APVMA Gazette no. 25, 18 December 2012

2Agricultural and Veterinary Chemicals Code Act 1994Commonwealth of Australia Gazette

No. APVMA 2-3 February 2009

Commonwealth of AustraliaGazette

No. APVMA 25, Tuesday, 18 December 2012

Published by The Australian Pesticides & Veterinary Medicines Authority

Agricultural and Veterinary Chemicals

Australian Government

Australian Pesticides and Veterinary Medicines Authority

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 7629Commonwealth of Australia Gazette

No. APVMA 25, Tuesday, 18 December 2012Agricultural and Veterinary Chemicals Code Act 19942

Commonwealth of Australia 2012

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Australian Pesticides and Veterinary Medicines Authority. Requests and inquiries concerning reproduction and rights should be addressed to:

The Manager, Public AffairsThe Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182 Kingston ACT 2604

Email: communications@apvma.gov.au 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 53(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications made for the purpose of notifying minor variations to registration details. The APVMA will however report notifications activity in quarterly statistical reports.

Distribution and subscription

From February 2010, the APVMA will publish the APVMA Gazette in electronic format only. The APVMA Gazette and information about subscribing to the gazette alert service are available on the APVMA website, www.apvma.gov.au.

Copies of the APVMA Gazette from November 1999 until July 2009 will remain available from the APVMA website.

APVMA Contacts

For enquiries regarding the publishing and distribution of the APVMA Gazette:Telephone: +61 2 6210 4870

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

Commonwealth of Australia Gazette

No. APVMA 25, Tuesday, 18 December 2012Agricultural and Veterinary Chemicals Code Act 19943

CONTENTS

Erratum Notice3

Notice of Registrations4

Agricultural Chemical Products4

Veterinary Chemical Products11

Notice New Agricultural Chemical Products12

Cyflufenamid in the product Cyflamid 50EW Fungicide12

Notice New Agricultural Active Constituent17

Cyflufenamid17

Other Notices20

Licensing of Veterinary Chemical Manufacturers20

Exemption for the Possession and Supply of Vets All Natural Shark Cartilage Powder and Vets All Natural Joint Formula22

Variations to Standard 1.4.2 of the Australia New Zealand Food Standards Code23

Addendum to the Record of Approved Active Constituents28

Application Summaries30

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 15, 31 July 2012.

The Notice for Exemption for the Possession and Supply of Vets All Natural Shark Cartilage Powder and Vets all Natural Joint Formula incorrectly identified the exemption period for Vets All Natural Shark Cartilage Powder in 200 gram and 1 kg containers as 12 June 2012 to 12 July 2012 and the period for Vets All Natural Joint Formula in 500 gram, 1 kg, 3 kg and 15 kg containers as 12 June 2012 to 12 July 2012.

The correct entry for the for the Exemption for the Possession and Supply of Vets All Natural Shark Cartilage Powder and Vets all Natural Joint Formula appears on page 22 of this Gazette.

Commonwealth of Australia Gazette

No. APVMA 25, Tuesday, 18 December 2012Agricultural and Veterinary Chemicals Code Act 199410

Notice of Registrations Agricultural Chemical Products

Notice of Registrations

Agricultural Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following products, with effect from the dates shown.

Agricultural Products Based on New Active Constituents

Product Name:

Zampro Fungicide

Active Constituent/s:

225g/L dimethomorph, 300g/L ametoctradin

Applicant Name:

BASF Australia Ltd.

Applicant ACN:

008 437 867

Summary of Use:

For control of downy mildew in grapevines

Date of Registration:

5 December 2012

Label Approval No:

63651/49642

Agricultural Products Based on Existing Active Constituents

Product Name:

EzyCrop Bromoxynil 200 Herbicide

Active Constituent/s:

200g/L bromoxynil present as the n-octanoyl ester

Applicant Name:

EzyCrop Pty Ltd

Applicant ACN:

156 476 827

Summary of Use:

For the control of weeds in wheat, oats, barley, cereal rye and triticale (alone or under sown), linseed, clover and lucerne pastures, turf, fallow, non-crop, roadsides and right-of-way

Date of Registration:

29 November 2012

Label Approval No:

68188/57736

Product Name:

Novaguard Clethodim 240 Herbicide

Active Constituent/s:

240g/L clethodim

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of certain grass weeds in beetroot, cabbage, canola, celery, chickpeas, cotton, faba beans, field peas, forestry, lentils, lettuce, lupins, mung beans, non-bearing fruit trees, onions, ornamentals, peanuts, potatoes and soybeans

