TABLE OF CONTENTS - Australian Pesticides and Veterinary

TABLE OF CONTENTS

Notice of Registrations Agricultural Chemical Products Page 4 Veterinary Chemical Products Page 8 Notice – New Agricultural & Veterinary Active Constituents Ibafloxacin Page 10

Other Notice Licensing of Veterinary Chemical Manufacturers Page 14 APVMA Management of Defects in Categories 7, 6 and 5 Page 17 Application Summaries Page 20 Amendments to the MRL Standard Page 23 Policy on the Registration of Selenium Products for Use in Sheep Page 29 Cancellation of Product Registration at the Request of the Registrant Page 32 Addendum List of Approved Active Constituents Page 33

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: Homeguard Blue Termite Moisture Barrier Active Constituent/s: 1 g/kg bifenthrin Applicant Name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of Use: For the protection of structures from concealed termite entry. Date of Registration: 3 December 2007 Label Approval No: 62311/50m-150m/1107 2. AGRICULTURAL PRODUCTS

BASED ON NEW ACTIVE CONSTITUENTS:

Product Name: Profume Gas Fumigant Active Constituent/s: 998 g/kg sulfuryl fluoride Applicant Name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of Use: A new product for the control of insects in buildings (commercial and residential), timber, construction materials, furnishings, 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. Date of Registration: 28 November 2007 Label Approval No: 59952/56.7/1107 Product Name: Redigo Fungicidal Seed Treatment Active Constituent/s: 100 g/L prothioconazole. Applicant Name: Bayer Cropscience Pty Ltd Applicant ACN: 000 226 022 Summary of Use: For the control of common bunt in wheat. Date of Registration: 29 November 2007 Label Approval No: 59232/10/1107, 59232/1107

3. AGRICULTURAL PRODUCTS

BASED ON EXISTING ACTIVE CONSTITUENTS:

Reissue of 62295 Product Name: Coles $mart Buy Why Pay More For Everyday Basics? Surface Spray Low Irritant Active Constituent/s: 2.79 g/kg permethrin (25:75::cis:trans), 1.38 g/kg tetramethrin 20:80. Applicant Name: Coles Supermarkets Australia Pty Ltd Applicant ACN: 004 189 708 Summary of Use: Low irritant surface spray for the control of a range of crawling insects in the home. Date of Registration: 12 November 2007 Label Approval No: 62295/250g/1007 Reissue 62032 Product Name: Aakomectine Miticide/Insecticide Active Constituent/s: 18 g/L abamectin Applicant Name: Aako Australia Pty Limited Applicant ACN: 122 279 109 Summary of Use: For the control of certain mites and insect pests on apples, capsicums, citrus, hops, ornamentals, pears, tomatoes and strawberries. Date of Registration: 15 November 2007 Label Approval No: 62032/0607, 62032/500ML/0607, 62032/1L/0607, 62032/5L/0607, 62032/20L/0607 Reissue 61170 Product Name: H20 Pool Chemical Algaecide Weekly Maintenance Treatment Active Constituent/s: 200 g/L benzalkonium chloride Applicant Name: Kleenco Australia Pty Limited Applicant ACN 003 131 539 Summary of Use: For the control of algae in swimming pools. Date of Registration: 15 November 2007 Label Approval No: 61170/5/1007, 61170/15/1007, 61170/2/1007, 61170/2.5/1007 Reissue of 61168 Product Name: H20 Pool Chemicals Longterm Algaecide Treatment Active Constituent/s: 40 g/L copper (cu) present as copper complex. Applicant Name: Kleenco Australia Pty Limited Applicant ACN: 003 131 539 Summary of Use: For the control of algae in

swimming pools. Date of Registration: 16 November 2007 Label Approval No: 61168/1L/0807, 61168/5L/0807 Product Name: Frontier-P Herbicide Active Constituent/s: 720 g/L dimethenamid-p. Applicant Name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of Use: For the control of certain broadleaf weeds and grasses in green beans, navy beans, sweetcorn, corn, poppies, green peas, pumpkins and kabocha. Date of Registration: 19 November 2007 Label Approval No: 56059/5/1007, 56059/1007 Product Name: Chemag Annihilate 200 SC All Purpose Insecticide Active Constituent/s: 200 g/L imidacloprid Applicant Name: Imtrade Australia Pty Ltd Applicant ACN: 090 151 134 Summary of Use: A suspension concentrate of a product for the control of various insect pest in cotton, fruit, vegetables, ornamentals and turf. Date of Registration: 19 November 2007 Label Approval No: 60465/0807, 60465/200/0807, 60465/5/0807, 60465/10/0807, 60465/20/0807, 60465/60/0807, 60465/2.5/0807, 60465/1/0807 Product Name: Titan Atlas 500 WG Aphicide Active Constituent/s: 500 g/kg pirimicarb Applicant Name: Titan AG Pty Ltd Applicant ACN: 122 081 574 Summary of Use: For the control of certain aphids on a range of crops and pastures. Date of Registration: 19 November 2007 Label Approval No: 61797/5-10kg/1007, 61797/1007 Product Name: Etogas 1000 Fumigant Active Constituent/s: 1000 g/kg ethylene oxide. Applicant Name: Industrial Products Marketing Pty Ltd Applicant ACN: 099 484 876 Summary of Use: For the sterilisation and fumigation of medical devices and for quarantine treatment. Date of Registration: 20 November 2007 Label Approval No: 62262/700kg/0907 Product Name: Yates Fungus Fighter Copper Fungus Spray Active Constituent/s: 375 g/kg copper present as copper hydroxide

