apvma gazette no. 7, 10 april 2012 · no. apvma 7, tuesday, 10 april 2012 agricultural and...

No. APVMA 7, Tuesday, 10 April 2012

Published by The Australian Pesticides & Veterinary Medicines Authority

AGRICULTURAL AND

VETERINARY CHEMICALS

The Agricultural and Veterinary Chemical Code Act 1994 (the Act) commenced on 15 March 1995. The

Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Act requires notices to be

published in the Gazette containing details of the registration of agricultural and veterinary chemical products

and other approvals granted by the Australian Pesticides and Veterinary Medicines Authority. The Agvet Code

and related legislation also requires certain other notices to be published in the Gazette.

ISSN 1837 - 7629

Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2012

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 the Commonwealth. Requests and inquiries concerning reproduction and rights

should be addressed to:

The Manager, Public Affairs

The Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website: www.apvma.gov.au

GENERAL INFORMATION

The APVMA (Australian Pesticides and Veterinary Medicines Authority) Gazette is published fortnightly and contains details of

the registration of agricultural and veterinary chemicals products and other approvals granted by the APVMA, notices as requi red

by the Agricultural and Veterinary Chemicals Code (the Agvet Code) and related legislation and a range of regulatory material

issued by the APVMA.

Pursuant to section 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activ ity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information

about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette, please email: [email protected].

For enquiries on the APVMA Gazette content, please refer to the individual APVMA contacts listed under each notice.

mailto:[email protected]

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



CONTENTS

Notice of Registrations 4 Agricultural Chemical Products .............................................................................................................................................. 4 Veterinary Chemical Products .............................................................................................................................................. 13

Notice – New Agricultural Chemical Products 15 Prosulfuron in the product Casper Turf Herbicide ................................................................................................................ 15 Particulars of The Application ............................................................................................................................................... 15

Other Notices 19 Licensing of Veterinary Chemical Manufacturers ................................................................................................................. 19 Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene ........................................................................................................................................ 22 Cancellation of Label Approvals of Products Containing Virginiamycin................................................................................ 25 Voluntary Cancellation of Label Approvals at the Request of the Registrants...................................................................... 27 Amendments to the APVMA MRL Standard ......................................................................................................................... 29 Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code................................................... 34 Addendum to the Record of Approved Active Constituents .................................................................................................. 37 Application Summaries ......................................................................................................................................................... 39

Erratum Notice

The Australian Pesticides and Veterinary Medicines Authority advises that an error was published in the

Commonwealth of Australia Gazette for Agricultural and Veterinary Chemicals, No. APVMA 5, Tuesday 13 March 2012.

In the Notice for Excede Sterile Suspension, the active constituent was misspelled.

The correct entry for the Notice of Registration for Excede Sterile Suspension appears on page 13 of this Gazette.


Notice of Registrations

NOTICE OF REGISTRATIONS

Agricultural 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.

1. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Defender Concentrate Maxguard Systemic, Contact & Residual Insecticide

Active Constituent/s: 1g/L acetamiprid

Applicant Name: Scotts Australia Pty Ltd

Applicant ACN: 003 123 162

Summary of Use: For the control of insect pests on ornamental plants in the home garden

Date of Registration: 21 March 2012

Label Approval No: 65588/51368

Product Name: Rentokil Wasp Eliminator Insecticide

Active Constituent/s: 1.3g/kg d-allethrin, 1.2g/kg d-phenothrin

Applicant Name: Rentokil Initial Pty Ltd


Summary of Use: For outdoor control of wasps



Product Name: Prospect Post Harvest Fruit Treatment

Active Constituent/s: 717 g/L paraffinic oil

Applicant Name: Caltex Australia Petroleum Pty Ltd


Summary of Use: For use as a post-harvest fruit dip for the control of light brown apple moth on citrus and mealy bugs on rambutan and lychees



Product Name: Richgro Beat-A-Weed Weedkiller Concentrate

Active Constituent/s: 270g/L acetic acid, 120g/L sodium chloride

Applicant Name: A. Richards Pty Ltd T/A Richgro Garden Products


Summary of Use: For the control of various weeds, moss and algae in paths, driveways, around sheds and spot spraying in lawns and turf





Product Name: Liberty 280 Herbicide

Active Constituent/s: 280g/L glufosinate-ammonium

Applicant Name: Bayer Cropscience Pty Ltd


Summary of Use: For use in Liberty Link cotton varieties to control broadleaf weeds



Product Name: Imtrade Boost 250 SC Plant Growth Regulator

Active Constituent/s: 250g/L paclobutrazol

Applicant Name: Imtrade Australia Pty Ltd


Summary of Use: For the reduction of vegetative growth in mango, stonefruit and apple trees



Product Name: Agspray 2,4-D IPA 300 Herbicide

Active Constituent/s: 300g/L 2,4-D present as the isopropylamine salt

Applicant Name: Agspray Chemical Co. Pty. Ltd.


Summary of Use: For the control of emerged broadleaf weeds prior to sowing crops and pastures in conservation tillage situations and for selective weed control in crops



Product Name: Value Fluroxypyr 200 Herbicide

Active Constituent/s: 200g/L fluroxypyr present as the methyl heptyl ester

Applicant Name: Value Chem Pty Ltd


Summary of Use: For the control of a wide range of broadleaf weeds in fallow, lucerne, maize, pastures, sorghum, sugar cane, sweet corn, winter cereals



Product Name: Nova Agro Chlorsulfuron 750 WG Herbicide

Active Constituent/s: 750g/kg chlorsulfuron

Applicant Name: Nova Agro Pty Ltd


Summary of Use: For the control of annual (Wimmera) ryegrass and certain broadleaved weeds in wheat, barley, oats, cereal rye and triticale





Product Name: Apparent Phosphine Fumigation Tablets

Active Constituent/s: 330g/kg phosphine (PHз) present as aluminium phosphide

Applicant Name: Apparent Pty. Ltd.


Summary of Use: For the control of insect pests in certain situations and control of rabbits in burrows



Product Name: Kenso Agcare Captan 800 WG Fungicide

Active Constituent/s: 800g/kg captan

Applicant Name: Kenso Corporation (M) Sdn. Bhd.

