Commonwealth of Australia Gazette No. APVMA 3-7 March …no. apvma 3-7 march 2006 agricultural and veterinary chemicals code act 1994 6jg #itkewnvwtcn cpf 8gvgtkpct[ %jgokecnu %qfg

Commonwealth of Australia GazetteNo. APVMA 3-7 March 2006 Agricultural and Veterinary Chemicals Code Act 1994 �

Commonwealthof Australia Gazette

No. APVMA 2, Tuesday, 7 February 2006Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL ANDVETERINARY CHEMICALS

No. APVMA 3, Tuesday, 7 March 2006Published by The Australian Pesticides & Veterinary Medicines Authority

26466 Cat. No. 0� 900�5ISSN �322-0438© Commonwealth of Australia, 2005Print Post approved PP: 349�57/00407

No. APVMA 2, Tuesday, 5 February 2008Published by The Australian Pesticides & Veterinary Medicines Authority

26466 Cat. No. 0191857ISSN 1322-0438© Commonwealth of Australia, 2005Print Post approved PP: 349157/00407

No. APVMA 4, Tuesday, 7 April 2009Published by The Australian Pesticides & Veterinary Medicines Authority

26466 Cat. No. 0189542ISSN 1322-0438© Commonwealth of Australia, 2005Print Post approved PP: 349157/00407

Commonwealth of Australia Gazette2 Agricultural and Veterinary Chemicals Code Act 1994 No. APVMA 4-7 April 2009

Commonwealth of Australia Gazette2 Agricultural and Veterinary Chemicals Code Act 1994 No. APVMA 2-3 February 2009

IMPORTANT COPYRIGHT NOTICE © Commonwealth of Australia, 200

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from theCommonwealth available from the Attorney-General’s Department. Requests andinquiries concerning reproduction and rights should be addressed to: Commonwealth Copyright Administration Copyright Law Branch Attorney-General’s Department

National Circuit Canberra ACT 2600 email: [email protected] web: http://www.ag.gov.au/cca

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Commonwealth of Australia GazetteNo. APVMA 4-7 April 2009 Agricultural and Veterinary Chemicals Code Act 1994 3

TABLE OF CONTENTS Notices.............................................................................................................................................4

Licensing of Veterinary Chemical Manufacturers ......................................................................4 Amendments to Product Labels for Organophosphorus (OP) and Carbamate Pesticide Products.......................................................................................................................................8 “Recall” of Unregistered Agricultural Chemical Products - T&D Trading Co Pty Ltd ...........11 “Recall” of Unregistered Agricultural Chemical Products - Resene Paints Ltd .......................12

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

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Notices

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 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: DR CHET’S PTY LTD ACN: 128 197 731 45 Aquila Street REDLAND BAY QLD 4165

Product Types:* Category 3: Liquids and sprays. Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, packaging, labelling, analysis and testing (physical), storage and release for supply. Licence No: 3033 Amended licence issued 01/02/09, update to licence format.

FLYCAM PTY LTD ACN: 059 194 491 Unit 7, 36 Achievement Crescent ACACIA RIDGE QLD 4110

Product Types:* Category 6: Single step Step(s) of Manufacture: Secondary packaging, secondary/supplementary labelling. Licence No: 6110 Amended licence issued 01/02/09, update to licence format.



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INTERTEK TESTING SERVICES (AUSTRALIA) PTY LTD TRADING AS PROBE ANALYTICAL ACN: 001 722 854 Building 1 19-23 Paramount Road WEST FOOTSCRAY VIC 3012

Product Types:* Category 6: Single step Step(s) of Manufacture: Analysis and testing (chemical). Licence No: 6084 Amended licence issued 01/02/09, change to key personnel.

LIVESTOCK NUTRITION TECHNOLOGIES PTY LTD ACN: 060 272 068 381-385 Woolcock Street GARBUTT QLD 4814

Product Types:* Category 2: Tablets (mineral supplements), tablets (slow release intra-ruminal mineral supplements) and capsules (intra-ruminal slow release only) Category 4: Supplements Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation including blending, filling, capsule filling from bulk, packaging, labelling, tableting, analysis and testing (physical and chemical), storage and release for supply. Licence No: 2165 Amended licence issued 01/02/09, extension of licence scope, change of conditions, addition of steps.

