apvma gazette no. 7, 7 april 2020 · 2020. 4. 7. · gazette agricultural and veterinary chemicals...

Gazette

Agricultural and

Veterinary Chemicals

No. APVMA 7, Tuesday, 7 April 2020

Published by the 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 1837-7629

© Commonwealth of Australia 2020

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

GPO Box 3262

Sydney NSW 2001

Email: [email protected]

Website: 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 requi red

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.

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Commonwealth of Australia Gazette No. APVMA 7, Tuesday, 7 April 2020 Agricultural and Veterinary Chemicals Code Act 1994 3

CONTENTS

Agricultural Chemical Products and Approved Labels..................................................................................................... 4

Veterinary Chemical Products and Approved Labels .................................................................................................... 11

Approved Active Constituents ....................................................................................................................................... 14

New agricultural active constituent: trifludimoxazin ....................................................................................................... 15

New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil .................................................. 17

Amendments to the APVMA MRL Standard .................................................................................................................. 19

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

Variations to Schedule 20 of the Australia New Zealand Food Standards Code ........................................................... 25

Consultation on use patterns for anticoagulant rodenticide products ............................................................................ 32


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.: 123172

Product name: Loveland Adopt Spray Oil

Active constituent/s: 582 g/L paraffinic oil, 240 g/L alkoxylated alcohol non-ionic surfactants

Applicant name: Loveland Products Inc

Applicant ACN: N/A

Summary of use: For use to improve the spreading and wetting of herbicides, insecticides and defoliants on plant surfaces

Date of registration: 17 March 2020

Product registration no.: 89017

Label approval no.: 89017/123172


Product name: Farmalinx Spectacle Seed Dressing

Active constituent/s: 25 g/L tebuconazole, 4 g/L triflumuron

Applicant name: Farmalinx Pty Ltd

Applicant ACN: 134 353 245

Summary of use: For control of bunt, flag smut and loose smut in wheat, covered and loose smut of barley and oats and for protection against insect pests of stored grain





Product name: Double Nozzle Technology Raid Max Flying Insect Killer

Active constituent/s: 0.5 g/kg imiprothrin, 0.5 g/kg prallethrin, 0.15 g/kg cyfluthrin

Applicant name: S.C. Johnson & Son Pty Ltd


Summary of use: For the control of flying and crawling insects in household situations





Product name: Campbell EcoFOG-160 PYR Fungicide

Active constituent/s: 160 g/L pyrimethanil

Applicant name: Colin Campbell (Chemicals) Pty Ltd


Summary of use: For control of postharvest diseases of apples and pears caused by Penicillium spp, Botrytis spp and Neofabrea spp







Product name: Weed Force Big Cat Broadleaf Herbicide

Active constituent/s: 250 g/L MCPA as the ethyl hexyl ester, 25 g/L diflufenican

Applicant name: Weed Force Pty Ltd


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





Product name: Titan Terbutryn 275 g/L + 160 g/L MCPA Herbicide

Active constituent/s: 275 g/L terbutryn, 160 g/L MCPA present as the potassium salt

Applicant name: Titan Ag Pty Ltd


Summary of use: For the control of seedling broadleaf weeds in wheat, barley, some varieties of oats, pasture and sugar cane





Product name: Sanonda Fungicide Flutriafol 500SC

Active constituent/s: 500 g/L flutriafol

Applicant name: Sanonda (Australia) Pty Ltd


Summary of use: For the control of certain fungal diseases on wheat, barley and canola





Product name: Thanos 225 Insecticide

Active constituent/s: 225 g/L methomyl

Applicant name: Sunrise Crop Science Co Ltd

Applicant ACN: N/A

Summary of use: For the control of insect pests in various crops





Product name: Pest Controllers Own Fipronil 100 SC Termiticide & Insecticide

Active constituent/s: 100 g/L fipronil

Applicant name: Amgrow Pty Ltd


Summary of use: For the protection of structures from subterranean termite damage and for the control of subterranean termites and ants around domestic and commercial structures







