apvma gazette no. 7, 09 april 2019 · web view2agricultural and veterinary chemicals code act...

No. APVMA 7, Tuesday, 9 April 2019Published 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 ristration 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 GazetteNo. APVMA 7, Tuesday, 9 April 2019 Agricultural and Veterinary Chemicals Code Act 1994

Commonwealth of Australia 2023

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:

Assistant Director, Communications

Australian Pesticides and Veterinary Medicines Authority

PO Box 6182

Kingston ACT 2604

Email: [email protected]

Website

GENERAL INFORMATION

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

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

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

issued by the APVMA.

Pursuant to section 8J(1) of the Agvet Code, the APVMA has decided that it is unnecessary to publish details of applications

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

quarterly statistical reports.

DISTRIBUTION AND SUBSCRIPTION

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

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

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APVMA CONTACTS

For enquiries regarding the publishing and distribution of the APVMA Gazette: Telephone: +61 2 6210 4812

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

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

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


CONTENTS

Agricultural Chemical Products and Approved Labels.............................................................................................................Veterinary Chemical Products and Approved Labels............................................................................................................Approved Active Constituents................................................................................................................................................New Agricultural Active Constituent Mefentrifluconazole......................................................................................................Belanty Fungicide Containing Mefentrifluconazole................................................................................................................New Active Constituent and Veterinary Chemical Product PLASMID DNA..........................................................................Amendments to the APVMA MRL Standard..........................................................................................................................Proposal to Amend Schedule 20 in the Australia New Zealand Food Standards Code........................................................


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.: 116248

Product name: Roundup 15.2 Glyphosate + 20.5 Nonanoic acid Ready to Use Weedkiller

Active constituent/s: 20.5 g/L nonanoic acid, 15.2 g/L glyphosate present as the isopropylamine salt

Applicant name: Evergreen Garden Care Australia Pty Ltd

Applicant ACN: 003 123 162

Summary of use For the control of various weeds in the home garden

Date of registration: 13 March 2019

Product registration no.:

86640

Label approval no.: 86640/116248


Product name: Evopure Algae Extreme, Treat & Prevent

Active constituent/s: 100 g/L benzalkonium chloride, 50 g/L copper present as an organo-copper complex

Applicant name: Evolution Water and Lighting Solutions Pty Ltd


Summary of use For the control of blackspot algae and general algae in swimming pools



87156



Product name: F.S.A. Oxyfluorfen 240 EC Herbicide

Active constituent/s: 240 g/L oxyfluorfen

Applicant name: Four Seasons Agribusiness Pty Ltd


Summary of use For selective control of broadleaf weeds and some grasses



87536





Product name: Topbait Professional Cockroach Gel Bait

Active constituent/s: 0.5 g/kg fipronil

Applicant name: Term-Seal Australia Pty Ltd


Summary of use For crevice, crack, or spot treatment for the control of cockroaches in commercial, industrial and residential premises



87600/118745

Label approval no.: 87600


Product name: F.S.A. Chlorsulfuron 750 WG Herbicide

Active constituent/s: 750 g/kg chlorsulfuron

Applicant name: Four Seasons Agribusiness Pty Ltd


Summary of use For the control of annual wimmera ryegrass and certain broadleaf weeds in wheat, barley, oats, cereal rye and triticale



87596



Product name: Genfarm Paclobutrazol 250 Plant Growth Regulator

Active constituent/s: 250 g/L paclobutrazol

Applicant name: Landmark Operations Limited


Summary of use To reduce vegetative growth in mango, stone fruit and apple trees



86503



Product name: Quadrant Herbicide

Active constituent/s: 250 g/L MCPA present as the ethyl hexyl ester, 240 g/L bromoxynil present as the octanoate, 20 g/L diflufenican, 10 g/L picolinafen

Applicant name: Adama Australia Pty Ltd


Summary of use For the control of various broadleaf weeds in barley, cereal rye, oats, triticale and wheat



85692





Product name: Picaro Hi-Load 550EC Fungicide

Active constituent/s: 550 g/L propiconazole

Applicant name: Ruralco Holdings Limited


Summary of use For the control of certain fungal diseases of bananas, oats, peanuts, perennial ryegrass, pineapples, stone fruit, sugar cane, wheat and other crops; and the control of dollar spot in bent and Queensland blue couch and spring dead spot in couch



87634



Product name: Theodore Copper Sulfate Aquatic Algicide

Active constituent/s: 250 g/kg copper present as copper sulfate pentahydrate

Applicant name: Theodore Water Pty Ltd


Summary of use For the control of algae in the Theodore irrigation channel scheme



87058



Product name: PIN UP Glyphoste 540g/L SL Herbicide

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

Applicant name: Zagro Australia Pty Ltd


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



87635



Product name: Kenso Agcare Mungo 224 Herbicide

Active constituent/s: 224 g/L acifluorfen present as the sodium salt

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

Applicant ACN: N/A

Summary of use For the selective control of certain broadleaf weeds and grasses in mung beans, peanuts, soybeans, green beans and seed crops of siratro and stylo



87589





Product name: Lookout 600 Seed Dressing

Active constituent/s: 600 g/L imidacloprid

Applicant name: American Vanguard Australia Pty Ltd


Summary of use For the control of various insect pests in a range of crops and the prevention of the spread of barley yellow dwarf virus in cereal crops



87768



Product name: Swat Pro Extra Strength Crawling Insect Spray

Active constituent/s: 2.0 g/kg cypermethrin, 1.4 g/kg imiprothrin

Applicant name: Sundew Solutions Pty Ltd


Summary of use For the control of a large range of crawling insects, cockroaches, bedbugs, ants, spiders, fleas and millipedes



87514



Product name: ACP Thiram Seed Dressing Fungicide

Active constituent/s: 600 g/L thiram

Applicant name: Australis Crop Protection Pty Ltd


Summary of use For use as a seed treatment to control various fungal diseases of seeds and as a drench to control fungal diseases of turf



87620



Product name: Family Protection Aerogard Fabric Insect Repellent Eucalyptus does not Stain Fabric 6 hours of Protection without Skin Contact