RIDLEY AGRIPRODUCTS PTY LTD ACN: 006 544 145 94 and 98 Buckland Street TOOWOOMBA QLD 4350

Product Types:* Category 4: Premixes and supplements. Step(s) of Manufacture: Quality assurance (QA) of raw materials, filling, packaging, labelling, storage and release for supply. Licence No: 4080 Amended licence issued 12/02/09, change to licence format.

TRENWELL AGRICULTURE PTY LTD ACN: 096 511 045 25 Brassey Court MICKLEHAM VIC 3064

Product Types:* Category 1: Hyperimmune colostrum powder Step(s) of Manufacture: Management and immunisation of donor animals, colustrum collection, packaging and labelling, storage and release for supply. Licence No: 1065 Amended licence issued 01/02/09, update to licence format.



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3. LICENCE CANCELLATIONS: (The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). AUSTRALIAN ALOE LIMITED ACN: 082 577 026 26 Steindl Street EAST BUNDABERG QLD 4670

Licence No: 2121 Cancelled: 01/02/09 Reason for cancellation: s127 (1)(e)

CEDARDALE FARMS PTY LIMITED ACN: 003 646 571 AS TRUSTEE OF THE N&M WARNE TRUST AND BENLINK PTY LIMITED ACN: 103 614 768 AS TRUSTEE OF THE WEBSTER FAMILY TRUST, TRADING AS WARNE & WEBSTER SERUM (ABN: 76 435 477 502) ABN: 76 435 477 502 200 Fardons Lane CASINO NSW 2470

Licence No: 1080 Cancelled: 01/02/09 Reason for cancellation: s127 (1)(d)

CHEMEQ LTD. ACN: 009 135 264 Corner Patterson and Alumina Roads EAST ROCKINGHAM WA 6168


COMAX-PHARMA PTY LTD ACN: 003 966 603 Units 1, 2, 5 & 6 24-28 Skarrat Street SILVERWATER NSW 2128

Licence No: 2173 Cancelled: 16/02/09 Reason for cancellation: s127 (1)(f)

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


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




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RAPIDVITE INDUSTRIES AUSTRALASIA PTY. LTD. ACN: 006 269 683 2/47 Power Road BAYSWATER VIC 3153

Licence No: 4039 Cancelled: 01/02/09 Reason for cancellation: s127 (1)(e)

VIRBAC (AUSTRALIA) PTY LTD ACN: 003 268 871 15 Pritchard Place PEAKHURST NSW 2210

Licence No: 2045 Cancelled: 01/02/09 Reason for cancellation: s127(1)(d)

ZACKER, JUDITH MARY TRADING AS: TINTINARA HERBS ABN: 96 548 670 955 Emu Springs Road TINTINARA SA 5266

Licence No: 2118 Cancelled: 01/02/09 Reason for cancellation: s127(1)(e)

4. LICENCE SUSPENSIONS: (The APVMA has suspended the following licences under subsection 127(1) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). Nil 5. REVOCATION OF LICENCE CANCELLATION: (The APVMA has revoked the cancellation of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). Nil 6. REVOCATION OF LICENCE SUSPENSION: (The APVMA has revoked the suspension of the following licences under subsection 127(7) of the Agricultural and Veterinary Chemicals Code [‘the Agvet Code’]). Nil APVMA Contact: Michelle Elliott GMP Section Veterinary Medicines Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Ph: (02) 6210 4745 Fax: (02) 6210 4813 Email: [email protected]


