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No. APVMA 7, Tuesday, 5 April 2016 Published by The Australian Pesticides and 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. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction. ISSN 1837 - 7629

APVMA Gazette No. 7, 5 April 2016...No. APVMA 7, Tuesday, 5 April 2016 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND VETERINARY CHEMICALS

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Page 1: APVMA Gazette No. 7, 5 April 2016...No. APVMA 7, Tuesday, 5 April 2016 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND VETERINARY CHEMICALS

No. APVMA 7, Tuesday, 5 April 2016 Published by The Australian Pesticides and 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. A reference to Agvet Codes in this publication is a reference to the Agvet Code in each state and territory jurisdiction.

ISSN 1837 - 7629

Page 2: APVMA Gazette No. 7, 5 April 2016...No. APVMA 7, Tuesday, 5 April 2016 Published by The Australian Pesticides and Veterinary Medicines Authority AGRICULTURAL AND VETERINARY CHEMICALS

Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2016

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 Australian Pesticides and Veterinary Medicines Authority. Requests and

inquiries concerning reproduction and rights should be addressed to:

Director, Public Affairs and Communications

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 required

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 8J(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 activity in

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

The APVMA Gazette is published in electronic format only and is available from the APVMA website,

www.apvma.gov.au/news-and-publications/publications/gazette

If you would like to receive email notification when a new edition is published, please subscribe on the APVMA website.

APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4988

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

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Erratum Notice 1 ............................................................................................................................................................. 3 Erratum Notice 2 ............................................................................................................................................................. 3 Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 15 Approved Active Constituents ....................................................................................................................................... 16 New Active Constituent Bixafen .................................................................................................................................... 17 New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide ............................................................. 19 Cancellation of Label Approval at the Request of the Holder ........................................................................................ 24 Cancellation of Label Approval at the Request of the Holder ........................................................................................ 30 Cancellation of Registration and Approval at the Request of the Holder ....................................................................... 31 Amendments to the APVMA MRL Standard .................................................................................................................. 32 Proposal to amend Schedule 20 in the revised Australia New Zealand Food Standards Code .................................... 33 Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 37

Erratum Notice 1

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 No. 6, Tuesday, 22 March 2016.

In the notice of ‘New active constituent’, the active constituent bixafen was incorrectly identified as a veterinary active constituent.

The correct entry for the ‘New active constituent—bixafen’ is on page 17 of this Gazette.

Erratum Notice 2

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 No. 6, Tuesday, 22 March 2016.

In the notice ‘New agricultural chemical products bixafen in Aviator Xpro Foliar Fungicide’, the applicant was incorrectly identified as ‘Sumitomo Chemical Australia Pty Ltd’ and the product use was incorrectly described as for control and or suppression of foliar diseases in barley, oats, triticale, wheat and canola’. In addition, several minor typographical errors were also identified.

The correct entry for the notice ‘New agricultural chemical products bixafen in Aviator Xpro Foliar Fungicide’ is on page 19 of this Gazette.

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 4

Agricultural Chemical Products and Approved Labels

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 relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. AGRICULTURAL PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS

Application no.: 61667 Product name: Dupont Zorvec Enicade Fungicide Active constituent/s: 100 g/L oxathiapiprolin Applicant name: Du Pont (Australia) Pty Ltd Applicant ACN: 000 716 469 Summary of use For the control of downy mildew in bulb, brassica, cucurbit and leafy vegetable crops and

poppies Date of registration/approval: 17 March 2016 Product registration no.: 68375 Label approval no.: 68375/61667

Application no.: 55273 Product name: Siesta Granular Ant Bait Active constituent/s: 0.63 g/kg metaflumizone Applicant name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of use For control of nuisance ant species such as coastal brown ant, black ant and red

imported fire ant in and around gardens, golf courses, industrial areas, lawns, parks, turf, sports grounds and other non-crop land and non-food bearing nursery stock

Date of registration/approval: 24 March 2016 Product registration no.: 67126 Label approval no.: 67126/55273

2. AGRICULTURAL PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS

Application no.: 104421 Product name: Tonizone Flying Insect Killer Fast Knockdown Odourless Active constituent/s: 1.1 g/kg esbiothrin, 0.5 g/kg permethrin Applicant name: Pascoe’s Pty Ltd Applicant ACN: 055 220 463 Summary of use For use in home and garden Date of registration/approval: 8 March 2016 Product registration no.: 81922 Label approval no.: 81922/104421

Application no.: 102640 Product name: Nufarm NuCol Herbicide Active constituent/s: 500 g/L 2,4-D present as the choline salt Applicant name: Nufarm Australia Limited Applicant ACN: 004 377 780 Summary of use For the control of broadleaf weeds in wheat crops and in fallow situations Date of registration/approval: 16 March 2016 Product registration no.: 81242 Label approval no.: 81242/102640

Agricultural Chemical Products and Approved Labels

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Application no.: 102842 Product name: MacPhersons Chlorthal 900 WG Herbicide Active constituent/s: 900 g/kg chlorthal dimethyl Applicant name: Ronic International Pty Limited Applicant ACN: 101 193 131 Summary of use For pre-emergence weed control in certain vegetable crops including; onions, beans,

cabbages, cauliflowers, potatoes, carrots and for weed control in strawberries, cotton, lucerne, perennial grass crops, lawns and ornamentals

Date of registration/approval: 16 March 2016 Product registration no.: 81334 Label approval no.: 81334/102842

Application no.: 104762 Product name: Rophosate 450SL Herbicide Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use For use as a non-selective foliar herbicide for control of a wide range of annual,

perennial and woody weeds Date of registration/approval: 17 March 2016 Product registration no.: 81988 Label approval no.: 81988/104762

Application no.: 104872 Product name: Agro-Essence Fipronil 200SC Insecticide Active constituent/s: 200 g/L fipronil Applicant name: Agro-Alliance (Australia) Pty Ltd Applicant ACN: 130 864 603 Summary of use For the control of various insect pests in asparagus, bananas, brassicas, cotton,

forestry, ginger, wine grapevines, mushrooms, pasture, potatoes, sorghum, sugarcane and swede

Date of registration/approval: 17 March 2016 Product registration no.: 82050 Label approval no.: 82050/104872

Application no.: 100104 Product name: Sarritor Herbicide Active constituent/s: 50 g/L flumetsulam Applicant name: Zelam Pty Ltd Applicant ACN: 082 428 028 Summary of use For the post-emergence and salvage control of certain broadleaf weeds in winter

cereals (including those undersown with clover, lucerne or medics); clover, fenugreek, lathyrus, lucerne, medic, serradella, and vetch (popany only) seed crops and pastures; chickpeas, field peas, lentils, maize, peanuts; and for the pre-emergence control of certain broadleaf weeds in maize and soybeans

Date of registration/approval: 18 March 2016 Product registration no.: 80038 Label approval no.: 80038/100104

Agricultural Chemical Products and Approved Labels

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Application no.: 104402 Product name: Relyon Harrow 900WG Herbicide Active constituent/s: 900 g/kg diuron Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For selective weed control in the situations Date of registration/approval: 18 March 2016 Product registration no.: 81913 Label approval no.: 81913/104402

Application no.: 100449 Product name: Sanonda Herbicide Oxyfluorfen 240EC Active constituent/s: 240 g/L oxyfluorfen Applicant name: Sanonda (Australia) Pty Ltd Applicant ACN: 059 813 973 Summary of use For the selective control of certain broadleaf weeds and some grasses in various situations Date of registration/approval: 18 March 2016 Product registration no.: 80234 Label approval no.: 80234/100449

