apvma gazette no. 13, 30 june 2015...no. apvma 13, tuesday, 30 june 2015 agricultural and veterinary...

No. APVMA 13, Tuesday, 30 June 2015

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

Commonwealth of Australia Gazette No. APVMA 13, Tuesday, 30 June 2015 Agricultural and Veterinary Chemicals Code Act 1994 2

Commonwealth of Australia 2015

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:

The Manager, Public Affairs and Communications

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 grant ed 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 activ ity in

quarterly statistical reports.

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www.apvma.gov.au/publications/gazette/.

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APVMA CONTACTS

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

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CONTENTS

Erratum Notice ................................................................................................................................................................ 3 Agricultural Chemical Products and Approved Labels..................................................................................................... 4 Veterinary Chemical Products and Approved Labels .................................................................................................... 14 Approved Active Constituents ....................................................................................................................................... 20 Fluensulfone in the product Nimitz 480 EC Nematicide ................................................................................................ 21

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 1, Tuesday, 13 January 2015

In the Notice, the active constituent under ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic Fragrance was

incorrectly stated as 1.1 g/kg esbiothrin. The correct amount is 1.26 g/kg esbiothrin.

The correct entry for the Notice of Registration for ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic

Fragrance is on page 4 of this Gazette.


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 EXISTING ACTIVE CONSTITUENTS

Application no.: 100113

Product name: ATLAS Flying Insect Spray Fast Knockdown Hypoallergenic Fragrance

Active constituent/s: 1.26 g/kg esbiothrin, 0.5 g/kg permethrin

Applicant name: Pascoe's Pty Ltd

Applicant ACN: 055 220 463

Summary of use For use as a household insecticide to control a range of flying and crawling insects

Date of registration/approval: 16 December 2014

Product registration no.: 80044

Label approval no.: 80044/100113


Product name: General 100 EC Insect Growth Regulator

Active constituent/s: 100 g/L pyriproxyfen

Applicant name: Aako Australia Pty Limited


Summary of use For the control of silverleaf whitefly (Bemisia tabaci Biotype B) in cotton, rockmelon and capsicum, the control of silverleaf whitefly (Bemisia tabaci Biotype B) and greenhouse

whitefly in tomatoes

Date of registration/approval: 11 June 2015




Product name: Ruby 100 EC Systemic Fungicide

Active constituent/s: 100 g/L penconazole

Applicant name: Agritrading Pty Limited


Summary of use For the control black spot (apple scab and pear scab) of apples and pears, powdery mildew

of apples and grapes and ring spot of brussel sprouts





Product name: Farmalinx Metalax G Fungicide

Active constituent/s: 50 g/kg metalaxyl

Applicant name: Farmalinx Pty Ltd


Summary of use For control of phytophthora root rot of avocados, phytophthora root rot and trunk canker of macadamia nuts, phytophthora trunk rot of peaches, damping off of certain vegetable crops







Product name: Aimco Tree And Blackberry Killer

Active constituent/s: 50 g/L triclopyr present as butoxyethanol ester

Applicant name: Aimco KR Australia Pty Ltd


Summary of use For the control of hard-to-kill weeds and trees in the home garden





Product name: Goliath Liquid Ant Bait

Active constituent/s: 0.6 g/L fipronil

Applicant name: BASF Australia Ltd


Summary of use For control of ants in and around domestic, commercial and institutional buildings





Product name: Apparent Pound 240 Herbicide

Active constituent/s: 240 g/L carfentrazone-ethyl

Applicant name: Apparent Pty. Ltd.


