Pesticides Regulatory Newsletter, July 2023

• Directors update: Mr Hugh Dawick and Dr Gary Dorr
• New product registrations
• APVMA performance update
• Useful information for industry
• Modified Spray Drift Management Tool released
• Retirement of ‘fast-track’ option for Item 8 applications from 1 July 2023

Directors update: Mr Hugh Dawick and Dr Gary Dorr

Welcome to the July 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; tips for industry on product name requirements under the Agricultural Labelling Code, how to submit label variation applications, and demonstrate whether a product meets the efficacy criteria; and a reminder about the release of our modified Spray Drift Management Tool.

We are also pleased to announce that Dr Gary Dorr has been permanently appointed to the position of Director, Pesticides, and Mr Rodney Edmundson to the position of Director, Permits and Minor Use. Dr Dorr and Mr Edmundson are looking forward to continuing their work with stakeholders through the registration and permitted use of pesticide products.

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 and priorities, and to 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 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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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 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.

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 consultation opportunities.

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APVMA performance update

The Pesticides Team delivered another quarter of sustained timeframe performance in the March quarter 2023.

We completed:

• 94.2% of total pesticide product applications within timeframe
• 86.4% of pesticide product major applications within timeframe
• 99.3% of pesticide product minor (non-technical) applications within timeframe.

The full performance report for the March quarter 2023 is available on our website.

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Useful information for industry

In this edition, we’ve included helpful tips for a variety of topics, including recommendations for naming products to avoid user confusion, information on how to submit a label variation application, how to demonstrate whether a product meets the efficacy criteria, why consent letters are required for limits on use of information, and an update on our new section 6A Guideline.

Agricultural Labelling Code product name requirements

As part of our review of the Agricultural Labelling Code (ALC), the Pesticides Team have been considering the names of agricultural chemical products that may not comply with the ‘Product name’ requirements of the ALC.

The ALC states:

A product name must not be misleading, confusing or inconsistent with other label instructions or be easily confused with the names of other registered products.

To prevent user confusion from occurring, we have provided the following recommendations for stakeholders to consider when naming agricultural chemical products:

• To support the consideration of a new product name, we ask applicants to consider the ALC product name requirements. Providing justification for claims contained within the proposed product name can assist in the evaluation of your application. A comment in the application executive summary can be used to address your proposed product name. These claims should align with the nominated label particulars and be in accordance with the ALC.
• If the product includes 2 or more active constituents, all active constituents in the formulation should be included in the product name. Alternatively, the product name should exclude the actives. Identifying a single active in the name of a product with a combination of actives is considered misleading and not acceptable. In addition, active constituents should not be abbreviated in the product name.
• Product names should not include active constituents in the product name when the active constituent is not in the formulation. Further, the product name should not include common metals that users could misunderstand to be the active constituent, for example, gold, silver, or iron.
• If the term ‘organic’ is being requested in the product name, the APVMA will ask for evidence of certification when first registered.  It is the responsibility of the applicant to maintain certification to ensure the product name does not become misleading or, alternatively, amend the product name via the notifiable variation procedure should organic status no longer apply.

Label variations

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the legislative criteria for variation applications to registered chemical products and approved labels. Section 31(2) states:

The information must be presented in a way that shows how the variation affects the information (for example, all additions and deletions must be clearly identified).

One way this can be achieved is to submit a marked-up label with the application that clearly shows any changes to the currently approved label.

For situations where there are multiple reference products, it can be helpful to colour code the changes on the label to indicate the appropriate reference product to support each variation. This can also be beneficial for new product registrations where different uses on the label may be sourced from multiple reference products.

Failure to clearly identify the changes may result in a notice being issued to request clarification of the variations being requested, or the application being refused as it does not meet the application requirements.

Part 8 efficacy summaries

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the additional information required to demonstrate the chemical product meets the efficacy criteria when a full assessment is required. Section 18 gives the requirements for registrations of new chemical products and section 35 gives the requirements for variations to registered chemical products.

Section 18 states:

(1)  The application must contain, or be accompanied by, information relevant to whether the chemical product meets the efficacy criteria.

(2)  The application must contain, or be accompanied by, the results of any trials or laboratory experiments that have been carried out to determine the efficacy of the product, but only if the APVMA is required by subsection 5B(2) of the Code to have regard to that matter.

A part 8 summary should always be provided with any efficacy module to satisfy 18(1) or 35(1). This is in addition to the results of any trials or laboratory experiments as required under section 18(2) or 35(2). 

The part 8 summary should summarise any trial information provided and contain information or argument on how this information supports all the proposed label uses. For example, if relying on bioequivalence to a reference product, how the results from a limited range of studies can be extrapolated to support all the requested uses.

