PRECEPT SELECTIVE HERBICIDE and concluded that it can be used safely. Pyrasulfotole has displayed low acute oral, dermal and inhalational toxicity in male and female rats. It is not a skin irritant in rabbits or a skin sensitiser in guinea pigs. It was however a moderate eye irritant in rabbits. The product, PRECEPT SELECTIVE HERBICIDE, was considered likely to exhibit low acute oral, dermal and inhalational toxicity in male and female rats. It is a moderate skin irritant in rabbits but was not found to be a skin sensitiser. It was however a severe eye irritant in rabbits. Personal protective equipment statements for the Safety Directions of PRECEPT SELECTIVE HERBICIDE have been recommended by the OCS (OHS) section, and have been included on the draft label. The APVMA having considered the findings and recommendations of the OCS (OHS) evaluation accepts these findings and recommendations.

(ii) The APVMA is satisfied that the proposed use of PRECEPT SELECTIVE HERBICIDE will not be an undue hazard to the safety of people using anything containing its residues.

Residue data were assessed by the APVMA and Maximum Residue Limits (MRLs) and associated Withholding Periods (WHPs) are recommended for PRECEPT SELECTIVE HERBICIDE when used on barley, cereal rye, oats, triticale and wheat. Based on the data provided, the following residue definition is considered appropriate: The sum of pyrasulfotole and (5-hydroxy-1H-pyrazol-4-yl)[2-mesyl-4-(trifluoromethyl) phenyl]methanone, expressed as pyrasulfotole.

The recommended WHPs for PRECEPT SELECTIVE HERBICIDE are stated on the draft label. Pyrasulfotole MRLs are recommended for cereal grains (*0.02mg/kg), edible offal (mammalian) (0.5mg/kg), eggs (*0.01mg/kg), meat (mammalian) (*0.01mg/kg), milks (*0.01mg/kg), poultry meat (*0.01mg/kg), poultry, edible offal (*0.01mg/kg), bran, unprocessed of cereal grains (0.03), fodder and straw of cereal grain 0.02 mg/kg, forage of cereal grain 0.5 mg/kg. [* Denotes that the MRL has been set at the limit of quantitation (LOQ).]

(iii) The APVMA is satisfied that the proposed use of the active constituent pyrasulfotole in PRECEPT SELECTIVE HERBICIDE is not likely to be harmful to human beings if used according to the product label directions.

The APVMA has evaluated and proposes to approve the active constituent, pyrasulfotole, and finds that the chemistry and manufacturing details of the product are acceptable. The proposed product has been assessed by the National Drugs and Poisons Scheduling Committee and has been included in Schedule 5 of the SUSDP. The appropriate Signal Heading appears on the label. First Aid and Safety Directions (hazard statements) for pyrasulfotole and PRECEPT SELECTIVE HERBICIDE have been recommended by the Commonwealth Department of Health and Ageing, OCS (toxicology) section, and have been included on the label.

The product is formulated in Australia and will be packed in HDPE containers. PRECEPT SELECTIVE HERBICIDE is determined to be a hazardous substance, based on NOHSC hazard classification of active and non-active constituents and product toxicology information provided. The APVMA has considered the findings of its advisers on this criterion and accepts their recommendations.

(iv) The APVMA is satisfied that the proposed use of the product PRECEPT SELECTIVE

HERBICIDE containing the new active constituent pyrasulfotole, would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment. The Department of the Environment and Water Resources (DEW) has assessed data in support of the proposed use and has concluded that the risks to the environment from the proposed use are acceptable.

Pyrasulfotole is expected be persistent in soils and particularly water/sediment systems but is not considered to be bioaccumulative. Soil metabolism and field dissipation studies show a considerable slowing in the degradation rate over time with one major metabolite generated.

Pyrasulfotole is not toxic to birds, mammals, earthworms, bees, fish and daphnia but slightly harmful to parasitic wasps and predatory mites, slightly toxic to algae, moderately toxic to mysid shrimp, and very highly toxic to duckweed. It has no effect on the seedling emergence of monocot species but survival was significantly affected in dicot species. Significant effects were observed in the vegetative vigour of monocot and dicot seedlings.

There is unlikely to be an aquatic risk as a result of spray drift from ground and aerial application or from run-off as an amended label drift warning statement would suffice for the proposed use pattern. The main environmental risk is from aerial spray drift impacting non-target vegetation where buffers are required depending on droplet sizes, if PRECEPT SELECTIVE HERBICIDE is to be allowed to be aerially applied.

The APVMA has considered the findings of DEW and accepts its recommendations on this criterion.

(v) The APVMA is satisfied that the proposed use of pyrasulfotole in PRECEPT SELECTIVE

HERBICIDE would not adversely affect trade between Australia and places outside Australia.