Applicant ACN: N/A

Summary of Use: For the control of certain diseases in a range of fruit crops, turf and ornamentals



Product Name: Value Glyphosate 450 SL Herbicide

Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt



Summary of Use: For the non-selective herbicide control of most emerged weeds and plants in situations as indicated in the directions for use table



Product Name: Nova Agro Paraquat 250 SL Herbicide

Active Constituent/s: 250g/L paraquat present as paraquat dichloride

Applicant Name: Nova Agro Pty Ltd


Summary of Use: For the control of a wide range of grasses and broadleaf weeds



Product Name: Freezone Fenitrothion Insecticide

Active Constituent/s: 1000g/L fenitrothion

Applicant Name: Freezone Public Health Pty Ltd


Summary of Use: For the control of locust and grasshopper pests of broad acre and horticultural crops, for the protection of cereal grain against stored product insect pests and for the control of various pests of pasture





Product Name: Value MCPA 500 Selective Herbicide

Active Constituent/s: 500g/L MCPA present as the dimethylamine salt



Summary of Use: For selective control of broadleaf weeds in cereals, field peas, linseed, pastures, sugar cane and turf



Product Name: Protect-Us Crawling Insect Spray

Active Constituent/s: 0.7g/kg imiprothrin, 2g/kg cypermethrin

Applicant Name: Ensystex Australasia Pty Ltd


Summary of Use: For use in domestic and commercial situations for control of f lying and crawling insect pests



Product Name: Protect-Us Fast Knockdown Aerosol Insecticide

Active Constituent/s: 3.82g/kg tetramethrin, 1.19g/kg bioallethrin, 0.75g/kg bioresmethrin



Summary of Use: For control of flying and crawling insect pests



Product Name: Country Triclopyr 600 Herbicide

Active Constituent/s: 600g/L triclopyr present as butoxyethyl ester

Applicant Name: Accensi Pty Ltd


Summary of Use: For the control of a range of woody weeds and melons



Product Name: Zelam Brushweed Herbicide

Active Constituent/s: 75g/L triclopyr present as the butoxyethyl ester, 28g/L metsulfuron-methyl

Applicant Name: Zelam Pty Ltd


Summary of Use: For the control of certain brush species in native pasture, rights of way and commercial and industrial areas





Product Name: Fabulous Fly And Insect Spray Regular

Active Constituent/s: 1.08g/kg tetramethrin 20:80, 0.25g/kg d-phenothrin 20:80, 2.17g/kg piperonyl butoxide, 3.18g/kg n-octyl bicycloheptene dicarboximide

Applicant Name: Spar Australia Limited


Summary of Use: For protection against flying and crawling insects



Product Name: All-Season 450 Weedkiller

Active Constituent/s: 450g/L glyphosate present as the isopropylamine salt

Applicant Name: Extol Australasia Pty Ltd


Summary of Use: For non-selective control of a broad range of annual, perennial, woody and aquatic weeds and for use in conservation tillage



Product Name: Fabulous Fly And Insect Spray Low Irritant

Active Constituent/s: 3.18g/kg n-octyl bicycloheptene dicarboximide, 2.17g/kg piperonyl butoxide, 0.25 g/kg d-phenothrin 20:80, 1.08g/kg tetramethrin 20:80

Applicant Name: Spar Australia Limited


Summary of Use: For protection against flying and crawling insects



Product Name: Coles Smart Buy Surface Spray Low Irritant

Active Constituent/s: 2.79g/kg permethrin 25:75, 1.38g/kg tetramethrin 20:80

Applicant Name: Coles Supermarkets Australia Pty Ltd


Summary of Use: For control of cockroaches, silverfish, ants, carpet beetles, fleas, spiders, bedbugs and clothes moths in household situations



Product Name: Triasulflex 750 WG Herbicide

Active Constituent/s: 750g/kg triasulfuron

Applicant Name: Hextar Chemicals Pty Ltd


Summary of Use: For pre-plant control of annual ryegrass, Paradoxa grass and certain broadleaf weeds in wheat and for post-emergent control of wild radish in wheat, oats and barley





Product Name: Agrocelhone C Soil Fumigant

Active Constituent/s: 985g/kg chloropicrin

Applicant Name: Agroquimicos De Levante, S.A.

Applicant ACN: N/A

Summary of Use: For the control of certain soil-borne pests

Date of Registration: 2 April 2012


Product Name: Rainbow Imazethapyr 700 WG Herbicide

Active Constituent/s: 700g/kg imazethapyr

Applicant Name: Shandong Rainbow International Co., Ltd.

Applicant ACN: N/A

Summary of Use: For the pre-or post-emergence control of certain weeds in centrosema (cavalcade), chickpeas, faba beans, field peas, lucerne, mung beans, peanuts, serradella, soybeans and subterranean clover



Product Name: Searles Trifend Garden Spray

Active Constituent/s: 9.6g/L tau-fluvalinate, 4.4g/L myclobutanil

Applicant Name: J C & A T Searle Pty Ltd


Summary of Use: For use as an insecticide to kill aphids, thrips, whitefly, budworm and earworm caterpillars; as fungicide for the systemic control of blackspot, rust and powdery mildew; and as a miticide to control two-spotted mite in the home garden



Product Name: AC Orca 700 Surfactant

Active Constituent/s: 350g/L soyal phospholipids, 353g/L propionic acid

Applicant Name: Axichem Pty Ltd


Summary of Use: For the use as an acidifying and penetrating surfactant



Product Name: Protect-Us Ensystex Professional Gel Cockroach Bait

Active Constituent/s: 0.5g/kg fipronil



Summary of Use: For the control of cockroaches in domestic and commercial premises.





2. VARIATIONS

Product Name: Imtrade Carbendazim 500 SC Fungicide

Applicant Name: Imtrade Australia Pty Ltd


Summary of Variation: To change the product name from ‘CHEMAG CARBENDAZIM 500 SC FUNGICIDE’ to ‘IMTRADE CARBENDAZIM 500 SC FUNGICIDE’, and to remove the use patterns for apples, pears, citrus, grapes, mango, stone fruit, cucurbits and turf

Date of Variation: 21 March 2012


Product Name: Genfarm Chlorpyrifos 500 Insecticide

Applicant Name: Landmark Operations Limited


Summary of Variation: To approve new registered label particulars



Product Name: Melpat Coppox WG Agricultural Fungicide/Bactericide

Applicant Name: Melpat International Pty Ltd


Summary of Variation: To reduce the application rates across the existing use patterns



Product Name: Blue Planet Pond Algae Control Blocks

Applicant Name: Beaphar Australia Pty Ltd


Summary of Variation: To change the product name from ‘AQUA MASTER POND ALGAE CONTROL BLOCKS’ to ‘BLUE PLANET POND ALGAE CONTROL BLOCKS’



Product Name: Blue Planet Aquarium Algae Control Block



Summary of Variation: To change product name from ‘AQUA MASTER AQUARIUM ALGAE CONTROL BLOCK’ to ‘BLUE PLANET AQUARIUM ALGAE CONTROL BLOCK’



Product Name: Ravensdown T-Oil Spray Tank Adjuvant

Applicant Name: Ravensdown Fertiliser Co-Operative Limited


Summary of Variation: To vary the product name from ‘UNITED FARMERS T-OIL SPRAY TANK ADJUVANT’ to ‘RAVENSDOWN T-OIL SPRAY TANK ADJUVANT’





Product Name: Yates Tree And Blackberry Killer

Applicant Name: Duluxgroup (Australia) Pty Ltd


Summary of Variation: To add additional uses for a range of weeds in the home and garden and change the product name from ‘YATES NON SELECTIVE ZERO WOODY WEEDER’ to ‘YATES TREE AND BLACKBERRY KILLER’



Product Name: Cropro Pounce Insecticide

Applicant Name: PCT Holdings Pty Ltd


Summary of Variation: To copy uses from a closely similar reference product and to add additional pack sizes



Product Name: Elantra Xtreme Herbicide

Applicant Name: Sipcam Pacific Australia Pty Ltd


Summary of Variation: To change the compatibilities to allow tank mixing with oil-based adjuvants



Product Name: Milbeknock Miticide



Summary of Variation: To extend the label claims to include control of two-spotted mite in capsicums



Product Name: Ecopar Herbicide



Summary of Variation: To include control of various broadleaf weeds in pastures and include use as tank m ix with glyphosate formulations



Product Name: Blue Planet Algae Cure



Summary of Variation: To change product name from ‘ARISTOPET AQUA MASTER ALGAE CURE’ to ‘BLUE PLANET ALGAE CURE’

Date of Variation: 2 April 2012




Product Name: Zolo 430 SC Fungicide

Applicant Name: United Phosphorus Ltd.


