Pesticides Regulatory Newsletter, September 2025

1. Pesticide Directors’ update: Dr Gary Dorr and Ms. Gaye Weller

Welcome to the September 2025 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Pesticides Regulatory Newsletter. 

In this edition we have included information on the update on application requirements for Item 6 and 7 applications, late payments on r70B recategorised applications, compatibility statements on product labels, and other regulatory updates and topics.

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.

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 current consultations.

3. APVMA performance update

• 83.4 % of total pesticide product applications within timeframe.
• 54.9 % of pesticide product major applications within timeframe.
• 94.1 % of pesticide product minor (non-technical) applications within timeframe.

The full performance report for the March quarter 2025 is available on our website.

4. Useful information for industry

This edition’s useful information for industry covers:

• Dr Heidi Mitchell and Cameron Dalgleish: Newly appointed Directors for Pesticides and Pre-evaluation and Quality
• Prescribed dates for payment of levy
• Update on Application Requirements for ‘closely similar’ Item 6 and 7 Applications
• Late payment of R70B recategorised application fees
• Tank mixes and Compatibility statements on APVMA-approved labels
• New Efficacy and Crop Safety Overview Instructional Templates for agricultural chemicals
• Updated minor use guidelines published
• Proposed suspension of dimethoate products
• Final regulatory decision on fenitrothion reconsideration
• APVMA seeking external scientific reviewers to support regulatory assessments

4.1. Dr Heidi Mitchell and Cameron Dalgleish: Newly appointed Directors for Pesticides and Pre-evaluation and Quality

We are delighted to announce that Dr Heidi Mitchell and Cameron Dalgleish have been appointed to the positions of Director in the Pesticides and Pre-evaluation and Quality Teams respectively. 

Cameron has been acting in the role of Director Pre-Evaluation and Quality in recent months. He also brings 6 years of experience with the Pesticides Team, and 8 years at the Australian Industrial Chemicals Introduction Scheme (AICIS).

Dr. Heidi Mitchell will be joining the APVMA as Director, Pesticides on 8 September 2025. Heidi brings a wealth of experience from her time at the Office of the Gene Technology Regulator (OGTR), where she has served since 2006—first as an evaluator, and more recently as Director of both the Contained Dealings Evaluation Section and the Plant Evaluation Section. Her deep scientific knowledge and proven leadership will be invaluable in this new role.

4.2. Prescribed dates for payment of levy

The due dates for payment of levy have changed from previous years to allow more effective compliance with the APVMA’s enabling legislation. Interested persons have the option to make payment of the entire levy payable in full by 15 January 2026, or nominate to pay the levy amount in 2 instalments of 50% of the total levy, with the first instalment amount payable by 15 January 2026, and the second instalment amount payable by 15 March 2026. The prescribed dates were published in Gazette No. 18.

4.3. Update on Application Requirements for ‘closely similar’ Item 6 and 7 Applications

On 11 June 2025, the APVMA provided an update on Item 6 and 7 Applications and their use of reference products. This update took effect immediately and applied to Item 6 and 7 applications already with the APVMA as well as those submitted in the future. Please note that while this update is specific to Item 6 and 7 applications, the APVMA is reviewing its position regarding the use of reference products more generally. As such, more updates should be anticipated.

More information regarding this update can be found on apvma.gov.au. Applicants are encouraged to contact the APVMA if they have any further questions regarding submissions of item 6 or 7 applications.

4.4. Late payment of recategorised application fees

Regulation 70B of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) provides that the APVMA may recategorise an application if the relevant application fee has been paid and the APVMA:

1. determines, at any time after preliminary assessment of the application, that the application is more correctly categorised as an application of a kind mentioned in a different item of the table in clause 2.1 of Schedule 6 to the Agvet Code Regulations, (the recategorised item); or
2. considers, at any time after preliminary assessment of the application, that different modules, levels, and types mentioned in Schedule 7 (the recategorised modules) are necessary for the application.

Recategorisation may result in a change of fees and, in some cases, an additional amount may be payable. When this happens, the additional amount must be paid within 28 days of the date of the notice (as per R70B(3)(a)(iii) of the Agvet Code Regulations).

