table of contents notice of registrations notice – new ... · applicant name: turf culture pty...

TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products 0 Notice – New Agricultural & Veterinary Chemical Products Azadirachta Indica [Neemazal Insecticide] Page 12 Flufenoxuron [FUROX TERMITE BAIT] Page 15 acibenzolar-S-methyl [BION PLANT ACTIVATOR SEED TREATMENT] Page 17 Other Notices Solid Termite Barriers Page 21 Amendments to the MRL Standard Page 22 Licensing of Veterinary Chemical Manufacturers Page 26 Interpretation of the CODEX CLASSIFICATION OF FOODS & ANIMAL FEEDS for the establishment of Rape Seed MRLs Page 29 Reconsideration of Approvals & Registrations Related to Carbendazim & Thiophanate-Methyl Page 31 Application Summaries Page 35 Addendum List of approved Active Constituents Page 37

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: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “ No entries” 3. AGRICULTURAL PRODUCTS

BASED ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: Product Name: Genfarm Imidacloprid 600 Flowable Seed Dressing Insecticide Active Constituent/s: 600 g/L imidacloprid Applicant Name: Genfarm Crop Protection Pty Ltd

Applicant ACN: 115 327 378 Summary of Use: For the control of thrips, aphids, brown flea beetle and wireworms in cotton and various insect pests of maize, sorghum, sunflower, sweetcorn, canola, forage and seed pasture, forage brassicas, lupins and cereals (inlcuding the spread of barley yellow dwarf virus). Date of Registration: 19 February 2007 Label Approval No: 60884/1/1106, 60884/2.5/1106, 60884/5/1106, 60884/10/1106, 60884/20/1106, 60884/100/1106, 60884/200/1106, 60884/1000/1106, 60884/1106 Product Name: Crop Care Jockey Systemic Seed Treatment Active Constituent/s: 167 g/L fluquinconazole. Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: For the supression and control of various diseases in wheat and canola when applied as a seed dressing. Date of Registration: 20 February 2007 Label Approval No: 61019/10L/0107, 61019/100L/0107, 61019/1000L0107, 61019/0107 Product Name: Richgro Bindii Killer For Buffalo Lawns 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: A Richards Pty Ltd T/A Richgro Garden Products Applicant ACN: 008 734 852 Summary of Use: For the control of garden weeds such as bindii, cat’s ear, clover, creeping oxalis, cudweed and thistles in buffalo lawns. Date of Registration: 21 February 2007 Label Approval No: 60956/250-500/0906 Product Name: Surface Spray Insect Killer Active Constituent/s: 1 g/kg allethrin (20:80), 2.85 g/kg permethrin (25:75). Applicant Name: Multi-Fill Pty Ltd Applicant ACN: 053 439 080 Summary of Use: For the control of 3cockroaches and other insect pests in the home. Date of Registration: 22 February 2007 Label Approval No: 61272/300/1106 Product Name: Searles Rose Aid Black Spot And Insect Killer Active Constituent/s: 0.10 g/L tau-fluvalinate, 0.05 g/L myclobutanil Applicant Name: J C & A T Searle Pty Ltd Applicant ACN: 002 898 893 Summary of Use: Controls various insects and

fungal diseases on roses and ornamentals in the home garden. Date of Registration: 22 February 2007 Label Approval No: 61488/1/1106 Product Name: Baygon Fly Control Window Stickers Sun Active Constituent/s: 5.4 mg imidacloprid Applicant Name: S.C. Johnson & Son Pty Ltd Applicant ACN: 000 021 009. Summary of Use: Fly control window sticker to help control flies in the home without spraying. Date of Registration: 23 February 2007 Label Approval No: 61468/2/1006 Product Name: Agspray Abamectin Miticide/Insecticide Active Constituent/s: 18 g/L abamectin. Applicant Name: Agspray Chemical Co Pty Ltd Applicant ACN: 005 329 573 Summary of Use: For mite and insect control on apples, capsicums, citrus, hops, ornamentals, pears, tomatoes and strawberries. Date of Registration: 26 February 2007 Label Approval No: 60612/1/1006, 60612/5-20/1006, 60612/1006 Product Name: Elanco AH0495 Elector PSP Animal Premise Spray Active Constituent/s: 480 g/L spinosad Applicant Name: Elanco Animal Health A Div of Eli Lilly Australia Applicant ACN: 000 233 992 Summary of Use: For control of house flies, stable flies and darkling beetles in3 and around agricultural premises. Date of Registration: 28 February 2007 Label Approval No: 59422/250mL/1206, 59422/1L/1206 Product Name: Smartfresh Smarttabs Active Constituent/s: 6.3 g/kg 1-methylcyclopropene Applicant Name: Rohm & HAAS Australia Pty Ltd Applicant ACN: 004 513 188 Summary of Use: Post harvest treatment of specific fruits and vegetables for improved quality after shipping, storage or handling. Date of Registration: 28 February 2007 Label Approval No: 59713/12.5g/0207, 59713/activator kit/0207, 59713/50mL activator/0207, 59713/2.8g activator/0207, 59713/leaflet/0207 Product Name: Tradelands Metolachlor 960 EC Herbicide Active Constituent/s: Containing 960 g/L

metolachlor Applicant Name: Tradelands Pty Ltd Applicant ACN: 115 285 679 Summary of Use: For control of various weeds in cereals, sorghum, maize and other crops. Date of Registration: 28 February 2007 Label Approval No: 60786/20L/0107, 60786/110L/0107, 60786/1000L/0107, 60786/LEAF/0107 Product Name: Repellex 6 Hour Protection Personal Insect Repellent Tropical Stregnth Active Constituent/s: 40 g/kg N-octyl bicycloheptene dicarboximide, 191 g/kg diethyltoluamide. Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: Tropical stregnth personal insect repellent spray with 6 hour protection against mosquitoes, repels flies, sandflies, leeches, ticks and other annoying biting insects. Date of Registration: 1 March 2007 Label Approval No: 61298/150G/1006 Product Name: Takein II Organosilicone Surfactant/Penetrant Active Constituent/s: 1020 g/L polyether modified polysiloxane Applicant Name: Grow Choice Pty Limited Applicant ACN: 069 839 961 Summary of Use: A non-ionic wetter/spreader/penetrant for use with agricultural chemicals. Date of Registration: 5 March 2007 Label Approval No: 61208/1L/1206, 61208/5L/1206, 61208/10L/1206, 61208/20L/1206 Product Name: Tradelands Clopyralid 300 Herbicide Active Constituent/s: 300 g/L clopyralid present as the triisopropanolamine salt Applicant Name: Tradelands Pty Ltd Applicant ACN: 115 285 679 Summary of Use: For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures, fallow land, forests and industrialsituations. Date of Registration: 6 March 2007 Label Approval No: 61255/5R/0207, 61255/20R/0207, 61255/LEAF/0207 Product Name: Hovex Fast Knockdown Fly And Insect Spray Active Constituent/s: 1.19 g/kg bioallethrin, 0.75 g/kg bioresmethrin, 3.82 g/kg tetramethrin 20:80 Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463