Summary of Variation: To approve an extension of use on grapes, lettuce and sugarcane



Product Name: Mortein Fast Knockdown Fly & Mosquito Killer Low Allergenic

Applicant Name: Reckitt Benckiser (Australia) Pty Limited


Summary of Variation: To change product name from ‘MORTEIN LOW ALLERGENIC FLY & MOSQUITO KILLER’ to ‘MORTEIN FAST KNOCKDOWN FLY & MOSQUITO KILLER LOW ALLERGENIC’





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.

3. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Product Name: Excede Sterile Suspension

Active Constituent/s: 200mg/mL ceftiofur as ceftiofur crystalline free acid

Applicant Name: Pfizer Animal Health A Div Of Pfizer Australia Pty Ltd


Summary of Use: For the treatment of bovine respiratory diseases caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni

Date of Registration: 23 February 2012


Product Name: Raisha Poultice

Active Constituent/s: 523.5g/kg light kaolin, 164g/kg magnesium sulphate heptahydrate, 8.5g/kg glycerol

Applicant Name: The Best Result C Pty Ltd T/A Raisha Imports


Summary of Use: For use as an aid in the temporary relief of soreness and swelling in horses



Product Name: Dicyclanil 50 Spray-On Blowfly Treatment

Active Constituent/s: 50g/L dicyclanil

Applicant Name: Novartis Animal Health Australasia Pty. Limited


Summary of Use: For the prevention of blowfly strike in sheep



Product Name: Cazitel Flavoured Allwormer Tablets For Dogs

Active Constituent/s: 49.8mg pyrantel (as pyrantel embonate), 50mg praziquantel, 250mg febantel



Summary of Use: For the control of roundworms, whipworms, hookworms and tapeworms in dogs



Product Name: Cazitel Flavoured Allwormer Tablets For Large Dogs

Active Constituent/s: 174.4mg pyrantel (as pyrantel embonate), 175mg praziquantel, 875mg febantel



Summary of Use: For the control of roundworms, whipworms, hookworms and tapeworms in large dogs





4. VARIATIONS

Product Name: Skin Support SS 23 Canine

Applicant Name: Royal Canin Australia Pty Ltd


Summary of Variation: To change the product name from ‘SKIN SUPPORT’ to ‘SKIN SUPPORT SS 23 CANINE’




Notice—New Agricultural Chemical Products - Prosulfuron in the product Casper Turf Herbicide

NOTICE—NEW AGRICULTURAL CHEMICAL PRODUCTS

Prosulfuron in the product Casper Turf Herbicide

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Syngenta

Crop Protection Pty Ltd., for registration of a new product containing the active constituent Prosulfuron. The

product is Casper Turf Herbicide. The product is a post-emergence herbicide intended for the post-emergence

control of certain broadleaf weeds in established turf.

Particulars of The Application

Proposed Product Name(s): Casper Turf Herbicide

Applicant Company: Syngenta Crop Protection Pty Ltd

Name of Active Constituent: Prosulfuron

Signal Heading: Schedule 6

Summary of Proposed Use: A herbicide for the post-emergence control of certain broadleaf weeds in

established turf

Pack Sizes: 1 kg, 2.5 kg and 3 kg

Withholding Period: Do not graze treated turf/lawn or feed turf/lawn clippings from any treated

area to poultry or livestock

SUMMARY OF THE APVMA’S EVALUATION OF CASPER TURF HERBICIDE IN ACCORDANCE WITH SECTION

14(3)(E) AND (F) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’),

SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental safety

under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Casper Turf Herbicide would not be an undue hazard to the

safety of people exposed to it during its handling and use.

The Office of Chemical Safety (OCS) in the Department of Health and Ageing has conducted a risk

assessment on the product and concluded that it can be used safely.

Workers may be exposed to the products when opening containers, mixing/loading, application, and cleaning

up spills and equipment. The main route of exposure to the product/spray will be dermal and inhalational,

although ocular exposure is also possible.

Exposure to the product during ground-boom application, and mixing and loading, is considered acceptable

when the operator is wearing a single layer of clothing (cotton overalls or equivalent clothing) with or without

gloves. Exposure to the product during low-pressure hand wand application, and mixing and loading, is

considered acceptable when the operator is wearing a second layer of clothing (cotton overalls over normal

clothing), and chemical resistant gloves and a respirator.

Users should follow the First Aid Instructions, Warning Statement, Safety Directions and Re-entry statement

on the product label.

The APVMA accepts the findings and recommendations of the OCS evaluation.


Notice—New Agricultural Chemical Products - Particulars of The Application

(ii) The APVMA is satisfied that the proposed use of Casper Turf Herbicide will not be an undue hazard to the safety of

people using anything containing its residues as the product will only be used on turf which is considered a non-

food producing situation.

(iii) The APVMA is satisfied that the proposed use of Casper Turf Herbicide containing the active constituent

Prosulfuron is not likely to be harmful to human beings if used according to the product label directions.

Prosulfuron is of low acute oral, dermal and inhalational toxicity in rats, is not a skin irritant but a slight eye

irritant in rabbits, and is not a skin sensitiser in guinea pigs. Prosulfuron was not an in vivo genotoxicant and

is not considered a neurotoxic hazard to human health.

Casper Turf Herbicide is considered to be of low acute oral and dermal toxicity in rats, a slight eye irritant in

rabbits, but not a skin irritant in rabbits or a skin sensitiser in guinea pigs based on available toxicology

information.

The new active constituent prosulfuron have been evaluated for approval. The appropriate signal heading is

on the label. First Aid and Safety Directions recommended by the Department of Health and Ageing have

been included on the label.

The APVMA accepts the findings and recommendations of its advisors on these criteria.

(iv) The APVMA is satisfied that the proposed use of the new products Casper Turf Herbicide containing the active

constituent Prosulfuron, would not be likely to have an unintended effect that is harmful to animals, plants or things

or the environment.

The Department of Sustainability, Environment, Water, Population and Communities (DSEWPaC) has

assessed data in support of the proposed use and has concluded that the risks to the environment from this

use are acceptable.

Prosulfuron is stable to hydrolysis and aquatic photolysis and can be expected to show persistence in natural

water systems. Soil photolysis and aerobic soil degradation are expected to be significant routes for

environmental degradation of the herbicide. Prosulfuron does not adsorb to soil very strongly and is expected

to be of very high to medium mobility, although it is not likely to reach groundwater in significant quantities.

