Pesticides Regulatory Newsletter, September 2021

20 September 2021

Directors update: Mr Hugh Dawick and Dr Gary Dorr

Welcome to the September 2021 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Pesticides Regulatory Newsletter.

In this edition, we have included information on several initiatives we are keen to progress in 2021–22, including a review of the Agricultural Labelling Code, our Item 13 project, and the introduction of a new ‘Emerging Technologies’ webpage that will feature the publication of the Organisation for Economic Co-operation and Development Working Group literature review relating to Remotely Piloted Aerial Spraying, which we hope you will find of interest.

The Pesticides Team has continued to focus on achieving strong timeframe performance for the delivery of applications within legislative timeframes, following the conclusion of the 2020–21 reporting period that saw us complete 99% of pesticides applications within timeframe.

Dr Maria Trainer has been seconded temporarily to another section of the APVMA, and we are pleased to welcome Dr Gary Dorr as acting Director in the Pesticides Team. Gary has many years of regulatory expertise and plays a primary role in the development of the APVMA’s Spray Drift Policy. 

If you have any suggestions or requests for future editions of the APVMA’s Pesticides Regulatory Newsletter, please send them through to communications@apvma.gov.au.

Please reach out to any member of the Pesticides Team if you require assistance related to the registration of pesticides. 

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Stakeholder engagement meetings

We invite registrants to meet with the Pesticides Team to discuss both ongoing applications and those planned for the year ahead. A key objective of these meetings is to ensure our team understands the timeframes you are working to in bringing your new product or use to market, to facilitate timely approval of your application.

These meetings also provide a good opportunity for registrants to provide and receive feedback about the application process to improve efficiency overall.

Due to current COVID-19 restrictions, these meetings will be held virtually, but once restrictions are lifted we would be pleased to meet with you in person. The meeting would be attended by your Case Manager, Pesticides Director(s) and relevant Risk Manager(s) and is expected to run for around one to 2 hours, with the frequency of meetings at your discretion.

Please contact your Case Manager at casemanagement@apvma.gov.au if you would like to schedule a meeting with the Pesticides Team. 

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Pre-application assistance advice

Pre-application assistance (PAA) is a great way to get advice on what you need to do to register or vary a product, apply for a permit, or to establish a project plan for a time-shift application. Unless you are seeking advice on a primary/secondary suite, you will need to submit one PAA per product. More information about PAA is available on our website.

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Performance report

The Pesticides Team delivered another strong quarter of timeframe performance at the end of the June quarter 2021.

We completed:

  • 99% of all pesticide product major applications within timeframe
  • 100% of all pesticide product minor (non-technical) applications within timeframe.

The full performance report for the June quarter 2021 is available on our website.

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Agricultural Labelling Code review

The Pesticides Team will be undertaking a review of the labelling requirements for agricultural products as set out in the Agricultural Labelling Code (ALC). The objective of the review is to produce an updated ALC that is clear, concise and consistent. We will also be revising the presentation of the ALC on our website to make sure all label related guidance is in one place and displayed in a user-friendly format. The review will not include changes to the ALC that would require legislative amendment.

The review will consider all general and specific labelling requirements that are detailed in the current ALC.

We will submit the revised ALC to stakeholders in batches in an iterative process of consultation, with the first batch release expected to occur in April 2022 and scheduled for completion in September 2024. Stakeholders will also be invited to propose suggestions about how the ALC could be improved in advance of the first batch release.

More information about the review, as well as information on how to propose your suggestions, will be provided on our website shortly.

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Project to amend products approved with incorrect label or registration particulars (aka the ‘Item 13’ project)

The APVMA or registrants may identify inconsistencies or errors in existing product labels or registered particulars that may extend beyond a single product – for example, a change in scheduling for either the active or an excipient, or new data demonstrating that current label directions need to be updated. These updates are required to ensure products available in the marketplace meet the legislative criteria and such changes are consistently applied across all affected products.

The Pesticides Team has initiated a project to address a number of identified cases and formalise the process moving forward. We have established a list of current issues to be resolved and these, along with information relating to how they will be actioned, will be published on our website shortly. 

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New ‘Emerging technologies’ webpage

The APVMA supports innovation and the development of new technologies that support Australian growers and protect the health and safety of people, animals and the environment.

Shortly we will launch a new webpage that will serve as the first point of reference for stakeholders interested in the APVMA’s position on emerging technology. The release of this webpage will feature RPAS technology (Remotely Piloted Aerial Spraying). 