The APVMA has determined that the use of product in accordance with the required instructions could potentially unduly prejudice trade and commerce between Australia and places outside Australia as per section 14(3)(e)(iv) of the Agvet Codes. Quantifiable residues are not anticipated in cereal grains, fodder or any poultry commodity, thus it is unlikely the use of pyrasulfotole would unduly prejudice the trade of these commodities. Residues in meat (mammalian) and milk are also expected to be below the LOQ, however detectable residues may be present in edible offal. Accordingly, a determination of undue

prejudice to trade or commerce should be made following the completion of the trade consultation process. Areas of potential concern and possible management strategies have been outlined in the draft Public Release Summary.

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

SELECTIVE HERBICIDE adequately demonstrates that under local conditions this product will be effective for the proposed uses.

Public Release Summary A Public Release Summary (PRS) of the evaluation is available by contacting Verity Scarlett on telephone (02) 6210 4748. Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Ranjit Gajanayake Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4760 Fax: (02) 6210 4776 Email: ranjit.gajanayake@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, 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 APVMA Gazette No. 8, 7 August 2007. Application No Product/Active Constituent Name

40573 RYGEL LOW VOLATILE ESTER 600 HERBICIDE 40681 MAKI PELLET RODENTICIDE 41203 CHEMAG BROMOX MA SELECTIVE HERBICIDE 41468 DAVID GRAYS HIGH PERFORMANCE ROACH SURFACE SPRAY

41599 FARMCARE VIRUGARD BROAD SPECTRUM VIRUCIDAL, BACTERICIDAL AND FUNGICIDAL POWDER DISINFECTANT

41927 BAYGON DO-IT-YOURSELF INDOOR EXPERT HOME SURFACE SPRAY 42048 NOT AVAILABLE 42094 WSD DIAZINON FOR SHEEP, CATTLE, GOATS AND PIGS 42140 NOT AVAILABLE 42189 PRECEPT SELECTIVE HERBICIDE 42201 TILMAX 200 PREMIX 42202 THIOVIT FUNGICIDE/MITICIDE/INSECTICIDE 42243 ETHIN GROWTH REGULATOR 42244 NOT AVAILABLE 42259 SNAILEM SLUG AND SNAIL PELLETS 42302 NOT AVAILABLE 42323 BARMAC ELECTRICUR NEMATICIDE AND INSECTICIDE 42330 SWIMFREE GRANULAR POOL CHLORINE POOL WATER SANITISER 42477 INNOVA TRICLOPYR 600 HERBICIDE 42480 NOT AVAILABLE 42482 GENFARM TOLEX LIQUID FUNGICIDE 42510 NOT AVAILABLE 42553 KILLS FAST SELECT WOOLWORTHS NATURAL PYRETHRUM INSECT SPRAY 42623 NOT AVAILABLE 42625 NOT AVAILABLE 42641 FARMOZ GUSATHION 200 SC INSECTICIDE 42642 CHEMFORCE PROPYZAMIDE 500SC HERBICIDE 42719 MEDLEY MZ SYSTEMIC AND PROTECTIVE FUNGICIDE 42723 MEDLEY 350 SEED TREATMENT 42264 2,4-D-2-ETHYLHEXYL ESTER 42261 NOT AVAILABLE 39991 NOT AVAILABLE 41043 PLASMITE TERMITE BLANKET 41595 REDOX GLYPHOSATE 450 HERBICIDE 41861 OSMOSE MICROPRO COPPER BASED TIMBER PRESERVATIVE 42023 TRICLOPYR BUTOXYETHYL ESTER 42031 MACSPRED GLYMAC DRI 700 HERBICIDE

42205 MORTEIN DO-IT-YOURSELF PROFESSIONAL COCKROACH GEL BAIT TRUSTED HOUSEHOLD PROTECTION

42213 PREMIUM QUALITY 12% LIQUID POOL CHLORINE 42220 DAVID GRAYS BIFENTHRIN AQUA TERMITICIDE AND INSECTICIDE 42256 DUPONT AVATAR INSECTICIDE 42324 EXPRA INSECT ELIMINATOR WITH 100% NATURAL PYRETHRINS 42352 SPACARE SANITISER AND OXIDISER BROMINATING CONCENTRATE

42355 SPACARE CHLORINATED CONCENTRATE SPA AND HOT TUB SANITISER AND OXIDISER

42450 MORNING ALKA MASTER LOW FOAMING LIQUID ALKALI DETERGENT FOR THE CLEANING OF DAIRY MILKING EQUIPMENT

42540 NOT AVAILABLE 42555 MAKI BLOCK WEATHER - PROOF RODENTICIDE 42722 MEDLEY PLUS SYSTEMIC FUNGICIDE 42858 NOT AVAILABLE 42821 DICHLORPROP-P 40544 SUMMIT SUPPORT HERBICIDE

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

38916 BAYCOX CATTLE COCCIDIOCIDE 40681 MAKI PELLET RODENTICIDE 38249 CHEMAG ANNIHILATE 200 SC ALL PURPOSE INSECTICIDE 41304 CHEMAG RALLY 750 SG HERBICIDE 40067 STARANE 333 HERBICIDE 36108 NOT AVAILABLE 39969 RENTOKIL MOUSE KILLER BOX 37231 NUFARM CORASIL PLANT GROWTH REGULATOR 41413 SYMPHONY INSECTICIDE 41357 NUFARM COMET 400 HERBICIDE 38358 ILIUM PROPERCILLIN ANTIBIOTIC INJECTION 40344 GF-1674