Prosulfuron is expected to dissipate quickly from soils via microbial degradation and it is not identified as a

persistent soil chemical. It is not expected to bioconcentrate in aquatic species.

Prosulfuron is practically non-toxic to birds while it and the proposed formulation are practically non-toxic to

fish and aquatic invertebrates. Prosulfuron and the proposed formulation are very highly toxic to aquatic

plants and algae while several of its metabolites are at worst slightly toxic to these organisms. Prosulfuron

and its combination with dicamba are very slightly toxic to bees and earthworms and are not expected to have

adverse effects on earthworm or collembola survival and reproduction. Statistically and biologically significant

effects on both reproduction and mortality of Typhlodromus pyri, a predatory mite, were found. Adverse

effects on soil nitrogen transformation and carbon turnover are not expected from the use of prosulfuron.

Prosulfuron being a herbicide, could have phytotoxic effects on non-target plants.

DSEWPaC has considered the potential risk to organisms in the terrestrial and aquatic environment from the

proposed uses of Casper Turf Herbicide, based on ground application by low boom sprayers as proposed by

the draft label and also by high boom sprayers. The risk assessment determined that under the p roposed use

pattern the proposed uses are unlikely to pose an environmental risk to birds from residues on exposed

surfaces, to aquatic and benthic organisms from spray drift or run-off provided an aquatic downwind no-spray

zone of 25 metres is established and the label bears appropriate statements regarding the need to minimise

runoff. Risk to bees is acceptable. Adverse effects on both reproduction and mortality of T. pyri, a predatory

mite, have resulted in a recommendation for a label statement for potential adverse effects on non-target



beneficial invertebrates in turfgrass. Risk, as a result of spraydrift, to non-target terrestrial plants at the edges

of the treated areas is acceptable provided application is with a coarse quality spray with a downwin d no

spray zone of 10 metres.

The APVMA has considered the findings of the Department of Sustainability, Environment, Water, Population

and Communities and accepts these conclusions.

(v) The APVMA is satisfied that the proposed use of Casper Turf Herbicide would not adversely affect trade between

Australia and places outside Australia as the product is not for use in food producing situations and therefore will

not impact on trade.

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

supporting the efficacy of the product adequately demonstrate that if used according to the product label directions,

the product can be used safely and effectively for its proposed uses.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public

Consultation’ page, www.apvma.gov.au/consultation/public or by contacting the evaluator listed below.

MAKING A SUBMISSION

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 of Casper Turf Herbicide should be granted.

Submissions should relate only to matters that the APVMA is required by legislation to take into account in deciding

whether to grant the application. These grounds include occupational health and safety, chemistry and

manufacture, residues, safety and first aid, environmental fate and toxicity, trade and efficacy. Submissions

should state the grounds on which they are based. Comments received outside these grounds cannot be

considered by the APVMA.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the

contact listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered

and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

contact name

company or Group name (if relevant)

email or postal address

the date you made the submission.

All personal and confidential commercial information (CCI)1 material contained in submissions will be treated

confidentially.

1 A full definition of ‘confidential commercial information’ is contained in the Agvet Code.

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

http://www.comlaw.gov.au/ComLaw/Legislation/ActCompilation1.nsf/current/bytitle/A06DDA96E680781ECA2573120082EBE6?OpenDocument&mostrecent=1



Written submissions on the APVMA’s proposal to grant the application for registration that relate to the grounds

for registration should be addressed in writing to:

Contact Officer

Pesticides Program

Australian Pesticides & Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Australia

Phone: 02 6210 4748

Fax: 02 6210 4776



* 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 Other Notices - Licensing of Veterinary Chemical Manufacturers

OTHER NOTICES

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 taken action, with respect to the licensing 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 website www.apvma.gov.au.

1. NEW LICENCES

Nil

2. CHANGES TO EXISTING LICENCES

CHEMINOVA (MFG) PTY LTD LICENCE NO: 2204

ACN: 132 767 956

16 Lucca Road

WYONG NSW 2259

Product Types: *

Category 2: powders, liquids, tablets (selenium supplements)

Category 3: powders and liquids

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, dry milling, wet milling, filling, tableting, packaging, labelling,

analysis and testing (physical, chemical), storage and release for supply

Amended Licence Issued: 30/03/2012

Change of licence scope and variation to licence conditions

PROBIOTEC PHARMA PTY

LIMITED

LICENCE NO: 2008

ACN: 076 755 354

83 Cherry Lane

LAVERTON NORTH VIC 3026

Product Types: *

Category 2: tablets, capsules, creams, lotions, ointments, pastes, powders, liquids

Category 4: premixes, supplements

Step(s) of Manufacture: Quality assurance (QA) of raw materials, formulation

including blending, dry milling, wet milling, granulation, filling, packaging, labelling,

strip, blister or sachet packaging, tableting, tablet coating, capsule filling from

bulk, spray drying, analysis and testing (physical, chemical), storage and release

for supply

Amended Licence Issued: 7 March 2012

Updated key personnel



3. LICENCE CANCELLATIONS

The APVMA has cancelled the following licences under subsection 127(1) of the Agricultural and Veterinary

Chemicals Code [‘the Agvet Code’].

ASPEN PHARMA PTY LTD LICENCE NO: 2181

ACN: 004 118 594

7 Maitland Place

Norwest Business Park

BAULKHAM HILLS NSW 2153

Date Cancelled: 6 March 2012

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’].

COSMETIC MANUFACTURERS

(AUST) PTY. LTD.

LICENCE NO: 2202

ACN: 010 501 327

26 Steindl Street

BUNDABERG QLD 4670

Date Suspended: 6 March 2012 (to 25 July 2012)

Reason for Suspension: [s127(1)(d)]

NEBAJ NOMINEES PTY LTD

TRADING AS KANINE

NUTRITION

LICENCE NO: 3026

ACN: 008 838 015

Unit 1, 92-94 Briggs Street

WELSHPOOL WA 6106

Date Suspended: 6 March 2012 (to 30 April 2012)


PHARMASCOPE PTY LTD LICENCE NO: 2212

ACN: 111 664 674

7 Kalgan Road

WELSHPOOL WA 6106

Date Suspended: 5 March 2012 (to 5 March 2014)




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

Riannon Cuschieri

GMP Officer

Veterinary Medicines Program

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4899

Fax: 02 6210 4741



Other Notices - Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene

Continued suspension of quintozene active constituent approvals, products containing quintozene and label approvals of products containing quintozene

The APVMA has decided to continue the suspension of the active constituent approvals for quintozene listed in Table 1

and the product registrations and label approvals of products containing quintozene listed in Table 2.