Such an argument should consider the basis for the crop/pest combination selected in terms of the level of challenge of the test product as well as the relative susceptibility of the crop variety tested compared to other crops on the label.  The location of the trial(s) and the extent to which it is representative of the range of climatic and edaphic conditions in the growing regions of the crop(s) for which approval is sought should also be considered.

Ultimately, the part 8 summary should provide the necessary context for all the submitted trial results, published papers and arguments, to explain how they constitute direct evidence of efficacy and safety for all proposed uses.

Providing such evidence facilitates timely assessment, minimises requests for further information, and ensures APVMA decision documentation contains sufficient evidence in support of all approved uses.

Providing appropriate consent letters for limits on use of information

Some registered pesticide products may have limits on use of information associated with their registration. This means that prior to the nomination of a reference product to support an application, applicants will need to check if any limits on use of information are associated with that reference product.

If limits do exist and they are relevant to the application, applicants must submit a written consent authorising the APVMA to rely on the information that is subject to limits on use. If the existing limits on use of information are not relevant to the application, then this should also be clearly identified and explained.

When a letter of consent is submitted to the APVMA, it is the applicant’s responsibility to ensure the consent has been issued by the appropriate entity, i.e. the entity that has the legal ownership of the information that is subject to limits on use.

This consent is required to be issued on the official letterhead of that entity and must be signed off by the authorising party. The consent should also clearly indicate which data item or items are permitted to be used for the respective assessment by the APVMA.

Once consent is given to use information that has limits on use, the APVMA can use the information even if the authorising party withdraws consent or later states it has not consented.

More information about the guidelines and requirements for drafting consent letters is available on our website.

New 6A Guideline: Requesting information from applicants

The APVMA is currently reviewing our suite of section 6A Guidelines, to ensure they are relevant to the decision-making process of APVMA staff. As noted in our March 2023 newsletter, the guidelines are being updated progressively to refine the information and ensure the content is suitable for a 6A Guideline compared with general information and guidance for applicants.

On 8 June 2023, the APVMA’s Interim Deputy Chief Executive Officer approved the publication of a new 6A Guideline ‘Requesting information from applicants’. This guideline includes guidance for staff on the 3 main provisions in the Agvet Code used to request information from applicants during the assessment of an application:

1. Preliminary assessment notice of defects (ss 11(3), 28(3), 110A(3))
2. Updating or clarifying information (under section 8C(a)(iii) and regulation 8AHAA taken together)
3. Notice of requirement of additional information, report or sample (s 159)

The guideline is presented in a format that provides the following content:

• The Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) provision to which the guidance relates.
• An explanation of the provision as deemed suitable.
• The matters APVMA staff need to take into account when considering the relevant decision.
• Legislative references and examples to provide additional context and information.

The previous 6A Guideline, ‘Section 159 in the context of applications under the Agvet Code’ has been revoked; however, is retained on our website for information purposes.

Under section 6A of the Agvet Code, the APVMA may make written guidelines for performing its functions and exercising its powers under the Agvet Code. If the APVMA makes a 6A Guideline, staff must have regard to it when making decisions.

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Modified Spray Drift Management Tool released

In May 2023 we released a modified version of our Spray Drift Management Tool (SDMT) to allow for the recalculation of buffer zones for products authorised under PER93132.

Permit 93132 is held by Grain Producers Australia and has been issued by the APVMA to allow applicators to access and use the modified version of the SDMT for selected products in cereals and fallow situations.

The modified SDMT will allow applicators to input site-specific information to calculate buffer zones, rather than simply applying ‘worse case’ buffers when planning their spraying programme.

Not only will the modified SDMT support work efficiencies for producers, but it will also help to support knowledge and understanding of the relationship between application parameters and off-target drift.

More information about the modified SDMT and PER93132 is available on our website.

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Retirement of ‘fast-track’ option for Item 8 applications from 1 July 2023

On 1 July 2023, the APVMA retired the 21-day service level standard ‘fast-track’ option for Item 8 applications, which are applications to register a product that is the same as a reference product (also known as a ‘repack’).

The fast-track option was introduced in 2016 for Item 8 applications that met certain criteria. The APVMA’s service level standard has been to complete the assessment of these applications in 21 days instead of the 3-month statutory timeframe. However, recent changes to the legislation made it unfeasible for the APVMA to continue to meet this service level standard.

Item 8 applications received up to 30 June 2023 will be processed in accordance with the 21-day service level standard, provided no additional or clarifying information is required. Item 8 applications received from 1 July 2023 onwards will be processed within the statutory 3-month timeframe.

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