Table of contents
1. Directors update: Mr Hugh Dawick and Dr Gary Dorr
Welcome to the December 2023 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
- the APVMA website upgrade
- changes to the APVMA Standard for Maximum Residue Limits (MRLs)
- the suspension of dimethoate and ongoing chemical reconsiderations
- the emergency permit renewal process
- formulation composition to be expressed in g/L or g/kg
- preliminary assessment where there are limits on use of information (‘protected data’)
- temporary requirements for submitting Certificate of Export (COEs) documents.
As this is the last Pesticides Regulatory Newsletter for 2023, we’ve also included notice of the APVMA’s holiday closure.
We continue to encourage applicants to participate in APVMA stakeholder meetings, which are a valuable forum for both industry and the APVMA Pesticides Team to discuss current and future applications, priorities, and to work through any concerns. These meetings can be organised through your Case Manager by emailing casemanagement@apvma.gov.au. Please reach out to any member of the Pesticides Team if you require assistance related to the registration of pesticides.
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 holiday closure
The APVMA will be closed for the holiday period from close of business Friday 22 December 2023 until Tuesday 2 January 2024. We will aim to finalise applications due during this period by Friday 15 December 2023. Please contact your Case Manager if you have any questions about applications due during this period.
As this is the final Pesticides Regulatory Newsletter for 2023, the Pesticides Team would like to take this opportunity to wish all our stakeholders a safe and happy holiday period.
3. 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.
Table 1 lists the new registration of an agricultural chemical product, based on a new active constituent, published in the Gazette to date for FY 2022–23 and not included in previous newsletters.
Table 1: New registration of an agricultural chemical product based on a new active constituent
|
Application number |
Product number |
Product name |
Active constituent |
Applicant name |
Date of registration |
|---|---|---|---|---|---|
|
133783 |
91885 |
SEEKER Duo Fungicide |
Fenpropidin |
Syngenta Australia Pty Ltd |
20 July 2023 |
The 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.
4. Performance update
The Pesticides Team delivered another quarter of sustained timeframe performance in the June quarter 2023.
We completed:
- 94.1% of total pesticide product applications within timeframe
- 81.2% of pesticide product major applications within timeframe
- 100% of pesticide product minor (non-technical) applications within timeframe.
The full performance report for the June quarter 2023 is available on our website.
5. apvma.gov.au upgrade
On Wednesday 29 November 2023, our flagship website, apvma.gov.au, was upgraded. Stakeholders may have noticed the website design has been refreshed, but no changes have been made to content or the website structure.
Our Communications Team intends to undertake a review of the website structure in 2024, and stakeholders will be invited to participate and provide feedback on how you use and navigate our website.
If you experience any issues or identify a problem on the website, please email WebPublishing@apvma.gov.au.
6. Change to the APVMA Standard for Maximum Residue Limits
A Maximum Residue Limit (MRL) is the maximum concentration of a residue resulting from the registered use of an agricultural or veterinary chemical that is legally permitted or recognised as acceptable to be present in or on a food, agricultural commodity, or animal feed.
The APVMA MRL Standard is referenced by various state laws. MRLs become standards that are used in determining whether approved directions for use of agricultural and veterinary chemicals have been followed. MRLs are established in Legislative Instruments, and a new Instrument has recently been established and is now in force.
The Agricultural and Veterinary Chemicals (MRL Standard for Residues of Chemical Products) Instrument 2023 is now in force and supersedes the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019, which has been repealed. Recent amendments made to section 7A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 allow for the APVMA to approve standards for residues of chemical products as often as we find necessary. The 2023 Instrument has been established so that this new mechanism for establishing MRLs by legislative instrument can be utilised.
The standards approved for residues of chemical products under the 2023 Instrument are identical to those previously provided for by the 2019 Instrument. This means that while the mechanism for establishing MRLs has changed, the existing MRLs have not.
7. Ministerial Direction update
On 13 July 2023, the APVMA received a direction from Senator the Hon Murray Watt, Minister for Agriculture, Fisheries and Forestry, consistent with section 10 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act) regarding ongoing chemical reconsiderations.
The direction refers to a number of matters, including reconsiderations that have been ongoing for more than 17 years. These are:
- Malathion
- Diazinon
- Chlorpyrifos
- Neomycin
- Fenitrothion
- Paraquat
- Diquat
- Fipronil.
The scientific assessments for all ongoing reconsiderations, including those not specifically referred to in the Ministerial Direction, are continuing.
Over the next few months, the APVMA expects to publish the Final Regulatory Decision for the malathion reconsideration and the Proposed Regulatory Decision for the chlorpyrifos reconsideration. The Proposed Regulatory Decision for the diazinon reconsideration is anticipated in the first quarter of 2024.
8. Suspension of dimethoate
On 19 September 2023, the APVMA suspended the registration and labels of chemical products containing dimethoate used as a post-harvest dip for tropical and sub-tropical fruit with inedible peel.