Table 1: Active constituent approvals for quintozene

Approval Number Approval Holder

46112 Barmac Industries Pty Ltd

53706 Amvac Chemicals Corporation

Table 2: Registered products containing quintozene

Product

Number

Product Name Label Approval

Numbers

Registrant

41110 Barmac Turf Renovation Mixture 41110/0203 Barmac Industries Pty Ltd

45883 Uniroyal Chemical Terraclor Super-X E.C.

Soil Fungicide

45883/0903

Barmac Industries Pty Ltd

47211 Barmac Chloroturf Dg Fungicide 47211/1102

47211/3427


48308 Barmac Rhysol Dg Turf Fungicide 48308/01

48308/0400


50787 Uniroyal Chemical Cotton Planter Box

Protectant

50787/0498

50787/0603


50788 Uniroyal Chemical Peanut Seed

Protectant Fungicide

50788/0898

50788/0903


50789 Uniroyal Chemical Terraclor Cotton Seed

Protectant

50789/0300

50789/0498


51382 Optimerge Peanut Seed Dressing 51382/0106

51382/1298

Peanut Company Of

Australia Limited

53533 Terraclor Soil Fungicide 53533/0702

53533/0201

53533/0403

53533/0703

53533/1100

53533/1206


55743 Terraclor Seed Treatment 55743/0105

55743/1106




The active constituent approval suspensions are in effect from 14 April 2012 until 14 April 2013.

The product and label suspensions apply as a consequence of the decision to continue the suspension of quintozene

active constituent approvals and are in effect from 14 April 2012 until 14 April 2013.

BASIS FOR CONTINUED SUSPENSION

The APVMA became aware of information in 2010 indicating the presence of undeclared dioxins as impurities in

products that contain quintozene as the active constituent. On this basis, the APVMA suspended quintozene active

approvals, effective 9 April 2010 until 12 April 2011. In April 2011, the APVMA acted again to continue the suspension of

all approvals of the active constituent quintozene for a further 12 months, to allow the manufacturer additional time to

generate the necessary data. The manufacturer has recently provided the APVMA with additional data and to allow

sufficient time to consider this application, the APVMA has continued the suspension of all approvals of the active

constituent quintozene for a further 12 months until 14 April 2013. Dioxins are listed as toxicologically significant

impurities in the Definition of Standards for Active Constituents (see

http://www.apvma.gov.au/products/constituents/standards/actives_definition.php). The presence of any impurity that is

listed as toxicologically significant is a matter that the APVMA considers to be a relevant particular to the approval of an

active constituent.

As stated in the Agricultural Manual of Requirements and Guidelines (AgMORAG)

(http://www.apvma.gov.au/products/constituents/standards/actives_definition.php), an active constituent approval is not

supportable unless any known impurities of toxicological significance have been adequately evaluated. AgMORAG

specifies that an impurity that is present at levels above 0.1 mg/kg should be declared and evaluated, and also

emphasises that toxicologically significant impurities in the active constituent should be declared when present,

regardless of the level present.

The APVMA considers that the active constituent quintozene may be an undue hazard to the safety of people exposed to

it during its handling and may have an effect that is harmful to human beings. A full assessment of the dioxin impurities

has not been conducted in accordance with section 14 of the Agvet Code Act. On this basis the APVMA has concluded

that it cannot allow the active constituent to be supplied and used in chemical products when it contains undeclared

dioxins. Consequently, the APVMA has suspended the approvals of quintozene active constituents.

The Agvet Code provides that if the APVMA suspends the only approval, or all the approvals, of an active constituent for

an existing chemical product, it must also suspend any registration of that product. In addition, if the APVMA suspends

the registration of a chemical product, it may also suspend any approval relating to a label for containers for the product.

IMPACT ON PRODUCT REGISTRANTS

Suspension action is based on the concern that undeclared dioxins may be present in quintozene active constituents and

formulated products. The APVMA considers that it may be possible to allow some use of existing stocks of quintozene

products during the period of suspension. Continued uses will only be permitted on the basis of test results for total

dioxins in each batch of product proposed for use, and following evaluation by the Office of Chemical Safety and

Environmental Health, to ensure that any continued use does not pose a risk to users.

INSTRUCTIONS FOR DEALING WITH SUSPENDED ACTIVE CONSTITUENTS AND PRODUCTS

Unless authorised by the APVMA, the following instructions apply for persons having possession or custody of stocks,

and are considering using or otherwise dealing with suspended active constituent and product during the period of

suspension.

http://www.apvma.gov.au/products/constituents/standards/actives_definition.php

http://www.apvma.gov.au/products/constituents/standards/actives_definition.php



INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH SUSPENDED ACTIVE

CONSTITUENTS AND PRODUCTS

Possession and custody

Possession and custody of existing stocks of quintozene active constituent and/or products is permitted.

Supply

No supply of the active constituent quintozene and/or any product that contains it as an active constituent is permitted.

Use

No use of suspended product containing quintozene is permitted.

Any person who possesses or has custody of, or otherwise deals with the active constituents or products listed in Tables

1 and 2 (above) in accordance with the instructions in this notice is taken to have been issued with a permit to possess,

have custody of, or deal with the active constituents or products during the period of suspension or until further notice.

WARNING

A person must not possess with the intent to supply, or deal with any materials containing quintozene during this period,

except in accordance with the instructions contained in this notice. A failure to comply with these instructions will result in

an offence against the Agvet Codes and the APVMA will take appropriate compliance action. It is an offence for any

person to possess with the intent to supply, use or deal with the active constituent after 9 April 2010 unless authorised to

do so by the APVMA. Similarly, it is an offence for any person to possess with the intent to supply, use or deal with

quintozene products after 12 April 2010, unless authorised to do so by the APVMA.

APVMA CONTACT

For further information please contact:

Contact Officer

Pesticides Program


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4749

Fax: 02 6210 4776



Commonwealth of Australia Gazette No. APVMA 7 Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 25

Other Notices - Cancellation of Label Approvals of Products Containing Virginiamycin

Cancellation of Label Approvals of Products Containing Virginiamycin

The APVMA has cancelled the following label approvals with regards to products containing virginiamycin. This action

affects the products, labels and batch numbers in the table below.

Table 1: Products containing virginiamycin and their cancelled label approvals

Product

No.

Product Name Registrant Cancelled Label

Approval Number

Batch

Number

Expiry Date

46049 Eskalin Feed Premix for

Cattle

Phibro Animal Health 46049/25/0104 BN 29759

BN 30796

BN 30797

BN 29758

BN 29759

BN30795

30/09/2012

31/12/2012

31/12/2012

30/09/2012

30/09/2012

31/12/2012

49111 Eskalin Wettable Powder

Spray-On Feed Premix

Phibro Animal Health 49111/50/0904

49111/50C/0904

BN 30868 31/01/2013

51354 Eskalin 500 Feed Premix Phibro Animal Health 51354/0103 -- --

The label approvals in Table 1 were cancelled on 03 April 2012. Note that the products listed above remain registered.

Stocks of these products bearing labels with APVMA Approval Numbers 46049/36251, 49111/36250 and 51354/36249

are current and are approved.

REASONS

The reasons for the cancellations are:

In 2008, the Administrative Appeals Tribunal (AAT) reviewed the APVMA’s decision on the reconsideration of

virginiamycin and decided that labels for Eskalin Feed Premix for Cattle, Eskalin Wettable Powder Spray-

On Feed Premix and Eskalin 500 Feed Premix must be varied with prudent use statements.