Application no.: 61814 Product name: Yates Zero Rapid 1-Hr Action Weedkiller Concentrate Active constituent/s: 205 g/L nonanoic acid, 100 g/L glyphosate as the ammonium salt Applicant name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of use For control of a wide range of annual and perennial weeds and grasses in home gardens Date of registration/approval: 18 March 2016 Product registration no.: 69819 Label approval no.: 69819/61814

Application no.: 104396 Product name: Relyon Astir 700 Surfactant Active constituent/s: 350 g/L soyal phospholipids Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use Acidifying and penetrating surfactant, reduces alkaline hydrolysis of dimethoate; assists with

uptake of foliar fertilisers and the management of spray droplet size Date of registration/approval: 18 March 2016 Product registration no.: 81909 Label approval no.: 81909/104396

Application no.: 101189 Product name: Precare 850 WG Herbicide Active constituent/s: 850 g/kg propyzamide Applicant name: Shandong Rainbow International Co., Ltd Applicant ACN: N/A Summary of use For the selective control of certain grasses and broad leaf weeds in lettuce, sports turf,

home lawns and legume seed crops and pastures Date of registration/approval: 21 March 2016 Product registration no.: 80592 Label approval no.: 80592/101189

Agricultural Chemical Products and Approved Labels

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 7

Application no.: 62442 Product name: Safe4 Disinfectant Cleaner Concentrate Active constituent/s: 4 g/L poly (hexamethylene biguanide) hydrochloride, 54 g/L benzalkonium chloride Applicant name: Safe4 All (Aust) Pty Ltd Applicant ACN: 164 233 158 Summary of use For use as a veterinary disinfectant/cleanser for hard surfaces, equipment and air spaces Date of registration/approval: 21 March 2016 Product registration no.: 70073 Label approval no.: 70073/62442

Application no.: 101262 Product name: Term-Seal Aqua Block Plus Termite Barrier Active constituent/s: 0.65 g/L bifenthrin Applicant name: Term-Seal (Aust) Pty Limited Applicant ACN: 104 603 983 Summary of use For protection of building components and other structures from concealed entry by

termites Date of registration/approval: 21 March 2016 Product registration no.: 80607 Label approval no.: 807607/101262

Application no.: 105059 Product name: Pepus 750 WG Herbicide Active constituent/s: 750 g/kg isoxaflutole Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use For the control and suppression of various broadleaf weeds and grasses in sugarcane

and chickpeas Date of registration/approval: 21 March 2016 Product registration no.: 82127 Label approval no.: 82127/105059

Application no.: 100370 Product name: TERM-Seal Aqua Block Plus Sealant Termite Barrier Active constituent/s: 0.75 g/L bifenthrin Applicant name: Term-Seal (Aust) Pty Limited Applicant ACN: 104 603 983 Summary of use For protection of building components and other structures from concealed entry by termites Date of registration/approval: 21 March 2016 Product registration no.: 80186 Label approval no.: 80186/100370

Application no.: 104988 Product name: Frenta 750 WG Herbicide Active constituent/s: 750 g/kg mancozeb Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use For the control of certain fungus diseases of fruit, field crops, tobacco, turf, vegetables and

ornamentals Date of registration/approval: 21 March 2016 Product registration no.: 82094 Label approval no.: 82094/104988

Agricultural Chemical Products and Approved Labels

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Application no.: 105021 Product name: Rotam MCPA 750 Amine Herbicide Active constituent/s: 750 g/L MCPA present as the dimethylamine salt Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use For the selective control of broadleaf weeds in cereals, linseed, pastures, rice, sugar

cane and turf Date of registration/approval: 21 March 2016 Product registration no.: 82102 Label approval no.: 82102/105021

Application no.: 102317 Product name: Siwar Herbicide Active constituent/s: 700 g/kg imazethapyr Applicant name: Rotam Agrochemical 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 and soybeans

Date of registration/approval: 22 March 2016 Product registration no.: 81095 Label approval no.: 81095/102317

Application no.: 104046 Product name: Relyon Subject 240EC Herbicide Active constituent/s: 240 g/L clodinafop-propargyl 60 g/L cloquintocet-mexyl Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use For the control of wild oats, paradoxa grass (annual phalaris), canary grass, and annual

ryegrass in wheat. Highly active on wild oats Date of registration/approval: 22 March 2016 Product registration no.: 81782 Label approval no.: 81782/104046

Application no.: 103907 Product name: 4Farmers S-Metolachlor 960 EC Herbicide Active constituent/s: 960 g/L s-metolachlor Applicant name: 4 Farmers Australia Pty Ltd Applicant ACN: 160 092 428 Summary of use For the control of certain annual grasses and broadleaf weeds in certain crops Date of registration/approval: 23 March 2016 Product registration no.: 81731 Label approval no.: 81731/103907

Application no.: 101332 Product name: Chateau Herbicide Active constituent/s: 500 g/kg flumioxazin Applicant name: Sumitomo Chemical Australia Pty Limited Applicant ACN: 081 096 255 Summary of use For the residual control of various grass and broadleaf weeds under grapevines Date of registration/approval: 23 March 2016 Product registration no.: 80647 Label approval no.: 80647/101332

Agricultural Chemical Products and Approved Labels

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Application no.: 104954 Product name: Remetri 750 WG Herbicide Active constituent/s: 750 g/kg metribuzin Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of use For selective weed control in potatoes, peas, soybeans, faba beans, tomatoes, barley

and white lupins Date of registration/approval: 23 March 2016 Product registration no.: 82085 Label approval no.: 82085/104954

3. VARIATIONS OF REGISTRATION

Application no.: 105586 Product name: Rotam Toledo 430SC Fungicide Active constituent/s: 430 g/L tebuconazole Applicant name: Rotam Agrochemical Co., Ltd Applicant ACN: N/A Summary of variation: To add a 50 L and 100 L pack size Date of variation: 4 February 2016 Product registration no.: 69174 Label approval no.: 69174/105586

Application no.: 105589 Product name: Apparent Double Down 700 Herbicide Active constituent/s: 700 g/kg glyphosate present as the mono-ammonium salt Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘APPARENT DOUBLE-UP 700 HERBICIDE’ to ‘APPARENT DOUBLE DOWN 700 HERBICIDE’

Date of variation: 5 February 2016 Product registration no.: 67110 Label approval no.: 67110/105589

Application no.: 105643 Product name: Apparent Immerse Floating Herbicide Active constituent/s: 150 g/L gamma-cyhalothrin Applicant name: FMC Australasia Pty Ltd Applicant ACN: 095 326 891 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘FMC TROJAN INSECTICIDE’ to ‘TROJAN INSECTICIDE’ Date of variation: 10 February 2016 Product registration no.: 63180 Label approval no.: 63180/105643

Agricultural Chemical Products and Approved Labels

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Application no.: 105657 Product name: Apparent Hardball 700 Dual Selective Herbicide Active constituent/s: 700 g/L 2,4-D present as dimethylamine and diethanolamine salts Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘APPARENT 2,4-D 700 DUAL SELECTIVE HERBICIDE’ to ‘APPARENT HARDBALL 700 DUAL SELECTIVE HERBICIDE’

Date of variation: 11 February 2016 Product registration no.: 81704 Label approval no.: 81704/105657

Application no.: 105672 Product name: Apparent Exceed 750 WG Herbicide Active constituent/s: 750 g/kg sulfosulfuron Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘APPARENT ALONZO 750 WG HERBICIDE’ to ‘APPARENT EXCEED 750 WG HERBICIDE’

Date of variation: 15 February 2016 Product registration no.: 69333 Label approval no.: 69333/105672

Application no.: 105725 Product name: Relyon Performa 500 Herbicide Active constituent/s: 500 g/L dicamba (present as the dimethylamine salt)

Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘RELYON SAMBA 500 HERBICIDE’ to ‘RELYON PERFORMA 500 HERBICIDE’ Date of variation: 22 February 2016 Product registration no.: 81884 Label approval no.: 81884/105725

Application no.: 105770 Product name: Apparent Immerse Floating Herbicide Active constituent/s: 300 g/L calcium dodecylbenzene sulphonate Applicant name: Apparent Pty. Ltd Applicant ACN: 143 724 136 Summary of variation: To change the distinguishing product name and the name that appears on the label

from ‘AGRICROP IMMERSE FLOATING HERBICIDE’ to ‘APPARENT IMMERSE FLOATING HERBICIDE’

Date of variation: 25 February 2016 Product registration no.: 58096 Label approval no.: 58096/105770

Agricultural Chemical Products and Approved Labels

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Application no.: 105789 Product name: Relyon Sulstice 750WG Herbicide Active constituent/s: 750 g/kg sulfosulfuron Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of variation: To change the distinguishing product name and the name that appears on the label

from ‘RELYON SULSA 750WG HERBICIDE’ to ‘RELYON SULSTICE 750WG HERBICIDE’

Date of variation: 26 February 2016 Product registration no.: 81947 Label approval no.: 81947/105789

Application no.: 105821 Product name: Macro Protect Devastator 250 Herbicide Active constituent/s: 250 g/L hexazinone Applicant name: Macrofertil Australia Pty Ltd Applicant ACN: 166 370 976 Summary of variation: To change the distinguishing product name and the name that appears on the label

from ‘RAVENSDOWN DEVASTATOR 250 HERBICIDE’ to ‘MACRO PROTECT DEVASTATOR 250 HERBICIDE’

Date of variation: 2 March 2016 Product registration no.: 62999 Label approval no.: 62999/105821

Application no.: 105821 Product name: Macro Protect Triallate 500 Herbicide Active constituent/s: 500 g/L tri-allate Applicant name: Macrofertil Australia Pty Ltd Applicant ACN: 166 370 976 Summary of variation: To change the distinguishing product name and the name that appears on the label from

‘RAVENSDOWN PRE-EMPT HERBICIDE’ to ‘MACRO PROTECT TRIALLATE 500 HERBICIDE’

Date of variation: 2 March 2016 Product registration no.: 66090 Label approval no.: 66090/105818

Application no.: 105819 Product name: Macro Protect Dicamba 500 Herbicide Active constituent/s: 500 g/L dicamba present as the dimethylamine salt Applicant name: Macrofertil Australia Pty Ltd Applicant ACN: 166 370 976 Summary of variation: To change the distinguishing product name and the name that appears on the label

from ‘RAVENSDOWN DICAMBA 500 HERBICIDE’ to ‘MACRO PROTECT DICAMBA 500 HERBICIDE’

Date of variation: 2 March 2016 Product registration no.: 64759 Label approval no.: 64759/105819

Agricultural Chemical Products and Approved Labels

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Application no: 102974 Product name: Genfarm QPE 200 Herbicide Active constituent/s: 200 g/L quizalofop-p-ethyl Applicant name: Landmark Operations Limited Applicant ACN: 008 743 217 Summary of variation: To add a new pack size Date of variation: 15 March 2016 Product registration no.: 66956 Label approval no.: 66956/102974

Application no.: 102415 Product name: Sipcam Echo 720 Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: Sipcam Pacific Australia Pty Ltd Applicant ACN: 073 176 888 Summary of variation: To extend the use to chickpeas and lentils and updating the WHP Date of variation: 16 March 2016 Product registration no.: 52518 Label approval no.: 52518/102415

Application no: 104993 Product name: Job's Done Weed & Feed For Lawns Active constituent/s: 2.3 g/L dicamba present as the dimethylamine salt,15 g/L MCPA present as the dimethylamine

salt Applicant name: Agcare Pty Ltd Applicant ACN: 159 778 757 Summary of variation: To change the name of the product from ‘JOB'S DONE GARDEN WEED & FEED’ to ‘JOB'S

DONE WEED & FEED FOR LAWNS’ and add pack size range from 2 L–4 L Date of variation: 16 March 2016 Product registration no.: 70042 Label approval no.: 70042/104993

Application no: 104951 Product name: Weed Force Evict Bio 360 Herbicide Active constituent/s: 360 g/L glyphosate present as the isopropylamine salt Applicant name: Weed Force Pty Ltd Applicant ACN: 602 207 152 Summary of variation: To extend use for control of annual and perennial weeds in the home garden and change the

name of the product from ‘WEED FORCE EVICT 360 HERBICIDE’ to ‘WEED FORCE EVICT BIO 360 HERBICIDE’

Date of variation: 17 March 2016 Product registration no.: 80724 Label approval no.: 80724/104951

Application no: 102972 Product name: Retain Plant Growth Regulator Soluble Powder Active constituent/s: 150 g/kg aminoethoxyvinylglycine present as the hydrochloride salt (AVG) Applicant name: Valent Biosciences A Div Of Sumitomo Chemical Australia Applicant ACN: 081 096 255 Summary of variation: To extend the use to cherries to extend flower life Date of variation: 17 March 2016 Product registration no.: 52453 Label approval no.: 52453/102972

Agricultural Chemical Products and Approved Labels

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Application no: 104999 Product name: Job's Done Ant Killer Granular Active constituent/s: 2 g/kg bifenthrin Applicant name: Agcare Pty Ltd Applicant ACN: 159 778 757 Summary of variation: To add a home garden label and vary the pack sizes Date of variation: 17 March 2016 Product registration no.: 69978 Label approval no.: 69978/104999

Application no.: 104047 Product name: Surefire Chlortan 720 Fungicide Active constituent/s: 720 g/L chlorothalonil Applicant name: PCT Holdings Pty Ltd Applicant ACN: 099 023 962 Summary of variation: To extend the use for the control of various diseases in pulses Date of variation: 18 March 2016 Product registration no.: 66860 Label approval no.: 66860/104047

Application no: 62425 Product name: Bioclear Paraffinic Oil Active constituent/s: 823 g/L paraffinic oil (as 1888–1976) Applicant name: Caltex Australia Petroleum Pty Ltd Applicant ACN: 000 032 128 Summary of variation: To extend uses in citrus Date of variation: 22 March 2016 Product registration no.: 58360 Label approval no.: 58360/62425

Application no.: 100588 Product name: Intake Combi Sapphire In-Furrow and Foliar Fungicide Active constituent/s: 500 g/L flutriafol Applicant name: Crop Care Australasia Pty Ltd Applicant ACN: 061 362 347 Summary of variation: To extend the use for control of barley leaf rust in barley Date of variation: 24 March 2016 Product registration no.: 66358 Label approval no.: 66358/100588

4. LABEL APPROVAL

Application no.: 105253 Product name: Relyon Glyphix 450 Herbicide Active constituent/s: 450 g/L glyphosate present as the isopropylamine salt Applicant name: Ruralco Holdings Limited Applicant ACN: 009 660 879 Summary of use: To add a new label for the product with the label name ‘RELYON GLYPHOSATE 450

HERBICIDE’ Date of approval: 18 March 2016 Label approval no.: 81791/105253

Agricultural Chemical Products and Approved Labels

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Application no.: 104397 Product name: IQ Pool Solutions Maintainance Algaecide Active constituent/s: 26 g/L copper (CU) present as cupric sulphate pentahydrate Applicant name: International Quadratics Pty Ltd Applicant ACN: 091 533 167 Summary of use: To add a new label for the product with the label name ‘POOLWISE LONGLIFE

COPPER ALGAECIDE’ Date of approval: 23 March 2016 Label approval no.: 63134/104397

