- Directors update: Mr Hugh Dawick and Dr Gary Dorr
- Christmas and New Year holiday shut-down dates
- Performance report
- Improvements Bill
- Lure and attractant decision tree now online
- Agricultural Labelling Code review
- Updates from the APVMA Chemical Review Team
- New product registrations
- Finalisation module tips
Directors update: Mr Hugh Dawick and Dr Gary Dorr
Welcome to the December 2021 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 implementation of the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 measures, updates from the APVMA Chemical Review Team, and the introduction of the lure and attractant decision tree. We have also provided details and key dates for the upcoming holiday period.
We continue to encourage applicants to participate in APVMA stakeholder meetings, which are currently being held remotely. These meetings are a valuable forum for both industry and the APVMA Pesticides Team to discuss current and future applications, priorities, and 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.
We extend seasonal greetings to all our stakeholders and wish you a peaceful and relaxing holiday period with friends and family.
Christmas and New Year holiday shut-down dates
The APVMA will be closed for the Christmas and New Year break from Saturday 25 December 2021 and will re-open on Tuesday 4 January 2022. All applications that are due during this period and the first week of January will be finalised before 25 December 2021. Please contact your Case Manager if you have any questions about applications due during this period.
Performance report
The Pesticides Team delivered another strong quarter of timeframe performance at the end of the September quarter 2021.
We completed:
- 97.4% of all pesticide product major applications within timeframe
- 99.5% of all pesticide product minor (non-technical) applications within timeframe.
The full performance report for the September quarter 2021 is available on our website.
Improvements Bill
The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (Improvements Bill) passed through Parliament on 1 December 2021.
The Improvements Bill includes measures to:
- establish a governance board for the APVMA
- allow for prescribed approvals and registrations for chemicals of low regulatory concern
- provide for extensions to limitation periods and protection periods as an incentive for chemical companies to register certain new uses of chemical products
- allow for computerised decision-making by the APVMA
- simplify industry reporting requirements for annual returns.
Implementation of the measures will be staggered, and a list of measures and the expected implementation date is available on our website.
Stakeholders are encouraged to subscribe to receive email updates from the APVMA to be notified as measures commence and are implemented.
More information is available on our website.
Lure and attractant decision tree now online
The APVMA has published a decision tree to assist applicants in determining whether a lure or attractant product requires registration.
This decision tree is based on the definition of:
- an agricultural chemical product in the Agricultural and Veterinary Chemicals Code Act 1994
- products declared not to be agricultural chemical products in the Agricultural and Veterinary Chemicals Code Regulations 1995.
The lure and attractant decision tree is available on the APVMA website.
Agricultural Labelling Code review
In the September 2021 Pesticides Regulatory Newsletter, we announced that the Pesticides Team would begin our revision of the Agricultural Labelling Code (ALC) in 2022.
We continue to invite interested stakeholders to provide feedback and suggestions for the improvement and useability of the ALC. More information about the ALC review and how to provide feedback can be found on our website.
Stakeholders can still submit their interest in participating in the consultation of ALC batches as they are released, starting in 2022. Please email your interest or any other questions to ALCReview@apvma.gov.au.
Updates from the APVMA Chemical Review Team
Proposed regulatory decision on molinate
The proposed regulatory decision on molinate was published in a Special Gazette on 11 October 2021.
The APVMA proposes to:
- affirm the currently approved active constituents
- vary the relevant particulars of the product registrations to allow them to be affirmed
- vary the labels to allow affirmation.
Details of the proposed variations and labels are included in the Special Gazette.
The proposed decision is currently open for public consultation. The closing date for submissions is 11 January 2022.
Reconsideration of anticoagulant rodenticides
The reconsideration of active constituent approvals, product registrations and associated label approvals of anticoagulant rodenticides was announced on 2 November 2021 and published in the APVMA Gazette.
The reconsideration includes both first generation anticoagulant rodenticides (warfarin, coumatetralyl, diphacinone) and second generation anticoagulant rodenticides (brodifacoum, bromadiolone, difenacoum, difethialone, and flocoumafen). The scope of the review includes chemistry, toxicology, worker and public exposure, residues and environment, and will consider whether the product labels carry adequate instructions and warning statements.
The APVMA has requested submission of information for consideration under the review. Details of how to make a submission are included in the APVMA Gazette of 2 November 2021. The closing date for submissions is 2 February 2022.
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.
At the time this newsletter was published, there were no new registrations of agricultural chemical products, based on new active constituents not included in previous newsletters.
Registration of agricultural chemicals products based on new active constituents requires consultation prior to registration. Please see the public consultations section on our website for consultation opportunities.
Finalisation module tips
Applicants can avoid re-categorisation by nominating the correct finalisation module when submitting their application. To assist stakeholders, the APVMA has updated Module Descriptors to clarify the use of finalisation modules when an application requires consideration of a number of modular assessment reports.
When lodging applications that have 3 or more technical assessments the correct finalisation Module is 11.1.
If your application relies on assessment reports from a previous application (either an Item 25 application or a previously refused or withdrawn application), you should account for those assessments when determining the finalisation module.
For example, an Item 14 application is lodged with Modules 1, 2.3 (chemistry), 8.2 (efficacy) and 12 (limits on use) and the residues assessment was previously conducted under a withdrawn application. The correct finalisation Module is 11.1 as in effect there are 3 technical modules – although the residues assessment was conducted under a withdrawn application it must be considered in the overall assessment of the new application.