Pesticides Regulatory Newsletter, June 2021

• Directors update: Mr Hugh Dawick and Dr Maria Trainer
• Performance report
• New spray drift guidance documents
• Useful information for industry
• Scheduling updates
• APVMA Stakeholder Engagement Framework
• New product registrations

Directors update: Mr Hugh Dawick and Dr Maria Trainer

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

The purpose of this newsletter is to establish a more tailored communication stream for our stakeholders, with updates and information relevant to the agricultural chemical industry.

In this edition, we have included information on a range of regulatory topics including spray drift guidance, information lists, variations that do not require notification and use of the trademark symbol.

We continue to encourage applicants to participate in APVMA stakeholder meetings, which we are currently hosting remotely via Skype. These meetings are an invaluable opportunity for us to discuss current and future applications, relative priorities and to work through any concerns. These meetings can be organised through your Case Manager by emailing casemanagement@apvma.gov.au.

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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Performance report

The Pesticides Team delivered a strong performance in the March quarter 2021.

In the March quarter 2021 we completed:

• 98% of all pesticide product major applications within timeframe, up from 91% in March quarter 2020
• 100% of all pesticide product minor (non-technical) applications within timeframe, holding steady from 100% in March quarter 2020.

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

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New spray drift guidance documents

In October 2020 we introduced new spray drift guidance documents to assist registrants with applications to update spray drift instructions, apply for a new spray drift risk assessment or apply for consideration of new drift reduction technology (DRT).

The new guidance documents form part of the APVMA’s current spray drift policy, which was introduced in July 2019, and provides practical examples to assist registrants in understanding how the APVMA will implement the policy.

Guidelines for updating spray drift instructions on labels when a full spray drift risk assessment has not been undertaken

This guidance document explains how spray drift instructions will be implemented for product applications where a full spray drift assessment has not been undertaken. The guidelines apply to product registration applications (Items 5, 6, 7, 8 and 10) and product variation applications (Items 12, 13 and 14), where a registrant requests updated spray drift restraints as part of an application, or where during assessment of an application the APVMA identifies that the spray drift restraints need to be updated in order to reflect the new spray drift policy.

Guidelines for applications to update spray drift instructions, update the spray drift risk assessment and recognise new drift reduction technology

This guidance document provides assistance to applicants seeking to update spray drift instructions and/or request a new spray drift risk assessment. It provides advice on the assessment modules, fees and timeframes that would apply to such applications. The guidelines also provide advice on how to submit applications for inclusion of new DRT into the spray drift management tool (SDMT).

Questions about the guidance documents, or the APVMA’s spray drift policy, can be directed to spraydrift@apvma.gov.au.

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Useful information for industry

2,4-D reconsideration final regulatory decision

Holders are reminded that, following the publication of the final regulatory decision for 2,4-D, products bearing a suspended or cancelled label cannot be supplied or used from 1 October 2021. Ahead of that deadline, holders are invited to submit an Item 13 application to vary their labels. More information about 2,4-D is available on our website.

Use of the trademark symbol

The registered trademark symbol, ®, is reserved for trademarks registered with an appropriate government agency. The trademark symbol itself is not part of a product name and is not considered to be a relevant particular in relation to the registration of a chemical product and label approval.

The APVMA will not include the trademark symbol in conjunction with a product name in any approval documentation we issue (e.g. the finalisation notice) or in PubCRIS. Registrants may continue to include the trademark symbol on the label submitted to the APVMA and we will not ask for it to be removed. Similarly, registrants can include the trademark symbol on the marketed label of a registered product without the need to notify the APVMA.

Questions about trademarks may be directed to enquiries@apvma.gov.au.

Product and label variations that do not require APVMA notification

The APVMA has provided advice to product holders on the types of product or label updates that can be made by a product holder without requiring APVMA application or notification.

Changes to the publication of public consultation submissions

The APVMA has updated the process for handling submissions received in response to formal public consultations conducted under the Agricultural and Veterinary Chemicals Code Act 1994.