Summary of use For the control of marshmallow and certain other broadleaf weeds prior to establishment of broadacre crops, fallow or forest plantations, in commercial, industrial, and public service areas, around agricultural buildings and yards and other situations





Product name: Ratshot-G Rodenticide Grain Bait

Active constituent/s: 0.05 g/kg difenacoum

Applicant name: Freezone Public Health Pty Ltd


Summary of use For the control of brown or norway rats and mice for use in and around buildings and domestic dwellings





Product name: Plant Doctor's Natural Plant, Garden & Indoor Insecticide

Active constituent/s: 880 g/kg diatomaceous earth, 2 g/kg pyrethrins, 10 g/kg piperonyl butoxide

Applicant name: Grow Choice Pty Limited


Summary of use Control of insect pests in the home garden and in the home







Product name: AC Difnil 275 EC Herbicide

Active constituent/s: 250 g/L bromoxynil present as the octanoate, 25 g/L diflufenican

Applicant name: Axichem Pty Ltd


Summary of use For the control of certain broadleaf weeds in winter cereals and pasture





Product name: Eureka! Isoxaflutole 750 WG Herbicide

Active constituent/s: 750 g/kg isoxaflutole

Applicant name: Eureka! Agresearch Pty Ltd


Summary of use For use in the control of various broadleaf weeds and grasses in sugarcane and chickpeas





Product name: Protect-us Aquavate Mosquito Growth Regulator

Active constituent/s: 12 g/kg (S)-methoprene

Applicant name: Ensystex Australasia Pty Ltd


Summary of use For the prevention of adult mosquito emergence in aquatic situations





Product name: Apollini 540 K Herbicide

Active constituent/s: 540 g/L glyphosate present as the potassium salt

Applicant name: Alpha Crop Protection Pty Ltd


Summary of use For the control of many annual and perennial weeds





Product name: Imtrade Carfentrazone-ethyl 240 EC Herbicide

Active constituent/s: 240 g/L carfentrazone-ethyl

Applicant name: Imtrade Australia Pty Ltd


Summary of use For the control of a range of broadleaf weeds in various situations in combination with other knockdown herbicides







Product name: Baracuda Duck Gone

Active constituent/s: 100 g/L benzalkonium chloride, 23.5 g/L alcohol ethoxylate

Applicant name: Zodiac Group Australia Pty Ltd


Summary of use To assist with discouraging ducks from entering swimming pools



Label approval no.: 80966_102015


Product name: Baracuda Spa Bromine Tablets

Active constituent/s: 650 g/kg available bromine and 280 g/kg available chlorine (Cl) present as bromochlorodimethylhydantoin



Summary of use For killing and controlling algae and bacteria in spas





Product name: Baracuda Pool Algaecide

Active constituent/s: 150 g/L benzalkonium chloride



Summary of use For the control of algae in swimming pools





Product name: AC Ruffle Herbicide

Active constituent/s: 420 g/L MCPA present as potassium salt 26 g/L picloram present as potassium salt



Summary of use For the control of climbing buckwheat, common sowthistle, skeleton weed, capeweed, doublegee and other broadleaf weeds in winter cereals and linseed crops





Product name: CSA Algae Killer

Active constituent/s: 28 g/L copper (Cu) present as copper sulphate pentahydrate, 20 g/L benzalkonium chloride

Applicant name: Chemical Systems Australia Pty Ltd









Product name: CSA Algae Killer

Active constituent/s: 32 g/L copper (Cu) present as copper sulphate pentahydrate

Applicant name: Chemical Systems Australia Pty Ltd







Product name: Baracuda Algae Killer

Active constituent/s: 40 g/L copper (CU) present as cupric ammonium complex



Summary of use For controlling algae in swimming pools





Product name: Spalding Dicamba 500 Selective Herbicide

Active constituent/s: 500 g/L dicamba (present as the dimethylamine salt)

Applicant name: Spalding Holdings Pty. Ltd.