Applicant Name: Yates Australia A Div Of Orica Australia Pty Ltd Applicant ACN: 004 117 828 Summary of Use: For control of various fungal diseases on fruit trees, vegetables and ornamentals in the home garden. Date of Registration: 20 November 2007 Label Approval No: 61144/75/0307, 61144/50/0307, 61144/125/0307, 61144/100/0307, 61144/120/0307 Product Name: Richgro Tree & Blackberry & Woody Weed Killer Active Constituent/s: 60 g/L triclopyr present as the butoxy ethanol ester. Applicant Name: A Richards Pty Ltd T/A Richgro Garden Products Applicant ACN: 008 734 852 Summary of Use: For use in home gardens, parks, golf courses, factories and other similar situations to control blackberry and other woody weeds. Date of Registration: 20 November 2007 Label Approval No: 61918/250/1107 Product Name: Power 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: 20 November 2007 Label Approval No: 61774/1-2kg/0407, 61774/8-20kg/0407 Product Name: Agroshine Flutriafol 250 SC In-Furrow And Foliar Fungicide Active Constituent/s: 250 g/L flutriafol Applicant Name: Agroshine Australia Pty Ltd Applicant ACN: 105 873 023 Summary of Use: For the control of certain fungal diseases on wheat, barley and canola when mixed with fertiliser or applied as a foliar spray. Date of Registration: 20 November 2007 Label Approval No: 62448/20/1007, 62448/200/1007, 62448/1000/1007 Product Name: K-Ethephon Growth Regulator Active Constituent/s: 480 g/L ethephon Applicant Name: Kendon Plant Care Pty Ltd Applicant ACN: 004 281 967 Summary of Use: For crop thinning, loosening or ripening of fruits & nut crops and sugarcane. Date of Registration: 21 November 2007

Label Approval No: 62291/0907, 62291/5-20L/0907, 62291/1-2.5L/0907 Product Name: Convict 520 Herbicide Active Constituent/s: 520 g/L haloxyfop present as haloxyfop-P methyl ester. Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: For the post-emergent control of a wide range of annual and perennial grass weeds in grain, legume and oilseed crops, lucerne, medic and clover pasture and seed crops, forestry, bananas, citrus, grapes, pineapples, pome and stone fruit, pyrethrum, tropical fruit and nut crops. Date of Registration: 22 November 2007 Label Approval No: 61998/250mL/0707, 61998/1L/0707, 61998/5L/0707, 61998/10L/0707, 61998/20L/0707, 61998/0707 Product Name: Rootx Pipeline Root Control Active Constituent/s: 5.5 g/kg dichlobenil Applicant Name: Nordkapp Investments Pty Ltd T/A Sewer Equip Co (Aust) Applicant ACN: 000 693 854 Summary of Use: For the control of roots in sanitary and stormwater sewers. Date of Registration: 27 November 2007 Label Approval No: 58791/454g-1.8kg/0807, 58791/9.1-18.2kg/0807 Product Name: Chemforce Diflufenican 500 Herbicide Active Constituent/s: 500 g/L diflufenican Applicant Name: Chemforce Diflufenican 500 Herbicide Summary of Use: For the control of certain broadleaf weeds in clover-based pasture, field peas, lentils, lupins and oilseed poppies. Date of Registration: 27 November 2007 Label Approval No: 62328/1007, 62328/1L/1007, 62328/5L/1007, 62328/10L/1007, 62328/15L/1007, 62328/20L/1007 Product Name: Power Chlor Pool Sanitiser Active Constituent/s: 660 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: 28 November 2007 Label Approval No: 61775/1-2kg/0307, 61775/4-5kg/0307, 61775/10-20kg/0307 Product Name: Country Fenamiphos 400 Nematicide Liquid Active Constituent/s: 400 g/L fenamiphos Applicant Name: Accensi Pty Ltd

Applicant ACN: 079 875 184 Summary of Use: For the control of nematodes in turf and nematodes and sucking insects in various crops. Date of Registration: 28 November 2007 Label Approval No: 62234/0707, 62234/5L/0707, 62234/20/0707, 62234/200/0707, 62234/10L/0707 Product Name: Tripicrin Soil Fumigant Active Constituent/s: 985 g/kg chloropicrin Applicant Name: Trical Incorporated Summary of Use: For the control of certain soil-borne pests. Date of Registration: 29 November 2007 Label Approval No: 62231/100kg/0707, 62231/165kg/0707, 62231/680kg/0707 Product Name: Chemforce Alpha-Cypermethrin 100 Insecticide Active Constituent/s: 100 g/L alpha-cypermethrin Applicant Name: Frank Vanderkley & Paul Richards T/A Chemforce Australia Summary of Use: For the control of insect pests of cereals, cotton, grain legumes, oilseeds, pastures, pome, stone fruits, trees, ornamentals, tobacco and vegetables. Date of Registration: 4 December 2007 Label Approval No: 61996/5L/1007, 61996/20L/1007, 61996/200L/1007, 61996/1007 Product Name: Genfarm Metribuzin 750 WG Herbicide Active Constituent/s: 750 g/kg metribuzin Applicant Name: Genfarm Crop Protection Pty Ltd Applicant ACN: 115 327 378 Summary of Use: Herbicide for the selective weed control in cereals, pastures and other crops including vegetables. Date of Registration: 4 December 2007 Label Approval No: 60543/2.5KG/0907, 60543/5KG/0907, 60543/10KG/0907, 60543/0907 Product Name: Multicrop Keep Off Dog & Cat Repellent Spray Active Constituent/s: 50 g/L aluminium ammonium sulfate Applicant Name: Multicrop (Aust) Pty Ltd Applicant ACN: 001 102 889 Summary of Use: A dog and cat repellent for use around the home garden. Date of Registration: 7 December 2007 Label Approval No: 61805/750mL/1007, 61805/1L/1007, 61805/3L/1007