Product name: AC Jettison 150 EC Insecticide

Active constituent/s: 150 g/L indoxacarb (S-isomer)

Applicant name: Axichem Pty Ltd


Summary of use: For control of various insect pests of azuki beans, chickpeas, cotton, faba beans, mungbeans and soybeans





Product name: Kelpie Tri-S 750 Herbicide

Active constituent/s: 750 g/kg triasulfuron

Applicant name: Sinochem International Australia Pty Ltd


Summary of use: For the pre-plant control of annual ryegrass, paradoxa grass and certain broadleaf weeds in wheat, and for post-emergent control of wild radish in wheat, oats and barley





Product name: Kelpie A-zine Easy Flow 600 SC Herbicide

Active constituent/s: 600 g/L atrazine

Applicant name: Sinochem International Australia Pty Ltd


Summary of use: For the control of weeds and grasses in TT canola, lupins, sorghum, maize, sugarcane, lucerne, potatoes, fallow area maintenance and other situations





Product name: Conquest Vipyr 250 EC Fungicide

Active constituent/s: 250 g/L Pyraclostrobin

Applicant name: Conquest Crop Protection Pty Ltd


Summary of use: For the control of leaf speckle and leaf spot in bananas; downy and powdery mildew in grapevines; husk spot in macadamia; and rust in almonds





Product name: Double Nozzle Technology Raid Max Multi Insect Killer

Active constituent/s: 0.5 g/kg imiprothrin, 0.5 g/kg prallethrin, 0.15 g/kg cyfluthrin

Applicant name: S.C. Johnson & Son Pty Ltd


Summary of use: For the control of flying and crawling insects in household situations







Product name: Sinon Clodinafop 240 EC Herbicide

Active constituent/s: 240 g/L clodinafop, 60 g/L cloquintocet-mexyl

Applicant name: Sinon Australia Pty Limited


Summary of use: For the control of wild oats, paradoxa grass (annual phalaris), canary grass and annual ryegrass in wheat. Highly active on wild oats and can be mixed with many broadleaf herbicides




2. VARIATIONS OF REGISTRATION


Product name: Vaporooter Foaming Root Inhibitor

Active constituent/s: 510 g/kg dichlobenil, 228 g/L metham present as sodium salt

Applicant name: Duke's Root Control Inc

Applicant ACN: N/A

Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Sanafoam Vaporooter ii Foaming Root Inhibitor’ to ‘Vaporooter Foaming Root Inhibitor’.

Date of variation: 5 March 2020




Product name: Elatus Ace Solatenol Active Fungicide

Active constituent/s: 250 g/L propiconazole, 40 g/L benzovindiflupyr

Applicant name: Syngenta Australia Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Elatus Ace Solatenol brand fungicide’ to ‘Elatus Ace Solatenol Active Fungicide’





Product name: Nufarm Kaiso 240EG Insecticide with Sorbie Technology

Active constituent/s: 240 g/kg lambda-cyhalothrin

Applicant name: Nufarm Australia Limited


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Kaiso 240EG Insecticide’ to ‘Nufarm Kaiso 240EG Insecticide with Sorbie Technology’







Product name: Durango Herbicide

Active constituent/s: 360 g/L glyphosate present as the isopropylamine and mono-ammonium salts

Applicant name: Production Agriscience (Australia) Pty Ltd


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Dupont Glyphosate Herbicide’ to ‘Durango Herbicide’





Product name: Ozcrop Dicamba 500 SL Herbicide

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

Applicant name: Ozcrop Pty Ltd


Summary of variation: To add use in pine plantations to encourage wood wasp attack and in rice to control dirty dora, sedges and starfruit





Product name: Eco-Oil Organic Miticide/Insecticide/Adjuvant Botanical Oil Concentrate

Active constituent/s: 850 g/L emulsifiable botanical oil

Applicant name: Duluxgroup (Australia) Pty Ltd


Summary of variation: To add control of mealybugs and sooty mould in ornamentals and black scale in olives