Summary of use For the control of certain broadleaf weeds in a variety of situations





Product name: Pendant Herbicide + Fertiliser 12–5–14

Active constituent/s: 5 g/kg pendimethalin

Applicant name: Amgrow Pty Ltd


Summary of use For the pre-emergent control of winter grass, summer grass and crowsfoot in turf





Product name: Kincho Powder Betacyfluthrin 1.5 Insecticide Dust

Active constituent/s: 1.5 g/kg betacyfluthrin

Applicant name: Shanghai Shengnong International Co., Ltd

Applicant ACN: N/A

Summary of use For control of ants in household situations







Product name: AC Mepipower 38 Cotton Growth Regulator

Active constituent/s: 38 g/L mepiquat (present as the chloride)



Summary of use For the management of fruiting and excessive vegetative growth in cotton





Product name: AC Dissaray Herbicide

Active constituent/s: 340 g/L MCPA (present as the dimethylamine salt), 80 g/L dicamba (present as the dimethylamine salt)



Summary of use For control of certain broadleaf weeds





Product name: AC Methoate 290 Insecticide

Active constituent/s: 290 g/L omethoate (an anticholinesterase compound)



Summary of use For control of redlegged earth mite, blue oat mite and lucerne flea on pastures, cereals, oilseed and legume crops and control of bluegreen aphid and cowpea aphid on pasture legumes, lucerne, faba beans and vetch




2. VARIATIONS OF REGISTRATION

Application no: 102562

Product name: Pool Pro Blackspot Algaecide

Active constituent/s: 32 g/L copper present as a complex blend of copper salts, 200 g/L benzalkonium chloride

Applicant name: The Pops Group Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘POOL PRO BLACK SPOT REMOVER’ to ‘POOL PRO BLACKSPOT ALGAECIDE’

Date of variation: 12 May 2015






Product name: Apparent Bow Saw 600 Herbicide

Active constituent/s: 600 g/kg metsulfuron-methyl

Applicant name: Apparent Pty. Ltd


Summary of variation: To change the distinguishing name of the product and the name that appears on the label from ‘APPARENT METSULFURON 600 WG HERBICIDE’ to ‘APPARENT BOW SAW 600 HERBICIDE’





Product name: Apparent Purge 450 IPA Herbicide

Active constituent/s: 450 g/L 2,4-D present as the isopropylamine salt

Applicant name: Apparent Pty. Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘APPARENT 2,4-D 450 IPA HERBICIDE’ to ‘APPARENT PURGE 450 IPA HERBICIDE’





Product name: Velpar DF Herbicide

Active constituent/s: 750 g/kg hexazinone

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘DUPONT VELPAR DF HERBICIDE’ to ‘VELPAR DF HERBICIDE’





Product name: Oust Herbicide

Active constituent/s: 750 g/kg sulfometuron-methyl

Applicant name: Bayer Cropscience Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘DUPONT OUST HERBICIDE’ to ‘OUST HERBICIDE’





Product name: Pool Algaecide MSA Extreme

Active constituent/s: 40 g/L copper present as copper sulfate pentahydrate

Applicant name: Biolab Australia Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘POOL ALGAECIDE BANISH’ to ‘POOL ALGAECIDE MSA EXTREME’







Product name: Ametrex 800 WG Herbicide

Active constituent/s: 800 g/kg ametryn

Applicant name: Adama Australia Pty Limited


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FARMOZ AMETREX 800 WG HERBICIDE’ to ‘AMETREX 800 WG HERBICIDE’





Product name: Scotts Lawn Builder Weed, Feed & Green-Up

Active constituent/s: 2.3 g/L dicamba present as the dimethylamine salt, 15 g/L MCPA present as the dimethylamine salt

Applicant name: Scotts Australia Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘SCOTTS LAWN BUILDER WEED & FEED’ to ‘SCOTTS LAWN BUILDER WEED, FEED & GREEN-UP’

Date of variation: 2 June 2015




Product name: Hopstop Humane Spray Control For Cane Toads

Active constituent/s: 40 g/kg chloroxylenol

Applicant name: Ensystex Australasia Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘HOPSTOP SPRAY CONTROL FOR CANE TOADS’ to ‘HOPSTOP HUMANE SPRAY CONTROL FOR CANE TOADS’