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NOTICE

Amendments to Product Labels for Organophosphorus (OP) and Carbamate

Pesticide Products The APVMA is requiring registrants of certain organophosphorus and carbamate pesticides to amend their labels to match the current First Aid Instruction and Safety Direction (FAISD) Handbook. This notice is published in accordance with section 41(3) of the Agvet Code. BACKGROUND Current legislative requirements stipulate that users of most OP and carbamate products must retain atropine sulphate tablets on site as a first-aid measure. However, atropine tablets are no longer available for sale in Australia. The lack of availability of atropine in prescribed tablet form means that current and future product users would be in breach of workplace health and safety legislation. In order to address the lack of availability of atropine sulfate tablets, the Office of Chemical Safety and Environmental Health (OCSEH) within the Department of Health and Ageing formed a Working Group and prepared a document titled Review of Emergency First-Aid Treatment of Anticholinesterase Pesticide Poisoning in Australia (2008) [see http://www.health.gov.au/internet/main/Publishing.nsf/Content/ohp-ocs.htm]. The findings and recommendations of this review have been considered and endorsed by the NDPSC and are published in the NDPSC June 2008 Record of Reasons [http://www.tga.gov.au/ndpsc/record/rr200806a.pdf]. The Department of Health and Ageing has amended the FAISD Handbook to remove the requirement to obtain an emergency supply of atropine tablets before using OP and carbamate products. Current labels for OP and carbamate products for use in Australia must display a statement directing the user to obtain an emergency supply of atropine tablets as an antidote in case of poisoning (Safety Directions statement ‘373’ – ‘Obtain an emergency supply of atropine tablets 0.6 mg’). This statement has now been removed. These products also require First Aid Instruction statement ‘m’ – ‘Give atropine if instructed’ in the event of poisoning. This statement is to be retained, as it does not specify the form of the product or the dose to be administered. This statement allows sufficient flexibility to allow for alternative dose forms of atropine if available, and under instruction from an appropriately qualified medical practitioner. Registrants will need to amend their labels to match the current FAISD Handbook. Users of these products should be aware that these changes do not indicate that there is any decrease in health hazards from OP and carbamate pesticides and should continue to use products with care, following all safety directions.


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LIST OF ORGANOPHOSPHORUS AND CARBAMATE ACTIVE CONSTITUENTS REQUIRING AMENDMENTS TO FIRST AID AND SAFETY DIRECTION

INSTRUCTIONS ON LABELS OF PRODUCTS 1. The amendments to the First Aid Instruction and Safety Direction statements

apply to registered products containing the following active constituent* Active Constituent Acephate Aldicarb Aldoxycarb Azinphos-methyl Bendiocarb Bensulide Cadusafos Carbaryl Carbetamide Carbofuran Carbosulfan Chlorpyrifos Chlorpyrifos-methyl Coumaphos Cyclanilide Cypermethrin Diazinon# Dichlorvos Dimethoate Disulfoton

Active Constituent Ethephon Ethion Ethoprophos Fenamiphos Fenitrothion Fenthion Furathiocarb Isofenphos Maldison Methamidophos Methidathion Methiocarb Methomyl Mevinphos Naled Naphthalophos Omethoate Oxamyl Oxydemeton-methyl Parathion-methyl

Active Constituent Phorate Phosmet Phoxim Pirimicarb Pirimiphos-methyl Profenofos Promecarb Propetamphos Propoxur Prothiofos Pyraclofos Temephos Terbufos Thiodicarb Thiometon Tribenuron methyl Trichlorfon Vamidothion

* Please note that not all registered products containing these active constituents will be required to amend the First Aid Instruction or Safety Direction statements to the label, as the formulation type or constituent amount may not require such requirements. Only those labels containing reference to obtaining and administering atropine in tablet form are required to be amended.


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Action by Registrants From the date of this notice, registrants of existing products containing OP or carbamate active constituents (see attached list) can apply to supply them under an amended label that incorporates the latest First Aid Instructions and Safety Directions from the FAISD Handbook. The APVMA will allow registrants a period of 12 months to amend their labels via a Category 13 application, or can update their labels at any time as part of their reprinting cycle. The approval of labels for new products formulated from OPs and carbamates will be dependent upon them complying with these amendments with effect from the date of this notice, as those labels no longer contain adequate instructions relating to the use of the product. The following amendments will apply as appropriate to the labels of products containing OP or carbamate active constituents (see attached list). 1. First Aid Instructions The first aid statement ‘m’ corresponding to safety direction statement ‘373’, was considered to remain appropriate. Therefore no update of the First Aid Instruction is required. This first aid instruction should be included as per the current edition of the FAISD Handbook, viz. m – IF SWALLOWED, SPLASHED ON SKIN OR IN EYES, OR INHALED,

CONTACT A POISONS INFORMATION CENTRE (PHONE AUSTRALIA 131 126; NEW ZEALAND 0800 764 766) OR A DOCTOR AT ONCE. IF SWALLOWED, ACTIVATED CHARCOAL MAY BE ADVISED. GIVE ATROPINE IF INSTRUCTED.