Product name: Flowable Gesaprim 600 SC Liquid Herbicide

Active constituent/s: 600g/L atrazine



Summary of variation: To add use to control purple top verbena in tea tree plantations





Product name: Zulu XT Herbicide

Active constituent/s: 720 g/L 2,4-D present as isopropylamine and dimethylamine salts

Applicant name: Adama Australia Pty Limited


Summary of variation: To add additional application methods for the control of fleabane, sowthistle and yellow vine in fallow situations and to make minor amendments to the direction for use







Product name: Virkon S The Broad Spectrum Virucidal Bactericidal Fungicidal Disinfectant

Active constituent/s: 494 g/kg potassium peroxomonosulfate triple salt, 132 g/kg sodium dodecyl benzene sulfonate, 15 g/kg sodium chloride

Applicant name: Alltech Lienert Australia Pty Ltd


Summary of variation: To add special cases of approved uses in horticulture and in agricultural buildings and general farm equipment





Product name: Talinor Herbicide

Active constituent/s: 175 g/L bromoxynil present as the octanoate, 37.5 g/L bicyclopyrone, 9.4 g/L cloquintocet -mexyl



Summary of variation: To include the control of matracia/Globe Chamomile and suppression of statice in wheat and barley





Product name: Gesaprim Granules Herbicide

Active constituent/s: 900 g/kg atrazine








Product name: Yanco Mosquito Coils

Active constituent/s: 2.5 g/kg pyrethrins

Applicant name: Yanco Limited

Applicant ACN: N/A

Summary of variation: To register an additional formulation





Product name: Accensi Atrazine 900 WG Herbicide

Active constituent/s: 900 g/kg atrazine

Applicant name: Accensi Pty Ltd









Product name: Bird Free Bird Deterrent

Active constituent/s: 720 g/kg polybutene, 5.3 g/kg peppermint oil

Applicant name: Bird Free Australia Pty Ltd


Summary of variation: For deterring starlings and mynahs





Veterinary Chemical Products and Approved Labels



Code Act 1994, the APVMA hereby gives notice that it has registered or varied the relevant particulars or conditions of

the registration in respect of the following products and has approved the label or varied the relevant particulars or

conditions of the approval in respect of the containers for the chemical product, with effect from the dates shown.

1. VETERINARY PRODUCTS BASED ON EXISTING ACTIVE CONSTITUENTS


Product name: Neovexx Injectable Solution

Active constituent/s: 100 mg/mL tulathromycin

Applicant name: Neove Pharma Australia Pty Limited


Summary of use: For the registration of an injectable solution product for the treatment of respiratory infections in cattle and pigs





Product name: Baycox Iron Suspension Injection for Pigs

Active constituent/s: 487.7 mg/mL iron gleptoferron (equivalent to 182 mg/mL iron), 36.4 mg/mL toltrazuril

Applicant name: Bayer Australia Ltd (Animal Health)


Summary of use: For the control of coccidiosis and prevention of iron deficiency anaemia in piglets





Product name: Elanco Flubenol Oral Wormer For Pigs And Chickens

Active constituent/s: 50 mg/g flubendazole

Applicant name: Elanco Australasia Pty Ltd


Summary of use: For aid in the control of sensitive strains of the following internal parasites: gastrointestinal worms (Ascaridia galli, Heterakis gallinarum, Capillaria spp., Raillietina spp. ) in chickens and gastrointestinal worms (Ascaris suum, Hyostrongylus rubidis, Oesophagostomum dentatum) and lungworm (Metastrongylus apri) in pigs






2. VARIATIONS OF REGISTRATION


Product name: Multimin Copper-Free Injection For Sheep And Cattle

Active constituent/s: 40 g/L zinc as zinc disodium EDTA, 10 g/L manganese as disodium manganese EDTA, 5 g/L selenium as sodium selenite