4.VARIATIONS Product Name: Meridian Turf Insecticide Applicant Name: Syngenta Crop Protection Pty Limited Applicant ACN: 002 933 717 Summary of Variation: Extension of use to include control of Argentinian scarab in turf. Date of Variation: 21 November 2007 Label Approval No: 58185/400/0907, 58185/2-4/0907 Product Name: Nufarm Flowable Diuron Liquid Herbicide Applicant Name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of Variation: Variation to add additional crops, pests and states from similar registered product. Date of Variation: 27 November 2007 Label Approval No: 31702/5L/1007, 31702/20L/1007, 31702/200L/1007, 31702/1007 Product Name: Caltex Summer Spray Oil Applicant Name: Caltex Australia Petroleum Pty Ltd Applicant ACN: 000 032 128 Summary of Variation: Variation of registration and label approval to copy uses from a similar registered product and update of the label. Date of Variation: 4 December 2007 Label Approval No: 49375/20/0907, 49375/205/0907, 49375/1000/0907, 49375/0907 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: Elanco AF0248 Tylan Granular Tylosin Phosphate Active Constituent/s: 260 g/kg tylosin as the phosphate. Applicant Name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd Applicant ACN: 000 233 992 Summary of Use: For the treatment and prevention of ileitis in pigs. For reduction in incidence of liver abscess in cattle. An aid in: controlling necrotic enteritis due to Clostridium perfringens in broiler and replacement chickens; controlling enteric diseases caused by organisms susceptible to tylosin in pigs; stimulating growth and improving feed efficiency in pigs.

Date of Registration: 23 November 2007 Label Approval No: 61525/25kg/0807 Product Name: Equiwormer LV Plus Tape Low Volume Oral Paste For Horses Active Constituent/s: 18.7 mg/g ivermectin, 140 mg/g praziquantel. Applicant Name: Aussie Veterinary Supplies Pty Ltd Applicant ACN: 060 417 352 Summary of Use: For the treatment and control of roundworms, tapeworms, bots and nematode skin lesions in horses. Date of Registration: 23 November 2007 Label Approval No: 62212/1/0907 Product Name: Cylence Ultra Insecticide Cattle Ear Tag Active Constituent/s: 200 g/kg piperonyl butoxide, 80 g/kg betacyfluthrin Applicant Name: Bayer Australia Ltd (Animal Health) Applicant ACN: 000 138 714 Summary of Use: For the control of synthetic pyrethroid susceptible strains of buffalo fly on beef and dairy cattle for up to 4 months. Date of Registration: 27 November 2007 Label Approval No: 60621/0807, 60621/100/0807, 60621/500/0807, 60621/20/0807 Product Name: Dairymaster Teat Care-Master Iodine Concentrate Active Constituent/s: 20 g/L iodine, 200 g/L glycerol, 2 g/L phosphoric acid. Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: Topical, emulsifiable concentrate product, for use as a post milking teat sanitiser and emollient in dairy cattle. Date of Registration: 29 November 2007 Label Approval No: 61942/20L/0707, 61942/110L/0707, 61942/200L/0707 Product Name: Dairymaster Teat Care-Master Iodine Ready To Use Active Constituent/s: 5 g/L iodine, 50 g/L glycerol. Applicant Name: Agvantage Pty Ltd Applicant ACN: 097 970 280 Summary of Use: An emollient antiseptic teat dip containing iodine for use after milking Date of Registration: 5 December 2007 Label Approval No: 62144/110L/0807, 62144/200L/0807, 62144/1000L/0807 Product Name: NV Joint Guard Powder For Cats Active Constituent/s: Each 2.5g contains 400 mg chondroitin sulfate, 500 mg glucosamine

hydrochloride Applicant Name: Nature Vet Pty Ltd Applicant ACN: 002 692 426 Summary of Use: Oral powder product for use in cats where long term use may help to reduce non-infectious joint inflammation. Date of Registration: 6 December 2007 Label Approval No: 62059/100G/1207 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”

NOTICE

IBAFLOXACIN

[in the products: Ibaflin 300mg Tablets for Dogs and Ibaflin 3% Gel for Dogs and Cats] The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Intervet Australia Pty Ltd for the approval of a new active constituent ibafloxacin. Ibafloxacin is a broad spectrum antimicrobial belonging to the fluoroquinolone group of antibiotics.

The APVMA also has before it applications from the same applicant, for the registration of two new products, IBAFLIN 300MG TABLETS FOR DOGS, and IBAFLIN 3% GEL FOR DOGS AND CATS (‘the products’) containing the active constituent.

The products are for use orally in the treatment of skin and soft tissue infections, urinary tract and respiratory tract infections in dogs (IBAFLIN 300MG TABLETS FOR DOGS) and dogs and cats (IBAFLIN 3% GEL FOR DOGS AND CATS), caused by organisms susceptible to ibafloxacin.

In accordance with sections 12 and 13 of the Agvet Code, the APVMA invites any person to submit relevant written submission as to whether the APVMA should grant the applications for approval of the active constituent and registration of the products. 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. The APVMA must receive comments within 28 days of the date of this notice.

Particulars of the Applications

Proposed product name: IBAFLIN 300MG TABLETS FOR DOGS Applicant company: Intervet Australia Pty Ltd Name of active constituent: Ibafloxacin Signal heading: Schedule 4 Prescription Animal Remedy Statement of claims: For use orally in the treatment of skin and

soft tissue infections in dogs, urinary tract and respiratory tract infections in dogs, caused by organisms susceptible to ibafloxacin

Pack sizes: PVC blister packs Withholding period: Not applicable. Proposed product name: IBAFLIN 3% GEL FOR DOGS AND

CATS Applicant company: Intervet Australia Pty Ltd Name of active constituent: Ibafloxacin Signal heading: Schedule 4 Prescription Animal Remedy

Statement of claims: For use orally in the treatment of skin and soft tissue infections in dogs and cats, urinary tract and respiratory tract infections in dogs and cats, caused by organisms susceptible to ibafloxacin

Pack sizes: 15 ml adjustable multi-dose syringe Withholding period: Not applicable. Summary of the APVMA’s assessment of the products in accordance with section 14(3)(e) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 The APVMA has assessed the applications 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 the products would not be an undue hazard to the safety of people exposed to them during their handling and use.