The old labels are non-compliant with the AAT’s decision of 20 October 2008.

The APVMA has issued the following instructions for using or dealing with products containing a cancelled

label.

INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH PRODUCTS

CONTAINING CANCELLED LABELS

Possession and custody

Any person already in possession of the products that were in existence or bearing the batch numbers and label

approval numbers listed in Table 1 may continue to possess, have custody of, use or otherwise deal with the products

with the intention of supply of such products until 03 April 2013 or until the expiry date on the label of the products,

whichever is earlier.

Commonwealth of Australia Gazette No. APVMA 7 Tuesday, 10 April 2012 Agricultural and Veterinary Chemicals Code Act 1994 26

Other Notices - Cancellation of Label Approvals of Products Containing Virginiamycin

Supply

A person may undertake wholesale and retail supply of the products in existence or bearing the batch numbers and label

approval numbers listed in Table 1.

All suppliers must at the time of the supply of the products covered by these instructions provide to the person taking

responsibility for the supplied product, a full copy of PER13462 which sets out the conditions and instructions for use.

Use

PERSONS who wish to use the products with the cancelled labels listed in Table 1 must read, or have read to them, the

instructions included in the relevant APVMA permit. Users who have had the instructions read to them must confirm to

the reader that they understand the instructions.

READ THESE INSTRUCTIONS before using or otherwise handling the product.

Prior to prescribing Eskalin Feed Premix for Cattle or Eskalin Wettable Powder Spray-On Feed Premix or Eskalin

500 Feed Premix, investigate the use of non-antibiotic options. If virginiamycin is indicated and selected for use,

prescription must be consistent with the AVA Code of Practice for Prescription and Use of Products which Contain

Antimicrobial Agents. Dosage regimens should be designed for each situation with an appropriate duration and

frequency to minimize treatment failure while minimizing the emergence of antimicrobial resistance. Review farm records

on the use of product containing virginiamycin to ensure compliance with prescribing instructions.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL.

Other than as specified above, the products must be used in accordance with the instructions on the label attached to the

container. Where the above instructions are inconsistent with the label instructions, the instructions in this notice must be

followed.

Subsections 45A(5) and 55(3) of the Avet Code cease to apply in respect of the products bearing labels identified in

Table 1. A person may not possess, have custody of, use or deal with the above products bearing the cancelled labels

listed in Table 1 after 03 April 2013.

Warning

A person must not possess with the intent to supply, or deal with the products with cancelled labels except in accordance

with the instructions contained in this notice. A failure to comply with them will result in an offence against the Agvet

Codes and the APVMA will take appropriate compliance action. It will be an offence for any person to possess with the

intent to supply, or deal with the products bearing the cancelled labels listed in Table 1 after 03 April 2013.

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Linden Moffatt

Senior Evaluator

Veterinary Medicines Program


PO Box 6182

SYMONSTON ACT 2609

Phone: 02 6210 4736

Fax: 02 6210 4741

Email: [email protected].


Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 27

Other Notices - Voluntary Cancellation of Label Approvals at the Request of the Registrants

Voluntary Cancellation of Label Approvals at the Request of the Registrants

In accordance with Section 42 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code), if an

interested or approved person in relation to an approval or registration gives to the APVMA a written notice requesting

the APVMA to cancel the approval or registration, the APVMA must give written notice of its decision on request to the

person(s) who made the request.

The APVMA has recently audited cancellations of label approvals, which were cancelled at the request of the interested

person. In some cases, while written notice was provided to the interested person and the cancellation was given effect,

a notice was not published in the APVMA Gazette.

Therefore, pursuant to Section 45A of the Agvet Code, this notice details label cancellations, given effect between 2007

and 2009. This notice specifies the reasons for the cancellation.

Please note that instructions for possessing, having custody of, using or otherwise dealing with the product during the 2-

year phase-out period after the date of cancellation are no longer required. Therefore a warning of the consequences if

the person fails to comply with the phase-out instructions is not relevant.

The APVMA has cancelled the label approvals listed in Table 1

Table 1: Label Approvals previously cancelled at the request of the registrant.

Product

No.

Product Name Registrant Voluntarily Cancelled

Label Approval

Numbers

Date of

Effect

30740 HYLITE TIMBER

PRESERVATIVE

OSMOSE AUSTRALIA PTY

LTD

30740/0799

30740/0500

30740/1100

11/05/2009

52878 FARMOZ HOWZAT SC

SYSTEMIC FUNGICIDE

FARMOZ PTY LIMITED 52878/0600

52878/0202

52878/1204

52878/1005

52878/0906

19/06/2007

53587 CAMPBELL GOLDAZIM

500SC SYSTEMIC

FUNGICIDE

AGRIPHAR S.A. 53587/1200

53587/1004

53587/0805

05/05/2009

59815 NUFARM SPIN FLO

SYSTEMIC FUNGICIDE

NUFARM AUSTRALIA

LIMITED

59815/0705

59815/1105

08/05/2009

SUPPLY AND USE

The phase out periods of permitted supply and use of products bearing the cancelled labels listed above have expired.

Additionally registrants advised that the cancelled label approvals had not been supplied for some time prior to

cancellation.

It is an offence against the Agvet Codes to have possession or custody of the product bearing a cancelled label with the

intention to supply, or to supply the product bearing a cancelled label.

Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 28

Other Notices - Voluntary Cancellation of Label Approvals at the Request of the Registrants

Please note that this cancellation does not affect the most recently registered labels of these products. The most recent

label is suspended and products bearing these labels may only be used in accordance with the suspension instructions

issued in the APVMA Gazette of 28 February 2012, available from

http://www.apvma.gov.au/publications/gazette/2012/04/gazette_2012-02-28.php.

Table 2: Label Approvals that have NOT been cancelled and may be supplied and used according to the

suspension instructions issued in the APVMA Gazette of 28 February 2012 .

Product

No.

Product Name Registrant Suspended Label Approval

Numbers

30740 HYLITE TIMBER

PRESERVATIVE

OSMOSE AUSTRALIA PTY LTD

30740/0607

52878 FARMOZ HOWZAT SC

SYSTEMIC FUNGICIDE

FARMOZ PTY LIMITED 52878/0507

53587 CAMPBELL GOLDAZIM 500SC

SYSTEMIC FUNGICIDE

AGRIPHAR S.A. 53587/0807

59815 NUFARM SPIN FLO SYSTEMIC

FUNGICIDE

NUFARM AUSTRALIA LIMITED 59815/0707

APVMA CONTACT

For any enquiries or further information about this matter, please contact:

Chemical Review /AERP Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4749

Fax: 02 6210 4776


http://www.apvma.gov.au/publications/gazette/2012/04/gazette_2012-02-28.php


Other Notices - Amendments to the APVMA MRL Standard

Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of

agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs

approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an

outcome from a review decision and are set out in the MRL Standard published by the APVMA. The MRL Standard lists

MRLs of substances that may arise from the approved use of agricultural and veterinary chemical products containing

those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also

provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue

definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.

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. In considering MRLs and variation to MRLs, the APVMA takes into account

studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary

exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an

undue hazard to human health.

