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

Welcome to the July 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 updates on the APVMA’s chemical review and cost recovery activities. We have also included lots of useful information for industry, including guidance on the emergency permit renewal process; instructions for identifying the current manufacturers of products; and advice for lodging an 8M application for nominated agents.

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. APVMA to review fees and levies

The APVMA is a fully cost-recovered agency. We are funded by the fees, charges, and levies imposed on the industry we regulate and, like all cost-recovered government agencies, we must periodically review these to ensure they reflect current operational costs.

We are currently reviewing our fees, charges, and levies to make sure the right structure is in place to effectively regulate and meet legislative requirements and community and industry expectations.

The APVMA has a long-standing practice of consulting in relation to proposed changes to fees, charges, and levies. We want to hear from regulated industries and members of the broader public to understand what any change will mean for you, your business, and your community.

On 16 May 2024 we commenced consultation with our key stakeholders, and formal consultation is expected to open in the second half of 2024. We will keep our website updated as this progresses.

3. New interchangeable constituent determination

The APVMA has made a new legislative instrument – the Agricultural and Veterinary Chemicals Code (Interchangeable Constituent) Determination 2024. This is the first interchangeable constituent determination the APVMA has made.

The new determination will allow holders who want to replace Tersperse 4896 with Tersperse 4894 to lodge a Notifiable Variation to update their product formulation, instead of an Item 12.

This new legislative determination is supported under regulation 19AEA of the Agvet Code Regulations, which states that the APVMA may determine one or more constituents be interchanged with another if the requirements in the determination are met.

4. Chemical review update

The APVMA’s Chemical Review Team continues to progress the reconsiderations subject to the Ministerial Direction on Chemical Reviews given by the Minister for Agriculture, Fisheries and Forestry, Senator the Hon Murray Watt, in July 2023.

At the time of publication:

  • The final regulatory decision for stage 2 of the chlorpyrifos reconsideration is expected to be published in August 2024.
  • Public consultation for the proposed regulatory decision for fenitrothion closed on 8 July 2024. The final regulatory decision is expected in December 2024.
  • Public consultation for the proposed regulatory decision for diazinon closed on 11 June 2024. The final regulatory decision is expected in September 2024.
  • Publication of the proposed regulatory decisions for diquat and paraquat is expected in late July 2024 and will be followed by a 3–month public consultation.
  • The APVMA completed the reconsideration of malathion on 2 May 2024. Products bearing the previously approved labels may continue to be sold and used during the 2–year phase out period, ending 1 May 2026.
  • The assessment of fipronil is in progress, with the proposed regulatory decision for agricultural products expected in March 2025.
  • Public consultation for the proposed regulatory decision for neomycin closed on 26 May 2024. The final regulatory decision is expected in October 2024.

In addition to the chemicals listed in the Ministerial Direction, the APVMA has been progressing its review of first and second generation anticoagulant rodenticides, which includes:

  • warfarin
  • coumatetralyl and diphacinone (first generation)
  • brodifacoum
  • bromadiolone
  • difenacoum
  • difethialone
  • flocoumafen (second generation).

Assessments of environmental safety (including primary and secondary poisoning of non-target domestic animals and wildlife); human health (including worker exposure and public health); residues (including livestock and edible wildlife exposure); consumer safety; and trade are ongoing. The proposed regulatory decision is currently anticipated to be published in December 2024.

Assessments for the neonicotinoid reconsideration (acetamiprid, clothianidin, dinotefuran, imidacloprid, thiacloprid, thiamethoxam) are also ongoing and publication of the proposed regulatory decisions for individual neonicotinoid actives are expected by June 2025.

5. Useful information for industry

This edition’s useful information for industry covers:

  • the emergency permit renewal process
  • identifying the current manufacturers of your product
  • efficacy and safety dossiers, and the effective use of published scientific literature
  • providing alternative contacts when applicants go on leave
  • guidance on nominated agents and 8M applications.

5.1. The emergency permit renewal process

To assist applicants with the timely processing of emergency permits, we would like to clarify some changes that have been made to the emergency permits application process.

The renewal of a previously issued emergency permit (either current or expired) is no longer accepted under an Item 20 application. As a result, applicants will be asked to consider withdrawing any Item 20 applications lodged for the extension of an emergency use permit. Instead, an Item 21 with minor use justification or an Item 22 with emergency use justification will be required. The parameters for these items are outlined below.

Item 21 (minor use permit)

An Item 21 is appropriate when a use pattern previously allowed by an emergency permit now meets the minor use criteria. An Item 21 application for a new minor use permit may be submitted if the holder wishes to apply for a continuation of the use pattern for a longer period.