Active constituent/s: 10 g/kg transfluthrin

Applicant name: Reckitt Benckiser (Australia) Pty Ltd


Summary of use For use on fabrics to repel mosquitoes, flies and other biting insects



87660





Product name: Spa Fresh Active Spa Sanitiser

Active constituent/s: 20 g/L polihexanide hydrochloride

Applicant name: M I International Pty Ltd


Summary of use For control of bacteria in spa pools



87715



Product name: Campbell Perasan Peracetic Acid Biocide

Active constituent/s: 160 g/L peroxyacetic acid, 110 g/L hydrogen peroxide

Applicant name: Colin Campbell (Chemicals) Pty Ltd


Summary of use For the control of bacterial growth in the process water for post-harvest processing of fruit and vegetables



87664



Product name: 4Farmers Picolinafen 750 WG Herbicide

Active constituent/s: 750 g/kg picolinafen

Applicant name: 4 Farmers Australia Pty Ltd


Summary of use For the control of wild radish in field peas and narrow leaf lupins



87655



Product name: Conquest Knockout 550 Double Salt Herbicide

Active constituent/s: 550 g/L glyphosate present as the potassium and monoethanolamine salts

Applicant name: Conquest Crop Protection Pty Ltd


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



87330



Product name: Diafuron Miticide/Insecticide

Active constituent/s: 500 g/L diafenthiuron

Applicant name: Shandong Rainbow International Co Ltd

Applicant ACN: N/A

Summary of use For the control of two-spotted mite and cotton aphids and the suppression of silverleaf whitefly in cotton



86273





Product name: Thermacell Mosquito Repellent II

Active constituent/s: 108.6 g/kg prallethrin

Applicant name: Thermacell Repellents Inc.

Applicant ACN: N/A

Summary of use For use to repel mosquitoes in outdoor areas



85777



Product name: Antiblu CC Concentrate Timber Fungicide

Active constituent/s: 450 g/L chlorothalonil, 100 g/L carbendazim

Applicant name: Arch Wood Protection (Aust) Pty Ltd


Summary of use For use to control sapstain on freshly sawn pine timber



85469



Product name: Contrac Soft Bait

Active constituent/s: 0.05 g/kg bromadiolone

Applicant name: Bell Laboratories Inc

Applicant ACN: N/A

Summary of use For the control of rats and mice



86331



Product name: Conquest Jupiter 800 EC Herbicide

Active constituent/s: 800 g/L thiobencarb

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use For the control of barnyard grass and certain annual sedges including dirty dora in rice



86784





Product name: Titan Propyzamide 900 WG Herbicide

Active constituent/s: 900 g/kg propyzamide

Applicant name: Titan Ag Pty Ltd


Summary of use For selective control of certain grasses and broadleaf weeds in canola, grain legumes, legume pasture, lettuce and turf



86871



Product name: Weed Force Wetter 1000 General Purpose Biodegradable Wetting Agent

Active constituent/s: 800 g/L nonyl phenol ethoxylate, 200 g/L diethylene glycol monobutyl ether

Applicant name: Weed Force Pty Ltd


Summary of use For use as a non-ionic wetting and spreading agent to increase spray contact, coverage and penetration of herbicides, fungicides and insecticides



87725



Product name: Sacoa Liquid AMS Spray Adjuvant

Active constituent/s: 417 g/L ammonium sulphate

Applicant name: Sacoa Pty Ltd


Summary of use For use with glyphosate based herbicides to minimize antagonism when tank mixing with flowable herbicides and improve performance under adverse environmental conditions



87573



Product name: AC Tubs 875 WG Herbicide

Active constituent/s: 875 g/kg terbuthylazine

Applicant name: Axichem Pty Ltd


Summary of use For the control of weeds in chickpeas, faba beans, field peas, lentils, lupins, sorghum and triazine tolerant canola



86678





Product name: Alphanex 250SC Insecticide

Active constituent/s: 250 g/L alpha-cypermethrin



Summary of use: For the control of certain insect pests including red legged earth mite on certain field crops and pastures and certain insect pests on fruit and vegetable crops

Date of registration: 1 April 2019


86990



Product name: Legacy MA-X Herbicide

Active constituent/s: 300 g/L MCPA present as the ethylhexyl ester, 30 g/L diflufenican



Summary of use For control/suppression of various broadleaf weeds in cereals and clover

Date of registration: 1 April 2019


86683


2. VARIATIONS OF REGISTRATION


Product name: Roundup Selective Weedkiller

Active constituent/s: 0.3 g/L dicamba present as dimethylamine salt, 1.5 g/L MCPA present as dimethylamine salt

Applicant name: Evergreen Garden Care Australia Pty Ltd


Summary of variation:

To change the distinguishing product name and the name that appears on the label from ‘Defender Home Garden Ready To Use Bindii Plus Clover Lawn Weeder’ to ‘Roundup Selective Weedkiller’

Date of variation: 27 February 2019


31495



Product name: Kenso Agcare Avior 250 SC Fungicide

Active constituent/s: 250 g/L azoxystrobin

Applicant name: Kenso Corporation (M) Snd. Bhd.

Applicant ACN: N/A


To extend the uses to anise myrtle leaves, carrot, lemon myrtle leaves, nursery stock, ornamentals, cut flowers and foliage, olives, pyrethrum, riberries and rubus fruit

Date of variation: 18 March 2019


70285





Product name: Hyclor Long Life Algaecide

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

Applicant name: Hy-Clor (Australia) Pty Ltd


Summary of variation

To approve a new label for the product 'HyClor Long Life Algaecide' with the label name 'HyClor Winteriser'



59579



Product name: Mesh for Mosquito and Moth Control

Active constituent/s: 100 g/kg metofluthrin

Applicant name: Sumitomo Chemical Australia Pty Ltd



To extend the use to include the control of pantry moth



70086



Product name: Amistar Xtra Fungicide

Active constituent/s: 200 g/L azoxystrobin, 80 g/L cyproconazole

Applicant name: Syngenta Australia Pty Ltd



To extend use to include non-food producing plants in commercial forests and native vegetation for myrtle rust