Product name: Klorman Watertech Chlorine Pellets

Active constituent/s: 680 g/kg available chlorine (CI) present as calcium hypochlorite

Applicant name: Klorman Industries Pty Ltd


Summary of variation: To add an additional label name to the product under ‘KLORMAN WATERTECH DRY CHLORINE 700’







Product name: Family Protection Aerogard Low Irritant* Odourless 4 Hours Protection Great For Kids 12 Months+ Insect Repellent

Active constituent/s: 95 g/kg picaridin

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS+ INSECT REPELLENT’ to ‘FAMILY PROTECTION AEROGARD LOW IRRITANT* ODOURLESS 4 HOURS PROTECTION GREAT FOR KIDS 12 MONTHS+ INSECT REPELLENT’





Product name: Family Protection Aerogard Low Irritant* Odourless 4 Hours Protection Great For Kids 12 Months + Insect Repellent Spray

Active constituent/s: 92.8 g/L picaridin

Applicant name: Reckitt Benckiser (Australia) Pty Limited


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘FAMILY PROTECTION AEROGARD ODOURLESS PROTECTION 4 HOURS PROTECTION LOW IRRITANT* GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT SPRAY’ to ‘FAMILY PROTECTION AEROGARD LOW IRRITANT* ODOURLESS 4 HOURS PROTECTION GREAT FOR KIDS 12 MONTHS + INSECT REPELLENT SPRAY’





Product name: DeLaval Cidisan Acid Milking Machine and Bulk Milk Tank Detergent Sanitiser

Active constituent/s: 213 g/L phosphoric acid, 116 g/L sulfuric acid

Applicant name: Delaval Pty Ltd


Summary of variation: To update the label rates





Product name: Melpat Captan 800 WG Fungicide

Active constituent/s: 800 g/kg captan

Applicant name: Melpat International Pty Ltd


Summary of variation: To extend use to include control of certain diseases in almonds







Product name: Genfarm QPE 200 Herbicide

Active constituent/s: 200 g/L quizalofop-p-ethyl

Applicant name: Landmark Operations Limited


Summary of variation: To add additional 20 L, 100 L, and 110 L pack sizes





Product name: Eradicate Snail And Slug Bait

Active constituent/s: 60 g/kg iron EDTA complex

Applicant name: Wattleglen Projects Pty. Limited


Summary of variation: To add a new 50 g pack size





Product name: Loveland Products Liberate Adjuvant

Active constituent/s: 490 g/L soyal phospholipids

Applicant name: Loveland Products, Inc

Applicant ACN: N/A

Summary of variation: To extend the number of herbicides that can be mixed with the product




Veterinary Chemical Products and Approved Labels



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. VETERINARY PRODUCTS BASED ON NEW ACTIVE CONSTITUENTS


Product name: Lacticon

Active constituent/s: Min. 108 CFU/mL Megashaera elsdenii NCIMB 41125

Applicant name: BEC Feed Solutions Pty Ltd


Summary of use For use in the establishment of viable Megasphaera elsdenii in the rumen of cattle and sheep to aid in the transition from roughage to grain rations by metabolising lactic acid produced in the gastrointestinal tract

Date of Registration/approval: 18 June 2015



2. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Norfenicol 300 mg/mL Solution For Injection For Cattle And Pigs

Active constituent/s: 300 mg/mL florfenicol

Applicant name: Norbrook Laboratories Limited

Applicant ACN: N/A

Summary of use For the treatment of bacterial infections susceptible to florfenicol in cattle and pigs





Product name: Envest (Spinosad) 560 mg Chewable Tablets

Active constituent/s: Each tablet contains 560 mg spinosad

Applicant name: Elanco Animal Health A Div Of Eli Lilly Aust Pty Ltd


Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs and cats
















Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 18.1–27 kg

Active constituent/s: Each tablet contains 810 mg spinosad, 13.5 mg milbemycin oxime



Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 18.1–27 kg


































Product name: Trifexis (Spinosad + Milbemycin Oxime) Chewable Tablets For Dogs 2.3–4.5 kg