Item 22 (emergency use permit)

For the extension of an emergency permit, a new Item 22 application is required in place of an Item 20 renewal application. Any such application will require renewed justification for the continuation of the emergency status for evaluation by the APVMA.

Re-categorising an Item 22 to an Item 21

An Item 22 application submitted for a situation that is determined to no longer be an emergency, but which may be considered minor use, may be re-categorised to an Item 21 application. If an application is re-categorised from an Item 22 to an Item 21, the related fees and modular timeframes of an Item 21 will apply, and additional information may be sought to support the assessment.

Please visit our website for details on the differences between emergency and minor use permits, plus more information about what determines the classification of emergency uses or research purposes.

5.2. Identifying the current manufacturers of your product

To request a record of the manufacturers listed for a product, including the steps of manufacture performed by each manufacturer, registrants can submit an Agvet Code request. It is important to note that manufacturer details are considered Confidential Commercial Information. This means the APVMA may not be able to release information to the holder in all cases. In these situations, the registrant may wish to consult with the relevant authorising party (for example, the holder of the original reference product) prior to lodging Item 12, or 14 and NV applications.

5.3. Tips for using published literature in support of efficacy and crop safety dossiers

Registrants often use published literature to support various aspects of pesticide product registration and variation applications. We acknowledge the value of using published scientific literature in supporting product registrations and variations as it may reduce the number of trials needed for studies to support registration. Scientific literature may also be used to respond to specific regulatory questions, identify data gaps, and inform protocol design.

To assist the APVMA with expediting our reviews and assessments, we have provided the following tips and reminders on how to use published literature in dossiers effectively.

  • Do not submit references that are irrelevant to an evaluation. Supporting literature should be meaningful with respect to the proposed formulation, use pattern, Australian conditions, and industry practices.
  • Do not submit abstracts. Only full versions of referenced literature are acceptable.
  • Do not submit multiple references which constitute the same evidence.
  • Scientific literature that supports a general understanding of the proposed product or active constituent, or information referencing other risk assessments (such as off-target effects), do not belong in the efficacy and safety dossier. Instead, this information should be categorised under general information.
  • Literature submissions must include all relevant findings on a particular aspect of a proposed product’s claims of efficacy or target safety. This is regardless of whether the literature supports your claims or not. ‘Cherry-picking’ studies for submission will not facilitate the weight of evidence approach to assessment taken by the APVMA.
  • Dossiers that contain excessive and unnecessary material for review may result in delays in assessment, particularly if the purpose of each paper is not clear.

Remember:

  • Large quantities of submitted literature will not necessarily support a positive assessment outcome.
  • The APVMA considers the quality, relevance, source integrity, and currency of the literature to be of paramount importance to the related assessment.

5.4. Alternative contacts when applicants go on leave

If you are listed as the contact for an application and are going on planned leave, please contact your APVMA case manager prior to your leave to arrange an alternate contact in your absence. If you are the only contact for that product application, please provide your case manager with an expected date of return. Failure to provide an alternate contact may result in delays to application assessments.

5.5. Nominated agents and 8M applications

A nominated agent acts on behalf of a holder and, under the Agvet Code, is taken to have the same responsibilities (see Division 4 of Part 1 of the Agvet Code – sections 8L to 8R).

The role of a nominated agent comes into effect once a product is registered or an active has been approved and endures for the life of the product unless withdrawn by the holder or by the nominated agent. Access is granted to specified product number/s or active approval/s.

The Agvet Code requires there to be a person in Australia with the same responsibilities as the holder (see section 8R). It is therefore a condition of registration for an overseas holder to appoint a nominated agent for each approval or registration.

The nominated agent must be a resident of, or have a registered business in, Australia.

To verify whether a nominated agent has a registered business in Australia, the APVMA refers to the Australian Securities and Investments Commission (ASIC) and/or the Australian Business Register to validate the agent’s stated Australian Company Number (ACN) or Australian Business Number (ABN).

When nominating an agent, please ensure their ABN/ACN is included in their acceptance letter as well as in the application form.

If a nominated agent is an individual then evidence that they are a resident of, or carry on business in, Australia must accompany the 8M application. This evidence could include documents such as:

  • a bank statement
  • council rates
  • utility bill
  • proof of employment by an Australian business rental or mortgage documents
  • Australian photo ID.

If unsure, please get in touch with your case manager or our Enquiries Team.

More information to assist with lodging an 8M application is available on our website:

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