Application no.: 105179 Product name: Ultraforce Aqua Termiticide & Insecticide Active constituent/s: 100 g/L fipronil Applicant name: Sherwood Chemicals Australasia Pty Ltd Applicant ACN: 136 993 630 Summary of use: To add a new label for the product with the label name ‘SHERWOOD FIPFORCE

AQUA TERMITICIDE’ Date of approval: 23 March 2016 Label approval no.: 69524/105179

Application no.: 105280 Product name: Hortico Bindii & Clover Killer Hose-On Active constituent/s: 15 g/L MCPA present as the dimethylamine salt, 2.3 g/L dicamba present as the

dimethylamine salt Applicant name: Duluxgroup (Australia) Pty Ltd Applicant ACN: 000 049 427 Summary of use: To add a new label for the product with the label name ‘YATES LAWN WEEDKILLER

BINDII & CLOVER HOSE ON’ Date of approval: 29 March 2016 Label approval no.: 61376/105280

5. VARIATION OF LABEL APPROVAL

Application no: 104940 Product name: Expedite Full Insecticide Active constituent/s: 500 g/kg sulfoxaflor Applicant name: Dow Agrosciences Australia Limited Applicant ACN: 003 771 659 Summary of variation: To update restraints, add critical comments and update the direction for use on the label Date of variation: 24 March 2016 Product registration no.: 65464 Label approval no.: 65464/104940

Agricultural Chemical Products and Approved Labels

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 15

Veterinary Chemical Products and Approved Labels

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 relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VARIATIONS OF REGISTRATION

Application no.: 105777 Product name: Abbey Tiamulin Premix

Active constituent/s: 25 g/kg tiamulin hydrogen fumarate

Applicant name: Abbey Laboratories Pty Ltd Applicant ACN: 156 000 430

Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘BOMAC TIAMULIN PREMIX’ to ‘ABBEY TIAMULIN PREMIX’

Date of variation: 26 February 2016

Product no.: 62394

Label approval no.: 62394/105777

Application no.: 103531 Product name: Selectan Solution for Injection for Cattle and Pigs Active constituent/s: 300 mg/mL florfenicol Applicant name: Laboratorios Hipra S.A Applicant ACN: N/A

Summary of variation: To extend the use to include the treatment of infections by causative organisms of pink-eye (moraxella bovis), bovine respiratory disease (mannheimia haemolytica, pasteurella multocida and haemophilus somnus) and footrot of cattle (fusobacterium necrophorum and acteroides melaninogenicus) in cattle

Date of variation: 16 March 2016 Product registration no.: 68700 Label approval no.: 68700/103531

Veterinary Chemical Products and Approved Labels

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Approved Active Constituents

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 approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSITUTENT

Application no.: 103162 Active constituent/s: Cloquintocet-mexyl Applicant name: Agrogill Chemicals Pty Ltd Applicant ACN: 094 672 107 Summary of use: For use in agricultural chemical products Date of approval: 16 March 2016 Approval no.: 81464

Application no.: 61643 Active constituent/s: Oxathiapiprolin Applicant name: Du Pont (Australia) Pty Ltd Applicant ACN: 000 716 469 Summary of use: For use in agricultural chemical products Date of approval: 17 March 2016 Approval no.: 69752

Application no.: 103513 Active constituent/s: MCPA Applicant name: Jiangsu Good Harvest-Weien Agrochemical Co Ltd Applicant ACN: N/A Summary of use: For use in agricultural chemical products Date of approval: 24 March 2016 Approval no.: 81639

Application no.: 56877 Active constituent/s: Metaflumizone Applicant name: BASF Australia Ltd Applicant ACN: 008 437 867 Summary of use: For use in agricultural chemical products Date of approval: 24 March 2016 Approval no.: 67787

Approved Active Constituent

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Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 17

New Active Constituent Bixafen

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, bixafen for use as a fungicide in agricultural products.

Common Name Bixafen

IUPAC Name: N-(3',4'-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide

Chemical Abstracts Name: N-(3′,4′-dichloro-5-fluoro[1,1′-biphenyl]-2-yl)-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide

CAS Number: 581809-46-3

Molecular Formula: C18H12Cl2F3N3O

Molecular Weight: 414.21

Structure:

Chemical Family: Anilide fungicide and pyrazole fungicide

Mode of Action: Inhibition of mitochondrial function by disrupting complex II (succinate dehydrogenase) in the respiratory electron transport chain

SUMMARY OF THE APVMA’S EVALUATION OF BIXAFEN ACTIVE CONSTITUENT

The Scientific Assessment and Chemical Review Program of the APVMA has evaluated the chemistry aspects of bixafen active constituent (manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

The Office of Chemical Safety has considered the toxicological aspects of bixafen, and advised that there are no objections on toxicological grounds to the approval of the active constituent bixafen. An Acceptable Daily Intake (ADI) of 0.02 mg/kg bw/d and an Acute Reference Dose (ARfD) of 0.2 mg/kg bw have been set. On 27 November 2015, the Delegate to the Secretary of the Department of Health published a final scheduling decision to create a new Schedule 5 entry for bixafen in the Standard for the Uniform Scheduling of Medicines and Poisons, with no exemption cut-off, and an implementation date of 1 February 2016.

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

N

Cl

Cl

F

H

C

O

N

N

HC F

F

CH3

New Active Constituent Bixafen

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The APVMA is satisfied that the proposed importation and use of bixafen would not be an undue toxicological hazard to the safety of people exposed to it during its handling and use.

MAKING A SUBMISSION

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of bixafen should be granted. Submissions should relate only to matters that the APVMA is required by legislation to consider in deciding whether to grant the approval. These grounds include chemistry and manufacture, and toxicity. 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. A summary of relevant comments and the APVMA’s response will be published on the APVMA website.

When making a submission please include a:

• contact name • company or group name (if relevant) • postal address • email address (if available) • date you made the submission.

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

Written submissions on the APVMA’s proposal to grant approval for bixafen that relate to the grounds for approval should be addressed in writing to:

Director of Chemistry and Manufacture Scientific Assessment and Chemical Review Program Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4701 Fax: +61 2 6210 4721 Email: [email protected]

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

New Active Constituent Bixafen

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Commonwealth of Australia Gazette Agricultural and Veterinary Chemicals Code Act 1994 19

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Bayer CropScience Pty Ltd for registration of a new product containing the new active bixafen and the existing active constituent prothioconazole. The product Aviator Xpro Foliar Fungicide is for use on canola.

PARTICULARS OF THE APPLICATION

Proposed Product Name(s): AVIATOR XPRO FOLIAR FUNGICIDE

Applicant Company: Bayer CropScience Pty Ltd

Name of Active Constituent: Bixafen

Signal Heading: Schedule 5 (CAUTION)

Summary of Proposed Use: For the control of black leg (Leptosphaeria maculans) in canola

Pack Sizes: 10 L, 15 L, 10 L, 20 L, 100 L, 110 L and 1000 L

Withholding Period: Harvest: Not required when used as directed

Grazing: Livestock Not Producing Milk for Human Consumption: Do not graze or cut for stock food for 4 weeks after application.

Livestock Producing Milk for Human Consumption: Do not graze livestock producing milk for human consumption on treated crops.

SUMMARY OF THE APVMA’S EVALUATION OF AVIATOR XPRO FOLIAR FUNGICIDE 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 AVIATOR XPRO FOLIAR FUNGICIDE 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.

Aviator Xpro Foliar Fungicide is intended only for professional use, and farmers and their employees will be the main users of the product. The product will be applied by various ground boom or aerial applications. Workers may be exposed to the product when opening containers, mixing/loading, application, cleaning up spills, maintaining equipment and entering treated crops. The main routes of exposure to the product spray will be dermal and inhalation, with possible ocular exposure.