The Office of Chemical Safety (OCS) in the Department of Health and Ageing evaluated the toxicology aspects of ibafloxacin and found it to have low acute oral toxicity in mice and dogs. It is not irritating to rabbit skin, but is a moderate eye irritant.

In repeat-dose studies in rats and dogs, the most sensitive toxicological finding was a reduction in bodyweights across both species, at doses >100 mg/kg bw/day, and was predominately associated with a reduction in food consumption. Arthrotoxicity was also observed in 3-month old dogs when doses >15 mg/kg bw/day were administered for periods greater than 14 days.

In reproduction and developmental studies in rats, maternotoxicity and embryo/foetotoxicity could only be induced with high oral doses; there was no evidence of any specific reproductive/developmental effect at low dose levels.

The toxicological studies indicate that ibafloxacin is not genotoxic or mutagenic. The applicant did not submit studies on carcinogenicity, however due to the absence of a chemical structural relationship to known carcinogens, the negative results of genotoxic assays and the lack of carcinogenic potential of similar fluoroquinolone antibiotics, OCS concluded that ibafloxacin is unlikely to be carcinogenic.

(ii) The APVMA is satisfied that the proposed use of the products will not be an undue hazard to the safety of people using anything containing their residues. The OCS determined that because the products are for use in companion animals only, ibafloxacin is unlikely to enter the food chain, and therefore the determination of an Acceptable Daily Intake (ADI) was unnecessary.

(iii) The APVMA is satisfied that the proposed use of the products is not likely to be harmful to human beings if they are used according to the product label directions.

The APVMA has evaluated and proposes to approve the active constituent, ibafloxacin and finds that the chemistry and manufacturing details of the products are acceptable.

The National Drugs and Poisons Scheduling Committee has assessed the products and has included them in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons.

The products will be manufactured overseas and imported already labelled. The OCS concluded that occupational health and safety risk assessment was not required. OCS advised that the products can be used safely because they are antibiotic tablets and an oral gel for administration to companion animals under veterinary prescription.

The National Health and Medical Research Council, Expert Advisory Group on Antimicrobial Resistance (EAGAR) has assessed the product applications. The products have been developed specifically for use in veterinary medicine. EAGAR has advised that it supports the statement of claims and the restraint statements which will be printed on the products’ labels:

DO NOT USE in food producing animals.

FOR USE ONLY in dogs (IBAFLIN 300 MG TABLETS FOR DOGS) and cats (IBAFLIN 3% GEL FOR DOGS AND CATS) where indicated by antibiotic sensitivity testing according to principles of prudent use.

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

(iv) The APVMA is satisfied that the proposed use of the products is not likely to have an unintended effect that is harmful to animals, plants or the environment.

Data from trials supporting the host animal safety of the products adequately demonstrate that the products are safe in dogs (IBAFLIN 300MG TABLETS FOR DOGS) and dogs and cats (IBAFLIN 3% GEL FOR DOGS AND CATS) for the proposed uses and when used according to the label directions.

The Department of the Environment and Water (DEW) has assessed data in support of product registration. In considering the proposed use pattern and the relatively low amount proposed for use, DEW has advised that this will not result in a significant environmental hazard.

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

(v) The APVMA is satisfied that the proposed use of the products would not adversely affect trade between Australia and places outside Australia as the product is for use in companion animals only.

(vi) In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that it is satisfied that the data from trials supporting the efficacy of the products demonstrate that the product is safe and effective for the proposed uses.

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

John Owusu Principal Evaluator Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: (02) 6210 4730 Fax: (02) 6210 4741 Email: [email protected]

_____________________________________________________________________________________________________________ * 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: NIL

2. CHANGES TO EXISTING LICENCES: CAMPBELL BROTHERS LIMITED Trading As: Deltrex Chemicals ACN: 009 657 489 7-11 Burr Court LAVERTON NORTH VIC 3026

Product Types:* Category 6: Single Step Step(s) of Manufacture: Filling, packaging, labelling, storage and release for supply. Licence No: 6003 Amended licence issued 16/11/2007, change in key personnel.

DFC PHARMAMED PTY LIMITED ACN: 075 718 302 23-25 Sefton Road THORNLEIGH NSW 2120

Product Types:* Category 2: Tablets, capsules, powders Category 4: Premixes Step(s) of Manufacture: Quality Assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, tableting, capsule filling from bulk, storage and release for supply. Licence No: 2041 Amended licence issued 15/11/07, change to licence name and extension of scope.

MAVLAB PTY LTD ACN: 009 708 187 29 – 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 16/11/07, extension of site.

3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under section 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code]). AMDEL LIMITED ACN: 008 127 802 Hornsby Laboratory 5 Kelray Place ASQUITH NSW 2077

Licence No. 6027 Cancelled 29/11/07 Reason for cancellation: s127(1)(d) and (e)

BIOPROTON PTY LTD ACN: 059 093 417 38/141 Station Road SUNNYBANK QLD 4109

Licence No: 6117 Cancelled: 29/11/07 Reason for cancellation: s127(1)(d) and (e)

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

Licence No: 2142 Cancelled: 29/11/07 Reason for cancellation: s127(1)(d)

GROPEP LIMITED ACN: 008 176 298 28 Dalgleish Street THEBARTON SA 5031



NORTH COAST SERUM PRODUCTS 3595 Bruxner Highway CASINO NSW 2470


NUMICO RESEARCH AUSTRALIA PTY LTD ACN: 064 854 244 180 Fosters Road OAKDEN SA 5086


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

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

APVMA Contact: Kathryn Winterton GMP Section Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Ph: (02) 6210 4804 Fax: (02) 6210 4813 Email: [email protected]


mailto:[email protected]

Operational notice

APVMA management of defects in Category 7, 6 and 5 applications for product registration

Use of Categories 7, 6 and 5

Category 7 is for application for registration of a product which is closely similar to a registered product, called the ‘reference product’. There are no data requirements for an application made under Category 7.

Category 6 is for application for registration of a product which is closely similar to a reference product, but there are sufficient differences between the applicant product and the reference product, that chemistry and manufacture data are required to support registration of the product.