Date of Registration:

29 November 2012

Label Approval No:

68214/57772

Product Name:

Distance Plus Ant Bait

Active Constituent/s:

5g/kg pyriproxyfen

Applicant Name:

Sumitomo Chemical Australia Pty Limited

Applicant ACN:

081 096 255

Summary of Use:

For the control of invasive and nuisance ants in domestic, commercial, environmental or agricultural situations

Date of Registration:

29 November 2012

Label Approval No:

65967/52408

Product Name:

Vacsol Azure Concentrate Wood Preservative

Active Constituent/s:

35.4g/L permethrin (25:75), 49.8g/L propiconazole, 49.8g/L tebuconazole

Applicant Name:

Arch Wood Protection (Aust) Pty Limited

Applicant ACN:

003 780 872

Summary of Use:

For the treatment of timber to prevent attack by borers, termites and fungi in above ground situations

Date of Registration:

4 December 2012

Label Approval No:

66725/54249

Product Name:

ACP Clodinafop 240 EC Selective Herbicide

Active Constituent/s:

60g/L cloquintocet-mexyl, 240g/L clodinafop-propargyl

Applicant Name:

Australis Crop Protection Pty Ltd

Applicant ACN:

150 711 185

Summary of Use:

For the control of wild oats, Paradoxa grass, (annual phalaris), canary grass and annual ryegrass in wheat

Date of Registration:

4 December 2012

Label Approval No:

68172/57693

Product Name:

FMC Glyder Offense 540 Herbicide

Active Constituent/s:

540g/L glyphosate present as the potassium salt

Applicant Name:

FMC Australasia Pty Ltd

Applicant ACN:

095 326 891

Summary of Use:

For use as a non-selective herbicide for the control of many annual and perennial weeds

Date of Registration:

4 December 2012

Label Approval No:

68237/57814

Product Name:

FMC Thiram/Thiabendazole Seed Dressing

Active Constituent/s:

360g/L thiram, 200g/L thiabendazole

Applicant Name:

FMC Australasia Pty Ltd

Applicant ACN:

095 326 891

Summary of Use:

For the control of seed-borne and seedling root pathogens of peas, chickpeas, lentils, faba beans and vetch

Date of Registration:

4 December 2012

Label Approval No:

68238/57815

Product Name:

Value 2, 4-D Amine 625 Herbicide

Active Constituent/s:

625g/L 2,4-D present as the dimethylamine and diethanolamine salt

Applicant Name:

Value Chem Pty Ltd

Applicant ACN:

151 004 223

Summary of Use:

For use on weeds in various crops

Date of Registration:

4 December 2012

Label Approval No:

66989/54881

Product Name:

Novaguard Clopyralid 750 SG Herbicide

Active Constituent/s:

750g/kg clopyralid present as the potassium salt

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of a wide range of broadleaf weeds in wheat, barley, oats, triticale, canola, pastures and fallow land

Date of Registration:

5 December 2012

Label Approval No:

68219/57778

Product Name:

Novaguard Clopyralid 300 Herbicide

Active Constituent/s:

300g/L clopyralid present as the triisopropanolamine salt

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of a wide range of broadleaf weeds in wheat, barley, triticale, oats, pastures, canola, fallow land, forests and industrial situations

Date of Registration:

5 December 2012

Label Approval No:

68221/57781

Product Name:

FMC Metolachlor 720 Herbicide

Active Constituent/s:

720g/L metolachlor

Applicant Name:

FMC Australasia Pty Ltd

Applicant ACN:

095 326 891

Summary of Use:

For the control of certain annual grasses and broadleaf weeds in certain crops

Date of Registration:

5 December 2012

Label Approval No:

68255/57845

Product Name:

AW Manacle LVE 570 EC Selective Herbicide

Active Constituent/s:

570g/L MCPA present as the 2-ethylhexyl ester

Applicant Name:

Agri West Pty Limited

Applicant ACN:

108 899 181

Summary of Use:

For selective control of certain weeds in agricultural crops

Date of Registration:

5 December 2012

Label Approval No:

68109/57518

Product Name:

Novaguard Imidacloprid 350 Soil Insecticide

Active Constituent/s:

350g/L imidacloprid

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For use as a soil applied treatment for the control of greyback and Childers canegrub in sugar cane and silverleaf whitefly in various vegetable crops

Date of Registration:

5 December 2012

Label Approval No:

68212/57770

Product Name:

Chaochen Glyphosate 360 SL Herbicide

Active Constituent/s:

360g/L glyphosate present as the isopropylamine salt

Applicant Name:

Jiangyin No 2 Pesticides Co., Ltd

Summary of Use:

For non-selective control of many annual and perennial weeds and grasses in certain situations

Date of Registration:

6 December 2012

Label Approval No:

67994/57240

Product Name:

Rainbow Hexazinone 750 SG Herbicide

Active Constituent/s:

750g/kg hexazinone

Applicant Name:

Shandong Rainbow International Co., Ltd.