Summary of use For the prevention of heartworm disease; the treatment and control of hookworm, roundworm and whipworm; the treatment, prevention and control of flea infestation; the control of flea allergy dermatitis in dogs 2.3–4.5 kg





Product name: Envest (Spinosad) Chewable Tablets For Dogs 18.1–27 kg




Summary of use For the prevention, treatment and control of flea infestations and the treatment of flea allergy dermatitis in dogs





Product name: Envest (Spinosad) Chewable Tablets For Dogs 27.1–54 kg




Summary of use For the prevention, treatment and control of flea infestations and for the treatment of flea allergy dermatitis in dogs






Active constituent/s: Each tablet contains 1620 mg spinosad, 27 mg milbemycin oxime








Product name: M-Eloxyn 20 mg/mL Injection For Horses

Active constituent/s: 20 mg/mL meloxicam

Applicant name: Zoetis Australia Pty Ltd


Summary of use For use as a non-steroidal anti-inflammatory, analgesic and antipyretic in horses







Product name: Selenium Oral Concentrate

Active constituent/s: 10 mg selenium (Se) per mL as sodium selenite



Summary of use For the prevention and treatment of conditions caused by selenium deficiency in cattle, sheep and poultry





Product name: Neove Meloxicam 20 Injection

Active constituent/s: 20 mg/mL meloxicam

Applicant name: Neove Pharma Australia Pty Limited


Summary of use For single dose rapid initiation of therapy of musculoskeletal disorders and relief of pain associated with colic





Product name: IO Independents Own Acid Neutralizer Mild Diuretic and Urinary Buffer For Horses and Greyhounds

Active constituent/s: 285 g/L sodium acid citrate

Applicant name: C M Laboratories Pty Ltd


Summary of use For use in the prevention and treatment of acidosis and muscle cramping in greyhounds

and horses





Product name: Urilin Syrup For Dogs

Active constituent/s: 50 mg/mL phenylpropanolamine hydrochloride

Applicant name: Dermcare-Vet Pty. Ltd


Summary of use For use in dogs (bitches) to control urinary incontinence associated with acquired urinary sphincter incompetence





Product name: Pharmachem Swat Insecticide for Horses

Active constituent/s: 87 g/L permethrin (25:75 cis:trans)

Applicant name: Bocko P/L & Flexsky P/L (In Partnership) T/A Pharmachem

Applicant ACN: 078 722 371 & 105 967 575

Summary of use For the control of biting and nuisance flies on horses and as an aid in the treatment of Queensland itch







Product name: Bob Martin since 1892 Flea Rid for Dogs, Cats, Puppies and Kittens Shampoo

Active constituent/s: 1 g/L pyrethrins, 10 g/L piperonyl butoxide

Applicant name: Bob Martin (Australia) Pty Ltd


Summary of use For the control of fleas and to aid in the control of adult brown dog tick on dogs and cats





Product name: Apex Clindamycin 150 Tablets

Active constituent/s: Each tablet contains 150 mg clindamycin (as clindamycin hydrochloride)

Applicant name: Apex Laboratories Pty Ltd


Summary of use For the oral treatment of dental infections, wounds, abscesses and osteomyelitis caused by bacteria susceptible to clindamycin in dogs and cats




3. VARIATIONS OF REGISTRATION


Product name: Cooling Gel Topical Cooling And Soothing Gel For Horses

Active constituent/s: 350 mg/g isopropyl alcohol, 2 mg/g eucalyptus oil, 6.26 mg/g camphor, 20 mg/g menthol

Applicant name: Floris Veterinaire Produkten B.V

Applicant ACN: N/A

Summary of variation: To change the distinguishing name from ‘TROY COOLING GEL TOPICAL COOLING AND SOOTHING GEL FOR HORSES’ to ‘COOLING GEL TOPICAL COOLING AND SOOTHING GEL FOR HORSES’





