Table of contents
1. Directors update: Mr Hugh Dawick and Dr Gary Dorr
Welcome to the April 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 timeframe performance and the APVMA’s chemical review activities, plus information about the requirement for reporting adverse experiences associated with agricultural chemicals. We’ve also provided several useful tips for industry, including information about section 159 notices, modular assessments for copying uses from a similar reference product, and Item 24V applications to remove a manufacturing site.
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. Planning your efficacy and crop safety trials programme?
If you’re planning your efficacy and crop safety trials programme for the season(s) ahead, then we recommend consulting with the APVMA in advance via our pre-application assistance (PAA) program.
PAA gives applicants the opportunity to obtain technical advice before submitting an application, to ensure adequate trials are undertaken to support all new uses. While it won’t necessarily guarantee a successful registration, seeking PAA from the APVMA can help to improve the likelihood and prevent delays arising from requests for further information later in the process.
3. APVMA performance update
The Pesticides Team delivered another quarter of timeframe performance in the December quarter 2023.
We completed:
- 94.7% of total pesticide product applications within timeframe.
- 78.3% of pesticide product major applications within timeframe.
- 100% of pesticide product minor (non-technical) applications within timeframe.
The full performance report for the December quarter 2023 is available on our website.
4. Chemical review activities
The 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.
On 12 December 2023, we published the proposed regulatory decision (PRD) for the reconsideration of chlorpyrifos. Public consultation on the PRD closed 11 March 2024, and the APVMA is now considering the submissions received.
On 27 February 2024, we published the PRD for reconsideration of neomycin, which is currently open for consultation until 26 May 2024.
The PRD for the reconsideration of diazinon was published on 12 March 2024 and is open for public consultation until 11 June 2024.
The PRD for the reconsideration of fenitrothion was published on 9 April 2024 and is open for public consultation until 8 July 2024.
A summary of work plans for the reconsiderations listed in the Ministerial Direction, including current forecast dates for PRDs, public consultations, and final regulatory decisions, is available on our website.
The Chemical Review Team is also preparing for the upcoming rescheduling of bromoxynil products containing more than 1.5% bromoxynil from schedule 6 (Poison) to schedule 7 (Dangerous Poison).
From 1 February 2025, products containing more than 1.5% weight/volume (w/v) bromoxynil will be classified as Schedule 7 Dangerous Poisons and will no longer be approved for use in home garden situations.
The signal heading and storage instructions on all commercial product labels will be updated from a Schedule 6 to Schedule 7 to coincide with the change in scheduling. Any current home garden products that will be re-classified to Schedule 7 will be cancelled as of the implementation date, as Schedule 7 products are not acceptable for home garden use.
Products containing 1.5% w/v bromoxynil or less will not be affected.
Enquiries about these changes should be directed to enquiries@apvma.gov.au or +61 2 6770 2300.
5. Requirement for reporting adverse experiences associated with agriculture chemicals
The APVMA’s Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered chemical product (or those issued under permit). Reports of adverse experiences are closely monitored by the APVMA, as it is vital to record, assess, and classify adverse experiences to detect uncommon events not evident during the initial registration of a product.
Section 161 of the Agvet Code requires registrants to provide the APVMA with any ‘new information’ that they become aware of. This new information includes adverse experience information relating to either:
- human health issues
- harm to animals
- damage to plants, property or the environment
- lack of efficacy when the products are used according to the approved label directions.
For veterinary products, a serious adverse experience is one that:
- results in death
- is life-threatening
- results in persistent or significant disability or incapacity, or prolonged duration of serious signs
- causes a congenital abnormality or birth defect in animals
- requires medical treatment or involves death in humans.
For agricultural chemical products, a serious adverse experience includes:
- significant off-target environmental damage, including fish kills and water quality issues
- crop and plant damage (for example, plant death, severe stunting, or significant yield loss).
Product registration holders are expected to report all serious adverse experiences to the APVMA as soon as they become aware of this information. If there is any doubt about the seriousness of a suspected adverse experience, the incident must be treated as a serious adverse experience and reported by the registration holder to the APVMA as soon as possible.