The MRL Standard is accessible via the APVMA website www.apvma.gov.au.

The APVMA has varied the MRL Standard as set out below with effect from the date of this notice.


Residues Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4837

Fax: 02 6210 4840






AMENDMENT No. 10O, 2012

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.

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)

Bentazone

ADD:

VA 0385 Onion, Bulb T0.1

Bifenazate

ADD:

FB 0264 Blackberries T5

FB 0277 Cloudberry T5

FB 0266 Dewberries (including Boysenberry and Loganberry) T5

FB 0272 Raspberries, Red, Black T5

Clothianidin

ADD:

VD 0541 Soya bean (dry) T0.02

2,2-DPA

DELETE:

FI 0353 Pineapple *0.1




Fluazifop-butyl

DELETE:

SB 0716 Coffee beans T1

VO 0440 Egg plant T0.1

FT 0305 Olives T0.05

VS 0627 Rhubarb *0.02

Imazamox

ADD:

GC 0640 Barley *0.05

Imazapyr

ADD:

GC 0640 Barley *0.05

Iprodione

DELETE:

VD 0560 Adzuki bean (dry) T0.1

VP 0522 Broad bean (green pods and immature seeds) 0.2

SO 0702 Sunflower seed T*0.05

VR 0505 Taro *0.05

Milbemectin

ADD:

VO 0445 Peppers, Sweet [capsicum] 0.02

Pirimiphos-methyl

DELETE:

FI 0341 Kiwifruit 2




Propachlor

ADD:

VL 0054 Brassica leafy vegetables T*0.05

VA 0387 Onion, Welsh T1

VL 0496 Rucola [rocket] T*0.05

VA 0388 Shallot T1

VA 0389 Spring onion T1

Pyraclostrobin

ADD:

FI 0351 Passion fruit T0.2

Sethoxydim

DELETE:

Bergamot *0.1

HH 4731 Burnet, Salad *0.1

VL 0465 Chervil *0.1

HS 0730 Dill seed *0.1

VA 0380 Fennel, Bulb 0.2

HS 0731 Fennel, seed *0.1

HH 0092 Herbs [except thyme] *0.1

Kaffir lime leaves *0.1

Lemon grass *0.1

DT 1111 Lemon verbena [fresh weight] *0.1

Mizuna *0.1

Rose and dianthus (edible flowers) *0.1

FB 0275 Strawberry 0.1

HH 0750 Thyme 0.5



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)

Imazamox

ADD:

Barley forage and fodder 0.7

Barley straw *0.05

Imazapyr

DELETE:

Forage of cereal grains [fresh weight] 0.2

Primary feed commodities [other than maize fodder (dry), maize

forage (green)[fresh weight], canola fodder (dry), canola forage

(green), forage of cereal grains [fresh weight] and wheat straw and

fodder, (dry)]

15

AS 0654 Wheat straw and fodder, dry *0.05

ADD:

Forage and fodder of cereal grains [except maize fodder and

maize forage]

0.7

Primary feed commodities [except maize fodder (dry), maize

forage (green)[fresh weight], canola fodder (dry), canola forage

(green), forage and fodder of cereal grains and straw of cereal

grains, dry]

15

Straw of cereal grains, dry *0.05


Other Notices - Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code

In the previous notice, the APVMA gazetted particular amendments which it has approved varying maximum residue

limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s

MRL Standard.

Under Section 82 of the Food Standards Australia New Zealand Act 1991 the APVMA is proposing to incorporate these

variations (numbered 10O) to MRLs into Standard 1.4.2 - Maximum Residue Limits of the Australia New Zealand Food

Standards Code.

MRLs contained in Standard 1.4.2 provide the limits for residues of agricultural and veterinary chemicals that may

legitimately occur in foods. By this means, Standard 1.4.2 permits the sale of treated foods and protects public health

and safety by minimising residues in foods consistent with the effective control of pests and diseases.

The APVMA and FSANZ are satisfied, based on dietary exposure assessments and current health standards, that the

proposed limits are not harmful to public health.

The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food

Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food

standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary

chemicals in food.

Food Standards Australia New Zealand (FSANZ) will make a Sanitary and Phytosanitary (SPS) notification to the World

Trade Organization (WTO).

The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this

notice, below the details of the proposed amendment.

The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with

the proposal, it will further notify any variations it makes to Standard 1.4.2 in the APVMA Gazette. The variations will take

effect as from the date of that subsequent notice.



DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

Note: The following amendments are in a format that accords with the proposed amending Legislative Instrument

which, in turn, has to be consistent with the existing format of Standard 1.4.2 (Maximum Residue Limits) of the

Australia New Zealand Food Standards Code.

PROPOSED AMENDMENT NO. 10O

Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards

are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

1. inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

Bentazone

Bentazone

Onion, bulb T0.1

Bifenazate

Sum of bifenazate and bifenazate diazene (diazenecarboxylic acid, 2-(4-methoxy-[1,1′-biphenyl- 3-yl] 1-methylethyl ester), expressed as bifenazate

Blackberries T5 Cloudberry T5 Dewberries (including boysenberry

and loganberry) T5

Raspberries, red, black T5

Clothianidin

Clothianidin

Soya bean (dry) T0.02

Imazamox

Imazamox

Barley *0.05

Imazapyr

Imazapyr

Barley *0.05

Milbemectin

Sum of milbemycin MA3 and milbemycin MA4 and their photoisomers, milbemycin (Z) 8,9-MA3 and (Z)

8,9Z-MA4

Peppers, Sweet 0.02

Propachlor

Sum of propachlor and metabolites hydrolysable to N-isopropylaniline, expressed as propachlor

Brassica leafy vegetables T*0.05 Onion, Welsh T1 Rucola (rocket) T*0.05 Shallot T1 Spring onion T1



Pyraclostrobin

Commodities of plant origin: Pyraclostrobin Commodities of animal origin: Sum of pyraclostrobin and metabolites hydrolysed to 1-(4-chloro-phenyl)-

1H-pyrazol-3-ol, expressed as pyraclostrobin

Passion fruit T0.2

INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the

proposal to vary Standard 1.4.2 - Maximum Residue Limits of the Australia New Zealand Food Standards Code.

Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and

safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these

grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by

referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in

sufficient detail to allow independent scientific assessment.

Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international

trade should be made to FSANZ in response to that notification.

All personal and confidential commercial information (CCI)2 material contained in submissions to the APVMA will be

treated confidentially.

Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to

Standard 1.4.2’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (Canberra time) 18 May 2012

SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT

Submissions received after this date will only be considered if agreement for an extension has been given prior to this

closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to

the submission period.


Residues Contact Officer


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4837

Fax: 02 6210 4840


2 A full definition of "confidential commercial information" is contained in the Agricultural and Veterinary Chemicals Code (Agvet Code),

which is scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.


Other Notices - Addendum to the Record of Approved Active Constituents

Addendum to the Record of Approved Active Constituents

The current Record of Approved Active Constituents for Registered Chemical Products is also accessible from the

APVMA website, www.apvma.gov.au

APPROVED SINCE GAZETTE NO. 6, MARCH 27 2012

For use in agricultural and/or veterinary chemical products:

Common Name Approval Holder Manufacturer and Site of Manufacture Approval No.