This followed the APVMA’s assessment of reports that indicated the maximum permitted level of pesticide residue (the MRL) for omethoate, the main degradation product of dimethoate, had been exceeded in avocados and mangoes. While the APVMA considered the level of residues detected were unlikely to pose a significant risk to human health they were above the acceptable level for an appropriate margin of safety. Following the suspension, most holders have voluntarily varied their labels to remove the suspended use patterns from their product and labels, allowing the suspension on the varied products to be revoked.
9. Useful information for industry
In this edition, we’ve included information on the process for continuing use of a product or active constituent after an emergency permit has expired; how the formulation composition of agricultural chemicals must be expressed in applications; and a reminder of the need to declare any data items that are subject to limits on use of information.
9.0.1. Emergency permit renewal process
The APVMA issues emergency permits to legalise the use of an agvet product or active constituent to address an emergency situation.
In instances where an emergency permit is due to expire or has expired, and the uses approved under the permit need to continue, then any request to continue these uses under emergency permit must be made through a new Item 22 application. This will allow for justification of the continued emergency status to be made and evaluated by the APVMA.
If the uses authorised under emergency permit need to continue beyond the permit expiry date for a situation that is no longer classified as an emergency, then an Item 21 application for a new minor use permit may be submitted where it can be sufficiently justified to meet the minor use criteria.
Holders who submit item 20 renewal applications for previously issued emergency permits, either current or expired, will be asked to withdraw and submit a new Item 22 or 21 application with appropriate justification .
Item 22 applications submitted for situations that are assessed and determined not to constitute an emergency, where appropriate, may be recategorised to an Item 21 application. These would then incur fee requirements and modular timeframes for their evaluation.
For information on the differences between emergency and minor use permits, please visit our website.
9.0.2. How to express formulation composition for agricultural chemicals
For applications that require the submission of product formulation details, applicants must provide the APVMA with a full description of the formulation of the product that includes its complete composition.
The concentrations of the constituents in a formulation should be expressed as g/L for liquid formulations and g/kg for solid formulations. If these units of measurement are not appropriate for a particular formulation, then alternate units of measurement should be proposed by the applicant.
Any formulation where constituent concentrations show only numbers (sans units of measurement), percentages, or are expressed in unsuitable measurement units or as a range will not be accepted.
You can access more information regarding how to express the formulation composition on our website.
9.0.3. Preliminary assessment where there are limits on use of information (‘protected data’)
Applicants are reminded of the need to declare any data items that are subject to limits on use of information (commonly referred to as ‘protected data’) on reference product(s) when submitting applications.
Data items that are subject to limits on use can be found on the APVMA’s Public Chemical Registration Information System Search (PubCRIS) database. PubCRIS generally lists each data item with the title, author, authorising party, and period of protection; however, specific data items may not appear for products registered as repacked products via an Item 8 application.
Under subsections 9(1)(e) and 9(1)(f) of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (Application Requirements Instrument), applicants are required to declare any relevant data items that are subject to limits on use of information in their application to register a chemical product.
Under subsections 2(1)(g) and 27(1)(h) of the Applications Requirements Instrument, applicants are required to declare any relevant data items that are subject to limits on use of information in their application to vary a currently registered chemical product.
‘Relevant’ data items are items the APVMA would need to assess to decide on an incoming application – for example, product specifications for the reference product on an Item 7 application.
Should subsections 9(1)(e), 9(1)(f), 27(1)(g) or 27(1)(h) apply, the APVMA will require written consent from the authorising party to rely on those data items during assessment. This is specified under subsection 9(2) for registration applications, or subsection 27(2) for variation applications of the Application Requirements Instrument.
The written consent should be included as a data item for the incoming application. Alternatively, applicants should indicate if they do not intend to provide consent and explain why any data items that are subject to limits on use are not relevant to their application. Applicants can do this in the Executive Summary of the application form.
Please note that written consent is not required when the applicant is the owner or authorising party of the protected information. Consent is implied in these situations.
Incoming applications will not pass preliminary assessment (sections 11 and 28 of the Agricultural and Veterinary Chemicals Code Act 1994 [Agvet Code Act]) if consent is not provided. In these situations, we will issue a defect notice and provide applicants with one month to rectify the situation. Alternatively, if the situation cannot be rectified, applications may be refused under section 14(2) of the Agvet Code Act at preliminary assessment.
9.0.4. Known system issue – attachments to Certificate of Export applications
Applicants can submit an application for an APVMA Certificate of Export through our Online Services Portal.
As part of the application process, applicants are asked to upload letters of support from manufacturers when the applicant is not the manufacturer, and the manufacturer details are to be listed on the certificate. This is because the manufacturer details are not publicly available.
Unfortunately, we are currently experiencing a system issue after applicants upload these letters of support. Although applicants can still upload the letters of support, they will not transfer across with the application. This issue is being investigated and we apologise for any inconvenience caused.
In the meantime, rather than uploading the letters of support, applicants are asked to please email these to the APVMA at certificatesofexport@apvma.gov.au. Please quote the certificate number in your email (COE-XXXXXXXXX).