Summary of Use: For the control of flying and crawling insects in the home. Date of Registration: 6 March 2007 Label Approval No: 61006/250G/0706 Product Name: Hovex Low Irritant Fly And Insect Spray Active Constituent/s: 3.18 g/kg n-octyl bicycloheptene dicarboximide, 2.17 g/kg piperonyl butoxide, 0.25 g/kg phenothrin 20:80, 1.08 g/kg tetramethrin 20:80 Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For the control of flying and crawling insects. Date of Registration: 7 March 2007 Label Approval No: 61008/250g/1006 Product Name: Hovex Low Irritant Surface Spray Active Constituent/s: 2.79 g/kg permethrin (25:75::cis:trans), 1.38 g/kg tetramethrin 20:80 Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For effective protection against crawling insects. Date of Registration: 7 March 2007 Label Approval No: 61007/250/0806 Product Name: Instar 200SC Insecticide Active Constituent/s: 200 g/L imidacloprid Applicant Name: Greenshed Pty Limited Applicant ACN: 105 996 307 Summary of Use: A 200g/L imidacloprid suspension concentrate product for control of certain insect pests in turf and ornamental situations. Date of Registration: 7 March 2007 Label Approval No: 60996/1/0107, 60996/5/0107, 60996/10/0107, 60996/0107 Product Name: Country Imidacloprid Ready To Use Insecticide Active Constituent/s: 0.13 g/L imidacloprid Applicant Name: Accensi Pty Ltd Applicant ACN: 079 875 184 Summary of Use: For the control of various insect pests on flowers, shrubs, trees, fruit trees and vegetables in the home garden. Date of Registration: 7 March 2007 Label Approval No: 60898/1L/0107, 60898/750mL/0107 Product Name: Turf Culture Tirem 200SC Insecticide Active Constituent/s: 200 g/L imidacloprid. Applicant Name: Turf Culture Pty Ltd Applicant ACN: 117 986 615 Summary of Use: Imidacloprid suspension concentrate product for the control of a range of

insect pests in turf and ornamental situations. Date of Registration: 7 March 2007 Label Approval No: 61094/1/0107, 61094/5/0107, 61094/10/0107, 61094/0107 Product Name: Enviroguard Turf & Ornamental Residual Insecticide Active Constituent/s: 80 g/L bifenthrin Applicant Name: Panchem Industries Pte Ltd Summary of Use: Urban, indoor and outdoor control of pests including mites, mosquitos, cockroaches, spiders and wasps, and for the control of pests in turf and ornamental plants. Date of Registration: 8 March 2007 Label Approval No: 61294/1/1106, 61294/5/1106, 61294/10/1106, 61294/20/1106, 61294/200/1106, 61294/1106 Product Name: Minehan Algacide 150 For Killing Algae And Black Spot Active Constituent/s: 142.5 g/L quaternary ammonium compound Applicant Name: Minehan Agencies Pty Ltd Applicant ACN: 010 895 100 Summary of Use: To control algae and black spot in various situations. Date of Registration: 9 March 2007 Label Approval No: 61594/5L/0107, 61594/25L/0107, 61594/200L/0107 Product Name: Aw Flutriafol 250SC Fungicide Active Constituent/s: 250 g/L flutriafol Applicant Name: Agri West Pty Ltd Applicant ACN: 108 899 181 Summary of Use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliarspray. Date of Registration: 12 March 2007 Label Approval No: 61514/1L/1206, 61514/5L/1206, 61514/10L/1206, 61514/20L/1206, 61514/110L/1206, 61514/200L/1206, 61514/1000L/1206 Product Name: Rygel Tebuconazole 430 Fungicide Active Constituent/s: 430 g/L tebuconazole Applicant Name: Rygel Australia Pty Ltd Applicant ACN: 106 839 007 Summary of Use: For the control of leaf spot and leaf speckle on bananas; rust spot and net blotch of peanuts; foliar disease on cereal crops; and other diseases on beans , peas, onions, pawpaw, pyrethrum and ryegrass and fescue seed crops. Date of Registration: 12 March 2007 Label Approval No: 60980/5L/0806, 60980/10L/0806, 60980/20L/0806, 60980/60L/0806, 60980/0806

Product Name: Matter 240EC Selective Herbicide Active Constituent/s: 60 g/L cloquintocet-mexyl, 240 g/L clodinafop-propargyl. Applicant Name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of Use: Controls wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat. Highly active on wild oats and can be mixed with many broadleaf herbicides. Date of Registration: 12 March 2007 Label Approval No: 61662/1L/0107, 61662/5L/0107, 61662/0107 Product Name: Sinmas 250 Insecticide Active Constituent/s: 225 g/L methomyl Applicant Name: Sinon Australia Pty Limited Applicant ACN: 102 741 024 Summary of Use: For the control of certain insect pests in a variety of crops as per the directions of use table. Date of Registration: 12 March 2007 Label Approval No: 60419/1/1106, 60419/5/1106, 60419/10/1106, 60419/20/1106, 60419/100/1106, 60419/200/1106, 60419/1106 Product Name: Amgrow Sir Walter Buffalo Lawn Weed Control Active Constituent/s: 200 g/L bromoxynil present as the n-octanoyl ester, 200 g/L MCPA present as the iso octyl ester. Applicant Name: Envirogreen Pty Ltd Applicant ACN: 069 900 456 Summary of Use: For the control of bindii and other weeds in buffalo and other lawns. Date of Registration: 12 March 2007 Label Approval No: 61534/250ML/1206 Product Name: Hovex Naphthalene Sachets Active Constituent/s: 990 g/kg naphthalene Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For use in the home to repel moths and silverfish. Date of Registration: 13 March 2007 Label Approval No: 61107/10g/0107, 61107/100g/0107, 61107/150g/0107, 61107/200g/0107, 61107/250g/0107, 61107/300g/0107, 61107/350g/0107, 61107/400g/0107, 61107/450g/0107, 61107/500g/0107 Product Name: Genfarm Boom Plus Insecticide Active Constituent/s: 250 g/L cypermethrin Applicant Name: Genfarm Crop Protection Pty Ltd

Applicant ACN: 115 327 378 Summary of Use: For control of certain insect pests on a range of broad acre crops. Date of Registration: 13 March 2007 Label Approval No: 61607/20/1206, 61607/110/1206, 61607/1206 Product Name: Sylon 300 Herbicide Active Constituent/s: 300 g/L clopyralid present as the triisopropanolamine salt Applicant Name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of Use: For the control of broadleaf weeds in wheat, barley, triticale, oats, pastures, canola, fallow land, forests and industrial situations. Date of Registration: 14 March 2007 Label Approval No: 61095/5L/1206, 61095/20L/1206, 61095/1206 Product Name: United Farmers Clethodim 240ec Herbicide Active Constituent/s: 240 g/L clethodim Applicant Name: United Farmers Cooperative Company Ltd Summary of Use: For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans. Date of Registration: 14 March 2007 Label Approval No: 60717/20L/1106, 60717/10L/1106, 60717/1106 Product Name: Gringo 600 Flowable Seed Dressing Insecticide Active Constituent/s: 600 g/L imidacloprid. Applicant Name: Echem (Aust) Pty Ltd Applicant ACN: 089 133 095 Summary of Use: For control of thrips, aphids, brown flea beetle and wireworms on cotton; protection of canola, pastures and lupins from damage by redlegged earth mite and blue oat mite; control of aphids and prevention of spread of barley yellow dwarf virus in cereal crops and control of some soil pests in summer crops. Date of Registration: 14 March 2007 Label Approval No: 60797/5/1206, 60797/20-200/1206, 60797/1000/1206, 60797/1206 Product Name: Maxforce Liquid Ant Bait Active Constituent/s: 0.05 g/L imidacloprid Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of white footed black house ants and black house ants, indoors and outdoors in commercial and domestic areas.