Category 5 is for application for registration of a product which is similar to a reference product, but there are sufficient differences between the applicant product and the reference product, that chemistry and manufacture data, and efficacy and target crop/animal safety data are required to support registration of the product.

Definition of ‘closely similar’ and ‘similar’: Relevant application category

Schedule 6 of the Agvet Code Regulations sets out the criteria by which agricultural and veterinary products are closely similar, or similar to a registered reference product. Ag MORAG and Vet MORAG provide further detail on the definitions of ‘closely similar’ and ‘similar’.

The APVMA sometimes receives Category 7, 6, or 5 applications for registration of a product, where the proposed product does not fit all the criteria for acceptance of the application under Category 7, 6, or 5. Common reasons include:

• the formulation is not closely similar, or similar, to the reference product

• the non-active constituents of the product differ from the reference product

• the active constituents or concentration of active constituents differ from the reference product.

Application for products which do not fit the criteria of Category 7 should be made under Category 6, or Category 5, or Category 10 depending on the nature of the product.

Similarly, applications for products which do not fit the criteria of Category 6 should be made under Category 5 or Category 10, and applications which do not fit the criteria of Category 5 should be made under Category 10.

Applications made under an incorrect application category

It is the responsibility of the applicant to ensure that the particulars of the product for which application for registration is being made under Category 7, 6 or 5, meet the criteria set out in Schedule 6 and in MORAG.

If the particulars of the product do not meet these criteria, the APVMA will issue a notice to the applicant to say that the application contains defects. In this notice, the APVMA will cite which of the following defects the application contains, relevant to the category of the application:

• the identity and/or concentration of the active constituent is/are not the same as the reference product;

• the non-active constituents are not the same or do not perform similar functions to the reference product [ag products], or are not equivalent to the reference product [vet products];

• the formulation type is not the same as the reference product;

• the proposed use pattern and use instructions are not the same as the reference product;

• the label claims are not the same, or are not reduced, compared to the claims of the reference product

• product specifications are not the same as the reference product [vet products];

• the site of manufacture is not the same as the reference product [vet products].

Exact details of the defects will be with reference to Schedule 6 of the Agvet Code Regulations and MORAG.

The APVMA will not provide details of any differences between the proposed chemical product which is the subject of the application, and the reference product, because this may inadvertently release commercially confidential information.

If the application does not satisfy the criteria for Category 7, 6 or 5 the applicant may:

• request the APVMA to amend the application to a more relevant application category; or

• withdraw the application and make a new application under a relevant application category, which includes the relevant data and fee.

The APVMA will not accept certain requests to amend the application

[1] The APVMA will not accept a request to amend an application made under Category 7, 6, or 5, to modify the formulation or formulation type of the proposed product.

If the applicant wishes to modify the formulation or formulation type of the proposed product, the applicant must withdraw the application and submit a new application.

[2] The APVMA will not accept a request to amend an application made under Category 7, 6, or 5, to change the reference product.

If the applicant wishes to change the reference product, the applicant must withdraw the current application and submit a new application.

If the applicant cannot rectify the defects in the application:

If the applicant cannot rectify the defects in the application by the due date contained in the defects notice, it is open to the applicant to:

1. Provide a valid reason why the APVMA should accept the application under Category 7, 6 or 5 as the case may be; or

2. Request the APVMA to defer consideration of the application until a specified date at which time the required information will be available; or

3. Inform the APVMA that they wish to withdraw the application.

If the applicant withdraws the application, or if the APVMA rejects the application, or treats the application as having been withdrawn, any data submitted with the application will not be eligible for data protection for this application nor any other application.

When an application is rejected or withdrawn, the APVMA will refund any fee paid by the applicant in respect of the application, other than the preliminary assessment fee of $460.

Applicants may only select a single reference product

All of the APVMA’s guidelines refer to ‘the reference product’ or ‘a reference product’. This phraseology implies that the applicant may select only a single reference product, but the APVMA has not made this explicitly clear.

From the date of this notice, applicants may select only a single reference product for any application for which a reference product is relevant.

APVMA November 2007

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 APVMA accepted the application 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 Agvet Code 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 those published in APVMA Gazette No.11, 6 November 2007.

Application Number Name

38427 NOT AVAILABLE 39949 H20 ALGAECIDE CONCENTRATE 39952 H20 BROMINE SANITISER 40161 ULTRAVAC 7 IN 1 VACCINE 41339 COPPER GUARD 41383 GP FLUPROPANATE 100 GRANULAR HERBICIDE 41790 KENSO AGCARE KEN-STAR 450 HERBICIDE 41830 NOT AVAILABLE 41841 RICHGRO ROGOR INSECTICIDE 42286 M+PAC MYCOPLASMA HYOPNEUMONIAE INACTIVATED VACCINE FOR PIGS 42720 NUFARM TRIATHLETE HERBICIDE 42904 NOT AVAILABLE 42912 COOPERS DIAZINON SHEEP BLOWFLY STRIKE DRESSING AND CATTLE AND PIG SPRAY 42955 TALON XT PRO RODENTICIDE WAX BLOCKS 43009 NOT AVAILABLE 43020 NOT AVAILABLE 43029 NOT AVAILABLE 43051 PROTIM OPTIMUM READY-TO-USE LOSP TIMBER PRESERVATIVE 43067 MORTEIN NEST KILL BAITS HOUSEHOLD PROTECTION 43152 OSPRAY QUINELLA HERBICIDE 43155 AW AGFEN 100EC INSECTICIDE 43156 AW PI BIFENTHRIN TERMITICIDE & INSECTICIDE 43157 GUARDIAN COMPLETE WORMING CHEW MONTHLY HEARTWORM AND INTESTINAL