Summary of Use:

For the control of certain sedges, perennial grasses, broadleaf and woody weeds in Pinus radiata forests and industrial weed control situations

Date of Registration:

6 December 2012

Label Approval No:

66512/56013

Product Name:

Novaguard Triadimefon 125 EC Fungicide

Active Constituent/s:

125g/L triadimefon

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of fungal diseases of wheat, barley, peas, grapevines, cucurbits, sugarcane and azaleas

Date of Registration:

6 December 2012

Label Approval No:

68206/57764

Product Name:

EzyCrop Cypermethrin 25 UL Insecticide

Active Constituent/s:

25g/L cypermethrin

Applicant Name:

EzyCrop Pty Ltd

Applicant ACN:

156 476 827

Summary of Use:

For the knockdown control of adult mosquitoes, biting midges, flies and cockroaches in and around domestic, public service areas, agricultural buildings, commercial and industrial areas, refuse tips and breeding areas

Date of Registration:

7 December 2012

Label Approval No:

68077/57438

Product Name:

Imtrade Avatar 900 EC Herbicide

Active Constituent/s:

900g/L tri-allate

Applicant Name:

Imtrade Australia Pty Ltd

Applicant ACN:

090 151 134

Summary of Use:

For control of wild oats in wheat, triticale, chickpeas, barley, peas, linseed, lupins, canola, faba beans and safflower

Date of Registration:

7 December 2012

Label Approval No:

66246/53425

Product Name:

Systemic Advanced Control Yates Rose Shield Advanced Insect, Mite & Disease Control

Active Constituent/s:

10g/L imidacloprid, 9.6g/L tau-fluvalinate, 4.4g/L myclobutanil

Applicant Name:

DuluxGroup (Australia) Pty Ltd

Applicant ACN:

000 049 427

Summary of Use:

For the control of insects and diseases on roses and ornamentals in the home garden

Date of Registration:

7 December 2012

Label Approval No:

66046/52591

Product Name:

Novaguard Metsulfuron 600 WG Herbicide

Active Constituent/s:

600g/kg metsulfuron-methyl

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of brush and broadleaf weeds in native pastures, rights of way, commercial and industrial areas and for the control of certain broadleaved weeds in winter cereal crops

Date of Registration:

10 December 2012

Label Approval No:

68224/57784

Product Name:

Easyfarm Glyphosate 360 SL Herbicide

Active Constituent/s:

360g/L glyphosate present as the isopropylamine salt

Applicant Name:

Easyfarm Pty Ltd

Applicant ACN:

158 294 109

Summary of Use:

For use as a general purpose, total herbicide for non-selective control of many annual and perennial weeds and grasses in certain situations

Date of Registration:

10 December 2012

Label Approval No:

67979/57216

Product Name:

EzyCrop Diflufenican + MCPA Selective Herbicide

Active Constituent/s:

25g/L diflufenican, 250g/L MCPA present as the ethyl hexyl ester

Applicant Name:

EzyCrop Pty Ltd

Applicant ACN:

156 476 827

Summary of Use:

For the control of certain broadleaf weeds in winter cereals and clover

Date of Registration:

10 December 2012

Label Approval No:

68195/57750

Product Name:

Py-Zapp Natural Pyrethrum Metered Insecticide

Active Constituent/s:

42.30 g/kg piperonyl butoxide, 9 g/kg pyrethrins

Applicant Name:

Nu-Cans Australia Pty. Ltd.