In June 2019, to aid regulatory understanding of RPAS, the Organisation for Economic Co-operation and Development (OECD) Working Party on Pesticides (WPP) set up a working group to consider the application of plant protection products by RPAS, with its first task to review what regulatory acceptable data currently exists. The outcome of this review will be published on our website shortly under the title State of the Knowledge Literature Review on Unmanned Aerial Spray Systems in Agriculture.

The document will also provide detailed background about the quality of the available data and an insight into the type of equipment being used (e.g. single rotor and multi-rotor, boom and nozzle configurations), the way in which it is being used (e.g. common flight heights and speeds), potential levels of drift in comparison to existing application methods, and recommend areas for development for regulatory purposes.

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Item 7 applications and pack size changes

Applications to register a new agricultural product, based on that product being closely similar to a reference product, can have additional pack sizes providing that no data are required to support the pack size.

For example, the reference product has the following approved pack sizes: 10 kg, 20 kg and 110 kg. Your proposed product meets the definition of ‘closely similar’ but you wish to add a 100 kg and 1,000 kg pack size, which are not approved on the reference product.

As no data are required to support the additional pack sizes, the formulation is closely similar to the reference product and the label instructions are the same as the reference product, this example application would meet the criteria of an Item 7 application.

These applications should not be submitted as an Item 10 with only a preliminary assessment (Module 1) and finalisation (Module 11.2) module with a 2-month timeframe. Applications of this nature will be re-categorised to an Item 7.

More information about the benefits of requesting pack size ranges rather than individual pack sizes is available on our website.

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Pool products

Applications for the registration of chlorinating pool products that contain the active constituent:

  • calcium hypochlorite tablet or granule product to provide available 650 to 700 g/kg chlorine
  • lithium hypochlorite granule product to provide available 350 g/kg chlorine
  • sodium hypochlorite liquid to provide available 100 to 130 g/L chlorine
  • sodium dichloroisocyanurate granule product to provide available 500 to 630 g/kg chlorine
  • trichloroisocyanuric acid tablet product to provide 800 to 900 kg available chlorine

Should either be submitted as an:

  • Item 9 application, if you meet the Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Home Swimming Pool and Spa Products) Standard 2014. An Item 9 application requires no reference product, must have an upper pack size limit of 25 kg or 25 L, and have identical label instructions to those contained in the Pool Standard. An Item 9 application has a 3-month timeframe with an application fee of $2,632.
  • Item 7 application, if you have a registered reference product where the formulation is the same or closely similar, with identical label instructions as the reference product. Additional pack sizes are permissible for these types of pool products as no data are required. Item 7 applications have a 3-month timeframe, with an application fee of $2,632.
  • Item 8 application, if all aspects of the product are the same as the reference product. Formulation, manufacturing site, pack sizes and label instructions are the same. Item 8 applications have a 3-month timeframe, with an application fee of $2,632.

Applications submitted as an Item 10 with a 2-month timeframe will be re-categorised as appropriate. Item 10 applications are defined in schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations as an application for registration for all situations other than those described in Items 1 to 9. Therefore, if the Item 10 application with no modules requires no technical assessment for chemistry or efficacy, the application falls within the definition of another Item (e.g. Item 7) and these applications will be re-categorised.

Note, applications for Items 7, 8 and 9 allow for you to pay the full fee at the time of submission and avoid the need for invoices to be issued during preliminary assessment.

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New product registrations

The APVMA publishes a fortnightly Gazette that includes information about new product registrations and variations to currently registered particulars or conditions for registration.

The following table lists the new registrations of agricultural chemical products, based on new active constituents, published in the Gazette to date for FY 2021–22 and not included in previous newsletters.

Application number

Product No

Product name

Active constituent

Applicant name

Date of registration

120826

88302

Maya Herbicide

Bromoxynil butyrate

Nufarm Australia Limited

7/5/2021

121359

88449

Fastrac Pro Blox Rodenticide

Bromethalin

Bell Laboratories Inc.

22/7/2021

123165

89013

Salibro Reklemel active Nematicide

Fluazaindolizine

Production Agriscience (Australia) Pty Ltd

1/9/2021

127117

90033

Intervene WG Fungicide

Polyoxin D zinc salt

Kaken Pharmaceutical Co., Ltd.

31/8/2021

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