Pesticides Regulatory Newsletter, March 2022

• Directors update: Dr Gary Dorr and Mr Rodney Edmundson
• APVMA performance update
• Agricultural Labelling Code review
• New product registrations
• Amendments to the non-standard conditions of registration for over the top herbicides
• Molinate reconsideration completed
• Notifiable variations and variations that can be made without notifying the APVMA
• New agvet chemical legislation
• Useful information for industry – Item 12 applications

Directors update: Dr Gary Dorr and Mr Rodney Edmundson

Welcome to the March 2022 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Pesticides Regulatory Newsletter. This quarter we welcome Mr Rodney Edmundson, who is acting in the role of Director while Mr Hugh Dawick is on extended leave.

In this edition, we have included information on a range of regulatory topics, including an update on our review of the Agricultural Labelling Code, Pesticides Team timeframe performance, as well as information on notifiable variations and variations that can be made without notifying the APVMA.

We continue to encourage applicants to participate in APVMA stakeholder meetings. 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.

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APVMA performance update

The Pesticides Team delivered another quarter of sustained timeframe performance in the December quarter 2021.

We completed:

• 99.4% of total pesticide product applications within timeframe
• 98.8% of pesticide product major applications within timeframe
• 99.6% of pesticide product minor (non-technical) applications within timeframe.

The full performance report for the December quarter 2021 is available on our website.

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Agricultural Labelling Code review

Our review of the Agricultural Labelling Code (ALC) is progressing well, with the Pesticides Team working to have the first batch of revised content released to interested stakeholders for their feedback in April 2022.

The first batch will cover the following sections of the ALC:

• Signal Heading
• Constituent Statement
• Restricted Chemical Products
• Name and address of person primarily responsible for marketing the product
• Not to be used statement
• Other Limitations and prohibitions
• Compatibility statements
• APVMA label approval number
• Dangerous goods and worker safety legislative requirements
• Australian and New Zealand harmonised labelling for aerosol products

Please contact the Project Team via ALCreview@apvma.gov.au to register your interest in reviewing the first batch of revised content, or to provide early suggestions to any of the above sections of the ALC.

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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.

The following table lists the new registrations of agricultural chemical products, based on new active constituents, published in the Gazette to date for FY 2021–22 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 consultations section on our website for consultation opportunities.

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Amendments to the non-standard conditions of registration for over the top herbicides

Herbicide-tolerant crops are developed to be treated over the top (OTT) with a specific herbicide product, for which the APVMA imposes additional non-standard conditions of registration designed to ensure the practice of preventative weed resistance management. As part of these conditions, registration holders are required to implement a resistance management strategy and undertake regular consultation with a suitable group of experts.

With an increased number of registrants in the trait and herbicide space, and in recognition of the growing complexity of multiple herbicide trait stacks, the APVMA recently reviewed the suitability of the existing approach and concluded the non-standard conditions should be amended to ensure they remain fit for purpose.

The revised non-standard conditions, which will primarily affect the ease of administration of the registrant’s resistance management obligations, will be applied to all new and existing OTT herbicide registrations.

The changes will not reduce the APVMA’s capacity for functional oversight of potential resistance development.

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Molinate reconsideration completed

The APVMA has completed its reconsideration of molinate, a pesticide used exclusively for the control of barnyard grass and silver top grass in flooded rice paddies in NSW.

Following a review of the latest scientific information, the APVMA is satisfied products containing molinate can be used safely in accordance with updated label directions to ensure safe levels of exposure are not exceeded.

More information about the reconsideration, including a copy of the updated label directions, is available on our website. 

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Notifiable variations and variations that can be made without notifying the APVMA

Notifiable variations

Certain variations to approvals or registrations are determined by the APVMA to be notifiable variations (NV), which are listed in the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2019.

A holder or their nominated agent may apply via the APVMA decision tree to give notice of one or more NV. Applicants can avoid delays by lodging their variation under the appropriate variation application type. In addition to the decision tree, our tailored guidance may assist applicants in identifying the appropriate application type for the required variation.