57949



Product name: PCT Reactor Red Dye Spray Marker Dye Liquid Marking Dye

Active constituent/s: 150 g/L rhodamine b

Applicant name: PCT Holdings Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘PCT Reactor Spray Marker Dye’ to ‘PCT Reactor Red Dye Spray Marker Dye Liquid Marking Dye’



64663





Product name: AW Mincer 750 Herbicide

Active constituent/s: 750 g/kg metribuzin

Applicant name: Agri West Pty Ltd



To update the poison scheduling and storage conditions



62828



Product name: Kenso Agcare Ken-Amine 625 Selective Herbicide

Active constituent/s: 625 g/l 2,4-D present as the dimethylamine and diethanolamine salts

Applicant name: Kenso Corporation (M) Sdn Bhd

Applicant ACN: NA


To incorporate the spray drift instructions from the APVMA’s reconsideration of 2,4-D



56339



Product name: EuroChem Azoxystrobin 250SC Fungicide


Applicant name: Eurochem Pty Ltd






86978



Product name: Surefire Stellar Fungicide


Applicant name: PCT Holdings Pty Ltd






66821





Product name: Beetlebeta 125 SC Insecticide

Active constituent/s: 125 g/L betacyfluthrin

Applicant name: Sundew Solutions Pty Ltd



To extend use to include control of a range of insect pests in the external areas surrounding buildings, turf, ornamentals and natives



66448



Product name: Wonstar 250SC Fungicide


Applicant name: Wonderful Agriculture Co., Limited

Applicant ACN: N/A





67956



Product name: Apparent Azoxystrobin 250 SC Fungicide


Applicant name: Apparent Pty Ltd






68733



Product name: Tordon 75-D Herbicide

Active constituent/s: 300 g/L 2,4-D as the triisopropanolamine salt, 75 g/L picloram as the triisopropanolamine salt

Applicant name: Dow Agrosciences Australia Limited



To incorporate spray drift instructions from the APVMA’s reconsideration action for 2,4-D



40487





Product name: Pro 2,4-D Amine 625 Herbicide

Active constituent/s: 625 g/L 2,4-D present as the dimethylamine and diethanolamine salts

Applicant name: Australian Progressive Supplies Pty Ltd



To incorporate spray drift instructions from APVMA reconsideration action



66630



Product name: OzCrop Azoxystrobin 250 SC Fungicide


Applicant name: OzCrop Pty Ltd






68703



Product name: Echem Acetam 225 Insecticide

Active constituent/s: 515 g/L dimethyl sulfoxide, 334 g/L n-methylpyrrolidone, 225 g/L acetamiprid

Applicant name: Echem (Aust) Pty Ltd



To add the use for green mirids in cotton and green peach aphid in potatoes



67783



Product name: Hit 'Em with the Old Pea Beu Fast Kill Flying Insect Killer Odourless

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

Applicant name: RB (Hygiene Home) Australia Pty Ltd



To change the distinguishing product name and the name that appears on the label from ‘Pea Beu Flying Insect Killer Fast Kill Low Irritant Odourless’ to ‘Hit 'Em With The Old Pea Beu Fast Kill Flying Insect Killer Odourless’



67874





Product name: Double Alpha Azoxystrobin 250 SC Fungicide


Applicant name: Alpha Crop Protection Pty Ltd






82591



Product name: Starane Advanced Herbicide

Active constituent/s: 333 g/L fluroxypyr as the methyl heptyl ester

Applicant name: Dow Agrosciences Australia Limited



To include biosafe as an alternative carrier to diesel for cut stump and basal bark applications



62287



Product name: Adama 2,4-D LV Ester 680 Herbicide

Active constituent/s: 680 g/L 2,4-D present as the 2-ethyl hexyl ester

Applicant name: Adama Australia Pty Limited



To vary pack sizes



61895



Product name: AC Axistrobin 250 SC Fungicide


Applicant name: Axichem Pty Ltd




Date of variation: 1 April 2019


69681





Product name: Sinon A-star 250 SC Fungicide


Applicant name: Sinon Australia Pty Ltd






85084



Product name: Mirador 250 SC Fungicide








64645




Veterinary Chemical Products and Approved Labels

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of the registration in respect of the following products and has approved the label or varied the relevant particulars or conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Doratron Injection

Active constituent/s: 10 mg/mL doramectin



Summary of use For the treatment and control of doramectin sensitive internal and external parasites in cattle and pigs



87683



Product name: Selapro for Dogs (20.1–40 Kg)

Active constituent/s: 120 mg/mL selamectin

Applicant name: Norbrook Laboratories Australia Pty Ltd


Summary of use For the treatment, control and prevention of fleas; control of flea allergy dermatitis; prevention of heartworm disease; treatment and control of sarcoptic mange; treatment of biting lice and sucking lice; and the treatment and control of ear mites in dogs 20.1 to 40 kg



86128



Product name: Deltashield Pour-On Lice And Fly Treatment For Cattle

Active constituent/s: 15 g/L deltamethrin



Summary of use For the control of synthetic pyrethroid susceptible stable fly, house fly, lice and buffalo fly on beef and dairy cattle; buffalo fly and stable fly on horses



87685












86125










86126










86127



Product name: Fasitak Pour-On for Cattle

Active constituent/s: 300 mg/mL triclabendazole, 5 mg/mL abamectin

Applicant name: Abbey Laboratories Pty Ltd


Summary of use For the treatment and control of roundworms, liver fluke and external parasites of beef cattle



87638





Product name: Independents Own Levistar Pig and Poultry Wormer

Active constituent/s: 16 g/L levamisole hydrochloride

Applicant name: Vetpharm Pty Ltd


Summary of use For the treatment of sensitive strains of round worms in pigs and poultry



87667



Product name: Independents Own Eprinomax Pour-On for Beef and Dairy Cattle

Active constituent/s: 5 mg/mL eprinomectin

Applicant name: Vetpharm Pty Ltd


Summary of use For the treatment and control of internal and external parasites of beef and dairy cattle, and internal parasites of deer



87549



Product name: Neovemox Long Acting Injection for Sheep

Active constituent/s: 20 g/L moxidectin

Applicant name: Neove Pharma Australia Pty Ltd


Summary of use For treatment and control of roundworms, nasal bot and itchmite in sheep and for protection against barber's pole for up to 4 months