Applicant ACN:

130 781 636

Summary of Use:

For the control of various flying insects

Date of Registration:

10 December 2012

Label Approval No:

67789/56874

Product Name:

Nail 240EC Herbicide

Active Constituent/s:

240g/L carfentrazone-ethyl

Applicant Name:

Crop Care Australasia Pty Ltd

Applicant ACN:

061 362 347

Summary of Use:

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

Date of Registration:

11 December 2012

Label Approval No:

68051/57375

Product Name:

Titan Glyphosate 700 Herbicide

Active Constituent/s:

700g/kg glyphosate present as the mono-ammonium salt

Applicant Name:

Titan Ag Pty Ltd

Applicant ACN:

122 081 574

Summary of Use:

For control of annual and perennial and aquatic weeds in agricultural areas, tree and vine crops, pasture, designated aquatic situations, commercial and industrial and public service areas

Date of Registration:

12 December 2012

Label Approval No:

67571/56370

Product Name:

Novaguard Propyzamide 500 SC Herbicide

Active Constituent/s:

500g/L propyzamide

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the selective control of certain grasses and broadleaf weeds in lettuce, sports turf, home lawns, legumes, seed crops and pastures

Date of Registration:

12 December 2012

Label Approval No:

68216/57774

Product Name:

Novaguard Diflufenican 500 Herbicide

Active Constituent/s:

500g/L diflufenican

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of certain weeds in clover-based pasture, field peas, lentils, lupins and oilseed poppy

Date of Registration:

12 December 2012

Label Approval No:

68211/57769

Product Name:

Novaguard Glufosinate 200 SL Herbicide

Active Constituent/s:

200g/L glufosinate-ammonium

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the non-residual control of broadleaf and grass weeds in various situations

Date of Registration:

12 December 2012

Label Approval No:

68197/57752

Product Name:

Flagcan Diflufenican 500SC Herbicide

Active Constituent/s:

500g/L diflufenican

Applicant Name:

Jiangsu Flag Chemical Industry Co., Ltd

Applicant ACN:

N/A

Summary of Use:

For the control of certain weeds in clover-based pasture, field peas, lentils, lupins and oilseed

Date of Registration:

12 December 2012

Label Approval No:

68006/57261

Product Name:

Novaguard Clomazone 30-GR Herbicide

Active Constituent/s:

30g/kg clomazone

Applicant Name:

Novaguard Pty Ltd

Applicant ACN:

153 121 156

Summary of Use:

For the control of certain annual grasses in rice

Date of Registration:

13 December 2012

Label Approval No:

68229/57793

Variations

Product Name:

Mortein Mozzie Repellent Mats

Applicant Name:

Reckitt Benckiser (Australia) Pty Limited

Applicant ACN:

003 274 655

Summary of Variation:

To change the product name from MORTEIN ODOURLESS MOZZIE ZAPPER LOW IRRITANT 15 NIGHTS PROTECTION to MORTEIN MOZZIE REPELLENT MATS

Date of Variation:

3 December 2012

Label Approval No:

54602/57794

Product Name:

Pool Algaecide Algi Destroyer

Applicant Name:

Biolab Australia Pty Ltd

Applicant ACN:

005 878 017

Summary of Variation:

To change the product name from BIOGUARD ALGIZINE ALGAECIDE to POOL ALGAECIDE ALGI DESTROYER

Date of Variation:

4 December 2012

Label Approval No:

45932/57641

Product Name:

Du-Wett Low Volume Application Spreader

Applicant Name:

Nufarm Australia Limited

Applicant ACN:

004 377 780

Summary of Variation:

To extend the use to include horticultural tree crops.

Date of Variation:

4 December 2012

Label Approval No:

58702/55150

Product Name:

Richgro Beat-A-Bug Natural Poss Off Possum Deterrent

Applicant Name:

A. Richards Pty Ltd T/A Richgro Garden Products

Applicant ACN:

008 734 852

Summary of Variation:

To change the product name from BEAT-A-BUG POSS OFF NATURAL POSSUM DETERRENT to RICHGRO BEAT-A-BUG NATURAL POSS OFF POSSUM DETERRENT and update the RLP

Date of Variation:

6 December 2012

Label Approval No:

62432/58293

Commonwealth of Australia Gazette

No. APVMA 25, Tuesday, 18 December 2012Agricultural and Veterinary Chemicals Code Act 199411

Notice of Registrations Veterinary Chemical Products

Veterinary Chemical Products

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the registration in respect of the following products, with effect from the dates shown.