Information about how product holders must notify the APVMA of this information is available on our website.
Anyone can report a problem with an agvet chemical product by submitting an AERP report online.
6. Useful information for industry
This edition’s useful information for industry covers section 159 notices and Item 12 and 24V applications, plus updates on our timeframes for registration-related activities and the Online Services Portal.
6.1. What is a section 159 notice and how do I respond to it?
During assessment of an application, the APVMA may require additional information from the applicant.
One way we can request this information is by issuing a notice under section 159 of the Agvet Code Act, which would require the applicant to provide specified information or take specified actions. As a result of a s 159 notice being issued, the application’s assessment timeframe would be extended for the first notice only. Assessment timeframes are not extended for any further notices.
Applicants must provide their response to a s 159 notice by the due date specified in the notice. This is usually within 28 days from the date the notice was issued, unless otherwise agreed by the APVMA. The maximum period an applicant must respond to this notice is the extended assessment period given in the regulations.
Generally, we will notify an applicant if a s 159 notice is to be issued before the notice is sent out. If the applicant provides the required information after receiving this notification and before the notice is issued, a s 159 notice will still be issued, and the application’s assessment timeframe will still be extended. This is because under subsection 8C of the Agricultural and Veterinary Chemicals Code Act 1994, the APVMA is unable to consider any new information submitted before the s 159 notice has been issued. We are also unable to reverse our decision to issue a s 159 notice.
6.2. Item 12 applications to copy uses from a similar (not closely similar) reference product
Item 12 applications allow variations to the label and/or conditions of registration where no data and associated technical consideration are required.
If applicants are seeking to copy existing approved uses from a reference product but the formulation composition and type are sufficiently different as to require supporting efficacy and crop safety data, the APVMA cannot accept the application as an Item 12. The application can either be withdrawn or recategorised as an Item 14 if supporting data can be made available within the stated timeframe.
For further information, please refer to the Efficacy and Safety 3 section of our module descriptors.
6.3. Item 24Vs to remove manufacturing sites from active records
An Item 24 application is a modular application that can be used to approve a new source of active as well as vary the relevant particulars for an active register. In the APVMA’s processing systems, this application will be designated as an ‘Item 24V’.
To apply for an Item 24v:
- there must be at least one approved manufacturing site on the active register
- the remaining manufacturing site(s) on the register must cover all manufacturing steps
- the remaining site(s) must still comply with their relevant approval conditions.
If these requirements are met, applicants can choose an Item 24 application from the Decision Tree and note in the Executive Summary that the application is to vary the active register to remove a site. No assessment modules are required, meaning only Module 1.0 ($902) and Module 11.3 Finalisation ($1,730) would apply.
Please see our website for guidance on active constituents and application options or contact enquiries@apvma.gov.au should you have any questions.
6.4. Timeframe update for registration-related activities
The APVMA has reallocated some of our internal resources following the Ministerial Direction issued to the agency requiring the prioritisation of chemical reviews. This has affected timeframes associated with some registration-related activities and may continue to do so until after the chemical reviews listed in the direction are complete.
During this period, the APVMA is taking a considered approach to ensure we balance and manage the entirety of our legislative responsibilities in responding to the direction. We will continue to work to minimise any potential impact on registrants and communicate potential delays as soon as possible.
6.5. Herbicides mode of action groupings and the E-label portal
The Australian herbicide mode of action groups based on alphabetic characters have been replaced with internationally recognised numeric codes.
The APVMA’s Online Services Portal has been updated following this change and users can now select the relevant numeric code(s) in the drop-down list for herbicide mode of action. The drop-down list only includes numbers that are currently assigned to active mode of action groups (i.e. it is not continuous between 1 and 30).
Additionally, a reminder that the mode of action group is not a relevant label particular assessed by APVMA. Therefore, applicants can update the mode of action on their marketed label without notifying the APVMA. The APVMA label record will be updated the next time an application is received.