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

Ph: 6210 4701 Fax: 6210 4721

_____________________________________________________________________________________________________________ * 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: CLYDE CONTRACT FILLERS PTY LTD ACN: 000 533 684 5 Kelray Place ASQUITH NSW 2077

Product Types:* Category 6: Single Step Step(s) of Manufacture: Filling, packaging, analysis and testing (physical), storage Licence No: 6131 Full licence issued 04/07/07

MCNEIL MANUFACTURING PTY LTD ACN: 122 159 915 32-40 Cawarra Road CARINGBAH NSW 2229

Product Types:* Category 6: Single Step Step(s) of Manufacture: Analysis and testing (microbiological) Licence No: 6128 Full licence issued 04/07/07

ARISTOPET PTY LTD ACN: 009 697 152 118 Links Avenue South EAGLE FARM QLD 4009

Product Types:* Category 2: Tablets, creams/lotions, ointments, pastes, powders, sprays, liquids, suspensions. Category 3: Liquids, sprays, powders and tablets (soluble for aquarium). Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, granulation, dry milling of powders, tableting, filling, packaging, labelling, analysis and testing (physical), storage and release for supply. Licence No: 2193 Full licence issued 17/07/07

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2. CHANGES TO EXISTING LICENCES: AGRICON PTY LTD T/As: AGRICON PRODUCTS ACN: 010 147 958 Enterprise Street Industrial Estate MARYBOROUGH QLD 4650

Product Types:* Category 4: Premixes and supplements Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, dry milling, filling, packaging, labelling, analysis and testing (physical), storage and release for supply Licence No: 4002 Amended licence issued 17/07/07, extension of licence scope.

INTERVET AUSTRALIA PTY LIMITED ACN: 008 467 034 91 – 105 Harpin Street BENDIGO EAST VIC 3550

Product Types:* Category 1: Immunobiologicals Step(s) of Manufacture: Quality assurance (QA) of raw materials, bacterial fermentation, fungal fermentation, virus cultivation, formulation including blending, aseptic filling, filling, packaging, labelling, sterilisation (heat and filtration), microbiological reduction treatment (heat, chemical and filtration), freeze drying, analysis and testing (physical, chemical, Limulus Amoebocyte Lysate test (LAL), sterility test, safety test, serological and microbiological), storage and release for supply Licence No: 1008 Amended licence issued 24/07/07, extension of licence scope, 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]). CLYDE CONTRACT FILLERS PTY LTD ACN: 000 533 684 3 Loyalty Road NORTH ROCKS NSW 2151

Licence No: 6020 Cancelled: 24/07/07 Reason for cancellation: Voluntary, s127(1)(d)

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

_____________________________________________________________________________________________________________ * 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

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CRESCENT CHEMICALS (AUSTRALIA) PTY LTD ACN: 072 294 181 54 Star Crescent HALLAM VIC 3803

Licence No: 2142 Suspended: 04/07/07 (to 01/04/08) Reason for suspension: Voluntary, s127(1)(d)

PRIMEGRO LIMITED ACN: 085 940 361 28 Dalgleish Street THEBARTON SA 5031

Licence No: 6093 Suspended: 25/07/07 (to 30/06/08) Reason for suspension: Voluntary, s127(1)(d)

APVMA Contact: Kathryn Winterton Quality Assurance and Compliance 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. 3K

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_standard.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) ADD: Difenoconazole VS 0624 Celery T2

ADD: Imidacloprid VS 0627 Rhubarb T1 ADD: Oryzalin

HS 0784 Ginger, root T*0.05 ADD: Phosphorous acid VS 0627 Rhubarb T100 Pyraflufen-ethyl DELETE: SO 0691 Cotton seed *0.02 ADD:

SO 0691 Cotton seed *0.05 ADD: Simazine

HS 0784 Ginger, root T*0.05

ADD: Tulathromycin

MF 0812 Cattle fat 0.1 MO 1280 Cattle, kidney 1

MO 1281 Cattle, liver 3 Cattle muscle 0.1 MO 1284 Pig, kidney 3 MO 1285 Pig, liver 2 Pig muscle 0.5 Pig skin / fat 0.3

TABLE 3: RESIDUE DEFINITION Where MRL(s) are recommended, the following residue definitions are applicable. COMPOUND RESIDUE ADD: Tulathromycin Sum of tulathromycin and its metabolites that are coverted by

acid hydrolysis to (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-2-ethyl-3,4,10,13-tetrahydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylohexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one, expressed as tulathromycin equivalents.

For further information please contact: Michelle Hemming Chemistry & Residues Program Phone: (02) 6210 4837 Fax: (02) 6210 4840 Email: michelle.hemming@apvma.gov.au