Veterinary Products Based on Existing Active Constituents

Product Name:

Vitapet Make Your Life As Easy As Theirs Flea & Tick Shampoo For Dogs, Cats, Puppies And Kittens

Active Constituent/s:

10g/L piperonyl butoxide, 1g/L pyrethrins

Applicant Name:

Beaphar Australia Pty Ltd

Applicant ACN:

145 418 882

Summary of Use:

For the control of fleas (Ctenocephalides spp.) and to aid in the control of adult brown dog ticks (Rhipicephalus sanguineus) on dogs, cats, puppies and kittens

Date of Registration:

4 December 2012

Label Approval No:

67532/56300

Product Name:

Felimazole 5 Mg Coated Tablet

Active Constituent/s:

5mg/Tb thiamazole (methimazole)

Applicant Name:

Dermcare-Vet Pty. Ltd

Applicant ACN:

010 280 010

Summary of Use:

For the stabilisation of feline hyperthyroidism as a pre-operative therapy and for the long-term treatment of feline hyperthyroidism

Date of Registration:

7 December 2012

Label Approval No:

63928/46936

Product Name:

Atipam Injection

Active Constituent/s:

5mg/mL atipamezole hydrochloride

Applicant Name:

Jurox Pty Limited

Applicant ACN:

000 932 230

Summary of Use:

For reversing and abolishing the effects of medetomidine hydrochloride in dogs and cats.

Date of Registration:

12 December 2012

Label Approval No:

65929/52317

Variation

Product Name:

Joint Guard Powder For Dogs

Applicant Name:

Ceva Animal Health Pty Ltd

Applicant ACN:

002 692 426

Summary of Variation:

To change the product name from NV JOINT GUARD POWDER FOR DOGS to JOINT GUARD POWDER FOR DOGS

Date of Variation:

3 December 2012

Label Approval No:

59927/56856

Commonwealth of Australia Gazette

Agricultural and Veterinary Chemicals Code Act 199416

Notice New Agricultural Chemical Products Cyflufenamid in the product Cyflamid 50EW Fungicide

Notice New Agricultural Chemical Products

Cyflufenamid in the product Cyflamid 50EW Fungicide

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Nippon Soda Co., Ltd, for registration of a new product containing the active constituent cyflufenamid. The product is Cyflamid 50EW Fungicide. The product is for use on grapevines and cucurbits.

Particulars of The Application

Proposed Product Name:

CYFLAMID 50EW FUNGICIDE

Applicant Company:

Nippon Soda Co., Ltd

Name of Active Constituent:

Cyflufenamid

Signal Heading:

Schedule 5

Summary of Proposed Use:

For the control of powdery mildew in cucurbits and grapevines.

Pack Sizes:

1L, 2.5L, 5L, 10L and 20L

Withholding Period:

Grapes: Do not harvest for 35 days after application.

Cucurbits:Do not harvest for 1 day after application.

Summary of the APVMAs evaluation of Cyflamid 50EW 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:

The APVMA is satisfied that the proposed use of Cyflamid 50EW 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.

Farmers and their employees will be the main users of the product Cyflamid 50 EW Fungicide. Workers may be exposed to the product when opening containers, mixing/loading, application and cleaning up spills and equipment. The main route of exposure to the product and diluted spray will be dermal and inhalational, although ocular exposure is also possible.

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. For repeated use, exposure to the product when mixing and loading, application to cucurbits by boom spray and hand-wand spraying, and application to grapes by airblast sprayer behind a tractor, were acceptable without the use of personal protective equipment. However, based on the product acute hazard of moderate skin irritation, it is recommended that when mixing, loading and applying the product cotton overalls buttoned to the neck and wrist (or equivalent clothing) and chemical resistant gloves are worn.

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

The APVMA is satisfied that the proposed use of cyflamid 50ew fungicide 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 (NEDI) calculation is acceptable. Estimation of short term (acute) dietary exposure as estimated by the National Estimated Short Term Intake (NESTI) calculation is also acceptable. MRLs for grapes, dried grapes, cucurbits and animal commodities have been recommended.

The APVMA is satisfied that the proposed use of cyflamid 50ew fungicide containing the active constituent cyflufenamid is not likely to be harmful to human beings if used according to the product label directions.

In rats, following oral administration, cyflufenamid was rapidly absorbed with around 70% of the administered dose absorbed, and widely distributed to organs and tissues, with the highest levels detected in the kidneys, muscle, fat, liver and gastro intestinal tract. It is extensively metabolised in the rat and rapidly eliminated from the body, predominantly via the faeces with the urine a lesser route of elimination. There was evidence in the rat that limited enterohepatic circulation may occur. There was no evidence of bioaccumulation following repeated oral dosingin rats.