87525



Product name: Selapro for Cats




Summary of use For the treatment, control and prevention of fleas, control of flea allergy dermatitis, prevention of heartworm disease, treatment and control of ear mites, treatment and control of intestinal hookworm and roundworm, and treatment of biting lice in cats. Also for the treatment of sarcoptic mange, ear and fur mites in rabbits



86131





Product name: Selapro for Puppies and Kittens




Summary of use For the treatment, control and prevention of fleas, control of flea allergy dermatitis, prevention of heartworm disease, treatment and control of ear mites in puppies and kittens; treatment and control of intestinal hookworm and roundworm, and treatment of biting lice in kittens; and also for the treatment of sarcoptic mange, ear and fur mites in rabbits



86133


2. VARIATIONS OF REGISTRATION


Product name: Propan B Injection

Active constituent/s: 300 mg/10mL propantheline bromide

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd


Summary of variation: To change the distinguishing name and the name that appears on the label from ‘NV Propan B Injection’ to ‘Propan B Injection’



51275



Product name: Numocaine Injectable Pain Relief

Active constituent/s: 17.2 mg/ml lignocaine

Applicant name: Mavlab Pty Ltd.


Summary of variation: To add a new target species, sheep and remove three target species, dogs, cats and horses and vary the dosage instructions for cattle.



87460



Product name: Ceprotect DC

Active constituent/s: 89.9 g/kg cephalonium dihydrate



Summary of variation: To update the storage conditions



83807





Product name: Doxy 50 Antibiotic Tablets

Active constituent/s: 50 mg doxycycline (as monohydrate)

Applicant name: Dechra Veterinary Products (Australia) Pty Ltd


Summary of variation: To change the distinguishing product name and the name that appears on the label from ‘Doxycycline 50 Antibiotic Tablets’ to ‘Doxy 50 Antibiotic Tablets’ and update the label



58341




Approved Active Constituents

Pursuant to the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSTITUENT


Active constituent/s:

propiconazole

Applicant name: Sinochem Agro Co, Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 27 March 2019

approval no.: 86414



fenoxycarb

Applicant name: TGAC Australia Pty Ltd




Approval no.: 86393



potassium silicate

Applicant name: Organic Crop Protectants Pty Ltd




Approval no.: 86313

Approved Active Constituents


New Agricultural Active Constituent Mefentrifluconazole

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for the approval of a new active constituent, mefentrifluconazole. Mefentrifluconazole will be used for the control of powdery mildew in grapes, and black spot and powdery mildew in apples.

Common Name: Mefentrifluconazole

IUPAC Name:(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol

CAS Name: α-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-α-methyl-1H-1,2,4-triazole-1-ethanol

CAS Registry Number: 1417782-03-6

Manufacturer’s Codes: BAS 750 F

Minimum Purity: 965 g/kg

Molecular Formula: C18H15ClF3N3O2

Molecular Weight: 397.8 g/mol

Structure:

Chemical Family:

Mode of Action:

Triazole fungicide.

Mefentrifluconazole is a fungicide belonging to the group of the sterol biosynthesis inhibitors in the sub group of demethylation inhibitors. The primary mode of action of this group is the blocking of ergosterol biosynthesis through inhibition of cytochrome P450 sterol 14-demethylase (Cyp51).

SUMMARY OF THE APVMA’S EVALUATION OF MEFENTRIFLUCONAZOLE ACTIVE CONSTITUENT

The APVMA has evaluated the chemistry aspects of mefentrifluconazole active constituent (physico-chemical properties, identification, manufacturing process, quality control procedures, batch analysis results and analytical methods) and found them to be acceptable.

The APVMA has completed a toxicological evaluation of mefentrifluconazole.

An Acceptable Daily Intake (ADI) of 0.05 mg/kg bw/d has been established, based on a No-Observed Adverse Effect Level (NOAEL) of 5.0 mg/kg bw/d in a two year dietary rat study, and applying an uncertainty factor of 100.

New Active Constituent Mefentrifluconazole


An Acute Reference Dose was not required for the general population or identifiable sub populations on the basis of its low acute toxicity, the lack of evidence for any acute neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to a single dose.

Based on the available data and with input from the Advisory Committee on Chemical Scheduling, the Scheduling Delegate made a decision to include mefentrifluconazole in Schedule 5 of the Poison Standard, except in formulations containing 7.5% or less of mefentrifluconazole, with an implementation date of 1 October 2018.

On the basis of the data provided, and the toxicological assessment, it is proposed that the following APVMA Active Constituent Standard be established for mefentrifluconazole:

Specification Level

Mefentrifluconazole content Minimum 965 g/kg

Other compounds of toxicological significance are not expected to occur in mefentrifluconazole technical active constituent.

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

MAKING A SUBMISSION

In accordance with sections 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for approval of mefentrifluconazole should be granted. Submissions should relate only to matters are considered in determining whether the safety criteria set out in section 5A of the Agvet Code are met. Submissions should state the grounds on which they are based.

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.

When making a submission please include a:

Contact name Company or Group name (if relevant) Email or postal address (if available) The date you made the submission.

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

Submissions should be addressed in writing to:

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


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


Director Chemistry and ManufactureScientific Assessments and Chemical Review ProgramAustralian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604

Phone: (02) 6210 4701Fax: (02) 6210 4712Email: [email protected]


mailto:[email protected]


Belanty Fungicide Containing Mefentrifluconazole

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a new product containing a new active constituent. The product is BELANTY FUNGICIDE.

PARTICULARS OF THE APPLICATION

Proposed product name(s): Belanty fungicide

Applicant company: BASF Australia Ltd

Name of active constituent: Mefentrifluconazole

Signal heading: Unscheduled

Summary of proposed use: For control of Powdery Mildew in Grapevines and Black Spot in Apples

Pack sizes: 1 L, 2 L, 2.5 L, 5 L, 10 L

Withholding periods: HARVEST:

APPLES: DO NOT HARVEST FOR 7 DAYS AFTER APPLICATION

GRAPES: DO NOT HARVEST FOR 7 DAYS AFTER APPLICATION

GRAZING:

DO NOT graze any treated area or cut for stockfood

SUMMARY OF THE APVMA’S EVALUATION OF BELANTY FUNGICIDE IN ACCORDANCE WITH THE REQUIREMENTS OF SECTION 14(1)(C) OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE (THE ‘AGVET CODE’), SCHEDULED TO THE AGRICULTURAL AND VETERINARY CHEMICALS CODE ACT 1994

1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of Belanty fungicide would not be an undue hazard to the safety of people exposed to it during its handling and use.