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 77 003 268 871

Summary of variation: To vary the product claims and label approval





Product name: Multimin Plus Copper Injection For Sheep

Active constituent/s: 40 g/L zinc as disodium zinc EDTA, 10 g/L copper as disodium copper EDTA,10 g/L manganese as disodium manganese EDTA, 3 g/L selenium as sodium selenite

Applicant name: Virbac (Australia) Pty Ltd

Applicant ACN: 77 003 268 871

Summary of variation: To vary the product claims and label approval




3. VARIATION OF LABEL APPROVAL


Product name: Avensin 400 Monensin Feed Additive Premix

Active constituent/s: 400 g/kg monensin as monensin sodium

Applicant name: Phibro Animal Health Pty Limited


Summary of variation: To vary the distinguishing product name and the name that appears on the label from ‘Phibromonensin 400 Monensin Feed Additive Premix’ to ‘Avensin 400 Monensin Feed Additive Premix’

Date of variation: 27 February 2020




Product name: Strikeforce-S Spray-On Sheep Blowfly Treatment

Active constituent/s: 50 g/L dicyclanil

Applicant name: Jurox Pty Limited


Summary of variation: To update label safety instructions







Product name: Elanco AF1375 Maxiban Narasin/Nicarbazin Anticoccidial Premix

Active constituent/s: 80 g/kg narasin, 80 g/kg nicarbazin



Summary of variation: To update product label in line with current label guidelines





Product name: Elanco AF0510 Monteban 100 Narasin Premix

Active constituent/s: 100 g/kg narasin



Summary of variation: Variation of product label approval to update the RLP according to the current label guidelines





Approved Active Constituents

Approved Active Constituents


Code Act 1994, the APVMA hereby gives notice that it has approved or varied the relevant particulars or conditions of

the approval of the following active constituents, with effect from the dates shown.

1. ACTIVE CONSTITUENT


Active constituent/s: Captan

Applicant name: Krishi Rasayan Exports Pvt Ltd

Applicant ACN: N/A

Summary of use: For use in agricultural chemical products

Date of approval: 23 March 2020

Approval no.: 87968


Active constituent/s: Tylosin tartrate

Applicant name: Abbey Laboratories Pty Ltd


Summary of use: For use in veterinary chemical products only


Approval no.: 88735


Active constituent/s: Dicamba

Applicant name: Monsanto Australia Pty Ltd


Summary of use: For use in agricultural chemical products


Approval no.: 88007


New agricultural active constituent: trifludimoxazin


The Australian Pesticides and Veterinary Medicines Authority (APVMA) has an application for the approval of a new

agricultural active constituent, trifludimoxazin, for use as a herbicide.

Common name: Trifludimoxazin (ISO)

IUPAC name: 1,5-Dimethyl-6-thioxo-3-[2,2,7-trifluoro-3-oxo-4-(prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-

benzoxazin-6-yl]-1,3,5-triazinane-2,4-dione

Chemical abstracts name: Dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-3,4-dihydro-3-oxo-4-(2-propyn-1-yl)-

2H-1,4-benzoxazin-6-yl]-1,3,5-triazine-2,4(1H,3H)-dione

CAS number: 1258836-72-4

Molecular formula: C16H11F3N4O4S

Molecular weight: 412.3 gmol-1

Structure:

Chemical family: Triazinone

Mode of action: Protoporphyrinogen oxidase inhibitor

SUMMARY OF THE APVMA’S EVALUATION

The APVMA has evaluated the chemistry aspects of trifludimoxazin active constituent (identification, stability,

physicochemical properties, manufacturing process, specifications, quality control procedures, batch analysis results and

analytical methods) and found them to be acceptable.

Impurities of toxicological significance are not expected to occur in trifludimoxazin as a result of the raw materials and the

synthetic route used.

The APVMA has considered the toxicological aspects of trifludimoxazin, and concluded that there are no toxicological

concerns regarding the approval of this active constituent. An Acceptable Daily Intake (ADI) of 0.1 mg/kg bw/d has been

established. There were no acute toxicological effects indicative of a need to establish an Acute Reference Dose (ARfD).