Product name: Pharmachlor CTC Chlortetracycline Soluble Powder

Active constituent/s: 950 g/kg chlortetracycline hydrochloride

Applicant name: Bayer Australia Ltd (Animal Health)


Summary of variation: To vary the registered particulars and label particulars





Product name: Y-Tex Agressor Cattle Ear Tags

Active constituent/s: 80 g/kg abamectin, 180 g/kg piperonyl butoxide



Summary of variation: To extend use to dairy cattle (including lactating dairy cattle)







Product name: Vetmedin 5 mg Chewable Tablets For Dogs

Active constituent/s: each tablet contains 5 mg pimobendan

Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division


Summary of variation: To update the claims to include use in large breed dogs with preclinical DCM





Product name: Vetmedin 2.5 MG Chewable Tablets For Dogs

Active constituent/s: each tablet contains 2.5 mg pimobendan

Applicant name: Boehringer Ingelheim Pty Limited, Vetmedica Division


Summary of variation: To update the claims to include use in large breed dogs with preclinical DCM




4. LABEL APPROVAL


Product name: Aristopet Stop-Itch

Active constituent/s: 15 g/L povidone-iodine, 6 g/L iodophor, (equivalent to 0.75% available iodine)

Applicant name: Aristopet Pty Ltd


Summary of use: To add an additional label name to the product under ‘GREASY HEEL AND FUNGAL

SKIN LOTION’

Date of approval: 12 June 2015


5. VARIATION OF LABEL APPROVAL


Product name: Ultravac Scourshield Vaccine

Active constituent/s: Bovine rotavirus G6≥1.3 RP/2 mL, Bovine rotavirus G10≥1 RP/2 mL, Bovine coronavirus ≥1 RP/2 mL, E. coli K99≥1 RP/2 mL

Applicant name: Zoetis Australia Pty Ltd


Summary of variation: To add subcutaneous route of administration




Approved Active Constituents

Approved Active Constituents


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


Active constituent/s: Trifloxystrobin

Applicant name: Yongnong Biosciences Co., Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products


Approval no.: 80311


Active constituent/s: Terbuthylazine

Applicant name: Shandong Binnong Technology Co., Ltd

Applicant ACN: N/A



Approval no.: 80351


Active constituent/s: Pymetrozine

Applicant name: Syngenta Australia Pty Ltd




Approval no.: 80303


Active constituent/s: Ethofumesate

Applicant name: Adama Australia Pty Limited




Approval no.: 70315


Active constituent/s: S-Metolachlor

Applicant name: Shandong Binnong Technology Co., Ltd

Applicant ACN: N/A



Approval no.: 80258


Fluensulfone in the product Nimitz 480 EC Nematicide


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

AUSTRALIA PTY LTD, for registration of a new product containing the active constituent fluensulfone. The product

NIMITZ 480 EC NEMATICIDE is for use prior to planting the following crops: Cucurbits, Tomatoes (not for processing),

Capsicum, Chilli, Eggplant and Okra.

PARTICULARS OF THE APPLICATION

Proposed product name(s): NIMITZ 480 EC NEMATICIDE

Applicant company: ADAMA AUSTRALIA PTY LTD

Name of active constituent: Fluensulfone

Signal heading: Schedule 6

Summary of proposed use: For control of Root-knot nematode in the following transplanted crops:

Cucurbits, Tomatoes (not for processing), Capsicum, Chilli, Eggplant and

Okra.

Pack sizes: 500 ml–1000 L

Withholding period:

States:

Harvest: Not required when used as directed.

Grazing: Do not graze treated crop, or feed treated crop

commodities to livestock.

Queensland only

SUMMARY OF THE APVMA’S EVALUATION OF NIMITZ 480 EC NEMATICIDE IN ACCORDANCE WITH SECTIONS

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 NIMITZ 480 EC NEMATICIDE containing the active constituent

fluensulfone 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 has conducted a risk assessment on the product

and concluded that it can be used safely.