ALLWORMER FOR DOGS 43166 COUNTRY DICLOFOP METHYL HERBICIDE 43168 RONSTAR G SELECTIVE HERBICIDE 43182 TURF CULTURE BREK 500SC HERBICIDE 43193 NOT AVAILABLE 43194 NOT AVAILABLE 43196 NOT AVAILABLE 43198 NOT AVAILABLE 43200 CHOICE HALOFOP 520 HERBICIDE 43202 TRADELANDS CAPTAN WG FUNGICIDE 43214 AGROSHINE TRIASULFURON 750 WG SELECTIVE HERBICIDE 43219 COUNTRY ALPHA-CYPERMETHRIN 100 INSECTICIDE

43245 TITAN ASULAM 400 HERBICIDE 43255 TITAN METOLACHLOR 960 HERBICIDE 43257 SYNGENTA IPRODIONE 250 TURF FUNGICIDE 43258 NOT AVAILABLE 43270 NOT AVAILABLE 41666 QM PENDIMETHALIN 330 HERBICIDE 40354 GARDEN PRO OUTDOOR INSECT SPRAY 41239 AUSSIE MOZZI WRIST BAND 41746 NUFARM MIDAS HERBICIDE FOR CLEARFIELD WHEAT 41776 SACOX 120 MICROGRANULATE BROAD SPECTRUM COCCIDIOCIDAL FEED ADDITIVE

PREMIX 41941 WSD TRICLOPYR 600 HERBICIDE 42043 DU-WETT LOW VOLUME APPLICATION SPREADER 42131 NOT AVAILABLE 42363 PENCONAZOLE 42422 VIRBAC JETDIP SHEEP JETTING FLUID & BLOWFLY DRESSING 42437 CYPERMETHRIN 42577 FYFANON 1000 EC INSECTICIDE 42578 ELANCO AF0374 SURMAX 200 AVILAMYCIN PREMIX 42590 BUFFODINE FISH FARMING DISINFECTANT 42695 CHAMELEON DRY CHLORINE 42707 DAVID GRAYS FRUIT FLY GARDEN SPRAY 42811 BREACH PENETRANT 42812 BRODIFACOUM 42820 DOW AGROSCIENCES DIMENSION HERBICIDE 42840 OFF! FAMILYCARE INSECT REPELLENT SPRAY SMOOTH & DRY 42915 GF-1644 HERBICIDE 42941 NUFARM FILAN FUNGICIDE 42947 NOT AVAILABLE 42970 FARMOZ MERPAN FUNGICIDE 42998 NOT AVAILABLE 43011 NOT AVAILABLE 43012 NOT AVAILABLE 43013 NOT AVAILABLE 43014 NOT AVAILABLE 43033 IPRODIONE 43076 SMARTFRESH 41309 NOT AVAILABLE 43175 NOT AVAILABLE 43210 NOT AVAILABLE 43218 NOT AVAILABLE 43220 RUFUS & COCO BUG OFF INSECTICIDE AND REPELLANT SPRAY IDEAL FOR DOGS &

CATS NATURAL PYRETHRINS 43233 NOT AVAILABLE 43236 CMS DICLOFOP-METHYL 375 EC HERBICIDE 43241 BIFORCE 80SC TERMITICIDE & INSECTICIDE 43248 TITAN FLUTRIAFOL 250 SC FUNGICIDE 43267 NOT AVAILABLE 43303 AIROMIST PEST INSECT CONTROL WITH NATURAL PYRETHRINS 43304 ETHREL 720 GROWTH REGULATOR 43327 ALAMYCIN OXYTETRACYCLINE INJECTABLE SOLUTION 43355 NOT AVAILABLE 43398 COUNTRY FLUTRIAFOL 250 IN-FURROW AND FOLIAR FUNGICIDE 43269 NOT AVAILABLE 43271 NOT AVAILABLE 43276 NOT AVAILABLE 43293 TITAN CLOPYRALID 750SG HERBICIDE 41521 EXILIS 42674 COXIDIN 400 MONENSIN FEED ADDITIVE 42680 COUNTRY FENAMIPHOS 400 NEMATICIDE LIQUID 42826 CISLIN DP INSECTICIDAL DUSTING POWDER

42883 4FARMERS DICLOFOP-METHYL 500 EC SELECTIVE HERBICIDE 42962 LINURON 43226 SANONDA PARAQUAT/DIQUAT HERBICIDE 43227 CHEMFORCE CLODINAFOP 240EC HERBICIDE 43360 SMART CLETHODIM 240EC HERBICIDE 43365 SMART FLUTRIAFOL 250SC FUNGICIDE 39861 IODANE 330 SOIL FUMIGANT 39862 IODANE 500 SOIL FUMIGANT 41411 ROTAM CROPZIM FUNGICIDE 42481 WSD APLHACYPER 100 EC INSECTICIDE 42739 NUFARM BRINDLE HERBICIDE 42743 NUFARM TABBY HERBICIDE 42750 FIL EMOLLIENT SALVE 42824 TALSTAR RTU SURFACE SPRAY 42892 NOT AVAILABLE 43058 AW MCPA LVE HERBICIDE 43064 MORTEIN DO-IT-YOURSELF PROFESSIONAL INDOOR SURFACE SPRAY SAME

TECHNOLOGY USED BY PROFESSIONALS HOUSEHOLD PROTECTION HOUSEHOLD PROTECTION

43073 NOT AVAILABLE 43150 DOW AGROSCIENCES MCPA 500 LVE SELECTIVE HERBICIDE 43215 BIFFO NON-SELECTIVE HERBICIDE 43223 NOT AVAILABLE 43246 TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE 43286 IQ EZI-CHLOR 43288 IQ SALT WATER BOOST MAXI CHLOR STABILISED CHLORINE 43297 NOT AVAILABLE 43363 SMART 2,4-D ESTER LV HERBICIDE 43367 SMART TRICLOPYR 600 HERBICIDE 43382 COUNTRY METALAXYL SYSTEMIC FUNGICIDE GRANULES 43386 SMART SIMAZINE 900DF HERBICIDE 43442 COUNTRY FLUROXYPYR HERBICIDE 43474 COUNTRY TEBUCONAZOLE 430 FUNGICIDE