After consideration of recommendations by the Advisory Committee on Chemical Scheduling, the Scheduling Delegate

made a final decision to include trifludimoxazin in Schedule 5 of the Standard for the Uniform Scheduling of Medicines

and Poisons, with a cut-off to being unscheduled when in formulations at 12.5 per cent or less, and with an

implementation date of 1 February 2020.

The APVMA is satisfied that the proposed use of trifludimoxazin 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 section 12 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether the application for approval of trifludimoxazin should be granted. 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.

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.

Written submissions should be addressed in writing to:

Director of Chemistry and Manufacture

Risk Assessment Capability


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300


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



New chemical product Voraxor Herbicide containing trifludimoxazin and saflufenacil


The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application for registration of a

new product containing, Voraxor Herbicide a new active constituent trifludimoxazin and an approved active constituent

saflufenacil.

PARTICULARS OF THE APPLICATION

Proposed product name: Voraxor Herbicide

Applicant company: BASF Australia Pty Ltd

Name of active constituents: Trifludimoxazin, saflufenacil

Signal heading: Schedule 5

Summary of proposed use: For control of weeds in a variety of situations

Pack sizes: 5–110 L

Withholding period: Harvest: not required when used as directed

Grazing: do not graze or cut for stock food for 6 weeks after application

Do not allow livestock to graze treated weeds

SUMMARY OF THE APVMA’S EVALUATION OF VORAXOR HERBICIDE 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 Voraxor Herbicide containing the active constituents

trifludimoxazin and saflufenacil would not be an undue hazard to the safety of people exposed to it during its

handling and use.

(ii) The APVMA is satisfied that the proposed use of Voraxor Herbicide containing the active constituents

trifludimoxazin and saflufenacil 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 Voraxor Herbicide containing the active constituents

trifludimoxazin and saflufenacil is not likely to be harmful to human beings if used according to the product label

directions.

(iv) The APVMA is satisfied that the proposed use of the new products Voraxor Herbicide containing the active

constituents trifludimoxazin and saflufenacil, 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 satisfied that the proposed use of Voraxor Herbicide would not adversely affect trade between

Australia and places outside Australia as the product is not for use in animals producing any major Australian

export commodities.

FURTHER INFORMATION

A Public Release Summary (PRS) of the evaluation of this product is available from the APVMA website’s ‘Public

Consultation’ page, or by contacting the evaluator listed below.

MAKING A SUBMISSION

In accordance with section13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission

as to whether Voraxor Herbicide 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.

Submissions must be received by the APVMA within 28 days of the date of this notice and be directed to the contact

listed below. All submissions to the APVMA will be acknowledged in writing via email or by post.

Relevant comments will be taken into account by the APVMA in deciding whether the product should be registered and

in determining appropriate conditions of registration and product labelling.

When making a submission please include 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)2 material contained in submissions will be treated

confidentially.

Written submissions should be addressed in writing to:

Case Management and Administration Unit


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2300


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

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

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



Amendments to the APVMA MRL Standard

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 (MRL Standard)

Instrument 2019. 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 (MRL Standard) Amendment

Instrument (No. 3) 2020.

The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code (MRL

Standard) Instrument 2019.

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

For further information please contact:

MRL Contact Officer


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401


https://www.legislation.gov.au/Series/F2019L01105



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

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

In the previous notice on page 19 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 (MRL Standard) Amendment Instrument (No. 3) 2020) 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.

A Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO) will be made.

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.



PROPOSED VARIATION TO SCHEDULE 20 IN THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

(31 March 2020)

Note: Subsection 82(2) of the Food Standards Australia New Zealand Act 1991 provides that variations to standards

are legislative instruments, but are not subject to disallowance or sunsetting.

