Pesticides Regulatory Newsletter, October 2024

1. Directors update: Mr Hugh Dawick and Dr Gary Dorr

Welcome to the October 2024 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Pesticides Regulatory Newsletter.

In this edition we have included information on a range of regulatory topics, including an update on our chemical review activities. We have also included useful advice for applicants concerning R70B re-categorised applications, reference product data – limits on use of information, and best practice tips when making an application.

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.

2. New product registrations

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

Table 1 below lists the new registration of an agricultural chemical product, based on a new active constituent, published in the Gazette to date for FY 2024–25 and not included in previous newsletters.

Table 1: New registration of an agricultural chemical product based on a new active constituent

Registration of agricultural chemicals products based on new active constituents requires consultation prior to registration. Please see the public consultation section on our website for consultation opportunities.

3. Annual returns

Each year, holders must report the total amount of product used or sold after being imported into, or manufactured in, Australia to comply with S35(1) of the Agvet Levy Act 1994. Annual returns are available in online services from 1 July until 30 November 2024.

Note that all reporting exemptions have now been removed – all product imported or manufactured in Australia which were then used or sold must be reported for the previous financial year. Holders should report the quantity of product sold or used in units matching their registered formulation. See the website for more information.

Annual returns and levy collection are 2 separate processes. You are required to report product quantity for annual returns and product dollar value for levy purposes.

4. Australia adopts global herbicide mode of action classification system

In March 2020, the Global Herbicide Resistance Action Committee (HRAC) completed an extensive review of its mode of action (MoA) classification system. One key outcome of the review was the decision to transition from an alphabetical code to a numerical code. Adoption of a numerical code provides a greater capacity to accommodate new modes of action and facilitate global harmonisation.

The new MoA symbols have been included on all new APVMA-approved labels since 2022. Holders of existing registered products can update their marketplace labels to reflect the new classification without notification to the APVMA. For more information, please refer to: https://www.croplife.org.au/wp-content/uploads/2024/04/Herbicide-MoA-classification-poster-April-2024-Printer-version.pdf

5. Chemical review update

The final decision for diazinon was published on the APVMA Website on 10 September 2024. A one year phase-out period has been provided for possession, custody, use, and supply of the cancelled and varied products that have the previously approved labels.

The final decision for chlorpyrifos was published on the APVMA Website on 3 October 2024. A one year phase-out period has been provided for possession, custody, use, and supply of the cancelled and varied products that have the previously approved labels.

The APVMA cancelled all agricultural products containing chlorthal dimethyl on 9 October 2024 due to an immediate risk to human health. While a permit has been issued that allows for possession of products, it is not legal to sell or use these products. Recall action will commence shortly. For further details about the decision please refer to the Special Gazette, 10 October 2024.

The proposed decisions for both paraquat and diquat were published on 30 July 2024. Public consultation closed on the 29 October 2024. The APVMA received more than 100 submissions. All submissions with permission to publish, and our responses to them, will be published on the APVMA website when we release the final regulatory decision.

The update to labels of bromoxynil products containing more than 1.5% bromoxynil to comply with the requirements of Schedule 7 is due to be completed on 1 February 2025. Holders will be contacted again in late 2024 or early 2025 to formalise the label updates.

Finally, the list of chemicals currently prioritised for reconsideration is available on the APVMA website. This list will be updated in November 2024 as part of our annual prioritisation process. Where we receive information that requires us to act more urgently to consider chemicals that were not previously on the priority list, we will do so.

 Enquiries about these changes should be directed to enquiries@apvma.gov.au or +61 2 6770 2300.

6. Useful information for industry

This edition’s useful information for industry covers:

• R70B re-categorised applications
• reference product data – limits on use of information
• best practice tips when making an application.

6.1. R70B re-categorised applications

The APVMA may determine any time after preliminary assessment that an application is more suitable in another item stream and/or different modules are required as prescribed under R70B(1)(a)(ii) of the AgVet Code Regulations. Recategorisation may result in a change of fees and additional fees payable under R70B(3). All outstanding fees are payable within 28 days of receiving the notice and invoice under R70B(3)(a)(iii).

The APVMA must refuse the application under R70B(3)(a)(iv) if the final payment is not received by the due date listed on the invoice, regardless of whether payment is received afterwards.

6.2. Reference product data – limits on use of information

The APVMA can use information from any source for the purpose of performing its functions or exercising its powers under the Agvet Code and the Agvet Code Regulations. However, this is subject to certain limitations on use and confidential commercial information provisions contained in the Agvet Code and the Agvet Code Regulations.

Reference products are nominated for a range of applications submitted to the APVMA and some of those have limits on use of information. The limits on use status of a reference product can be found on the APVMA’s Public Chemical Registration Information System Search (PubCRIS) database.