Date of Registration: 14 March 2007 Label Approval No: 60885/200mL-1L/0107 Product Name: Maxforce Liquid Ant Bait Active Constituent/s: 0.05 g/L imidacloprid Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of white footed black house ants and black house ants, indoors and outdoors in commercial and domestic areas. Date of Registration: 14 March 2007 Label Approval No: 60885/200mL-1L/0107 Product Name: Hovex Moth Sachets Active Constituent/s: 1000 g/kg camphor Applicant Name: Pascoe's Pty Ltd Applicant ACN: 055 220 463 Summary of Use: For repelling moths and silverfish in the home. Date of Registration: 15 March 2007 Label Approval No: 61221/10g/1006, 61221/100g/1006, 61221/150g/1006, 61221/200g/1006, 61221/250g/1006, 61221/500g/1006 Product Name: Pool Pro Granular Chlorine Tablets Active Constituent/s: 650 g/kg chlorine present as calcium hypochlorite Applicant Name: The Pops Group Pty Ltd T/A The Pool Shops Trust Applicant ACN: 095 828 461 Summary of Use: For the control of algae and bacteria in swimming pools. Date of Registration: 15 March 2007 Label Approval No: 59776/1kg/1105, 59776/2kg/1105, 59776/10kg/1105, 59776/20kg/1105, 59776/40kg/1105 Product Name: Supremo 450 CT, Non-Selective, Translocated Herbicide Active Constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant Name: S.K. Chemicals Enterprise Pty Ltd Applicant ACN: 109 797 024 Summary of Use: For the control of a diverse range of annual, perennial and woody weeds in a broad range of crop and non-crop situations. Date of Registration: 20 March 2007 Label Approval No: 59586/5/0606, 59586/20/0606, 59586/110/0606, 59586/120/0606, 59586/200/0606, 59586/800/0606, 59586/1000/0606, 59586/0606 Product Name: Cyperforce 25 ULV Insecticide Active Constituent/s: 25g/L cypermethrin. Applicant Name: Webcot Pty Ltd

Applicant ACN: 098 262 198 Summary of Use: For knockdown control of adult mosquitoes, biting midges, flies and cockroaches in and around domestic areas, public service areas, agricultural buildings, commercial and industrial areas, refuse tips and breeding areas. Date of Registration: 20 March 2007 Label Approval No: 61610/1L/1206, 61610/1LL/1206, 61610/5L/1206, 61610/10L/1206, 61610/20L/1206, 61610/LEAF/1206 Product Name: Mortein Lure 'N' Kill Cockroach Baits Active Constituent/s: 2.5 g/kg indoxacarb Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: A bait to control American and German cockroaches in the home. Date of Registration: 20 March 2007 Label Approval No: 60632/1/0107, 60632/6/0107, 60632/12/0107 4.VARIATIONS Product Name Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: Product Name: Farmoz Diuron 500 Flowable Herbicide Applicant Name: Farmoz Pty Limited Applicant ACN: 050 328 973 Summary of Variation: Variation of registration to add additional of uses in puse crops (field peas, faba beans, lentils, narbon beans, chickpeas and vetch) and in cereals. Date of Variation: 19 February 2007 Label Approval No: 52176/20AG/1106, 52176/20AGLL/1106, 52176/1106 Product Name: Proclaim Insecticide Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Variation: Variation of label approval to extend use to include the control of heliothis on sweet corn and amend instructions for grapes and tomatoes. Date of Variation: 19 February 2007 Label Approval No: 50919/600/0107 Product Name: Dividend Fungicide Seed Treatment Applicant Name: Syngenta Crop Protection

Pty Limited Applicant ACN: 002 933 717 Summary of Variation: Addition of claims for suppression of Rhizoctonia on wheat and barley, and control of Pythium on barley. Date of Variation: 20 February 2007 Label Approval No: 56880/10/0207, 56880/113.5/0207, 56880/1000/0207 Product Name: Repellex 6 Hour Protection Personal Insect Repellent Tropical Stregnth Active Constituent/s: 40 g/kg N-octyl bicycloheptene dicarboximide, 191 g/kg diethyltoluamide. Applicant Name: Reckitt Benckiser (Australia) Pty Limited Applicant ACN: 003 274 655 Summary of Use: Tropical stregnth personal insect repellent spray with 6 hour protection against mosquitoes, repels flies, sandflies, leeches, ticks and other annoying biting insects. Date of Registration: 1 March 2007 Label Approval No: 61298/150G/1006 Product Name: Jockey Systemic Seed Fungicide Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Variation: Variation to uses to include control of loose smut, covered smut, leaf scald and powdery mildew of barley. Date of Variation: 1 March 2007 Label Approval No: 52622/10/0107, 52622/20/0107, 52622/100/0107, 52622/200/0107, 52622/1000/0107, 52622/0107 Product Name: Dithane Rainshield Neo Tec Fungicide Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Variation: Variation to the product registration and current label approval to make a minor formulation change and to extend the expiry date on the product, and updates to label instructions for various pulses grown for dried and fresh production. Date of Variation: 1 March 2007 Label Approval No: 59688/20/1106 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: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: “No Entries” 3. VETERINARY PRODUCTS BASED

ON EXISTING ACTIVE CONSTITUENTS:

Product Name: Active Constituent/s: Applicant Name: Applicant ACN: Summary of Use: Date of Registration: Label Approval No: Product Name: Fly Liquid Sheep Blowfly Treatment Active Constituent/s: 500 g/L cyromazine. Applicant Name: Bomac Animal Health Pty Limited Applicant ACN: 084 248 206 Summary of Use: For use on long wool sheep by jetting or dipping to provide protection from

blowfly strike for up to 14 weeks. Date of Registration: 19 February 2007 Label Approval No: 61444/1L/0107, 61444/5L/0107, 61444/10L/0107, 61444/15L/0107 Product Name: Omoguard Paste For Horses Active Constituent/s: 370 mg/g omeprazole. Applicant Name: Nature Vet Pty Limited Applicant ACN: 002 692 426 Summary of Use: An oral past which limits gastric acid by parietal cells for use in horses and foals. Date of Registration: 22 February 2007 Label Approval No: 59496/33G/0207, 59496/6x33G/0207 Product Name: Lucifly Liquid Sheep Blowfly Treatment Active Constituent/s: 500 g/L cyromazine. Applicant Name: Norbrook Laboratories Australia Pty Limited Applicant ACN: 080 972 596 Summary of Use: For controlling browfly strike (Lucillia cuprina) in long wool sheep. Date of Registration: 22 February 2007 Label Approval No: 61517/5L/1106, 61517/10L/1106 Product Name: Saicom Sheep Dewormer Active Constituent/s: 1000 g/kg albendazole. Applicant Name: Agvet Chemical Consultancies Pty Ltd Applicant ACN: 072 899 239 Summary of Use: For use in feed for sheep desined for export only, to control susceptible gastrointestinal roundworms, lungworms, tapeworms and to aid in control of adult liver fluke. Date of Registration: 26 February 2007 Label Approval No: 60880/25/0107 Product Name: Tylodox 50 Bmp Microgranulate Feed Additive Active Constituent/s: 50 g/kg tylosin as tylosin phosphate Applicant Name: Dox-Al Australia Pty Ltd Applicant ACN: 079 454 265 Summary of Use: For growth promotion and prevention of ileitis in pigs and reduction in incidence of liver abscess in cattle. Date of Registration: 27 February 2007 Label Approval No: 60891/5/0207, 60891/10/0207, 60891/20/0207, 60891/25/0207 Product Name: Methylene Blue By Aquasonic Active Constituent/s: 12 mg/mL methylene blue Applicant Name: Aquasonic Pty Ltd Applicant ACN: 001 427 256