Fluroxypyr-meptyl SINON AUSTRALIA PTY LIMITED

SINON CORPORATION

NO 111, CHUNG SHAN RD

CHUNG-HO VILLIAGE TA-TU DISTRICT

TAICHUNG HSIEN 432 TAIWAN

REPUBLIC OF CHINA

65404

Imidacloprid LANXESS PTY LTD JIANGSU FENGSHAN GROUP CO LTD

CAOMIAO TOWN

DAFENG CITY

JIANGSU PROVINCE 224134

PR CHINA

66743

Clothianidin SUMITOMO CHEMICAL AUSTRALIA PTY LIMITED

SUMITOMO CHEMICAL COMPANY LTD

OITA WORKS

2200 TSURUSAKI, OITA-CITY

OITA 870-0106

JAPAN

66933

Fipronil NUFARM AUSTRALIA LIMITED

JIANGSU CHANGQUING AGROCHEMICAL CO., LTD

NO. 1 JIANGLING ROAD

PUTO TOWN

JIANGDU CITY

PR CHINA

67155

Imazethapyr AGROGILL CHEMICALS PTY LTD

NANTONG JIAHE CHEMICALS CO., LTD.

QINGLONG PORT CHEMICAL PORT

DISTRICT HAIMEN

226121 JIANGSU PROVINCE

CHINA

66829

Alpha-cypermethrin SINON AUSTRALIA PTY LIMITED

SINON CORPORATION

NO 111, CHUNG SHAN RD

CHUNG-HO VILLIAGE TA-TU DISTRICT

TAICHUNG HSIEN 432 TAIWAN

REPUBLIC OF CHINA

67135



Other Notices - Addendum to the Record of Approved Active Constituents

APVMA CONTACT


Application Management & Enquiries


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4701

Fax: 02 6210 4721


Other Notices - Application Summaries

Application Summaries

The APVMA publishes complete application summaries on the APVMA website, www.apvma.gov.au. They are

published in weekly instalments using the date the application was accepted for assessment. If an application summary

has been amended, the APVMA will publish the amended version on the website and list it separately in the APVMA

Gazette Notice for Application Summaries.

As a requirement of Regulations 8C and E of the Agvet Code, some product names will appear as 'NOT AVAILABLE'.

A summary will be removed from the website 28 days after the application has been finalised. Therefore, some

summaries published in this notice may have already been removed prior to the Gazette being published.

APPLICATION SUMMARIES PUBLISHED SINCE THOSE PUBLISHED IN APVMA GAZETTE NO.6 27 MARCH 2012

Application No. Name

50961 VIRALOX SP, THE BROAD SPECTRUM BACTERICIDAL, VIRUCIDAL FUNGICIDAL

DISINFECTANT

52694 RUFUS & COCO FLEA FLEE SHAMPOO WITH A FRESH SCENT FOR CONTROL OF FLEAS,

LICE AND AIDS CONTROL OF ADULT BROWN DOG TICKS SUITABLE FOR DOGS, CATS,

PUPPIES AND KITTENS NATURAL PYRETHRINS

53634 4FARMERS SULFOSULFURON 750 HERBICIDE

54197 SNAILEM ALL WEATHER SLUG AND SNAIL BAIT

54207 DIETHYLTOLUAMIDE

54931 ADVOCATE FOR DOGS OVER 25KG

55080 XTRA BOOST HERBICIDE

55115 EQUIHEAL STABLE OINTMENT

55222 ULTRATHOR WATER BASED TERMITICIDE

55527 BAYTICOL POUR-ON LIVE EXPORT CLEARING TICKICIDE

55543 CERENIA INJECTABLE SOLUTION

55589 BOMAZEAL SENIOR PALATABLE TABLETS

55746 POOL SANITISER SMARTER STICKS

55854 MISSION TRI-ACTIVE HERBICIDE

56001 TITAN AZOXYSTROBIN 250 FUNGICIDE

56084 SWANCORP AMMONIUM SULPHATE SPRAY GRADE ADJUVANT

56165 SABAKEM CLETHODIM 240EC HERBICIDE

56177 VALOR 500 WG HERBICIDE

56180 NOT AVAILABLE

56218 NOT AVAILABLE

56220 NOT AVAILABLE

56235 NOT AVAILABLE




Application No. Name

56239 BIOGUARD PACIFIC BLUE POWER FLOATER POOL SANITISER

56259 AGRO-ESSENCE GLYPHOSATE 700 HERBICIDE

49795 IMTRADE METAKILL

50404 SPOREKILL AGRICULTURAL DISINFECTANT

51402 BUZZ ULTRA 750 WG FUNGICIDE

52070 IMTRADE TIGER GOLD 250 HERBICIDE

53639 MORTEIN NATURGARD AUTOMATIC INDOOR INSECT CONTROL SYSTEM ODOURLESS

53640 MORTEIN NATURGARD AUTOMATIC INDOOR INSECT CONTROL SYSTEM HOUSEHOLD

PROTECTION

53871 FOSTERRA TEBUCONAZOLE 430 FUNGICIDE

54880 XL-LOAD HERBICIDE

55154 TYLOPHARM SOLUBLE TYLOSIN TARTRATE SOLUBLE POWDER

55180 NUFARM TAMIFUME 365 SOIL FUMIGANT

55226 KENSO AGCARE BUCKO 75-D HERBICIDE

55508 PROTECT-US ENSYSTEX PROFESSIONAL FOR HOME AND FARM BLOCK RODENTICIDE

55582 AMMO ALLWORMER FOR LARGE DOGS

55584 PARABAN 40 INTESTINAL ALLWORMER FOR LARGE DOGS

55767 TRICLOPYR BUTOXYETHYL ESTER

55995 POOL PRO COPPER FREE ALGAECIDE

56004 ZINC PHOSPHIDE

56058 NOT AVAILABLE

56059 NOT AVAILABLE

56072 CROP CULTURE TRICLOPS HERBICIDE

56073 AC ZEPPLIN HERBICIDE

56173 SABAKEM TRIALLATE 500EC HERBICIDE

56179 SUREFIRE FORTUNE ULTRA TEMITICIDE AND INSECTICIDE

56188 SUSCON MAXI SOIL INSECTICIDE

56189 NOT AVAILABLE

56219 NOT AVAILABLE

56227 NOT AVAILABLE

56285 NOT AVAILABLE

56301 NOT AVAILABLE

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



Application No. Product/Active Constituent Name

50039 HOMEGUARD TERMIFLEX TERMITICIDAL ADHESIVE & SEALANT

53840 MCW 710 SC FUNGICIDE

APVMA CONTACT


Application Management and Enquiries Team (AME)


PO Box 6182

KINGSTON ACT 2604

Phone: 02 6210 4701

Fax: 02 6210 4721

apvma gazette no. 7, 10 april 2012 · no. apvma 7, tuesday, 10 april 2012 agricultural and...

Documents