To commence: on gazettal of variation

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

[1.1] inserting in alphabetical order

Agvet chemical: tetraniliprole

Permitted residue: tetraniliprole

Almonds 0.05

Apricots, dried 3

Banana *0.01

Cherries 1

Edible offal (mammalian) 0.02

Eggs *0.01

Macadamia nuts *0.01

Milks *0.01

Pome fruits 0.5

Poultry, edible offal of *0.01

Poultry meat *0.01

Prunes 3

Stone fruits (except cherries) 0.7

Agvet chemical: trifludimoxazin

Permitted residue: trifludimoxazin

Barley *0.01

Edible offal (mammalian) *0.01

Eggs *0.01

Meat (mammalian) *0.01

Milks *0.001


Poultry meat *0.01

Wheat *0.01

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

Agvet chemical: chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprole

Permitted 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 chlorantraniliprole

Almonds 0.1

Pistachio nut T0.05

Root and tuber vegetables T0.05

Walnuts T0.05



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

Agvet chemical: chlorantraniliprole

Permitted residue—plant commodities and animal commodities other than milk: chlorantraniliprole

Permitted 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 chlorantraniliprole

Potato *0.01

Root and tuber vegetables (except potato)

T0.5

Tree nuts 0.1

Agvet chemical: methomyl

Permitted residue: methomyl

Brassica leafy vegetables T0.7

Fennel, bulb T0.2

Fennel, leaf T3

Leek T0.5

Onion, bulb T0.1

Spinach T0.7

Agvet chemical: spinetoram

Permitted residue: sum of Ethyl-spinosyn-J and Ethyl-spinosyn-L

Maize cereals T*0.01

Olives for oil production T0.07

Onion, bulb T*0.01

Sorghum grains and millet T*0.01

Table olives T0.07

[1.4] 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: fluopyram

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

Assorted tropical and sub-tropical fruits—inedible peel (except banana; pineapple)

2



Agvet chemical: trifloxystrobin

Permitted residue: sum of trifloxystrobin and its acid metabolite ((E,E)-methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents


2



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) 5 May 2020.

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.


MRL Contact Officer


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2401




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


The APVMA has previously gazetted particular amendments which it had made to the APVMA MRL Standard and which

have been proposed as variations to maximum residue limits (MRLs) for substances contained in agricultural and

veterinary chemical products as set out as in Schedule 20—Maximum Residue Limits of the Australia New Zealand Food

Standards Code. This notice pertains to proposal (No. 1) gazetted on 14 January 2020 (No. APVMA 1).

Submissions have been sought on these proposals and the APVMA has written separately to each person or

organisation that made a submission. All matters raised in the submissions have been resolved.

Under subsection 82(1) of the Food Standards Australia New Zealand Act 1991, the APVMA has, by legislative

instrument, incorporated these variations to MRLs into Schedule 20. A copy of the Amendment Instrument (No. APVMA

3, 2020) accompanies this notice. For a complete and up-to-date version of Schedule 20, including these amendments

together with their Explanatory Statement, please refer to the Federal Register of Legislation available on the Legislation

website.

Based on dietary exposure assessments and current health standards, the APVMA and Food Standards Australia and

New Zealand (FSANZ) are satisfied that these MRLs are not harmful to public health. MRLs contained in Schedule 20

provide the limits for residues of agricultural and veterinary chemicals that may legitimately occur in foods. By this

means, Schedule 20 permits the sale of treated foods and protects public health by minimising residues in foods

consistent with the effective control of pests and diseases.

The agreement between the 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.

Food Standards Australia New Zealand (FSANZ) made Sanitary and Phytosanitary (SPS) notification to the World Trade

Organization (WTO) in relation to these variations and no comment was received in response to that notice.

A copy of these variations have been given to FSANZ.

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

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


MRL Contact Officer


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2383


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

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



Australia New Zealand Food Standards Code—Schedule 20—Maximum residue limits Variation

Instrument No. APVMA 3, 2020

I, Jason Lutze, delegate of the Australian Pesticides and Veterinary Medicines Authority, acting in

accordance with my powers under subsection 11(1) of the Agricultural and Veterinary Chemicals

(Administration) Act 1992, make this instrument for the purposes of subsection 82(1) of the Food

Standards Australia New Zealand Act 1991.