The product will be used for commercial use situations, and farmers and their employees will be the main users of

the product. Workers may be exposed to the product when opening containers, mixing/loading, application (or

connecting containers during chemigation and cleaning up spills and equipment). The main route of exposure to

the product/spray will be dermal and inhalation, with limited occupational exposure possible during mixing/loading

and application.

In the absence of exposure data for the proposed mode of application, the Pesticide Handler Exposure Database

(PHED) Surrogate Exposure Guide was used to estimate exposure. Exposure to the product by the stated



application methods was at an acceptable level when a single layer of clothing (cotton overalls or equivalent

clothing) and elbow-length chemical resistant gloves are worn.

Based on the risk assessment, a First Aid Instruction, Safety Directions and a Warning statement have been

recommended for the product label.

(ii) The APVMA is satisfied that the proposed use of NIMITZ 480 EC NEMATICIDE will not be an undue hazard to the

safety of people using anything containing its residues provided the product is used in accordance with the

proposed label directions.

Long term (chronic) dietary exposure as estimated by the national estimated dietary intake calculation is

acceptable. The short term (acute) dietary exposure as estimated by the national estimated short term intake

calculation is also acceptable.

Maximum Residue Limits (MRLs) for cucurbits, fruiting vegetables (other than cucurbits) and animal commodities

have been recommended.

(iii) The APVMA is satisfied that the proposed use of NIMITZ 480 EC NEMATICIDE containing the active constituent

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

A comprehensive toxicology and public health dataset was submitted for registration of the active constituent

fluensulfone and associated product in the United States of America, Canada and Australia as part of a Global

Joint Review. The toxicology assessment of fluensulfone was conducted jointly by scientists from the United States

(US EPA), Canada (PMRA), and Australia (OCS).

Fluensulfone is a new chemical class of nematicide. The product, NIMITZ 480EC Nematicide an emulsifiable

concentrate formulation containing 480 g/L fluensulfone, is a commercial use nematicide and is to be applied to

bare soil pre-planting of seedlings and immature plants, including cucurbits and fruiting vegetables. The product will

be available in high density polyethylene (HDPE) containers of 500 mL to 1000 L and will be applied at a label rate

of 4–8 L/ha as a coarse spray using conventional broadcast spray application equipment or by ground application

through band application or drip irrigation methods. The maximum proposed application rate is a single application

of 3.84 kg a.i. per hectare.

Fluensulfone was of low acute oral, acute dermal and acute inhalational toxicity in rats. It was a slight skin irritant in

rabbits but was not an eye irritant in the same species. It was a skin sensitiser in guinea pigs.

The systemic toxicity of fluensulfone in dietary studies consisted primarily of decreased body weight and body

weight gain, and changes in haematology parameters. This systemic toxicity profile was observed in short-term,

subchronic and chronic toxicity studies in rats, mice and dogs, with the available data indicating that rats and dogs

were more sensitive than mice. No treatment related effects were observed upon short term dermal administration

of fluensulfone up to 400 mg/kg bw/day in rats. In a 90–day inhalational study in rats (nose only), effects were seen

at the lowest concentration tested of 40 mg/m3 (decreased weight gain, increased prothrombin time, decreased

thymus weight and histopathology in the epiglottis).

In a dietary carcinogenicity study in mice, an increase was seen in the incidence of alveolar/bronchiolar adenomas

and alveolar/bronchiolar adenomas and carcinomas combined in female mice. The relevance of this finding to

humans was considered in Mode of Action studies; however, the available data were insufficient. No increased

incidence of tumours was seen in male mice, or male and female rats in a 2–year dietary study.

Fluensulfone was a neurotoxicant producing neurobehavioural changes following administration of a bolus (i.e.

gavage) dose, but such findings were not seen for dietary administration. Fluensulfone was not an in vivo



genotoxicant, a reproductive or teratogenic toxicant, or an immunotoxicant, and studies on metabolites provided no

data that indicates that the observed level of these metabolites and their limited toxicity profile presents a

toxicological concern.