If we don’t receive payment by the due date listed on the invoice, we must refuse the application, (as per R70B(3)(a)(iv)of the Agvet Code Regulations) regardless of whether payment is received afterwards.

It is the applicant's responsibility to ensure that payment is made on time, noting that the APVMA has no mechanism to block electronic payment if it is made beyond the due date.

Please be mindful of the fact that the application cannot proceed to assessment until the fees are paid. Timely payment of the outstanding fee will minimise delays with the application. 

The R70B notice regulations are in Part 9 - Miscellaneous / Division 9.2 – Fees of the Agricultural and Veterinary Chemicals Code Regulations 1995.

4.5. Tank mixes and Compatibility statements on APVMA-approved labels

Product labels must contain certain information (commonly referred to as relevant particulars) to meet the labelling criteria and this information is assessed by the APVMA as part of our evaluation. A list of the information required on the product label is available on the APVMA website.

Product labels may include instructions for tank mixing a product with compatible products. In general, there are 2 scenarios for tank mixes, each handled differently:

4.5.1. Scenario 1

• A specific tank mix is listed within the Directions for Use table of the APVMA-approved label to achieve control of a certain pest or weed. In this case, the APVMA assesses the tank mix to ensure that the product mix, when used according to label directions, will meet the statutory criteria of safety, efficacy, and trade. Products listed must be registered (at the time of label approval) and should be referred to by the active constituent’s name and concentration.

4.5.2. Scenario 2

• The marketplace label contains a Compatibility Statement, listing other compatible partner products that can be mixed with the product and applied at the same time. The compatibility of products listed in this scenario is not assessed by the APVMA as it is not directly relevant to the application to register the product. Compatibility Statements are not a relevant particular; therefore, the APVMA does not approve them as part of the APVMA-approved label.

Some exceptions may apply. For instance, the label may include general Best Practice Statements, such as ‘test compatibility of a small amount of product first’. Such situations will be assessed on a case-by-case basis.

If there is a known incompatibility between products, this information should be included on the label. Warnings for specific incompatibility of the product with other products, should be included in the ‘General Instructions’ section. Any additional advice in this section would require supporting data; for example, statements such as, ‘use in conjunction with [Chemical A] will cause crop discoloration but this is transient and will not impact yield’.

The holder may include compatibility and other statements on the commercial label provided they are reasonable and do not contradict the approved label wording. Similarly, product names in the compatibility section can be updated without application to the APVMA. 

4.5.3. What this means for you

Compatibility between products for general tank mixes are not assessed by the APVMA and therefore a Compatibility Statement listing products that may be tank mixed with a given product will not be included on the APVMA-approved product label. These details may be included on the marketed label provided they do not contain information that is inconsistent with the APVMA approved label.

If you need any further clarification, please reach out via the APVMA Enquiries inbox enquiries@apvma.gov.au.

4.6. New Efficacy and Crop Safety Overview Instructional Templates for agricultural chemicals

The APVMA has published 3 new Instructional Templates.

1. Efficacy and Crop Safety Overview – Instructional Template (Crops)
2. Efficacy Overview – Instructional Template (Non-crop situations)
3. Efficacy and Crop Safety Overview – Instructional Template (Permits)

The templates provide guidance and examples on the structure and content that is required in Efficacy and Crop Safety Overviews, supporting applications for new agricultural products and new uses.

The templates were drafted in consultation with stakeholders during 2 Efficacy Workshops held on 21 May and 1 July 2025.

The use of these templates is not mandatory but is strongly recommended. Using the templates will help to ensure all necessary information is provided and presented in a manner that will assist the APVMA in the evaluation of your application, reducing the likelihood of requests for further information during the assessment.

The APVMA aims to develop completed examples to further assist stakeholders in their applications.  Continued feedback from users on the content of these templates is welcomed and can be provided via the following address Efficacy@apvma.gov.au.

4.7. Updated minor use guidelines published

The APVMA have published updated guidelines for determining minor use. These new guidelines came into effect on 5 August 2025. 

Implementation of the new guidelines will be accompanied by a 12-month phase-in period, as outlined in the transition map. A detailed response addressing the consultation feedback has now been published on apvma.gov.au.

