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: [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 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
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