Jason Lutze

Delegate of the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines

Authority

Dated this Thirty first day of March 2020



Part 1 Preliminary

1 Name of instrument

This instrument is the Australia New Zealand Food Standards Code—Schedule 20—maximum residue limits Variation Instrument No. APVMA 3, 2020.

2 Commencement

In accordance with subsection 82(8) of the Food Standards Australia New Zealand Act 1991, this instrument commences on the day it is published in the Gazette.

Note: A copy of the variations made by the Amendment Instrument was published in the Commonwealth of

Australia Agricultural and Veterinary Chemicals Gazette.

3 Object

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

4 Interpretation

In this instrument: —

APVMA means the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992; and

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

Part 2 Variations to Schedule 20—Maximum Residue Limits

5 Variations to Schedule 20

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



Schedule

Variations to Schedule 20—Maximum residue limits

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

[1.1] inserting in alphabetical order

Agvet chemical: bixlozone

Permitted residue: bixlozone

Barley *0.01


Eggs *0.01


Milks *0.01


Poultry meat *0.01

Rape seed (canola) *0.01

Wheat *0.01

Agvet chemical: carbetamide

Permitted residue: carbetamide


Eggs *0.05


Milks *0.05


Poultry meat *0.05

Pulses *0.01

Agvet chemical: flubendazole

Permitted residue—commodities other than eggs:

sum of flubendazole and 2-amino-1 H-benzimidazole-5-yl)(4-fluorophenyl methanone, expressed as flubendazole

Permitted residue—eggs: flubendazole

Chicken fat/skin 0.03

Chicken liver 0.2

Chicken kidney 0.1

Chicken muscle *0.02

Eggs 0.6

Pig fat/skin *0.02

Pig liver 0.4

Pig kidney 0.3

Pig muscle *0.02



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

Agvet chemical: lasalocid

Permitted residue: lasalocid

Poultry, edible offal of 0.4

Poultry meat 0.7

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

Agvet chemical: diafenthiuron

Permitted residue: sum of diafenthiuron; N-[2,6-bis(1-methylethyl)- 4-phenoxyphenyl]-N′-(1,1-dimethylethyl)urea; and N-[2,6-bis(1-methylethyl)-4-phenoxyphenyl]-N′-(1,1-dimethylethyl)carbodiimide, expressed as diafenthiuron

Fruiting vegetables, cucurbits 0.5

Fruiting vegetables, other than cucurbits 0.5

Agvet chemical: difenoconazole

Permitted residue: difenoconazole

Coffee beans T*0.01

Agvet chemical: etoxazole

Permitted residue: etoxazole

Sweet corn (kernels) T*0.01

Agvet chemical: fluopyram

Permitted residue—commodities of plant origin: fluopyram

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


T2

Agvet chemical: fluralaner

Permitted residue: fluralaner

Chicken eggs 1.3

Chicken fat/skin 0.6

Chicken kidney 0.4

Chicken liver 0.6

Chicken muscle 0.06

Agvet chemical: halosulfuron-methyl

Permitted residue: halosulfuron-methyl

Soya bean (dry) T*0.01



Agvet chemical: imazamox

Permitted residue: imazamox

Eggs *0.01

Poultry meat *0.01




Poultry kidney 0.7

Poultry liver 1.2

Poultry muscle 0.4

Agvet chemical: napropamide

Permitted residue: napropamide

Basil T*0.1

Agvet chemical: prosulfocarb

Permitted residue: prosulfocarb

Safflower seed T*0.1

Agvet chemical: tebuconazole

Permitted residue: tebuconazole

Coffee bean T0.1

Agvet chemical: trifloxystrobin

Permitted residue: sum of trifloxystrobin and its acid metabolite ((E,E)- methoxyimino-[2-[1-(3-trifluoromethylphenyl)-ethylideneaminooxymethyl] phenyl] acetic acid), expressed as trifloxystrobin equivalents