The APVMA has conducted a risk assessment on the product and concluded that it can be used safely.

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

(iii) The APVMA is satisfied that the proposed use of Belanty fungicide containing the active constituent mefentrifluconazole is not likely to be harmful to human beings if used according to the product label directions.

Belanty Fungicide containing Mefentrifluconazole


(iv) The APVMA is satisfied that the proposed use of Belanty fungicide containing the active constituent mefentrifluconazole, would not be likely to have an unintended effect that is harmful to animals, plants or things or the environment.

2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

(i) 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.

3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5C of the Agvet Code, and proposes to determine that:

(ii) The APVMA is considering whether the proposed use of Belanty fungicide would not adversely affect trade between Australia and places outside Australia.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public Consultation’ page, www.apvma.gov.au/consultation/public or by contacting the evaluator listed below.

MAKING A SUBMISSION

In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether BELANTY FUNGICIDE should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.


Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and in determining appropriate conditions of registration and product labelling.

When making a submission please include:

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

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

Written submissions should be addressed in writing to:


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


Case Management and Administration Unit


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721


Commonwealth of Australia GazetteNo. APVMA 7, Tuesday, 9 April 2019 Agricultural and Veterinary Chemicals Code Act 1994 30

New Active Constituent and Veterinary Chemical Product PLASMID DNA

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Boehringer Ingelheim Animal Health Australia Pty Ltd for the approval of the new active constituent, PLASMID DNA, and registration of a new product containing this active constituent. The proposed product is ONCEPT® CANINE MELANOMA VACCINE, DNA.

PARTICULARS OF THE ACTIVE CONSTITUENT

Name of active constituent: PLASMID DNA

Appearance: Suspension

Sterility: As per 9 CFR USDA

Extraneous agents: As per 9 CFR USDA

Gene technology: Not Applicable

Mode of action: Induction of immunological response

SUMMARY OF THE APVMA’S EVALUATION OF THE NEW ACTIVE CONSTITUENT

The APVMA has assessed the chemistry and manufacturing aspects of the active PLASMID DNA and has determined

that the active constituent is manufactured to an acceptable standard. The assessment included starting materials,

master seeds (source, identity, and purity), culture media, vaccine production, quality control, shelf life and batch release

analysis.

The APVMA has considered the health aspect of the active. Based on the data supplied, in conjunction with an exposure assessment which indicated low potential exposure of humans to the vaccine, that the vaccine is unlikely to be associated with any significant toxic effects in humans. The pINGhT plasmid does not contain any genetic elements that would be considered to pose a risk in terms of virulence factors or transmissible genetic elements. There are no concerns on human health grounds regarding approval of the new active constituent, plasmid DNA (rE. coli DH5α pINGhT). The inclusion of the plasmid DNA (rE. coli DH5α pINGhT) in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) was implemented in the Poisons Standard on 1 February 2018.

The APVMA is satisfied of the safety of the active constituent and that the proposed use of PLASMID DNA would not be an undue hazard to the safety of people exposed to it during its handling and use; and would not be likely to have an effect that is harmful to human beings; and would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

PARTICULARS OF THE PRODUCT

Proposed name: ONCEPT CANINE MELANOMA VACCINE, DNA

Applicant Company: Boehringer Ingelheim Animal Health Australia Pty Ltd

Active constituent: PLASMID DNA

Adjuvant: Not applicable

Scheduling: Schedule 4

New Active Constituent and Veterinary Chemical Product Plasmid DNA


Pharmaceutical form: Suspension

Pack sizes: 4 x 1 Dose (0.4ml) vials

SUMMARY OF PROPOSED USE:

ONCEPT CANINE MELANOMA VACCINE, DNA is a therapeutic vaccine with plasmid DNA vaccine recombinant E. coli, DH5α pINGhT as the active constituent. The vaccine is indicated for use as an adjunctive treatment under specialist veterinary supervision and aids in extending survival times of dogs with Stage II or III oral melanoma for which local disease control has been achieved.

Dose and route of administration: The vaccine is administered in a 0.4ml dose volume using the VET-JET® transdermal vaccination system. The site of injection for all dogs is into the muscle of the medial thigh just caudal to the femur. Initial treatment requires administration of four doses of vaccine at two week intervals. A booster dose should be administered at six month intervals.

Side effects: Transdermal injection has been associated with injection site pain, swelling, and bruising. A transient, low-grade fever may be observed in some dogs. In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Treatment may include antihistamines, anti-inflammatories, and/or epinephrine.

Summary of the APVMA’s evaluation of ONCEPT CANINE MELANOMA VACCINE, DNA in accordance with THE REQUIREMENTS OF SECTION 14(1)(C) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994

1. The APVMA has evaluated the application and in its assessment in relation to whether the safety criteria have

been met in accordance with the definition set out in section 5A of the Agvet Code, and proposes to determine that:

(i) The APVMA is satisfied that the proposed use of ONCEPT CANINE MELANOMA VACCINE, DNA would not be an

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

ONCEPT CANINE MELANOMA VACCINE, DNA does not contain any adjuvants or novel excipients. The

excipients in the proposed formulations are present in several vaccines registered for use in Australia or overseas,

and would be expected to be of low oral, dermal and inhalational toxicity. The APVMA has concluded that there are

negligible risks to the health and safety of people from the proposed commercial release of PLASMID DNA (rE. coli

DH5α pINGhT), either in the short or long term.

The proposed product labelling includes appropriate first aid instructions and the additional user safety. Given this

product is injectable, human exposure to ONCEPT CANINE MELANOMA VACCINE, DNA is expected to be

minimal. Veterinarians will be the main occupations directly exposed to ONCEPT CANINE MELANOMA VACCINE,

DNA. First aid instructions and safety directions of “Wash hands after use” are to be labelled to mitigate the risk.