A change or correction has been made to the following application summaries:

Application Number Name

37445 CARBONYL SULFIDE 37408 COSMIC FUMIGANT 41443 MULTIMIN COPPER-FREE INJECTION FOR SHEEP AND CATTLE

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

Ph: (02) 6210 4701 Fax: (02) 6210 4721

AMENDMENT No. 7K

AMENDMENTS TO THE MRL STANDARD

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

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

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

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

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

http://www.apvma.gov.au/residues/mrl.shtml

TABLE 1: MAXIMUM RESIDUE LIMITS OF PESTICIDES,

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

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

VP 0562 Common bean *0.02 MO 0105 Edible offal (Mammalian) *0.01 PE 0112 Eggs *0.01 GC 0645 Maize *0.02 MM 0095 Meat (mammalian) *0.01 ML 0106 Milks *0.01 VP 0063 Peas *0.02 SO 0698 Poppy seed *0.01 PO 0111 Poultry, Edible offal of *0.01 PM 0110 Poultry meat *0.01 VD 0070 Pulses *0.02 VC 0429 Pumpkins *0.02 VO 0447 Sweet corn (corn-on-the-cob) *0.02

Fluorine (inorganic salts) DELETE:

Fruits 7 Vegetables 7

ADD: DF 0167 Dried fruit 5 SO 0697 Peanut 30 TN 0085 Tree nuts 30 CF 1210 Wheat germ 10

Methomyl DELETE: Bergamot T5

VL 0465 Chervil T5 HS 0779 Coriander seed T5 Coriander (leaves, stems and roots) T5 HS 0730 Dill seed T5 HS 0731 Fennel seed T5 VR 0581 Galangal, Greater T*0.02 Kaffir lime leaves T5 Lemon grass T5 DT 1111 Lemon verbena (dry leaves) T5 Mizuna T5

Rose and dianthus (edible flowers) T5 VL 0496 Rucola (rocket) T5 HH 4731 Salad burnett T5 HS 0794 Turmeric, root T5 Metsulfuron-methyl DELETE: SO 0693 Linseed T*0.02 ADD:

SO 0693 Linseed *0.02 Piperonyl butoxide DELETE: ML 0812 Cattle milk *0.05 ADD:

ML 0812 Cattle milk 0.05 Prothioconazole DELETE: MO 0105 Edible offal (mammalian) T*0.05

PE 0112 Eggs T*0.01 MM 0095 Meat (mammalian)[in the fat] T*0.01 ML 0106 Milks T*0.01 PO 0111 Poultry, Edible offal of T*0.05 PM 0110 Poultry meat [in the fat] T*0.05 GC 0654 Wheat T*0.05

ADD: MO 0105 Edible offal (mammalian) *0.05

PE 0112 Eggs *0.01 MM 0095 Meat (mammalian)[in the fat] *0.01 ML 0106 Milks *0.004 PO 0111 Poultry, Edible offal of *0.05 PM 0110 Poultry meat [in the fat] *0.05 GC 0654 Wheat *0.05

ADD: Sulfuryl fluoride

GC 0080 Cereal grains 0.05 DF 0167 Dried fruit 0.07 SO 0697 Peanut 7 TN 0085 Tree nuts 7

Tolylfluanid ADD:

VC 0424 Cucumber T2

TABLE 3: RESIDUE DEFINITION Where MRL(s) are recommended, the following residue definitions are applicable. COMPOUND RESIDUE ADD: Dimethenamid-P Sum of dimethenamid-P and its (R)-isomer Prothioconazole DELETE: (T)For commodities of plant origin: sum of prothioconazole

and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole. (T) For commodities of animal origin: sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

ADD: For commodities of plant origin: sum of prothioconazole and prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole.

For commodities of animal origin: sum of prothioconazole, prothioconazole desthio (2-(1-chlorocyclopropyl)-1-(2-chlorophenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), prothioconazole-3-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-3-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol) and prothioconazole-4-hydroxy-desthio (2-(1-chlorocyclopropyl)-1-(2-chloro-4-hydroxyphenyl)-3-(1H-1,2,4-triazol-1-yl)-propan-2-ol), expressed as prothioconazole

ADD: Sulfuryl fluoride Sulfuryl fluoride

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) ADD: Dimethenamid-P

AL 0061 Bean fodder *0.02 AL 1030 Bean forage (green) *0.02 Forage and fodder of maize and sweet corn *0.02

Forage and fodder of pulses *0.02 AL 0072 Pea hay or Pea fodder (dry) *0.02 AL 0528 Pea vines (green) *0.02

Metsulfuron-methyl ADD:

Safflower forage and fodder 0.2 Linseed forage and fodder 0.2

Prothioconazole DELETE: Wheat forage (fresh weight) T*0.05 AS 0654 Wheat straw and fodder T*0.05 ADD: Wheat forage (fresh weight) *0.05 AS 0654 Wheat straw and fodder *0.05

TABLE 5: USES OF SUBSTANCES WHERE MAXIMUM RESIDUE

LIMITS ARE NOT NECESSARY SUBSTANCE USE DELETE: Gonadotrophin Releasing Hormone (GnRH)-protein conjugate - Vaccine for the control of boar taint in male pigs ADD: Gonadotrophin Releasing Factor (GnRF)-protein conjugate - Vaccine for the control of boar taint in male pigs For further information please contact: Michelle Hemming Residues Contact Officer Phone: (02) 6210 4837 Fax: (02) 6210 4840 Email: [email protected]

OPERATIONAL NOTICE

POLICY ON THE REGISTRATION OF SELENIUM PRODUCTS FOR USE IN SHEEP

Purpose The purpose of this operational notice is to clarify the circumstances under which selenium products used in sheep require registration or not. This notice should be read in conjunction with the “Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino Acids and Containing Only ‘Nutritional Messages” (http://www.apvma.gov.au/guidelines/guideline_8_stockfeed_suppl.pdf) Definition of a veterinary chemical product Section 5(3) of the Agvet Code states that a veterinary chemical product includes a vitamin, a mineral substance, or an additive, if and only if, the vitamin substance or additive is used for:

(a) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or

(b) curing or alleviating an injury suffered by the animal; or (c) modifying the physiology of the animal:

(i) so as to alter its natural development, productivity, quality or reproductive capacity; or

(ii) so as to make it more manageable; or (iii) modifying the effect of another veterinary chemical product.