T2

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

Agvet chemical: bifenthrin

Permitted residue: bifenthrin

Sugar cane T0.7

Agvet chemical: glufosinate and glufosinate-ammonium

Permitted residue: sum of glufosinate-ammonium, N-acetyl glufosinate and 3-[hydroxy(methyl)-phosphinoyl] propionic acid, expressed as glufosinate (free acid)

Podded pea (young pods) (snow and sugar snap)

T*0.05





Poultry fat/skin 0.6

Agvet chemical: oxamyl

Permitted residue: sum of oxamyl and 2-hydroxyimino-N,N-dimethyl-2-(methylthio)-acetamide, expressed as oxamyl

Sweet potato 0.2

Agvet chemical: trinexapac-ethyl

Permitted residue: trinexapac acid

Poppy seed 20

Sugar cane 0.1


Consultation on use patterns for anticoagulant rodenticide products


CONSULTATION PERIOD ENDS 3 JULY 2020.

KEY ISSUES

1. Products considered anticoagulant rodenticides have been prioritised for reconsideration on the basis of concerns

for worker exposure, public health and environmental safety.

2. The use of products in domestic premises, animal production facilities and food production facilities is currently

allowed.

3. International jurisdictions (including the United States Environmental Protection Agency and the European

Chemicals Agency) have taken action to limit access to these products by non-professional users, and to restrict the

product formulations available and the situations in which these products may be used.

4. The APVMA is consulting with the states and territories and relevant holders regarding the registered particulars and

conditions of use for anticoagulant rodenticide products. This does not include the intentional misuse of the products,

not in accordance with the label instructions.

FOCUS OF THE CONSULTATION

Registered products containing the following active constituents are included in this consultation:

First-generation anticoagulant rodenticides (FGARs):

warfarin

coumatetralyl

diphacinone

Second-generation anticoagulant rodenticides (SGARs):

brodifacoum

bromadiolone

difenacoum

difethialone

flocoumafen

CONSIDERATIONS

5. During this consultation, the APVMA welcomes submissions on matters related to:

a) The need for anticoagulant rodenticide products to be used in home garden or domestic settings;

b) The need for anticoagulant rodenticide products to be used in residential or suburban settings, for example, for

public health or public sanitation programs;

c) The need for anticoagulant rodenticide products to be used in or around buildings, including those used to house

livestock, or in or around on-farm buildings (including homesteads);

d) The need for anticoagulant rodenticide products to be formulated as powders, gels, liquids, pellets, grains or pastes;

https://www.epa.gov/rodenticides/rodent-control-pesticide-safety-review

https://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/bpc-opinions-on-active-substance-approval

https://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/bpc-opinions-on-active-substance-approval



e) The likelihood of compliance with post-application sanitisation instruction (eg the timely collection of poisoned rodent

carcasses, and the appropriate disposal of carcasses);

f) The label instructions, particularly the adequacy of instructions to prevent inadvertent exposure to the product;

g) Critical uses for anticoagulant rodenticide products, particularly in primary production; and,

h) Other relevant matters related to the use of anticoagulant rodenticide products.

WRITTEN SUBMISSIONS ARE INVITED

6. The deadline for submissions is 3 July 2020. Electronic submissions are preferred, and submissions with an email

address will be acknowledged electronically.

7. Note that all submissions received are subject to legislation, including the Freedom of Information Act 1982,

the Privacy Act 1988 and the Agvet Codes. In providing your submission to the APVMA, you agree to the APVMA

publicly disclosing your submission in whole or summary form. Submissions should not contain confidential

commercial information.

APVMA CONTACT

Questions and submissions should be directed to:

Chemical Review

Office of the Chief Regulatory Scientist


GPO Box 3262

Sydney NSW 2001

Phone: +61 2 6770 2400



apvma gazette no. 7, 7 april 2020 · 2020. 4. 7. · gazette agricultural and veterinary chemicals...

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