2. Product’s Safety Directions The actives listed in the attached table will require the deletion of the ‘373’ safety direction code in each entry. 373 – OBTAIN AN EMERGENCY SUPPLY OF ATROPINE TABLETS 0.6mg If you have any questions regarding the above, please contact Chemical Review on (02) 6210 3213 or [email protected].


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Notice Under Section 101 of the Agvet Codes

No.0001 of 2009

“Recall” of Unregistered Agricultural Chemical Products - T&D Trading Co Pty Ltd

On 06 March 2009 the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a Notice to T&D Trading Co Pty Ltd (ACN 104 234 040)(“the supplier”) pursuant to Section 101 of the Agvet Codes, in relation to the following products that contain label wording in a foreign language and lack APVMA approval numbers:

Mortein Odourless (all varieties, sizes & batches) Mortein Instant Kill (all varieties, sizes & batches) Mortein Power (all varieties, sizes & batches) Raid Maxs (all varieties, sizes & batches)

The affected products are unregistered agricultural chemical products. The Notice does not apply to Mortein products supplied by Reckitt Benckiser Australia and which have the Australian Reckitt Benckiser address and APVMA (or NRA) approval number on the label. The Notice does not apply to Raid products supplied by SC Johnson Australia and which have the Australian SC Johnson address and APVMA (or NRA) approval number on the label. The Notice requires the supplier to recall all stocks of the affected products directly supplied to Distributors, Retailers and End Users, to stop supply and quarantine any stocks of the products they hold, and to report to the APVMA. Safety: Persons handling the Products must not use the Products. If poisoning occurs, contact a doctor or the Poisons Information Centre on: 131126. Supplier Details T&D Trading Co Pty Ltd Unit 14 / 38-62 Hume Highway Lansvale, NSW 2166 This matter is published in accordance with section 104 of the Agvet Codes. For further information about this matter, please contact: Drew Ward Assistant Manager Compliance Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: 02 6210 4800 Email: [email protected]


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Notice Under

Section 101 of the Agvet Codes No.0002 of 2009

“Recall” of Unregistered Agricultural Chemical Products - Resene Paints Ltd

On 06 March 2009 the Australian Pesticides and Veterinary Medicines Authority (APVMA) issued a Notice to Resene Paints (Australia) Limited (ARBN 050 034 529)(“the supplier”) pursuant to Section 101 of the Agvet Codes, in relation to the following products:

Altex No.10 Antifouling (all varieties, sizes & batches) Altex AF1000 Antifouling (all varieties, sizes & batches) Altex Alloy Antifouling (all varieties, sizes & batches) Altex AF4000 Antifouling (all varieties, sizes & batches) Pettit Vivid Antifouling (all varieties, sizes & batches) Trinidad SR Antifouling (all varieties, sizes & batches)

The Notice requires the supplier to recall all stocks of the products directly supplied to Distributors, Retailers and End Users, to stop supply and quarantine any stocks of the products they hold, and to report to the APVMA. The products are unregistered agricultural chemical products. Supplier Details Resene Paints (Australia) Limited 7 Production Avenue Ernest, QLD 4214 This matter is published in accordance with section 104 of the Agvet Codes. For further information about this matter, please contact: Drew Ward Assistant Manager Compliance Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: 02 6210 4800 Email: [email protected]





Documents

Commonwealth of Australia Gazette No. APVMA 3-7 March …no. apvma 3-7 march 2006 agricultural and veterinary chemicals code act 1994 6jg #itkewnvwtcn cpf 8gvgtkpct[ %jgokecnu %qfg