Summary of Use: An ornamental aquarium antiseptic product. Date of Registration: 27 February 2007 Label Approval No: 60872/1L/1005, 60872/100/1005, 60872/250/1005 Product Name: Procare Abamectin Plus Selenium Active Constituent/s: 2 g/L abamectin, 1 g/L selenium as sodium selenate Applicant Name: Allfire Enterprises Pty Ltd Applicant ACN: 097 970 280 Summary of Use: For the treatment and control of gastrointestinal roundworms, lungworm, nasal bot and the treatment and prevention of selenium deficiencies in sheep. Date of Registration: 9 March 2007 Label Approval No: 60273/2.5L/1006, 60273/5L/1006, 60273/10L/1006, 60273/20L/1006 Product Name: Purina Total Care Flea Control Shampoo For Dogs Active Constituent/s: 10 g/L piperonyl butoxide, 8 g/L melaleuca oil, 2 g/L permethrin 25/75. Applicant Name: Nestle Purina Petcare A Div Of Nestle Australia Ltd Applicant ACN: 000 011 316 Summary of Use: Kills fleas and lice and aids in the control of brown dog ticks. This product does not kill paralysis tick. Date of Registration: 15 March 2007 Label Approval No: 61403/300mL/0307, 61403/900mL/0307 4.VARIATIONS Product Name: Applicant Name: Applicant ACN: Summary of Variation: Date of Variation: Label Approval No: “No Entries” 5. RESTRICTED PRODUCT

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

1

NOTICE

Azadirachta Indica

[in the product: Neemazal Insecticide]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from EID Parry (India) Limited for registration of a new product containing the active constituent Azadirachta Indica. The product is Neemazal Insecticide. The product is intended for the purposes of controlling two-spotted mites, aphids and whitefly in floriculture and ornamentals and fungus gnats in potting soil. 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 this Notice. Particulars of Application Proposed product name: Neemazal Insecticide Applicant company: EID Parry (India) Limited Name of active constituent: Azadirachta indica extract Signal heading: Schedule 5 Statement of claims: For the purposes of controlling two-spotted mites, aphids

and whitefly in floriculture and ornamentals and fungus gnats in potting soil.

Pack sizes: 1L, 5L, 10L, 20L Withholding period: Not required when used as directed. Summary of the APVMA’s evaluation of NEEMAZAL INSECTICIDE 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 Neemazal Insecticide 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 Neemazal Insecticide and concluded that it can be used safely. Neemazal insecticide has a low acute oral, dermal and inhalational toxicity. It is a slight skin and eye irritant, but not a skin sensitiser. The main route for exposure is dermal. The product has low dermal toxicity but is a slight skin irritant. The use of gloves will mitigate any skin irritation. Exposure through inhalation is possible but the hazard is low and unlikely to require any exposure mitigation.

2

Based on the risk assessment, gloves have been recommended when opening and preparing the product for use. The following Hazard statements have been recommended: Will irritate eyes and skin. Avoid contact with eyes and skin. The APVMA accepts the findings and recommendations of the OCS evaluation.

(ii) The APVMA is satisfied that the proposed use of Neemazal Insecticide will not be an undue hazard to the safety of people using anything containing its residues. The product will not be applied to crops or animals destined for consumption by humans.

(iii) The APVMA is satisfied that the proposed use of Neemazal Insecticide is not likely to be harmful to human beings if used according to the product label directions. The active constituent Azadirachta indica extract has previously been evaluated and approved, but has not yet been used in any registered products. The Office of Chemical Safety (OCS) has assessed the proposed product and advised the scheduling for the active constituent is appropriate for the product. Therefore Neemazal Insecticide is included in Schedule 5. First aid and safety directions for Azadirachta Indica have been recommended by the OCS and have been included on the label. The APVMA accepts the findings and recommendations of its advisers on this criteria.

(iv) The APVMA is satisfied that the proposed use of Neemazal Insecticide for the purposes of

controlling two-spotted mites, aphids and whitefly in floriculture and ornamentals and fungus gnats in potting soil 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 (DEW) has assessed data in support of the proposed use and has concluded that the risks to the environment are acceptable. DEW indicated that there is acceptable risk to birds, mammals and aquatic species and terrestrial plants from use, including spraydrift and runoff events, provided the product is used as proposed. Honey bees were not affected by exposure to Azadirachta indica extract (active only), however published literature indicate some adverse effects on mortality, foraging behaviour and pupae survival with the formulated product. Therefore the following honey bee warning statement will be included on the label to mitigate risk: Dangerous to bees. DO NOT spray any plants in flower while bees are foraging. The APVMA accepts the findings and recommendations of its advisors on this criteria.

(v) The APVMA is satisfied that the proposed use of Neemazal Insecticide would not unduly

prejudice trade between Australia and places outside Australia as the product is not for use on any major Australian export food commodities.

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 Neemazal Insecticide

adequately demonstrate that under local conditions this product is effective for the proposed uses.

3

Submissions Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Laura Leis Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: (02) 6210 4763 Fax: (02) 6210 4776

NOTICE

Flufenoxuron

in the product: FLUROX TERMITE BAIT The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Janssen-Cilag Pty Ltd for registration of a new product containing the active constituent flufenoxuron. The product is FLUROX TERMITE BAIT. The product is for use by professional pest controllers as part of a termite baiting system for the management of subterranean termite infestations. 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: FLUROX TERMITE BAIT Applicant company: Janssen-Cilag Pty Ltd Name of active constituent: Flufenoxuron Signal heading: Unscheduled Statement of claims: For use as part of a termite interception and

baiting system for the management of subterranean termite infestations.

Pack sizes: 1.6kg, 6kg Withholding period: N/A Summary of the APVMA’s evaluation of FLUROX TERMITE BAIT 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 FLUROX TERMITE BAIT 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 (OCS) has conducted a risk assessment on FLUROX TERMITE BAIT and concluded that it can be used safely. The APVMA accepts the findings and recommendations of the OCS evaluation. The product will be formulated Overseas; repackaging will not be required in Australia.

(ii) The APVMA is satisfied that the proposed use of FLUROX TERMITE BAIT will not be an undue hazard to the safety of people using anything containing its residues. The product is not intended for use on food commodities and Maximum Residue Limits

(MRLs) and Withholding Periods (WHPs) were not required to be set for FLUROX TERMITE BAIT when used as part of a termite baiting system.

(iii) The APVMA is satisfied that the proposed use of the product FLUROX TERMITE BAIT is not likely to be harmful to human beings if used according to the product label directions. The active constituent flufenoxuron has been evaluated and approved, the active is of low acute toxicity, and has been exempted from inclusion in a poison schedule. As such the product is not required to be a scheduled poison. At the low concentration in the product, formulation composition, form of presentation of the product and proposed use pattern, it was determined that First Aid and Safety Directions for flufenoxuron need not be specified for this product. The APVMA accepts the findings and recommendations of its advisers on this criteria.

(iv) The APVMA is satisfied that the proposed use in bait stations of FLUROX TERMITE

BAIT by professional pest controllers in intergrated termite management programs in and around buildings, utility poles, logs, tree stumps, or termite mounds is not likely to have an unintended effect that is harmful to animals, plants or the environment. Environment Australia has assessed data in support of FLUROX TERMITE BAIT and believes that the application contains adequate environmental fate and toxicity data to demonstrate that the use of FLUROX TERMITE BAIT according to the label is unlikely to result in primary poisonings of terrestrial or aquatic wildlife. The APVMA accepts the findings and recommendations of its advisers on this criteria.

(v) The APVMA is satisfied that the proposed use of FLUROX TERMITE BAIT would not

adversely affect trade between Australia and places outside Australia as the product is not intended for use on food commodities.

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 FLUROX

TERMITE BAIT adequately demonstrates that under local conditions this product is effective for the proposed uses.

Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Paul Jung Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: (02) 6210 4752 Fax: (02) 6210 4776

NOTICE

acibenzolar-S-methyl

in the product: BION PLANT ACTIVATOR SEED TREATMENT

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Syngenta Crop Protection Pty Limited for the registration of a new product containing the active constituent acibenzolar-S-methyl. The product, BION PLANT ACTIVATOR SEED TREATMENT, is for the protection of cotton in supressing fusarium wilt and black root rot, by activating the plant’s natural resistance mechanisms, when applied as a seed treatment and used as a component of an integrated management strategy.

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: BION PLANT ACTIVATOR SEED TREATMENT Applicant Company: Syngenta Crop Protection Pty Limited. Active Constituent: Acibenzolar-S-methyl Poisons Sheduling: Schedule 7 Statement of Claims: For the protection of cotton in supressing fusarium wilt and

black root rot, by activating the plant’s natural resistance mechanisms, when used as a component of an integrated management strategy

Pack sizes: 1L, 2L, 5L Withholding Period: Cotton: Not required when used as directed.

Summary of the APVMA’s evaluation of BION PLANT ACTIVATOR SEED TREATMENT 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 BION PLANT ACTIVATOR SEED

TREATMENT 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 (OCS) Occupational Health and Safety (OHS) section, has conducted a risk assessment on BION PLANT ACTIVATOR SEED TREATMENT and concluded that it can be used safely. Acibenzolar-S-methyl has displayed low acute oral, dermal and inhalational toxicity in rats. It was not a skin irritant in rabbits nor a skin sensitiser, but was a slight eye irritant in rabbits. The product, BION PLANT ACTIVATOR SEED TREATMENT, was considered likely to exhibit low oral, dermal and inhalational toxicity. It is not likely to be a skin irritant nor a skin sensitiser but likely to be a slight eye irritant. 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 BION PLANT ACTIVATOR SEED TREATMENT 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) are recommended for BION PLANT ACTIVATOR SEED TREATMENT when used on cotton seed. A Withholding Period (WHP) is not required when the product is used as directed.

MRLs established at the Limit(s) of Quantitation (LOQs) for acibenzolar-S-methyl in the relevant substrates, are recommended for cotton seed (*0.02mg/kg), edible offal (mammalian) (*0.02mg/kg), eggs (*0.02mg/kg), meat (mammalian) (*0.02mg/kg), milks (*0.005mg/kg), poultry meat (*0.02mg/kg) and poultry, edible offal of (*0.02mg/kg).

(iii) The APVMA is satisfied that the proposed use of the active constituent acibenzolar-S-methyl in BION PLANT ACTIVATOR SEED TREATMENT is not likely to be harmful to human beings if used according to the product label directions. The active constituent, acibenzolar-S-methyl, has been evaluated and approved and the chemistry and manufacturing details of the product have been found acceptable to the APVMA. The proposed product has been assessed by the National Drugs and Poisons Scheduling Committee (NDPSC) and has been included in Schedule 7 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The appropriate Signal Heading appears on the label. First Aid and Safety Directions for acibenzolar-S-methyl and BION PLANT ACTIVATOR SEED TREATMENT have been recommended by the Department of Health and Ageing, OCS Toxicology and OHS sections, and have been included on the label. The product will be formulated overseas and imported ready to use in HDPE containers. BION PLANT ACTIVATOR SEED TREATMENT 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 BION PLANT ACTIVATOR

SEED TREATMENT containing the new active constituent, acibenzolar-S-methyl, when applied as a cotton seed treatment, is not likely to have an unintended effect that is harmful to harmful to animals, plants or things or to the environment.

The Department of the Environment and Water Resources (DEW) has assessed the data submitted in support of registration of this product. Laboratory studies indicate that acibenzolar-S-methyl will degrade in the environment through hydrolysis, aqueous and soil photolysis and microbial processes. Field dissipation studies confirm that acibenzolar-S-methyl and its initial hydrolysis metabolite dissipate rapidly in soil and the parent compound does not move down the soil profile. Acibenzolar-S-methyl is practically non-toxic to birds, bees and earthworms, and was shown to be harmless to a range of beneficial terrestrial arthropods. Some transient effects on N-mineralisation due to soil micro-organisms may occur, but not at the low rates proposed for use in this assessment. Acibenzolar-S-methyl was toxic to aquatic organisms including fish, aquatic invertebrates, algae and aquatic plants, but the main hydrolysis metabolite was slightly to practically non-toxic to aquatic organisms based on a limited number of tests.

The concentrations predicted in bird diet and in soils through use as a seed treatment, and in water as a consequence of sub-surface run-off, have been compared with the ecotoxicity test results. Based on these comparisons, which show an acceptable risk in all cases, DEW has recommended that the APVMA be satisfied that use of BION PLANT ACTIVATOR SEED TREATMENT as proposed and in accordance with good agricultural practices would not be likely to have an unintended effect that is harmful to animals, plants or things, or to the environment. 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 acibenzolar-S-methyl in BION PLANT

ACTIVATOR SEED TREATMENT would not adversely affect trade between Australia and places outside Australia. Detectable residues of acibenzolar-S-methyl are not expected to occur in harvested cotton seed, cotton seed meal and hulls and therefore the proposed use of acibenzolar-S-methyl in cotton seed is unlikely to unduly prejudice trade in these commodities. Harvested cotton seed and its processed commodities, may be used as livestock feeds. Residues of acibenzolar-S-methyl in these commodities are expected to be below the LOQ. The feeding of these commodities to livestock is not expected to result in detectable residues in animal commodities, and thus unlikely to prejudice trade in animal commodities. The overall risk to export trade in cotton seed and processed commodities, and animal food commodities derived from livestock fed on produce grown from treated seed, from the registration of BION PLANT ACTIVATOR SEED TREATMENT, is considered to be negligible.

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 BION PLANT

ACTIVATOR SEED TREATMENT adequately demonstrates that under local conditions this product will be effective for the proposed uses.

Public Release Summary A Public Release Summary of the evaluation is available by contacting David Hutchison on telephone (02) 6210 4748 Written submissions on the APVMA’s proposal to grant the application for registration should be addressed in writing to: Pat Robinson Pesticides Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: (02) 6210 4756 Fax: (02) 6210 4776

NOTICE

Solid Termite Barriers – Registration Requirements On 27 September 1996 the APVMA registered Kordon Manufacturing Concentrate (product number 48772). The product is used to manufacture Kordon Termite Blanket and the product label contains instructions to use Kordon Termite Blanket for the prevention of termite infestations. In addition, the APVMA has also registered Plasmite Manufacturing Concentrate (56176) which has similar label instructions in allowing production of a solid termite barrier product. After careful consideration, the APVMA now considers that the solid termite barrier products impregnated with the manufacturing concentrate and not the manufacturing concentrate itself is the product that requires registration. This is because the barrier product is the product that is used to protect a ‘place or thing’ (in this case a structure) as is described in section 4 of the Agricultural and Veterinary Chemicals Code Act 1994 (Definition of an Agricultural Chemical Product). The APVMA has already registered a number of termite barrier products in line with this decision, eg, Trithor Termite Protection System (59139) and Homegaurd Termite Moisture Barrier (59621). The result of this notice is that any termite barrier products (ie products used to protect a place or a thing other than itself), that are manufactured using another APVMA registered product or contain a substance that has termiticidal or termite repellant properties do require registration under the Agvet Codes. To ensure those companies who have been compliant with the APVMA’s registration requirements for these products prior to this notice are not disadvantaged by this decision, the APVMA has issued a permit (PER8925) to allow the currently unregistered Kordon Termite Blanket and Plasmite Termite Blanket to be supplied and used. The APVMA currently has applications for registration for both of these products. Without this permit it would be an offence under the Agvet Codes for a person to possess, supply and use the unregistered barrier products. Only those products specifically mentioned in this permit can be possessed, supplied and used in accordance with this permit’s instructions. This permit only applies to termite barrier products where the APVMA has assessed and registered the pesticide concentrate used to manaufacture the barrier product, including label instructions allowing the product to be used to manufacture a termite barrier product. A company or person that intends to supply a product which fits the description of a solid termite barrier products impregnated with a contain a substance that has termiticidal or termite repellant properties, must apply to the APVMA to register the product before supplying it for use. The APVMA is unlikely to issue permits to any other persons to allow supply and use of these products as registration is the appriopriate regulatory mechanism. For more information please contact: Gavin Hall Manager Insecticides, Pesticides Program Ph: 02 6210 4761 Email: gavin [email protected]