Since 2 September 2020, submissions made in response to a public consultation will be published on our website unless:

• the author requests the submission (or part(s) of it) remain confidential, or
• we determine it would be unreasonable to publish the submission.

Updated manufacturers’ declaration templates

We have recently updated our manufacturer’s declaration templates, to be provided in applications where the product being registered is the same as a reference product. These new templates are available on our website.

Pre-application assistance

The APVMA offers assistance for applicants before they submit their applications. This technical advice, known as pre-application assistance (PAA), is offered on a fee-for service basis and applicants or future registrants are encouraged to apply for this assistance.

PAA provides applicants with the opportunity to reduce uncertainty for a specific prospective application, with assistance provided via a written response and a face-to-face meeting, or a teleconference if requested.

PAA can also be used to obtain an appraisal on a trial protocol and is required for the submission of a project plan for a timeshift application or an application with relevant international assessments.

In some circumstances, you may be eligible for a rebate of PAA fees paid in relation to a proposed product application as prescribed in the Agvet Code Regulations.

Requirements for information lists when submitting an application for agricultural and veterinary products

The Agvet Code and Agvet Code Regulations require the APVMA to record and publish a short description of each item of information contained in, or accompanying, applications for approval, registration or variation of relevant particulars, or conditions of approvals and registration (known as an information list).

This includes, but is not limited to, the following items:

• The title shown on the item of information.
• The name and address of the authorising party for the information.
• The name of the author, or each of the authors, of the information.

Registrants for agricultural and veterinary products must abide by the legislative requirements when submitting information lists to the APVMA. Information lists that do not comply with the Agvet Code and Agvet Code Regulations will be returned to the registrant for amendment, which may result in delays during the evaluation period.

Our guidance for preparing information lists provides additional detail about the specific types of information that may be consolidated into a single document or entry in an information list.

Questions about the legislative requirements for information lists may be directed to enquiries@apvma.gov.au.

Admin Team tips and tricks for preparing information lists

The APVMA receives many applications with large data lists and a large amount of supporting data. In order to pass preliminary assessment, an Administration or Case Management Officer must match each file received against its corresponding data/information list entry to ensure all data items have been received. This can take a lot of time, particularly if data item descriptions and file names do not match. Furthermore, data lists will not upload if entries are not provided for mandatory fields.

Our tips and tricks to avoid issues with data lists are:

• Use a unique reference code under 25 characters for each data item.
• If possible, incorporate the reference code into the file name. This allows us to easily match received data items with the data/information list. If you are asked for a ‘missing data item’ please ensure this reference code is incorporated for easy identification.
• Ensure the date in the data list is in the correct format – YYYY; month YYYY; DD month YYYY; or DD.MM.YYYY. Variations, including abbreviating the month/year, or adding a ‘the’ (e.g. 12th) will prevent it from importing correctly in to the APVMA system.
• Do not use diacritics (e.g. é, œ, ŭ) in any section of the data list as they are incompatible with our system and will prevent the data item being imported into our internal database.
• If data items are to be shared between modules, please consider providing a separate reference table titled ‘Instructions for data list’ with an outline of which data items are to be shared. Alternatively, for a small number of items, please add an explanation into the Executive Summary of the application. This will prevent duplicate files being imported as separate data items.

Further guidance on preparing information lists and using the information list editor is available on our website.

Please contact casemanagement@apvma.gov.au or datalist@apvma.gov.au if you require assistance.

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Scheduling updates

In its recent decision, the Scheduling Committee has confirmed its interim decision to include tetrahydrofurfuryl alcohol (THFA) in Schedule 6 of the Poisons Standard (SUSMP). We are currently reviewing the Register to identify affected products and will be contacting holders in due course to update their labels.

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APVMA Stakeholder Engagement Framework

In case you missed it, we published our Stakeholder Engagement Framework in September 2020. The Framework sets out the APVMA’s strategic approach to stakeholder consultation and collaboration for the 2020–23 period.

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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 2020–21.

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