If you have any further enquiries about the new guidelines, please contact enquiries@apvma.gov.au.

4.8. Proposed suspension of dimethoate products

On 5 August 2025, the APVMA proposed to suspend the product registration and label approval of chemical products containing dimethoate for use on blueberries, raspberries and blackberries.

The APVMA received new information, gathered by Food Standards Australia and New Zealand (FSANZ), indicating Australians’ consumption of blueberries, blackberries and raspberries has increased significantly since the most recent dimethoate reconsideration, completed in 2017.

Based on these updated consumption figures, the APVMA reassessed the potential level of dietary exposure for all chemicals approved for use in these berries and found that use of dimethoate following the approved label directions does not leave an adequate safety margin between the possible level of dimethoate residues and the maximum acceptable level of exposure. The level of residues detected are unlikely to pose a serious risk to human health, but the APVMA has proposed suspension as a precautionary measure.

The APVMA remains satisfied that all other approved uses of dimethoate are safe. In addition, no other chemicals used on blueberries, raspberries or blackberries require regulatory action at this stage.

Holders of dimethoate registrations and other relevant stakeholders had 20 days to provide any information that would demonstrate why the products should not be suspended. Members of the public were also invited to comment on the proposed suspension. Consultation closed on 2 September. The APVMA will consider all submissions before making a final decision.

Registered chemical products containing dimethoate can continue to be used during the consideration period, in accordance with the approved label instructions.

4.9. Final regulatory decision on fenitrothion reconsideration

On 15 August the APVMA published the final regulatory decision on fenitrothion reconsideration to impose wide-ranging additional restrictions on the insecticide, fenitrothion, in the interests of worker safety and protection of animals, the environment and trade.

Fenitrothion has been subject to a chemical review and public consultation related to its active constituents, chemical products and labels which concluded on 8 July 2024.

As a result of the APVMA’s final decision, most uses in broad acre, pasture, horticulture and the treatment of grain storage areas and poultry houses, will no longer be authorised as the APVMA has determined that there is no viable way to mitigate environmental and worker safety risks.

There is no imminent risk to workers or the environment and safety of food.

The use of fenitrothion on bulk stored grain entering silos remains authorised. For the limited uses remaining in other settings, additional restraints will be introduced.

At the conclusion of a 12-month phase-out period, fenitrothion will only be able to be used in extremely limited circumstances and with strict controls.

No uses involving hand-held spraying will be authorised.

The APVMA always takes a conservative approach to safety margins for protection of human health and the environment. The new instructions for use and further restraints will reinforce the safety margins for fenitrothion and remove authority for the product to be used in any way that erodes these safety margins.

In addition to the priority considerations around worker safety, the final decision by the APVMA has been driven by evidence of potential negative impact on the environment related to the vast majority of uses. The environmental risk was predominantly related to birds, but also small mammals and sensitive aquatic species as a result of spray drift.

Fenitrothion is an insecticide that has been used to control various insects in pastures and agricultural crops, including for control of plague locusts and grasshoppers. It has also been used to control litter beetles in poultry houses, as a structural treatment in grain storage facilities, and as a grain protectant for long term protection of cereal grains in storage. For most agricultural uses that will now be cancelled or restricted, there are alternatives available.

A summary of fenitrothion uses, which are supported or not supported, is available on the APVMA website. A summary of the underlying risk assessments has also been published in the Fenitrothion Final Review Technical Report.

4.10. APVMA seeking external scientific reviewers to support regulatory assessments

The APVMA is seeking to expand its pool of External Scientific Reviewers (ESRs) to support the scientific assessment of agricultural chemical products.

As an ESR, you will be engaged under contract to independently assess technical information submitted by applicants. These assessments may relate to new product registrations, variations to existing approvals, or chemical reconsiderations (reviews) undertaken to ensure that registered products continue to meet contemporary scientific standards.

This is an opportunity to contribute to the regulation of chemical products used across Australia’s agvet sectors, and to play a direct role in maintaining the safety and effectiveness of these products in the market.

If you are interested in joining the pool of ESRs, more information is available on apvma.gov.au.