AMENDMENT No.10J

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) Abamectin ADD: FI 0351 Passion fruit T0.1 Azoxystrobin DELETE: Mizuna T10 ADD: VL 0054 Brassica leafy vegetables T10 Chlorpyrifos DELETE: Vegetables [except asparagus; brassica vegetables; cassava; celery, leek; peppers, sweet [capsicums], potato; tomato] T*0.01 ADD: VR 0505 Taro 0.05 Vegetables [except asparagus; brassica vegetables; cassava; celery; leek; peppers, sweet [capsicums]; potato; taro; tomato] T*0.01 Diuron DELETE: MO 0812 Cattle, Edible offal of 3 MM 0812 Cattle meat 0.1 ML 0812 Cattle milk 0.1 VD 0561 Field pea (dry) *0.05 FI 0353 Pineapple 0.5 ADD: MO 0105 Edible offal (mammalian) 3

MM 0095 Meat [mammalian] 0.1 ML 0106 Milks 0.1 VD 0070 Pulses *0.05 Emamectin ADD: VO 0447 Sweet corn (corn-on-the-cob) *0.002 Fenitrothion ADD: SO 0088 Oilseeds T0.1 VD 0070 Pulses T0.1 Fipronil ADD: FB 0269 Grapes (except wine grapes) T*0.01 Fluquinconazole ADD: GC 0640 Barley *0.02 Nitroxynil ADD: ML 0812 Cattle milk T0.5 Prometryn ADD: VD 0560 Adzuki bean (dry) T*0.1 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) Diuron DELETE:

Primary feed commodities 50 ADD: AL 0157 Legume animal feeds 2 Primary feed commodities (except legume animal feeds) 50 ADD: Emamectin Fodder and forage of sweet corn 0.05 Fluquinconazole DELETE: Wheat forage [dry weight] 2 ADD: Barley forage 2 AS 0640 Barley straw and fodder, dry 0.5 Wheat forage 2 Pirimicarb ADD: Almond Hulls 2 For further information please contact: Joan Downing Chemistry & Residues Program Phone: (02) 6210 4820 Fax: (02) 6210 4840

_________________________________________________________________________________________________________________ * 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: BIOPROTON PTY. LTD. ACN: 059 093 417 39 Colebard Street West ACACIA RIDGE QLD 4110

Product Types:* Category 4: Supplements Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, storage, release for supply Licence No: 4079 Full licence issued 09/02/07

E.M.L. CONSULTING SERVICES PROPRIETARY LIMITED ACN: 006 308 774 Unit 2; 7-11 South Street RYDALMERE NSW 2116

Product Types:* Category 6: Single Step Step(s) of Manufacture: Analysis and testing (microbiological). Licence No: 6115 Full licence issued 09/02/2007

PHIBRO ANIMAL HEALTH PTY LIMITED ACN: 093 869 991 Unit 4; 129 Magowar Road GIRRAWEEN NSW 2145

Product Types:* Category 6: Single Step Step(s) of Manufacture: Quality assurance (QA) of raw materials, quality assurance (QA) of packaging materials and release for supply. Licence No: 6121 Full licence issued 09/02/07


PHOENIX ANALYTICAL SERVICES PTY LTD ACN: 119 847 871 Unit 1; 21 Smallwood Place MURARRIE QLD 4172

Product Types:* Category 6: Single Step Step(s) of Manufacture: Analysis and testing (physical and chemical). Licence No: 6123 Full licence issued 15/02/2007

2. CHANGES TO EXISTING LICENCES: MAVLAB PTY LTD ACN: 009 708 187 31 – 33 Rowland Street SLACKS CREEK QLD 4127

Product Types:* Category 1: Sterile products. Category 2: Tablets, powders, liquids and gels. Category 3: Liquids, sprays and powders. Category 4: Premixes and supplements. Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, tableting, sterilisation (heat), aseptic filling, wet milling of powders, microbiological reduction treatment (filtration, heat and chemical), analysis and testing (physical), storage and release for supply. Licence No: 1009 Amended licence issued 16/02/07, extension of licence scope.

3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). CLIFTONS RURAL PRODUCTS (CWL) PTY LTD ACN: 003 358 923 18-22 Denison Street CROOKWELL NSW 2583

Licence No: 2046 Cancelled: 13/02/06 Reason for cancellation: s127(1) (e)

BIOTECH PHARMACEUTICALS PTY LTD ACN: 009 701 517 100 Antimony Street CAROLE PARK QLD 4300

Licence No: 2135 Cancelled: 19/02/2007 Reason for cancellation: s127(1)(d)


DEPARTMENT OF PRIMARY INDUSTRIES, WATER AND ENVIRONMENT, TASMANIA ABN: 58 259 330 901 Animal Health Wing 165 Westbury Road PROSPECT TAS 7250

Licence No: 1047 Cancelled: 20/02/2007 Reason for cancellation: s127(1)(b) and (f)

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

APVMA Contact: Kathryn Winterton Quality Assurance and Compliance Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Ph: (02) 6210 4804 Fax: (02) 6210 4813 Email: [email protected]

mailto:[email protected]

NOTICE

Interpretation of the CODEX CLASSIFICATION OF FOODS AND ANIMAL FEEDS for the establishment of Rape Seed MRLs

The APVMA is seeking public comment on a proposal regarding the interpretation of the CODEX CLASSIFICATION OF FOODS AND ANIMAL FEEDS in relation to canola, rape seed and other Brassica oilseed species. Introduction Historically, the APVMA has established Maximum Residue Limits (MRLs) to regulate chemical use in canola under the CODEX classification code SO 0495 ‘Rape seed’. This code is specific to oilseed cultivars of Brassica napus. However, cultivation of other closely related Brassica oilseed species is increasing and this code no longer adequately defines these new Brassica oilseed producing crops. The APVMA proposes that current and future MRLs pertaining to SO 0495 ‘Rape Seed’ and its crude (OC 0495) and edible (OR 0495) oil commodities will also encompass oilseed cultivars of the following species: SO 0485 Mustard seed Brassica nigra (L.) Koch: Sinapis alba L., syn: Brassica hirta Moench. SO 0694 Mustard seed, Field Brassica campestris L., var. sarson Prain: B. campestris L., var. toria

Duthie & Fuller: B. rapa SO 0478 Mustard seed, Indian Brassica Juncea (L.) Czern. & Coss. SO 4721 Rape seed, Indian, see Mustard seed, Field Brassica campestris L., var. toria Duthie & Fuller Cultivars of B. juncea or Sinapis alba grown specifically for condiment use will remain classified under codes ‘SO 0478 Mustard seed, Indian’ and ‘SO 0485 Mustard seed’, respectively. In keeping with current convention, mustard and other Brassica cultivars grown for salad production will be classified according to the Codex VL class most appropriate to the proposed use pattern. Provision of data for registration or permitted use in oilseed Brassica species It must be noted that this proposal for reinterpretation of the CODEX code pertains specifically to;

• Established Maximum Residue Limits and • the provision of residues data to support establishment of MRLs in oilseed cultivars of

the above listed species. This proposal for reinterpretation of the existing CODEX classification DOES NOT include the provision of data for the assessment of efficacy or crop safety considerations. Submissions requiring these data will be assessed on an individual basis.