The product NIMITZ 480EC Nematicide has low acute oral, dermal and inhalational toxicity in rats, is a moderate

skin and eye irritant in rabbits, and is a skin sensitiser in guinea pigs. Additionally, NIMITZ 480EC Nematicide is

considered to be an aspiration hazard based on the formulated products toxicological profile.

The APVMA has considered the findings of the Department of Health and accepts these conclusions. Based on an

assessment of the toxicology, it was considered that there should be no adverse effects on human health from the

use of NIMITZ 480 EC NEMATICIDE when used in accordance with the label directions.

(iv) The APVMA is satisfied that the proposed use of fluensulfone in the product NIMITZ 480 EC NEMATICIDE for the

control of soil nematodes would not be likely to have an unintended effect that is harmful to animals, plants or

things or to the environment if used according to the product label directions.

The Department of the Environment has assessed data in support of the proposed use and has concluded that the

risks to the environment from this use are acceptable.

Fluensulfone is stable to hydrolysis but it readily degrades by aquatic photolysis, and can be expected to be fairly

degradable in water systems. Aerobic soil microbial degradation is expected to be a significant route for

environmental degradation of the nematicide which is not identified as persistent. Fluensulfone does not very

strongly adsorb to soil and is expected to be of high to medium mobility. It is not expected to bioconcentrate in

aquatic species.

Fluensulfone is practically nontoxic to birds with acute exposure and did not exhibit toxicity in reproduction studies.

Acute toxicity tests showed that the chemical and its metabolites are slightly toxic to fish and aquatic invertebrates,

chronic studies indicated also only slight toxicity. Fluensulfone and the proposed formulation are very highly toxic to

green algae; while several of its metabolites are at worst slightly toxic to these organisms. Acute oral or contact

exposure studies showed it is only very slightly toxic to honeybees. Fluensulfone is slightly toxic to earthworms and

is not expected to have adverse effects on earthworm or soil arthropod survival and reproduction. It is not expected

to have significant effects on soil nitrogen transformation and carbon turnover. Fluensulfone is not expected to

have significant phytotoxic effects on non-target plants.

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

proposed uses of the product, based on ground application by low boom sprayers and by drip irrigation as

proposed by the draft label. The risk assessment determined that under the proposed use pattern the uses are

unlikely to pose an environmental risk to birds and mammals. The risk to aquatic organisms from leaching, spray

drift or runoff is acceptable provided a downwind no-spray zone is established and the label bears appropriate

warning statements regarding to avoid runoff.

The APVMA has considered the findings of the Department of the Environment and accepts these conclusions.

(v) The APVMA is considering whether the proposed use of NIMITZ 480 EC NEMATICIDE containing the active

constituent fluensulfone would not adversely affect trade between Australia and places outside Australia.



Fruiting vegetables, including cucurbits are not considered major export commodities1 and the overall risk to export

trade is considered to be low.

There is potential for residues of fluensulfone to occur in rotational crops, however the initial registration will be

restricted to Queensland only, which together with the proposed plant back intervals appropriately mitigate the risk

of residues of fluensulfone metabolites occurring in rotational crops that are major export commodities or can be

used as animal feeds. For sugarcane, a 2–year plant back interval and also the processing of sugar reduces the

risk to 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 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, www.apvma.gov.au/news-and-publications/public-consultations or through the contact 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 NIMITZ 480 EC NEMATICIDE 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.

1 Part 5B of the Vet Requirements Series and Ag Requirements Series, Overseas Trade Aspects of Residues in Food Commodities, August 2004.

http://www.apvma.gov.au/news-and-publications/public-consultations



All personal and confidential commercial information (CCI)2 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 Administration Unit

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]

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

mailto:[email protected]

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

apvma gazette no. 13, 30 june 2015...no. apvma 13, tuesday, 30 june 2015 agricultural and veterinary...

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