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

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In the absence of exposure data for bixafen and for the proposed aerial mode of application for prothioconazole, the Pesticide Handler Exposure Database (PHED) Surrogate Exposure Guide was used to estimate exposure. The database was also used to verify the calculated exposure of workers to prothioconazole via ground boom application from submitted exposure studies.

Estimated exposures to the product when preparing and using the spray by ground boom or aerial application were at acceptable levels when wearing personal protective equipment (PPE). Based on the risk assessment, First Aid Instructions, Safety Directions and Re-entry statements have been recommended for the product label.

Based on the risk assessment, First Aid Instructions, Safety Directions and Re-entry statements have been recommended for the product label.

Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Aviator Xpro Foliar Fungicide when used in accordance with the label directions.

(ii) The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE will not be an undue hazard to the safety of people using anything containing its residues.

The product will be used as a foliar spray in canola. The APVMA Residues and Trade Section has evaluated the residues aspects of the proposed product and has recommended amendments to the APVMA MRL Standard for bixafen and for inclusion in the Food Standards Code. Dietary intake modelling has shown the expected chronic and acute dietary exposures to bixafen are both below the relevant health standards. Recommendations in regard to the withholding period and protection statements for livestock have been included on the label.

The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE containing the active constituents bixafen and prothioconazole is not likely to be harmful to human beings if used according to the product label.

Bixafen is a carboxamide fungicide belonging to the sub-class of the pyrazole-carboxamides, a succinate dehydrogenase inhibitor of fungal pathogens. The proposed use of a new emulsifiable concentrate product, Aviator Xpro Foliar Fungicide, containing bixafen at 75 g/L and prothioconazole at 150 g/L, is for the control and/or suppression of foliar diseases in canola. Aviator Xpro Foliar Fungicide will be available in pack sizes between 10 and 1000 L.

In toxicokinetics studies in rats, bixafen was absorbed rapidly and overall oral absorption was high. After absorption, bixafen was widely distributed and detected, at low concentrations, in most examined tissues. Elimination of absorbed bixafen was rapid, with the majority of the administered radioactivity eliminated in faeces within the first 24 hours. Bixafen was highly metabolised with only approximately 9 % was excreted in the unchanged form.

Based on the findings of the acute toxicological studies evaluated, bixafen has low acute oral, dermal and inhalational toxicity in rats. Bixafen is not a skin or eye irritant in rabbits. No determination on whether bixafen is a skin sensitiser could be made, as a guideline-compliant skin sensitisation study was not provided.

Bixafen was generally well tolerated across the species tested in repeat-dose toxicity studies, with decreases in body weight and body weight gain identified along with increases in liver weights, with associated histopathological changes, as the main treatment-related effects. Carcinogenicity studies indicated that bixafen was not carcinogenic in mice or rats. Bixafen was negative in in vitro and in vivo mutagenicity and/or genotoxicity studies.

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

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Bixafen was not a reproductive or developmental toxicant, as measured reproductive and developmental indices, including malformation/variation frequencies, were only seen at doses that showed significant maternal toxicity. Across acute and subchronic studies, bixafen was not a neurotoxicant.

Based on the findings of the acute toxicological studies evaluated, the product Aviator Xpro Foliar Fungicide has low acute oral and dermal toxicity in rats and has low estimated inhalational toxicity. Aviator Xpro Foliar Fungicide was a severe eye and a slight skin irritant in rabbits, and was not a skin sensitiser in mice (LLNA method).

Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Aviator Xpro Foliar Fungicide when used in accordance with the label directions.

(iii) The APVMA is satisfied that the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE containing the active constituents bifaxen and prothioconazole is not likely to have an unintended effect that is harmful to animals, plants or the environment if used according to the product label directions.

Data provided in support of the proposed use have been assessed and it is concluded that the risks to the environment from this use are acceptable provided that the draft label is updated to meet current spray drift requirements.

Bixafen is stable to hydrolysis and photolytic degradation. It is persistent in the terrestrial environment with field half-lives potentially exceeding 1000 days. However, it is not expected to be mobile in soil. When released to water, bixafen may be expected to partition to the sediments where again, it is likely to be very persistent. Bixafen is not likely to bio-accumulate.

Bixafen is practically non-toxic to birds based on acute and dietary exposure. No effects on avian reproduction are expected based on application rates and uses assessed. It was found to be very highly toxic to fish and moderately toxic to aquatic invertebrates based on both acute and chronic exposure.

Bixafen was very highly toxic to two of four standard algal test species and was at worst highly toxic to the standard floating aquatic macropyte, Lemna gibba.

Bixafen generally did not exhibit toxicity towards terrestrial invertebrates or soil microorganisms at levels expected through the proposed use pattern. Tier 1 testing using the formulated end-use product showed some terrestrial plants were potentially based on growth measurements, but mortality was not observed at use rates higher than those currently proposed.

In spite of conservative modelling, the risk assessment determined that the chemical is unlikely to pose an environmental risk under the proposed use pattern, provided the draft label is updated to meet current requirements, and appropriate down-wind spray drift buffer zones are implemented for the protection of sensitive aquatic and terrestrial areas.

The APVMA has considered these findings accepts these conclusions.

(iv) The APVMA is considering whether the proposed use of AVIATOR XPRO FOLIAR FUNGICIDE would not adversely affect trade between Australia and places outside Australia.

Export of treated produce containing finite (measurable) residues of bixafen and prothioconazole may pose a risk to Australian trade in situations where (i) no residue tolerance (import tolerance) is established in the importing country or (ii) where residues in Australian produce are likely to exceed a residue tolerance (import tolerance) established in the importing country.

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

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No changes to established prothioconazole MRLs for rape seed and animal commodities are proposed and therefore the proposed use of prothioconazole is unlikely to increase the risk to international trade.

The proposed residue definition for bixafen is the same as that established by Codex, the EU and New Zealand. International MRLs have not been established for bixafen by Codex, the USA, Korea and Taiwan.

An MRL for canola is proposed at the LOQ (*0.01 mg/kg) and therefore the export of treated canola is unlikely to result in an undue risk to international trade.

Bixafen MRLs for meat [mammalian] [in the fat] and edible offal (mammalian) at 0.1 and 0.3 mg/kg respectively are required for the proposed use on canola. The proposed export slaughter interval of 7 days should adequately prevent residues above the LOQ of 0.02 mg/kg in animal commodities destined for export.

The following label statements have been proposed to manage the trade risk associated with the proposed use:

‘EXPORT OF TREATED PRODUCE: Growers should note that MRLs or import tolerances do not exist in all markets for produce treated with Aviator Xpro. If you are growing produce for export, please check with Bayer CropScience for the latest information on MRLs and import tolerances before using Aviator Xpro’, and, ‘EXPORT SLAUGHTER INTERVAL (ESI)—7 DAYS: Livestock not producing milk for human consumption that have been grazing on treated crops should be placed on clean feed for 7 days prior to slaughter’.

Comment is sought from the relevant industry groups on the perceived level of risk and whether any industry-initiated strategies are required to manage that risk.

(v) 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 is effective 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, or by contacting the APVMA via the details 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 AVIATOR XPRO FOLIAR FUNGICIDE 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)

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

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• 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.

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:

Case Management and Evaluation Registration Management and Evaluation Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4700 Fax: +61 2 6210 4776 Email: [email protected]

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

New Agricultural Chemical Products Bixafen in Aviator Xpro Foliar Fungicide

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Cancellation of Label Approval at the Request of the Holder At the request of the holder, the APVMA has cancelled the following label approvals:

Product no. Product name Holder Cancelled Label Approvals

Date of effect

62511 TITAN DIMETHOATE 400 SYSTEMIC INSECTICIDE

TITAN AG PTY LTD 62511/0108

62511/0808

11 March 2016

The following instructions set out how a person can deal with the product bearing a cancelled label.