A reference product that has limits on use should be identified in Section 7 (Access to Information with a Limitation of use Period) of the application form. Relevant consent to access and use this information must also be submitted along with the related application. Applications that cite a reference product, but do not contain the relevant information in Section 7 and related consent documentation will not pass Preliminary Assessment, resulting in additional delays in application processing.

A reference product without limits on use does not need to be listed under Section 7. In these cases, Section 7 can be left blank.

Additional information about accessing information for reference products including limits on use can be found on our website.

6.3. Best practice tips when making an application

The APVMA processes hundreds of applications every year, many of which are highly complex in nature. Often insufficient detail is provided to help APVMA staff understand what is intended and how it is supported. At times, the APVMA may issue a notice to applicants under section 159 of the Agricultural and Veterinary Chemicals Code Act 1994 or regulation 8AHAA of the Agricultural and Veterinary Chemicals Code Regulations 1995. These notices require the applicant to provide further information.

When the APVMA issues the first s159 notice, the assessment timeframe for the application is automatically extended by a period defined in the Regulations (subsequent s159 notice requests do not extend the timeframe). 8AHAA requests may also cause delays in application assessments.

Ensuring the application dossier includes one or more of the following can help streamline the assessment process and typify what a good application looks like.

6.3.1. A clear and comprehensive application overview

The executive summary section in the application form only has room for a brief introduction as to the purpose of the application. A separate application overview document can provide greater context by presenting all relevant information the APVMA should be aware of, including references to:

• any previous applications (withdrawn, refused, approved)
• previously submitted data and associated technical assessments
• advice received via PAAs (pre-application assistance requests)
• a list of all the proposed variations in case of a variation application
• other relevant history. 

6.3.2. A marked-up label

Registration and variation applications associated with label approvals are required to include a copy of the draft label. For variation applications, a marked-up label makes it easier to understand what content is being varied/amended compared to the currently approved label.

• A marked-up label submitted for a registration/variation application nominating more than one reference product should show which content is copied over from which reference product.
• When proposed label content is based on provided data, it may also be indicated on the draft label.
• Track changes, comments, coloured fonts and highlighters can be used for drafting a clear and concise marked-up labels.

6.3.3. A GAP table where appropriate

A GAP (Good Agricultural Practice) table can be used in reporting details of intended uses. A GAP table shows the main use patterns relevant to an application with the respective ‘risk envelopes’ (i.e. those use patterns that represent the worst-case scenarios for risk assessment purposes). 

Please see the following for more information.

• GAP Table – Pesticide Registration Toolkit – Food & Agriculture Organisation of the United Nations.
• An example of a GAP table, as recommended by the OECD (Organisation for Economic Cooperation and Development). 

6.3.4. A comparative table where appropriate

A comparative table compares the proposed use pattern(s) with the relevant use pattern(s) on the reference label(s). A comparative table is especially useful when multiple reference products are nominated. Preferably this should be in excel format. An appropriate situation for providing a comparison table is when 2 reference products are nominated, each with a single active constituent, for registration of a product containing both active constituents. The comparison table can reflect the similarities and differences between the reference products and the proposed product in relation to each of the actives and use patterns.

The following information of the proposed label can be compared with the reference label(s).

• Active concentration.
• Formulation type (according to APVMA formulation types).
• Hosts (crop, crop group or situation) and pests.
• Application rate of the active constituent (if relevant, minimum and maximum rates).
• Application method(s).
• Application interval(s) and timing.
• Number of applications (if relevant, minimum and maximum number of applications).
• Withholding periods.
• Export slaughter intervals.
• Restraints.
• When tank mixes are involved, active rates of the proposed product and each proposed tank mix partner for each proposed use with the respective rates on the reference labels.
• Any other relevant aspect(s).

6.3.5. A part 8 summary (Efficacy Overview)

Each application with an efficacy module should be accompanied by an Efficacy Overview that explains the relevance of the provided data to the proposed claims.

As per section 2.1.1 of the Pesticides Efficacy and Crop Safety General Guideline (Part 8), it is your responsibility to present adequate information to support all product uses on the proposed label and any related efficacy and safety claims. You should interpret the information that you provide, demonstrating how it supports the label claims and proposed instructions. It is not sufficient to simply provide trial reports and other papers without explaining their relevance to the proposed use of the product.

Please refer to the Pesticides Regulatory Newsletter published on 20 July 2023 for information on providing an appropriate part 8 summary. 

6.3.6. Consent letters for limits on use of information

If any limits on use of information are associated with reference product(s) and they are relevant to the application, applicants must submit a written consent authorising the APVMA use of the protected information. If the existing limits on use of information is not relevant to the application, this should also be clearly identified in the application.

Please see APVMA website – Consent Letter and the Pesticides Regulatory Newsletter published on 20 July 2023 for more information on providing appropriate consent letters.