The product label will contain first aid statement if poisoning occurs, contact a doctor or Poisons Information

Centre. Phone Australia 13 11 26.

(ii) The APVMA is satisfied that the proposed use of ONCEPT CANINE MELANOMA VACCINE, DNA will not be an

undue hazard to the safety of people using anything containing its residues. The product is for use in non-food

produce animals (dogs), therefore, there are no concerns regarding residues in food regarding the registration of

this product.



(iii) The APVMA is satisfied that the proposed use of the product is not likely to be harmful to human beings if used

according to the product label directions.

The active ingredient is a genetically modified plasmid construct pINGhT containing the human tyrosinase gene. It

is a non-live organism. The product will be included in Schedule 4 of the SUSMP.

The history of the strain was well documented. The origin, preparation, passage history and testing of the master

seed had been described adequately, and the results were acceptable. The working seed bacteria was also tested

appropriately and the results were also acceptable.

(iv) The APVMA is satisfied that ONCEPT CANINE MELANOMA VACCINE, DNA would not have an unintended effect that is harmful to dogs, plants or things or the environment.

A safety study was undertaken in which 50 healthy dogs were administered the four dose regimen transdermally. Only mild responses, including pain, exudation of blood or serum at the injection site or wheal formation, were reported, and all of which were resolved within an hour. Seven dogs had moderate febrile responses. A high dose safety study in which 25 dogs were administered the product at a 2.5 fold overdose on four occasions, the incidence of adverse reactions was similar to that seen at the recommended dose.

Reports on vaccinated dogs included in the efficacy trial shown that none of the dogs experienced severe adverse acute reactions, with only mild to moderate pain on injections and occasionally wheal formation reported. Bruising was reported in 11 dogs and this was resolved in all but one within 2 weeks.

In a published report (Grosenbaugh et al, 2011), which included additional cases compared to the study in this application, no dogs had systemic adverse reactions requiring veterinary intervention, 84 inoculations (36.2%) resulted in signs of pain during injection, 72 (31.0%) of which were mild and 12 (5.2%) moderate. There were 2 (0.9%) cases with acute wheal formation and 5 (2.2%) with wheals 30 minutes after vaccination. In 115 (49.6%) inoculations there was encrustation at the inoculation site and leakage of fluid from the injection site in 11 (4.7%) of cases. There were 2 (0.9%) reports of acute haematoma formation. At the follow up vaccination 2 weeks later, 1 (0.4%) case had an unresolved bruise, 2 (0.9%) had some encrustation at the injection site and 3 (1.3%) had mild pain on palpation of the injection site. None of the adverse reactions reported by owners were judged by the clinicians responsible for the cases to be vaccine related.

Consistently, the Europe Union (EU) assessment report states that in general, the vaccine was well tolerated. Transient fever up to 40.7 °C, and lasting up to 10 days was observed post-vaccination in some dogs. Minor transient local reactions were observed in some dogs, ie red skin marks, local swelling, redness in the injection site. It was considered that some of the local reactions were related to the route of administration rather than to the vaccine, and particularly to the device (pressure spring) used for the administration of the product.

The adverse experience report covered global reports for the period 2007–18. The rate of reported adverse events

(AE) is very low with an incidence of 0.124%. Additionally, Experience Reports supplied by local specialist users

are suggestive of a high level of safety for the ONCEPT CANINE MELANOMA VACCINE, DNA although

interpretation of the safety data is potentially confounded by the compromised health status of the dogs being

treated.

To assess the possibility of genome integration after injection, studies in other species with other plasmids

supported that the inoculation of a plasmid was unlikely to result in a high rate of integration into the genome of the

cells of the inoculated host animals. Plasmid DNA was found to persist in the muscle at the site of injection; no

aberrant muscle pathology or auto-immune mediated pathology indicative of an auto-immune disease was



observed in the injected muscles. After a period of weeks to a few months, the plasmid will be cleared from the

injection site.

No specific reproductive safety test was performed in dogs, relevant warnings will be labelled, eg “ safety of the

veterinary medicinal product has not been established during pregnancy and lactation”.

No auto-immune sequelae have been reported in the submitted data in dogs with oral melanoma treated with ONCEPT CANINE MELANOMA VACCINE, DNA. No such side effects have been observed in the field safety studies or included in the pharmacovigilance data available from the use of the product in authorised markets.

The diffusibility of the active into the environment was assessed through review of the the EU assessment. A high dose of plasmid DNA pINGhT vaccine was administered to 3–4 month-old healthy Beagle dogs (n=6) by the transdermal route into the left thigh (0.4 ml). Two further dogs were non vaccinated in-contact controls. DNA was extracted from blood and from various and was subsequently amplified using a PCR technique. The plasmid DNA was not shed in urine but was detected in nasal swabs, rectal swabs and blood at least during 3 days after vaccination. Shedding of plasmid DNA did not result in transmission to in-contact dogs. The chance of dissemination of the vaccine construct to the environment is considered to be low.

In conclusion, safety studies for the vaccine in conventional dogs and those affected with canine oral melanoma

demonstrated a small number of mild, per-acute responses which resolved within an hour of vaccination. Although

some adverse events related to treatment were reported, it is proposed that the risks associated with treatment are

ameliorated by the therapeutic benefits of ONCEPT CANINE MELANOMA VACCINE, DNA as an adjunctive

therapy for canine melanoma. The product does not appear to result in a high prevalence of severe adverse

effects. The most frequently reported signs were lethargy, anorexia, vomiting, injection site haematoma and

lameness. These mostly non-serious signs are consistent with those expected of the immune response to

vaccination or the delivery method of the vaccine itself.

2. The APVMA has evaluated the application and in its assessment in relation to whether the efficacy criteria have

been met in accordance with the definition set out in section 5B of the Agvet Code, and proposes to determine that:

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 demonstrate that if used according to the product label directions, the product

is effective for its proposed uses.