SUPPLY

A person may supply or cause to be supplied product bearing a cancelled label manufactured prior to 11 March 2016 only in accordance with the instructions at the end of this notice, at wholesale and retail level, until 11 March 2017.

After 11 March 2017 it will be 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.

USE

A person may continue to use the product bearing a cancelled label only in accordance with the instructions at the end of this notice, until 11 March 2017.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing a cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product bearing a cancelled label after the approval has been cancelled until 11 March 2017.

The supply and use of the product bearing a cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

Permits, with modified instructions for use of dimethoate products, have been issued under section 114 of the Agvet Code (PER 13155 for agricultural products). The instructions for use have been reproduced at the end of this Notice. This permit still applies to product bearing this cancelled label.

It is an offence to possess, have custody of, use, or deal with the product bearing a cancelled label listed in the table in a manner that contravenes the above instructions.

WARNING

Failure to comply with the instructions in this Notice attracts a penalty under section 45C(5) of the Agvet Code. The penalty is 300 penalty units (equivalent to $54,000 for individuals and $270,000 for corporations).

Cancellation of Label Approval at the Request of the Holder

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APVMA CONTACT

For any enquiries or further information about this matter, please contact: Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 SYMONSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

INSTRUCTIONS FOR POSSESSING, HAVING CUSTODY OF, USING OR DEALING WITH REGISTERED PRODUCTS CONTAINING DIMETHOATE BEARING CANCELLED LABELS

Possession and custody

A person may possess, have custody of, use or otherwise deal with the registered dimethoate products, bearing a cancelled label only in accordance with these instructions or permits PER 13155 for agricultural products issued by the APVMA.

Supply

A person may supply or cause to be supplied product bearing the cancelled label approvals 62511/0108 or 62511/0808 manufactured prior to 11 March 2016, at wholesale and retail level only in accordance with the instructions in this notice, until 11 March 2017.

After 11 March 2017 it will be an offence against the Agvet Codes to have possession or custody of a product bearing a cancelled label with the intention to supply.

All suppliers must at the time of the supply of a product covered by these instructions provide to the person taking responsibility for the supplied product:

• a copy of the relevant permit (PER 13155 for agricultural products) in full setting out the conditions and instructions for use, and

• supply product with a copy of the instructions contained in that permit securely affixed to each container of product.

Use

PERSONS who wish to use registered products containing dimethoate, bearing cancelled labels (as listed above) 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.

Cancellation of Label Approval at the Request of the Holder

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READ THESE INSTRUCTIONS before using or otherwise handling the product.

When using or otherwise handling the product, follow the instructions of the current label except as follows:

PROHIBITED CROP USES: AGRICULTURAL PRODUCTS The existing (cancelled) label may include instructions for use on the crops listed below. The use of dimethoate on these crops is no longer approved and the following restraints apply.

DO NOT USE as a post-harvest treatment for capsicums or tomatoes.

DO NOT USE as a post-harvest quarantine treatment for capsicums or tomatoes.

DO NOT USE on tomatoes grown in covered or protected situations such as glasshouses, green houses or plastic tunnels.

DO NOT USE on cherry, grape or mini tomatoes

DO NOT USE as a foliar, post harvest or quarantine treatment on: • Tropical or subtropical edible peel fruit [babacos, carambolas (Five Corner), figs and edible peel varieties of guavas,

kiwifruit and persimmons]. • Pome fruit [apples, loquats, pears, quinces], • Stone fruit after petal fall [apricots, cherries, nectarines, peaches, plums, apricot], • Grapes after commencement of flowering, • Berry fruit, (other than blackberries, raspberries, bilberries, blueberries and other vaccinium berries) • Strawberries (except strawberry runners – vegetative planting material only) • Cucurbits (other than melons, watermelons and zucchini) • Vegetables, other than those listed below

o Dimethoate may be used on artichoke (globe), asparagus, beans, beetroot, broccoli, cabbage (drumhead varieties only),capsicums, carrot, cauliflower, celery, chilli peppers, peas, potatoes and sweet potatoes, onion, parsnips, radish, rhubarb, sweetcorn, tomatoes for processing, tomatoes (large field grown for fresh consumption, prior to commencement of flowering), turnip and zucchini,

Directions for Use:

These directions for use must be used in conjunction with existing label directions and the restraint statements. Where the instructions in this notice are inconsistent with the label instructions, the instructions in this notice must be followed.

Table 1 Crops where existing label directions may continue to be followed. Fruit crops Vegetable crops Non-food crops

Abius Avocado Banana Blackberries Cactus fruit Casimiroas (white sapote) Chinese Gooseberries (kiwifruit) (inedible peel varieties ONLY) Citrus fruit Custard apple and cherimoya Feijoa Granadillas Guavas (inedible peel varieties only) Litchis (lychee) Mangoes Passionfruit and banana passionfruit Pawpaw (papaya) Persimmons (American—inedible peel varieties ONLY) Pomegranates Raspberries Santols Sapodillas (chikus) Tamarillos Wax jambus

Existing labels include preharvest uses only Asparagus Melons and watermelons Onions Rhubarb Watermelons Zucchini Seed dressings (vetches, lupins, peas, lucerne, clover, linseed, canola)

Duboisia, Farm and forest trees Eucalyptus Kurrajongs Oil tea-tree Ornamentals, protea Shrubs Umbrella trees Wildflowers

Cancellation of Label Approval at the Request of the Holder

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 27

Table 2: Crops that are subject to additional restrictions/variations to their existing approved use patterns

Crop Additional use restrictions Blueberries, bilberries and other vaccinium berries

DO NOT exceed a maximum number of 7 applications per crop per season with a minimum retreatment interval of 21 days between consecutive applications. DO NOT harvest for 1 day after final application.

Grapes DO NOT use after flowering commences Stone fruit DO NOT use after petal fall Artichoke, globe

DO NOT harvest for 14 days after final application Beetroot

Beans DO NOT harvest for 7 days after application DO NOT graze or cut for stockfood for 7 days after application

Broccoli DO NOT harvest for 21 days after final application

Cabbage specified drumhead varieties only when grown to maturity to be harvested as head cabbages (see Attachment 3)

DO NOT harvest for 21 days after final application

Capsicum DO NOT USE as a post-harvest treatment for capsicums. DO NOT USE as a post-harvest quarantine treatment for capsicums..

Chilli Preharvest uses DO NOT harvest for 3 days after application

Carrots DO NOT harvest for 14 days after final application

Cauliflower DO NOT harvest for 21 days after final application

Celery

Peas DO NOT harvest for 7 days after application DO NOT graze or cut for stockfood for 7 days after application

Parsnips DO NOT harvest for 14 days after final application

Potatoes DO NOT harvest for 14 days after final application

Sweet potatoes

Radishes DO NOT harvest for 14 days after application

Strawberry (runner production—vegetative planting material only)

DO NOT use on fruiting strawberries

Sweet corn DO NOT harvest for 7 days after application DO NOT graze or cut for stockfood for 7 days after application

Tomatoes for processing only DO NOT harvest for 21 days after final application DO NOT USE as a post-harvest treatment for tomatoes. DO NOT USE as a post-harvest quarantine treatment for tomatoes. DO NOT USE on tomatoes grown in covered or protected situations such as glasshouses, green houses or plastic tunnels DO NOT USE on cherry, grape or mini tomatoes

Tomatoes, large, field grown for fresh consumption

DO NOT apply after commencement of flowering DO NOT USE on tomatoes grown in covered or protected situations such as glasshouses, green houses or plastic tunnels. DO NOT USE as a post-harvest treatment for tomatoes. DO NOT USE as a post-harvest quarantine treatment for tomatoes. DO NOT USE on cherry, grape or mini tomatoes