According to this definition of a veterinary chemical product provided by the Agvet Code, a selenium product whose label makes none of these claims is not a veterinary chemical product and does not require registration. However, selenium and selenium salts are also approved active constituents. At certain concentrations, selenium and selenium salts are used for prevention or therapy of diseases such as white muscle disease in cattle and sheep, and for dermatological conditions in companion animals. Which selenium products for sheep require registration? The situation is described in Table 1:

Table 1: Selenium products for sheep which require registration. Therapeutic product claims ?

Route of administration

Level of selenium

Dose of selenium

Registration required?

Label advisory statement

http://www.apvma.gov.au/guidelines/guideline_8_stockfeed_suppl.pdf

Therapeutic product claims ?

Route of administration

Level of selenium

Dose of selenium

Registration required?

Label advisory statement

NO Oral dosage forms administered in animal feed

Levels so that the product does not fall into S4 or S7 of the SUSDP

Any dose less than or equal to 0.1 mg/kg Se BW1.

NO

Refer Label Advisory Statement below

YES Any route Any level

The APVMA will assess the safety and effectiveness of the label recommended dose

YES

To be decided during registration

NO Oral dosage forms provided in animal feed

Levels so that the product does not fall into S4 or S7 of the SUSDP

Any dose greater than 0.1 mg/kg Se BW

YES

Refer Label Advisory Statement below

NO

(1) Injection (2) Oral dosage forms for dosing the animal directly, not administered in animal feed, eg boluses or pellets

Any level


YES


NO Any route

Levels so that the product falls into S4 or S7 of the SUSDP


YES


Label Advisory Statement Even if the selenium product need not be registered, the APVMA strongly advises manufacturers to include a warning on the product label that care should be taken to avoid over-supplementing with selenium. The use of selenium pellets and treatment of the pasture at the same time can lead to excessive tissue levels in sheep. A veterinarian or advisor should also be consulted to ascertain the animals’ selenium status. The product should not be used in areas of seleniferous plants/soils in Queensland before a veterinarian has ascertained the selenium status. By way of example, the current label advisory statement on registered products reads:

SELENIUM Contraindication

1 Feeding Standards for Australian Livestock Ruminants Standing Committee on Agriculture and Resource Management CSIRO Australia 1990 p 168

This product should not be used when selenium intake from pasture is high or selenium is provided by other means (such as pasture top dressing, vaccine, pellets or selenium drenches) if blood selenium levels at treatment are high. Users can determine the sheep’s selenium status by consulting their veterinarian.

For enquiries about this notice: Jonathan Taylor Manager, Veterinary Registration Australian Pesticides and Veterinary Medicines Authority PO Box 61282 KINGSTON ACT 2604 Ph: (02) 6210 4732 Fax: (02) 6210 4741 Email: [email protected]

NOTICE

Cancellation of product registration at the request of the registrant The APVMA, at the request of the registrant, has cancelled the following label approvals:

Product No.

Product name Registrant Date of effect

Label Approval

56204 CERTIFIED ORGANICS CONCENTRATE ORGANIC INTERCEPTOR CONTACT WEED CONTROL

CERTIFIED ORGANICS (AUST) PTY LTD

31 August 2007 56204/0703 56204/1202

The following instructions set out how a person can deal with the cancelled products. ---------------------------------------------------------------------------------------------------------------- Supply A person may supply or cause to be supplied the product at retail level for two years after the ‘date of effect’ of cancellation. Two years after the ‘date of effect’ of cancellation it will be an offence against the Agvet Codes to have possession or custody of the product with the intention of supply, or to supply the product. Use A person may continue to use the product according to its label instructions until two years after the ‘date of effect’ of cancellation. Any person who possesses, has custody of, uses or otherwise deals with the listed product in accordance with the above instructions is, under s.45A(5) and 55(3) of the Agvet Codes, taken to have been issued with a permit to so possess, have custody of, use or otherwise deal with the product after the registration has been cancelled. It is an offence to possess, have custody of, use or deal with the product listed in the table in a manner that contravenes the above instructions. For any queries or further information about this matter, please contact: Sara Keating Contact Officer, Pesticides and Veterinary Medicines Review Australian Pesticides and Veterinary Medicines Authority PO Box E240 KINGSTON ACT 2604 Phone: (02) 6210 4749 Fax: (02) 6210 4776

- 1 -

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. 12, 4 December 2007

For Use in Agricultural Chemical Products: IMAZAPIC FARMOZ PTY LIMITED AGAN CHEMICAL MANUFACTURERS LTD

NORTHERN INDUSTRIAL ZONE ASHDOD 77102 ISRAEL

62016

METHAM-SODIUM MANUFACTURING CONCENTRATE

ACCENSI PTY LTD LAINCO, S.A. AVDA. BIZET, 8-12, 08191 RUBI BARCELONA SPAIN

61544

FLUTRIAFOL SINON AUSTRALIA PTY LIMITED

SINON CORPORATION NO 111, CHUNG SHAN RD TA-TU HSIANG TAICHUNG HSIEN 432 TAIWAN Or SINON CHEMICAL (SHANGHAI) CO LTD NO 2, XINSHEN ROAD XINSI TOWN FENGXIAN DISTRICT SHANGHAI CHINA

60459

For enquiries please contact: Chemistry Section Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: 02 6210 4818 Fax: 02 6210 4840 Email: [email protected]

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

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

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TABLE OF CONTENTS - Australian Pesticides and Veterinary