ONCEPT CANINE MELANOMA VACCINE, DNA is recommended as an adjunctive treatment to aid in extending

survival times of dogs with stage II or stage III oral melanoma and for which local disease control has been

achieved, ie negative local lymph nodes or positive lymph nodes that were surgically removed or irradiated. The

data to support the efficacy aspects consist of supporting information (published data) and one pivotal field efficacy

study.

In the efficacy study, there was a comparison of survival times in 53 dogs with stage II or III oral melanoma in

which local disease control had been achieved that were administered four doses of the vaccine at 2 week

intervals, followed by booster doses at 6 month intervals. Dose confirmation and dose regimen studies were not

conducted. The vaccine was administered transdermally into the medial aspect of the thigh. Vaccinated animals

were compared to historical controls. A published report extended to include 58 prospectively enrolled cases that

were treated with the vaccine, with these cases compared to the same 53 historical controls.



There was no significant difference between the vaccinated group and the historical controls in age, sex or stage of

disease. Of the 58 vaccinated dogs, 16 died from causes not attributable to metastatic melanoma, 10 were lost to

follow up and 9 were removed from the study for other modes of treatment. These cases were censored from the

statistical analysis. In historical controls, 7 cases died from other causes and 1 was lost to follow up. At the

conclusion of the study 15 vaccinated cases had died of melanoma and 8 remained alive, while in the historical

controls 34 had died of melanoma and 11 remained alive. It was observed that in this study, time to death was

significantly longer for dogs in the vaccinated group (P < 0.001). The median survival times could not be compared

because 50% of the vaccinated group had not died over the period of study, but the survival time of the first quartile

in the vaccinated group was 464 days, while it was 156 days in the historical controls. Vaccinates that had stage II

melanoma at the time of enrolment had a significantly greater survival time (P < 0.001, median not reached) than

those that had stage III melanoma at the time of enrolment (235 days). There was no significant difference in

survival time between the dogs with different stages of melanoma in the historical controls. There was no

significant difference in survival time between cases with histological evidence of complete excision and those with

evidence of incomplete excision. However, the unequal level of censoring of data in the vaccinated group could

have an effect on the efficiency of the statistical test used to evaluate the effect of treatment. While there are

limitations with the controls used, the product has been demonstrated to be likely to have some efficacy as an

adjunct to surgical therapy for treatment of oral melanoma. To further address the efficacy issue, the

Pharmacovigilance data (for the period 2007–18) and Experience Reports for ONCEPT CANINE MELANOMA

VACCINE, DNA were supplied for review. The rate of reported sLOE is very low with an incidence of 0.084%.

ONCEPT CANINE MELANOMA VACCINE, DNA vaccine has been imported into Australia by specialist veterinary

centres under individual import consents issued by the APVMA. Four Experience Reports were supplied by the

specialists who imported and used the proposed product. Findings from the Pharmacovigilance data and

Experience Reports suggest an encouraging trend for ONCEPT CANINE MELANOMA VACCINE, DNA in

sometimes extending survival times for dogs with locally contained oral melanoma and with no nodal or metastatic

disease.

It is noted that the proposed product will be used as part of an appropriate treatment strategy under specialist

veterinary supervision only as an aid in extending survival times of dogs with stage II or stage III oral melanoma for

which there is no reasonable alternative. Statements of “ONCEPT® DNA Canine Melanoma Vaccine is

recommended for use as an adjunctive treatment under specialist veterinary supervision.” and “Individual

responses to treatment may vary. This is likely due to individual differences in immune responses in the context of

a complex pathophysiological process.” will be labelled.

The APVMA has concluded that the data generated from the studies are consistent with the claim: use as an

adjunctive treatment under specialist veterinary supervision to aid in extending survival times of dogs with stage II

or stage III oral melanoma for which local disease control has been achieved, ie negative local lymph nodes or

positive lymph nodes that were surgically removed or irradiated.

3. The APVMA has evaluated the application and in its assessment in relation to whether the trade criteria have been met in accordance with the definition set out in section 5c of the Agvet Code, and proposes to determine that:

The trade risk associated with the proposed use of ONCEPT CANINE MELANOMA VACCINE, DNA is low. Review

of the formulation indicates that the excipients are not novel, and the vaccine product is not for a food producing

animals (dogs). Therefore, there are no concerns from a trade perspective relating to the registration of this

product.



MAKING A SUBMISSION

In accordance with section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether PLASMID DNA should be approved. Submissions should relate only to matters that are considered in determining whether the safety criteria set out in section 5A of the Agvet Code have been met. Submissions should state the grounds on which they are based.

In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether ONCEPT CANINE MELANOMA VACCINE, DNA should be registered. Submissions should relate only to matters that are required by the APVMA to be taken into consideration in determining whether the safety, efficacy or trade criteria have been met. Submissions should state the grounds on which they are based.


When making a submission please include:

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

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

Written submissions should be addressed in writing to:

Enquiries

Registration Management and Evaluation


PO Box 6182

KINGSTON ACT 2604

Phone: +61 2 6210 4701

Fax: +61 2 6210 4721

Email: [email protected]




Amendments to the APVMA MRL Standard

The Australian Pesticides and Veterinary Medicines Authority (APVMA) approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. The MRLs approved by the APVMA are associated with a regulatory decision to register a product, grant a permit approval, or as an outcome from a review decision and are set out in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012. The MRL Standard lists MRLs of substances that may arise from the approved use of agricultural and veterinary chemical products containing those substances on commodities used for human consumption as well as livestock feeds. The MRL Standard also provides the relevant residue definitions to which these MRLs apply. There may be situations where the residue definition for monitoring and enforcement is different to the definition used for dietary risk assessment purposes.

MRLs are set at levels which are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with approved label instructions. In considering MRLs and variation to MRLs, the APVMA takes into account studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice and dietary exposure. In approving MRLs, the APVMA is satisfied, from dietary exposure assessment, that the levels set are not an undue hazard to human health.

The APVMA has amended the MRL Standard and the changes will have affect the day after the instrument is registered.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2019 (No. 3).

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

The MRL Standard is accessible via the Federal Register of Legislation website or the links above.