NV are limited to the specific changes to particulars defined in the NV instrument. Due to an increased number of invalid NV applications, we’ve compiled several tips to assist applicants through the NV process:

• Changes to net contents must be within the range recorded in the Register for the product.
• When varying the name of any other registered products referred to within the instructions for use on the label, the varied referred-to product must have the same APVMA distinguishing number.
• An NV must only contain notifiable variations and no other variations. The APVMA does not have discretion to find that a notice partly meets the notice requirements, or to vary only some of the particulars of the approval or registration as proposed in the notice. If part of the notice is invalid, the NV will be considered invalid.
• Changes to the relevant label particulars outside of what is permitted under an NV, however minor, will not be accepted.

Variations that can be made without notifying the APVMA

Some changes can be made to registered products and approved labels without the holder needing to notify, or make an application to, the APVMA. These are changes to things that are not relevant particulars or conditions of registration, do not alter the way the product is used, and do not contradict existing information on the product label.

Product changes the APVMA does not need to be notified of include changing the:

• source of active constituent in a registered product to a different approved source of active constituent. It is a condition of registration that the active constituent must comply with the APVMA Standard and be manufactured at the site listed in the record of approval active constituents
• packaging material of a registered product. It is a condition of registration that products will be supplied in suitable packaging (regulation 18 of the Agvet Code Regulations).

Label changes the APVMA does not need to be notified of include:

• corrections to spelling mistakes and typographical errors
• updating a Mode of Action group in line with the relevant Labelling Code
• updating reference to a product holder on a label if this has changed (for example, in the resistance management strategy)
• compatibility statements for agricultural chemical products (this excludes ‘incompatibility’ statements that have been required by the APVMA).

If a holder makes any of the above changes to their product label, the APVMA-approved label on GrowCom will not be updated. However, holders are able to supply GrowCom with an updated label (Market Product Label), which can be presented next to the APVMA-approved label.

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New agvet chemical legislation

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. On 7 December 2021, the Improvements Bill received the Royal Assent and is now the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021 (Improvements Act). 

The Improvements Act 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 (limited to agricultural chemical products only at this time)
• allow for computerised decision-making by the APVMA
• simplify industry reporting requirements for annual returns.

In relation to the establishment of a new APVMA Board, on 3 March 2022, the Governor-General signed the proclamation that brought these changes into effect. As a result, from 4 March 2022, the Accountable Authority of the APVMA is the Board under the Public Governance, Performance and Accountability (PGPA) Act 2013.

The APVMA will continue to keep stakeholders updated as measures commence and Board members are announced. Stakeholders are encouraged to subscribe to receive email updates from the APVMA to be notified as this occurs.

More information about the Improvements Act is available on our website.

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Useful information for industry – Item 12 applications

The APVMA has seen an increase in the number of Item 12 applications where there are multiple reference products and/or scientific arguments submitted in support of a variation to include additional uses or to vary the label instructions of a registered agricultural chemical product.

Some of these applications include reference products that contain different concentrations of active constituent, or a different formulation type, and do not meet the Item 12 criteria. An Item 12 application is defined as an application to vary relevant particulars or conditions of registration or label approval if:

1. the variation is to allow a minor change; and
2. no data of a technical nature is required.

For a variation to proceed without a technical assessment (Item 12), the application is usually supported by referencing another registered product (reference product). The suitability of a reference product is based on the reference product having:

• the same active constituent/s at the same concentration/s
• the same non-active ingredients or, if different, they perform a similar function
• the same formulation type
• the same or equivalent use pattern
• no data items that are subject to limits on use of information (or consent to use is provided).

The term ‘reference product’ is generally a single registered reference product.

Applications that do not meet the Item 12 criteria may include:

• the use of a reference product that has a different concentration of active constituent and therefore involves application rate conversions. These applications require a technical assessment to calculate the application rate conversions for each use pattern
• the use of multiple reference products to copy uses from each different reference product. These applications require a technical assessment to ensure the safety, efficacy and labelling criteria of the Agvet Code is met for each of the proposed changes compared to the reference products
• scientific arguments, submission of previously submitted data, and/or reliance on previously submitted data or publicly available data or journals to support the variation. These applications require a technical assessment of the data submitted or referenced
• argument to support the difference in formulation type when compared to the reference product
• reference products that use a different form of salt of the active constituent when compared to the product to be varied.

Item 12 applications received by the APVMA that may fit the above criteria will either be re-categorised to an Item 14 (providing no further data/information is required for assessment); refused; or (from March 2022) granted a partial variation if applicable.

Further guidance on variations to registered chemical products can be found on our website.

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