Turnips DO NOT harvest for 14 days after final application

Cereals, (including maize, sorghum) DO NOT harvest for 4 weeks after application DO NOT graze or cut for stockfood for 14 days after application

Cotton

DO NOT harvest for 14 days after application DO NOT Feed Cotton Fodder, Stubble or Trash To Livestock

Oilseeds, pulses (grain legumes)

DO NOT harvest for 14 days after application DO NOT graze or cut for stockfood for 14 days after application

Pastures, forage crops and leucaena DO NOT graze or cut for stockfood for 14 days after application

Cancellation of Label Approval at the Request of the Holder

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 28

WITHHOLDING PERIODS (see Additional Use Restrictions above)

Citrus DO NOT harvest for 7 days after application

Blueberries (and other vaccinium berries including bilberries) DO NOT harvest for 1 day after application

Blackberries, raspberries DO NOT harvest for 7 days after application

Grapes, Stone fruit Harvest withholding period: Not required when used as directed

Assorted sub-tropical and tropical fruit—inedible peel (other than mango and pineapple), including abui, avocado, banana, banana passionfruit, casimiroas (white sapote), cherimoya, custard apple, granadillas, litchi/lychee, passionfruit, paw paw, santols, sapodillas (chikus), wax jambus DO NOT harvest for 7 days after application

Mango DO NOT harvest for 3 days after application

Post harvest dipping (avocados, bananas, cactus fruit, chilli, custard apples, feijoas, guavas, kiwifruit (chinese gooseberries inedible peel varieties), litchis (lychees), mangoes, melons, passionfruit, banana passionfruit, pawpaws, persimmons (inedible peel varieties), pomegranates, tamarillos, watermelons) NOT REQUIRED WHEN USED AS DIRECTED (dip uses only)

Litchis (Lychees) (pre-planting dip) Harvest withholding period: Not required when used as directed

Asparagus, onions, rhubarb, sweet corn DO NOT harvest for 7 days after application

Beans, peas (green vegetables), sweetcorn DO NOT harvest for 7 days after application DO NOT graze or cut for stockfood for 7 days after application

Beetroot, carrot, globe artichoke, parsnips potatoes, radish, sweet potatoes, turnip DO NOT harvest for 14 days after application.

Broccoli, cauliflower, celery DO NOT harvest for 21 days after application

Strawberry plants (runner production—vegetative planting material only) NOT REQUIRED WHEN USED AS DIRECTED

Tomatoes (for processing) DO NOT harvest for 21 days after application

Tomatoes, large, field grown for fresh consumption Harvest withholding period: NOT REQUIRED WHEN USED AS DIRECTED (ie. DO NOT apply after commencement of flowering)

Drumhead cabbage (specified varieties only) DO NOT harvest for 21 days after application

Capsicums, chilli peppers DO NOT harvest for 3 days after application

Melons (including watermelons), zucchini DO NOT harvest for 1 day after application

Cereals, (including maize, sorghum) DO NOT harvest for 4 weeks after application DO NOT graze or cut for stockfood for 14 days after application

Cotton DO NOT harvest for 14 days after application DO NOT Feed cotton fodder, stubble or trash to livestock

Oilseeds, Pulses (grain legumes) DO NOT harvest for 14 days after application DO NOT graze or cut for stockfood for 14 days after application

Pastures, forage crops and leucaena DO NOT graze or cut for stockfood for 14 days after application

Cancellation of Label Approval at the Request of the Holder

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 29

Seed dressings (vetches, lupins, peas, lucerne, clover, linseed canola), NOT REQUIRED WHEN USED AS DIRECTED

Table 3: Specified varieties of drumhead cabbage. dimethoate may be used on these varieties to be grown to maturity to be harvested as head cabbages

Seed company Drumhead Cabbage varieties Fairbanks seed Avachat F1, grandslam F1, superba Terranova Neptune, winterhead, red queen, green coronet, eureka Lefroy valley seeds Conquistador, burton, landini Rijk zwaan Racoma RZ F1 Ace Major F1, red gem S&G seeds Maxfield SPS Arixos, Asia, kameron, red jewel Bejo seeds Ducat F1, gazelle F1, megaton F1, benelli F1, gonzales F1, mandy F1, field

glory F1, score F1 Eden seeds Golden acre, mammoth red rock King seeds Campra F1, sunta Yates Racer drumhead, red dutch Australian seed Mammoth red rock, all seasons

Cancellation of Label Approval at the Request of the Holder

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 30

Cancellation of Label Approval at the Request of the Holder At the request of the holder, the APVMA has cancelled the following label approval:

Product no. Product name Holder Cancelled Label Approvals

Date of effect

66585 CUPRO ISAGRO 375 WG FUNGICIDE

ISAGRO AUSTRALIA PTY LIMITED

66585/53942 30 March 2016

The following instructions set out how a person can deal with the product bearing a cancelled label.

SUPPLY

A person may supply or cause to be supplied product bearing a cancelled label manufactured prior to 30 March 2016 at wholesale and retail level, until 30 March 2017.

After 30 March 2017 it will be 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.

USE

A person may continue to use the product bearing a cancelled label according to its label instructions until 30 March 2017.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product bearing a cancelled label in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product bearing a cancelled label after the approval has been cancelled until 30 March 2017.

The supply and use of the product bearing a cancelled label must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

It is an offence to possess, have custody of, use, or deal with the product bearing a cancelled label listed in the table in a manner that contravenes the above instructions.

APVMA CONTACT

For any enquiries or further information about this matter, please contact: Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 SYMONSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Cancellation of Label Approval at the Request of the Holder

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Cancellation of Registration and Approval at the Request of the Holder At the request of the holder, the APVMA has cancelled the registration and the associated label approvals of the following product:

Product/active no. Product/active name Registrant/approval holder Date of effect

59539 SARRITOR INSECTICIDE/MITICIDE

ZELAM PTY LTD 30 March 2016

The following instructions set out how a person can deal with the cancelled product.

SUPPLY

A person may supply or cause to be supplied product manufactured prior to 30 March 2016 at wholesale and retail level, until the 30 March 2017.

After 30 March 2017 it will be an offence against the Agvet Codes to have possession or custody of the product with the intention to supply, or to supply the product.

USE

A person may continue to use the product according to its label instructions until 30 March 2017.

Any person who possesses, has custody of, uses, or otherwise deals with the listed product in accordance with the above instructions is taken to have been issued with a permit under the Agvet Codes to so possess, have custody of, use or otherwise deal with the product after the registration has been cancelled until 30 March 2016.

The supply and use of the product must be in accordance with the conditions of registration or approval, including any conditions relating to the shelf life or expiry date.

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.

APVMA CONTACT

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

Chemical Review Australian Pesticides and Veterinary Medicines Authority PO Box 6182 SYMONSTON ACT 2609 Phone: +61 2 6210 4749 Fax: +61 2 6210 4776 Email: [email protected]

Cancellation of Registration and Approval at the Request of the Holder

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 32

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 Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012. 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 APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 4).

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.

The MRL Standard is accessible via the ComLaw website www.comlaw.gov.au or the links above.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Amendments to the APVMA MRL Standard

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 33

Proposal to amend Schedule 20 in the revised Australia New Zealand Food Standards Code

In the previous notice, the APVMA gazetted 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, have been made.

Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2016 (No. 4)) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.

MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 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 Schedule 20 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.

Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 34

PROPOSED AMENDMENT (AGRICULTURAL AND VETERINARY CHEMICALS CODE INSTRUMENT NO. 4 (MRL STANDARD) AMENDMENT INSTRUMENT 2016 (NO. 4))

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

[1] The table to section S20—3 in Schedule 20 is varied by

[1.1] omitting all entries for the following chemical

Agvet chemical: Propineb

see Dithiocarbamates

[1.2] inserting in alphabetical order

Agvet chemical: Propineb

Permitted residue: Propylenediamine (PDA), expressed as propineb Celery 2 Citrus fruits 10 Dried grapes 30 Edible offal (mammalian) *0.05 Fruiting vegetables, cucurbits 2 Grapes 20 Lettuce, head 10 Lettuce, leaf 10 Meat (mammalian) *0.05 Milks *0.05 Onion, bulb 2 Potato 0.3 Tomato 5

[1.3] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Difenoconazole

Permitted residue: Difenoconazole

Table grapes 2

Agvet chemical: Fenvalerate

Permitted residue: Fenvalerate, sum of isomers

Olives T1 Olive oil, refined T7

Agvet chemical: Imazapic

Permitted residue: Sum of imazapic and its hydroxymethyl derivative Barley 0.02

Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code

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Agvet chemical: Imazapyr

Permitted residue: Imazapyr

Eggs *0.01 Poultry, edible offal of *0.01 Poultry meat (in the fat) *0.01

Agvet chemical: Quinoxyfen

Permitted residue: Quinoxyfen Barley *0.01 Eggs *0.01 Milk fats 0.2 Poultry, edible offal of *0.01 Poultry meat (in the fat) *0.01

[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting

Agvet chemical: Bixafen

Permitted residue—commodities of plant origin: Bixafen

Permitted residue—commodities of animal origin: Sum of bixafen and N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1H-pyrazole-4-carboxamide (bixafen-desmethyl), expressed as bixafen Eggs *0.02 Milks *0.02 Poultry, edible offal of *0.02 Poultry meat (in the fat) *0.02 Rape seed *0.01

Agvet chemical: Difenoconazole

Permitted residue: Difenoconazole

Beetroot 0.5 Celery 3

Agvet chemical: Milbemectin

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

Pome fruits 0.03

Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 36

INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Schedule 20–Maximum residue limits in 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.

Submissions must be made in writing and should be clearly marked as a ‘submission on the proposed amendment to Schedule 20’ and quote the correct amendment number.

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 3 May 2016

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.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Proposal to amend Schedule 20 of the Australia New Zealand Food Standards Code

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 5 April 2016 Agricultural and Veterinary Chemicals Code Act 1994 37

Variations to Schedule 20 of the Australia New Zealand Food Standards Code

The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in Schedule 20–Maximum Residue Limits of the Australia New Zealand Food Standards Code. This notice pertains to proposals (No. 1) gazetted on 12 January 2016 (No. APVMA 1).

Submissions have been sought on these proposals and the APVMA has written separately to each person or organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA 3, 2016) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments together with their Explanatory Statement, please refer to the Federal Register of Legislative Instrument available on the Comlaw website at www.comlaw.gov.au.

Based on dietary exposure assessments and current health standards, the APVMA and FSANZ are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods consistent with the effective control of pests and diseases.

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) made Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

The variations take effect as from the date of this notice.

This notice is published in accordance with subsection 82(7) of the Food Standards Australia New Zealand Act 1991.

For further information please contact:

Residues Contact Officer Australian Pesticides and Veterinary Medicines Authority PO Box 6182 KINGSTON ACT 2604 Phone: +61 2 6210 4897 Fax: +61 2 6210 4840 Email: [email protected]

Variations to Schedule 20 of the Australia New Zealand Food Standards Code

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Australia New Zealand Food Standards Code—Schedule 20–Maximum residue

limits Variation Instrument No. APVMA 3, 2016

I, Rajumati Bhula, Executive Director, Scientific Assessment and Chemical Review and delegate of the Australian Pesticides and Veterinary Medicines Authority, acting in accordance with my powers under subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992, make this instrument for the purposes of subsection 82(1) of the Food Standards Australia New Zealand Act 1991.

Rajumati Bhula Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority

Dated this Thirty First day of March 2016

Variations to Schedule 20 of the Australia New Zealand Food Standards Code

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Part 1 Preliminary 1 Name of instrument This instrument is the Australia New Zealand Food Standards Code—

Schedule 20–Maximum residue limits Variation Instrument No. APVMA 3, 2016.

2 Commencement In accordance with subsection 82(8) of the Food Standards Australia New

Zealand Act 1991, this instrument commences on the day it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of Australia Agricultural and Veterinary Chemicals Gazette No. APVMA 7 of 5 April 2016.

3 Object

The object of this instrument is for the APVMA to make variations to Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits pertaining to agricultural and veterinary chemical products.

4 Interpretation In this instrument: — APVMA means the Australian Pesticides and Veterinary Medicines

Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

Principal Instrument means Schedule 20–Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the Code published in Gazette No. P 27 on 27 August 1987 together with any amendments of the standards in that Code. Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 (F2015L00468).

Part 2 Variations to Schedule 20–Maximum Residue Limits

5 Variations to Schedule 20

The Schedule to this instrument sets out the variations made to the Principal Instrument by this instrument.

Variations to Schedule 20 of the Australia New Zealand Food Standards Code

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Schedule

Variations to Schedule 20–Maximum residue limits [1] The table to section S20—3 in Schedule 20 is varied by

[1.1] omitting the chemical residue definition for Abamectin and substituting the following Permitted residue: Avermectin B1a

[1.2] omitting from each of the following chemicals, the foods and associated MRLs

Agvet chemical: Abamectin

Permitted residue: Sum of avermectin B1a, avermectin B1b and (Z)-8,9 avermectin B1a, and (Z)-8,9 avermectin B1b Chervil T0.5 Egg plant 0.02 Lettuce, head 0.05 Onion, Welsh T0.05 Peppers T0.1 Shallot T0.05 Spring onion T0.05 Tomato 0.05 Watercress T0.5

Agvet chemical: Sethoxydim

Permitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydim Brassica leafy vegetables T2 Chard (silver beet) T*0.1 Chicory leaves T2 Endive T2 Rucola (rocket) T2 Spinach *0.1

Variations to Schedule 20 of the Australia New Zealand Food Standards Code

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[1.3] inserting for each of the following chemicals the foods and associated MRLs in alphabetical order

Agvet chemical: Abamectin

Permitted residue: Sum of avermectin B1a, avermectin B1b and (Z)-8,9 avermectin B1a, and (Z)-8,9 avermectin B1b Beetroot leaves 0.5 Bulb vegetables T0.05 Cabbages, head T0.05 Celery T0.05 Fruiting vegetables, other than cucurbits [except mushrooms, sweet corn (corn-on-the-cob)]

T0.1

Leafy vegetables [except lettuce, leaf] T0.5 Legume vegetables [except peas (pods and succulent, immature seeds)]

T0.1

Root and tuber vegetables T*0.01

Agvet chemical: Sethoxydim

Permitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydim Leafy vegetables [except lettuce, head; lettuce, leaf]

T0.5

[1.4] omitting for each of the following chemicals, the maximum residue limit for the food and substituting

Agvet chemical: Abamectin

Permitted residue: Sum of avermectin B1a, avermectin B1b and (Z)-8,9 avermectin B1a, and (Z)-8,9 avermectin B1b Cucumber T0.05 Fruiting vegetables, cucurbits [except cucumber; squash, summer]

0.02

Squash, summer T0.05

Agvet chemical: Sethoxydim

Permitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydim Egg plant T0.1 Peas (pods and succulent, immature seeds)

T0.7

Peppers T2 Radicchio T0.5

Variations to Schedule 20 of the Australia New Zealand Food Standards Code