For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604

Phone: +61 2 6210 4897Fax: +61 2 6210 4840Email: [email protected]

Amendments to the APVMA MRL standard

https://edrms/id:A147213/document/versions/[email protected]

http://www.legislation.gov.au/

http://www.comlaw.gov.au/Current/F2012L02501

http://www.comlaw.gov.au/Current/F2012L02501


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

In the previous notice on Page 35 of APVMA Gazette No. 7, the APVMA gazetted amendments which it has approved to vary maximum residue limits (MRLs) for substances contained in agricultural and veterinary chemical products as set out as in the APVMA’s MRL Standard.

Under section 82 of the Food Standards Australia New Zealand Act 1991, the APVMA is proposing to incorporate those variations (Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2019 (No. 3)) to MRLs into Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code.

MRLs contained in Schedule 20 provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this means, Schedule 20 permits the sale of treated foods and protects public health and safety by minimising residues in foods consistent with the effective control of pests and diseases.

The APVMA and Food Standards Australia New Zealand (FSANZ) are satisfied, based on dietary exposure assessments and current health standards, that the proposed limits are not harmful to public health.

The agreement between the Australian Government and the New Zealand Government concerning a Joint Food Standards System, excludes MRLs for agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agricultural and veterinary chemicals in food.

FSANZ will make a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO).

The APVMA invites comment on these proposals. Details on how to make a submission appear near the end of this notice, below the details of the proposed amendment.

The APVMA will consider any public comments made in response to this proposal. If the APVMA decides to proceed with the proposal, it will further notify any variations it makes to Schedule 20 in the APVMA Gazette. The variations will take effect as from the date of that subsequent notice.

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


PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE 9 April 2019Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation

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

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

Agvet chemical: Glyphosate

Permitted residue: Sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosateOilseed [except cotton seed; peanut; linseed; poppy seed; rape seed (canola); sunflower seed]

T*0.01

Agvet chemical: Praziquantel

Permitted residue: Praziquantel

Tuna T*0.01

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

Agvet chemical: Bromoxynil

Permitted residue: Bromoxynil

All other foods except animal food commodities

0.1

Hempseed T*0.02

Agvet chemical: Chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: ChlorantraniliprolePermitted residue—milk: Sum of chlorantraniliprole, 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, and 3-bromo-N-[4-chloro-2-(hydroxymethyl)-6-[[((hydroxymethyl)amino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-carboxamide, expressed as chlorantraniliproleHempseed T1Sesame seed T0.5

Agvet chemical: Diflubenzuron

Permitted residue—Diflubenzuron

Fish muscle T*0.002



Agvet chemical: Fluopyram

Permitted residue—commodities of plant origin: FluopyramPermitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram

Eggs *0.02Poultry, Edible offal of *0.02Poultry meat *0.02

Agvet chemical: Glyphosate

Permitted residue: Sum of glyphosate, N-acetyl-glyphosate and aminomethylphosphonic acid (AMPA) metabolite, expressed as glyphosate

Oilseed [except cotton seed; peanut; linseed; poppy seed; rape seed (canola); sesame seed; sunflower seed]

T*0.01

Sesame seed T20

Agvet chemical: Haloxyfop

Permitted residue: Sum of haloxyfop, its esters and conjugates, expressed as haloxyfop

Hempseed T0.1

Agvet chemical: Indoxacarb

Permitted residue: Sum of indoxacarb and its R-isomerHempseed T*0.05

Agvet chemical: Mandestrobin

Permitted residue: MandestrobinBeans, except broad bean and soya bean

0.7

Edible offal (Mammalian) 0.02Lettuce, Head 0.7Lettuce, Leaf 7Meat (mammalian) (in the fat) 0.02Milk *0.02Beans, except broad bean and soya bean

0.7

Agvet chemical: Praziquantel

Permitted residue: PraziquantelFish muscle T*0.02



Agvet chemical: Pyrethrins

Permitted residue: Sum of pyrethrins i and ii, Cinerinsi i and ii and jasmolins i and ii, determined after calibration by means of the International Pyrethrum StandardAll other foods except animal food commodities

0.2

Edible offal (Mammalian) *0.05Eggs *0.05Meat (mammalian) (in the fat) *0.05Milks *0.05Poultry, Edible offal of *0.05Poultry, Meat (in the fat) *0.05

Agvet chemical: Sethoxydim

Permitted residue: Sum of sethoxydim and metabolites containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulfoxides and sulfones, expressed as sethoxydimSesame seed T0.5

Agvet chemical: Trichlorfon

Permitted residue: TrichlorfonAll other foods except animal food commodities

0.05

Fish muscle T*0.01

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

Agvet chemical: Fluopyram

Permitted residue—commodities of plant origin: FluopyramPermitted residue—commodities of animal origin: Sum of fluopyram and 2-(trifluoromethyl)-benzamide, expressed as fluopyram

Edible offal (Mammalian 0.5Meat (mammalian) 0.1Rape seed (canola seed) *0.01



INVITATION FOR SUBMISSIONS

Written submissions are invited from interested individuals and organisations to assist the APVMA in considering the proposal to vary Schedule 20–Maximum residue limits in the Australia New Zealand Food Standards Code. Submissions should be strictly confined to relevant matters that the APVMA must consider (such as public health and safety) which are associated with the occurrence of the proposed residues in foods. Comments received outside these grounds will not be considered by the APVMA. Claims made in submissions should be supported wherever possible by referencing or including relevant studies, research findings, trials, surveys etc. Technical information should be in sufficient detail to allow independent scientific assessment.

Please note that FSANZ will make a SPS notification to the WTO and submissions related to impacts on international trade should be made to FSANZ in response to that notification.

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

DEADLINE FOR PUBLIC SUBMISSIONS: 6 pm (AEST) 07 May 2019.SUBMISSIONS RECEIVED AFTER THIS DEADLINE WILL ONLY BE CONSIDERED BY PRIOR ARRANGEMENT

Submissions received after this date will only be considered if agreement for an extension has been given prior to this closing date. Agreement to an extension of time will only be given if extraordinary circumstances warrant an extension to the submission period. For further information please contact:

MRL Contact Officer Australian Pesticides and Veterinary Medicines AuthorityPO Box 6182KINGSTON ACT 2604

Phone: +61 2 6210 4897Fax: +61 2 6210 4840Email: [email protected]



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