1

Product Labelling Applications to register or extend use into Brassica oilseed species excluding canola must list each species individually by both common and scientific name and list its commercial purpose. For example; Indian Mustard (B. juncea, oilseed cultivars) Indian Mustard (B. juncea, condiment cultivars) Where the required crop safety and efficacy data have been provided for both canola and appropriate Brassica oilseed species the label crop description may be broadened appropriately. Timeframe for response Following appropriate review of any public comment all current or future Australian MRLs for Brassica oilseed crops will apply to the expanded definition of rape seed as stated above. Written submissions should be forwarded by the close of business 3 May 2007 to: [email protected] or by post to the Residues Contact Officer, PO Box E240, Kingston, ACT, 2604.

2

NOTICE

Reconsideration of Approvals and Registrations Related to Carbendazim and Thiophanate-Methyl

The APVMA, in accordance with Part 2, Division 4, of the Agvet Codes, intends to reconsider all approvals of the active constituents carbendazim and thiophanate-methyl, registrations of all products containing carbendazim or thiophanate-methyl, and the approvals of all associated product labels. Carbendazim and thiophanate-methyl are members of the benzimidazole group of fungicides. They are broad-spectrum systemic fungicides effective against a wide range of fungal diseases. Carbendazim products are used for the control of mould, spot, mildew, scorch, rot and blight in a variety of crops including cereals, fruit (pome, stone, citrus, currants, strawberries, bananas, pineapples, mangoes, avocados), vines, hops, vegetables, ornamentals, cotton, pasture and turf. It is also used as a timber preservative. Thiophanate-methyl is not registered in Australia for use on food producing species, only for the control of soil-borne diseases of ornamentals plants. The basis of the reconsideration of the approvals of the active constituents carbendazim and thiophanate-methyl is whether or not the continued use of, or any dealing with, the active constituent in accordance with the recommendations for its use or for such a dealing that the AMPVA has approved:

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

• would not be likely to have an effect that is harmful to human beings. The basis of the reconsideration of the approvals of products containing the active constituent carbendazim or thiophanate-methyl is whether or not the continued use of, or any dealing with, the product in accordance with the recommendations for its use or for such a dealing that the AMPVA has approved:

• 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.

It also appears that labels for products containing carbendazim and thiophanate-methyl may not contain adequate instructions and warning statements. Therefore the APVMA will review the following aspects of active constituent approvals, product registrations and label approvals for carbendazim and thiophanate-methyl:

• Toxicology, including: - The potential risks following exposure of humans via the oral, dermal and

inhalational routes; and - The potential for impairment of reproduction and development;

• Occupational health and safety, including:

- Risks arising from exposure during handling and applications;

- Re-entry exposure risks; and - Determination of appropriate personal protective clothing requirements.

• Residues, including:

- Residues in treated produce arising from application of carbendazim in accordance with label instructions; and

- Determination of dietary exposure resulting from the consumption of produce treated with carbendazim (both chronic and short-term).

The APVMA will also consider whether product labels carry adequate instructions and warning statements. The requirements for product labels are that the label contains adequate instructions. Such instructions include:

• the circumstances in which the product should be used; • how the product should be used; • the times when the product should be used; • the frequency of the use of the product; • the re-entry period after the use of the product; • the withholding period after the use of the product; • the disposal of the product and its container; • the safe handling of the product and first aid in the event of an accident caused by

handling the product; • any other matter prescribed by the regulations.

The active constituent approvals to be reconsidered are listed in Table 1. Table 2 lists all product registrations and label approvals that are to be reconsidered. The APVMA’s detailed reasons for these reconsiderations can be found in the APVMA Carbendazim and Thiophanate-methyl Review Scope document, available on the APVMA website (http://www.apvma.gov.au). Interested parties are invited to make comments or submissions on the Review Scope Document. These should reach the APVMA by 30 June 2007, by email to [email protected] or by mail to: Pesticides Review Manager Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 For further information please contact (02) 6210 4773 or [email protected].

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



Table 1: Active constituent approvals Carbendazim (10) Approval Number Approval Holder

44099 Du Pont (Australia) Ltd 44446 4Farmers Pty Ltd 44469 BASF Australia Ltd 52717 Colin Campbell (Chemicals) Pty Ltd 52720 Farmoz Pty Limited 53485 BASF Australia Ltd 53851 Bayer Cropscience Pty Ltd 55520 Imtrade Australia Pty Ltd 58049 Redox Pty Ltd 58228 Sinon Australia Pty Limited

Thiophanate-methyl (1) Approval Number Approval Holder

44214 Mitsui & Co (Australia) Ltd Table 2: Product registrations Carbendazim (21)

Product Number

Product Name Registrant Label Approval Number/s

30399 BASF Bavistin FL Systemic Fungicide

BASF Australia Ltd 30399/02 30399/1100

30740 Hylite Timber Preservative Osmose Australia Pty Ltd 30740/0799 30740/0500 30740/1100

47708 Hylite 80 Anti-Sapstain Osmose Australia Pty Ltd 47708/0799 50528 4Farmers Carbendazim 500 Fungicide

WP 4Farmers Pty Ltd 50528/0599

51514 Antiblu CC Concentrate Timber Fungicide

Koppers Arch Wood Protection (Aust) Pty Limited

51514/0299

52878 Farmoz Howzat SC Systemic Fungicide

Farmoz Pty Limited 52878/0600 52878/0202 52878/0906 52878/1005 52878/1204

53061 Boomer Systemic Fungicide Sipcam Pacific Australia Pty Ltd

53061/0600 53061/0505

53390 Chemag Carbendazim 500 SC Fungicide

Imtrade Australia Pty Ltd 53390/0101 53390/0203

53587 Campbell Goldazim 500 SC Systemic Fungicide

Colin Campbell (Chemicals) Pty Ltd

53587/1200 53587/0805 53587/1004

54167 Kendon Carbendazim SC Systemic Fungicide

Kendon Plant Care Pty Ltd 54167/1201

Product Number


54269 Nufarm Carbend Fungicide Nufarm Australia Limited 54269/0701 54269/0402 54269/0502

55949 Rotate SC Systemic Fungicide Kendon Chemicals & MNFG Co Pty Ltd

55949/0602

56497 Sava 500 Fungicide Allfire Enterprises Pty Ltd 56497/1102 56692 Superway Carbendazim 500 Systemic

Fungicide Superway Garden Ag & Pest Products Pty Ltd

56692/0703

56783 Halley Carbendazim 500 Systemic Fungicide

Halley International Enterprise (Australia) Pty Ltd

56783/0103

58452 Kenso Agcare Carbendazim 500 SC Systemic Fungicide

Kenso Corporation (M) SDN BHD

58452/0105

58832 Conquest Commodore 500 Fungicide Conquest Agrochemicals Pty Ltd

58832/0604

58886 Crop Care Bavistin FL Systemic Fungicide

Crop Care Australasia Pty Ltd

58886/1105 58886/0705 58886/0804

59434 Shincar 500 SC Fungicide Sinon Australia Pty Limited 59434/0905 59815 Nufarm Spin flo Systemic Fungicide Nufarm Australia Limited 59815/0705