Based on the submitted data, cyflufenamid was of low acute oral toxicity in the rat and mouse, and low acute dermal and inhalational toxicity in the rat. It was not a skin irritant in rabbits but is a slight eye irritant in the same species, and was not a skin sensitiser in guinea pigs.

In a formulation product similar to Cyflamid 50 EW Fungicide, it was estimated that in vivo human dermal absorption of cyflufenamid was limited.

Following repeat oral dosing in rats, mice and dogs, body weight changes, clinical chemistry alterations and histopathological changes in the liver and kidneys were seen in all species, along with histopathological changes in additional organs observed with increased study duration. Cyflufenamid was not mutagenic or genotoxic in vitro with and without metabolic activation, and in vivo was not genotoxic in mice and did not induce DNA damage in rat liver. There was no evidence from rats and mice that cyflufenamid would be a carcinogenic hazard to humans and. furthermore, cyflufenamid was not a reproductive toxicant in rats or a developmental toxicant in rats and rabbits. Cyflufenamid was not neurotoxic in a subchronic toxicity study in rats, and did not elicit oestrogenic activity in vitro or in ovariectomised rats in vivo.

Acute oral toxicity studies on a range of cyflufenamid impurities and metabolites revealed mainly low acute toxicity, with moderate acute toxicity seen in both sexes for one impurity and in males only for one metabolite. Additionally, all tested impurities and metabolites were negative in bacterial reverse mutation studies with and without metabolic activation.

Cyflamid 50 EW Fungicide is of low acute oral toxicity in rats and mice, and low acute dermal and inhalational toxicity in rats, is a moderate skin irritant in the rabbit and a slight eye irritant in the same species, and is not a skin sensitiser in guinea pigs.

Based on an assessment of the toxicology, it was considered that there should be no adverse effects on human health from the use of Cyflamid 50 EW Fungicide when used in accordance with the label directions.

The APVMA is satisfied that the proposed use of cyflamid 50ew fungicide containing the active constituent cyflufenamid, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.

The Department of Sustainability, Environment, Water, Population and Communities has assessed data in support of the proposed use and has concluded that the risks to the environment from this use are acceptable provided that the draft label contains the required environmental protection statements.

Cyflufenamid is stable with minimal or no detectable degradation by abiotic processes (photolysis and hydrolysis). However, it undergoes degradation by biotic processes in both soil and water under laboratory conditions and dissipates quickly from the aquatic compartment to sediment. Under field conditions cyflufenamid also degrades with field dissipation rates generally similar to degradation rates found under laboratory conditions. Cyflufenamid is not persistent and use as assessed is not likely to result in accumulation in soils.

Cyflufenamid 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. Cyflufenamid was considered either highly or moderately acutely toxic to aquatic species. It was slightly or moderately chronically toxic to fish or aquatic invertebrates. Cyflufenamid was slightly to very slightly toxic to sediment dwelling organisms. Acute effects on algae/aquatic plants could not be characterised based on the active constituent, but could be classed as very highly toxic when tested as the formulation. The active constituent was slightly toxic to aquatic plants based on chronic testing. Metabolites were less toxic than the parent substance.

Terrestrial invertebrates were at most slightly sensitive to either Cyflufenamid or its formulation. Soil organisms were not sensitive to Cyflufenamid or its metabolites and phytotoxicity was limited. Cyflufenamid is unlikely to bioaccumulate.

In spite of conservative modelling, acceptable risk to aquatic organisms was found from spray drift and run-off water entering environmental waters. Similarly the risk to sediment and soil dwelling organisms from spray drift and run-off was found to be acceptable. The risk assessment determined that the chemical is unlikely to pose an environmental risk under the proposed use pattern, provided the draft label contains the required environmental protection statements.

The APVMA has considered the findings of the Department of Sustainability, Environment, Water, Population and Communities and accepts these conclusions.

The APVMA is considering whether the proposed use of cyflamid 50ew fungicide would not adversely affect trade between Australia and places outside Australia.

Export of treated produce containing finite (measurable) residues of cyflufenamid 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.

The draft label includes the following recommendation for grapes for export:

Grapes (Export): Do not apply last spray after crop stage EL31 berries pea-size.

In the Australian residue trials provided in support of this application, quantifiable residues did not occur in wine when the last application was made at up to 2 the proposed concentration at this growth stage. The risk to Australian trade in wine is considered to be low.

In the Australian trials for application at 2 g ai/100 L (1) up to growth stage EL-31, residues in grapes were