59815/1105 60942 Ospray Carbendazim 500 Fungicide Ospray Pty Ltd 60942/0906

Thiophanate-methyl (3)

Product Number


52741 Banrot 400WP Broad Spectrum Fungicide for Ornamentals

Scotts Australia Pty Ltd 52741/0601

53163 Banrot 80G Broad Spectrum Fungicide for Ornamentals

Scotts Australia Pty Ltd 53163/0601

53760 Zyban WP Broad Spectrum Fungicide for Ornamental Plants

Scotts Australia Pty Ltd 53760/0602 53760/0803

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.3, 6 March 2007. Application No Product/Active Constituent Name

39898 NOT AVAILABLE 40447 SUMMIT PYRESTA LV HERBICIDE 40881 COUNTRY PHOSPOT 600 SYSTEMIC FUNGICIDE 41121 SWITCH WITH SELENIUM DOUBLE COMBINATION DRENCH FOR SHEEP 41143 OVILIS C INACTIVATED BIVALENT CAMPYLOBACTER VACCINE FOR SHEEP 41370 SEARLES BUFFALO MASTER SELECTIVE WEEDKILLER 41409 ROTAM GLIDER FUNGICIDE 41428 NOT AVAILABLE 41493 TITAN HERMES 520 HERBICIDE 38303 NOT AVAILABLE 38364 NOT AVAILABLE 38788 SIPCAM AGROXONE 750 HERBICIDE 38838 NOT AVAILABLE 39116 ZP MOUSE 39287 TYLODOX 50 BMP MICROGRANULATE FEED ADDITIVE 39573 NOT AVAILABLE 41071 CROP CARE CAPTAN 900WG FUNGICIDE 41075 NOT AVAILABLE 41126 VIRBAC VIRBAMEC LA INJECTION ENDECTOCIDE FOR CATTLE AND PIGS 41246 MORTEIN RAPID ACTION ALL INSECT KILLER HOUSEHOLD PROTECTION 41259 INNOVA 2,4-D AMINE 625 HERBICIDE 41266 INNOVA CLETHODIM 240 HERBICIDE 41278 INNOVA CLOPYRALID 300 HERBICIDE 41304 CHEMAG RALLY 750 SG HERBICIDE 41388 ECO ROD 41412 ALLEGRO INSECTICIDE 41434 DECOY 400 HERBICIDE 41437 NOT AVAILABLE 41442 NOT AVAILABLE 41519 NBL STATUS 240 EC HERBICIDE 41537 NOT AVAILABLE 41589 HALOXYFOP-P-METHYL 41593 NOT AVAILABLE 41630 NBL STATUS II 240 EC HERBICIDE

41674 MACPHERSONS FULLY LOADED GLYPHOSATE SOLUBLE GRANULAR HERBICIDE

41683 METSULFURON-METHYL 41699 NO ROT INJECTION GRADE GEL

41708 DIMETHOMORPH 41743 OSMOSE DETERMITE RESEAL 41744 TERMI-NATOR RESEAL 37676 NOT AVAILABLE 40937 NOT AVAILABLE 41271 NOT AVAILABLE 41368 INNOVA 2,4-D IPA 300 HERBICIDE 41413 SYMPHONY INSECTICIDE 41426 ILIUM TOLFEJEC ANTI-INFLAMMATORY INJECTION FOR CATTLE AND PIGS 41516 NOBILIS (R) INFLUENZA H5N2 41520 NOT AVAILABLE 41552 BARMAC DSMA CLEAR SELECTIVE HERBICIDE

41598 MORTEIN HIGH PERFORMANCE NEST KILL 2 IN 1 SURFACE SPRAY COCKROACH KILLER

41621 NOT AVAILABLE 41631 NOT AVAILABLE 41643 NOT AVAILABLE 41670 NOT AVAILABLE

41700 NOBILIS (R) INFLUZENZA H5N2 - AVIAN INFLUENZA TYPE A, SUBTYPE H5N2 INACTIVATED VACCINE

41727 TARGA 200EC HERBICIDE 41737 TORRENT 242 HERBICIDE 41738 GOVERN HERBICIDE 41760 PAKS 1080 CONCENTRATE 41768 NOVAPRID TURF INSECTICIDE 41822 GLUFOSINATE-AMMONIUM

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

39603 POOLGARD MULTI-CHLOR POOL SANITISER 39604 POOLGARD MULTI-SHOC POOL OXIDISER

Addendum list of Approved

ACTIVE CONSTITUENTS

The current Record of Approved Active Constituents is also accessible via the APVMA web page on: http://www.apvma.gov.au/actives/downloads/aa_AK.pdf and http://www.apvma.gov.au/actives/downloads/aa_LZ.pdf

Approved since Gazette No. 3, 6 March 2007

For Use in Agricultural Chemical Products:

http://www.apvma.gov.au/actives/downloads/aa_AK.pdf

http://www.apvma.gov.au/actives/downloads/aa_LZ.pdf

Clodinafop-propargyl AGROGILL CHEMICALS PTY LTD

MEGHMANI ORGANICS LIMITED BLOCK NO 403, 404, 452 POST CHHARODI TA. SANAND, DIST. AHMEDABAD 382 170 INDIA

60740

Clodinafop-propargyl OSPRAY PTY LTD CHEMINOVA AGRO A/S THYBORONVEJ 76-78 DK-7673 HARBOORE DENMARK

61458

Clodinafop-propargyl FARMOZ PTY LIMITED AGAN CHEMICAL MANUFACTURERS LTD NORTHERN INDUSTRIAL ZONE ASHDOD 77102 ISRAEL

61459

Cloquintocet-mexyl FARMOZ PTY LIMITED NUTRICHEM LABORATORY CO LTD BIOTECHNOLOGY BUSINESS INCUBATOR OF HAIDIAN SCIENCE PARK NO.05 SHANGDI KAITUO RD HAIDIAN DISTRICT BEIJING 100085 CHINA

61461

Deltamethrin AGROGILL CHEMICALS PTY LTD

MEGHMANI ORGANICS LIMITED BLOCK NO 403, 404, 452 POST CHHARODI TA. SANAND, DIST. AHMEDABAD 382 170 INDIA

60739

Difenoconazole KENSO CORPORATION (M) SDN BHD

JIXI AGROSINO BIOTECH CO., LTD NO 7 HUAYANG EAST ROAD JIXI COUNTRY ANHUI PROVINCE CHINA

59940

Ethyl dipropylthiocarbamate GENFARM CROP PROTECTION PTY LTD

JIANGSU AOLUNDA HIGH-TECH INDUSTRY CO LTD FENGSHUI ZHOUTIE YIXING JIANGSU PROVINCE 214262 PR CHINA

61455

Kresoxim-methyl SHANGHAI SAFE-CHEM INTERNATIONAL TRADE CO LIMITED

SHANGHAI SAFE-CHEM INTERNATIONAL TRADE CO LTD NO. 18 TONGZHOU ROAD TONGJING TOWN SHANGHAI PR CHINA

61217

MCPA-2-ethylhexyl ester CONQUEST AGROCHEMICALS PTY LTD

TRI-TECH CHEMICAL COMPANY PTY LTD 9-11 NORMANBY AVE SUNSHINE VIC 3020 AUSTRALIA

60929

Terbutryn AGROREG PTY LIMITED ZHEJIANG CHANGXING ZHONG SHAN CHEMICAL INDUSTRY CO LTD AGROREG PTY LIMITED NO 4 BRIDGE CHENGBEI CHANGXING ZHEJIANG 313116 PR CHINA

59924

For enquiries please contact: Chemistry & Residues Program Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: 02 6210 4818 Fax: 02 6210 4840 Email: [email protected]

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