Pesticides Regulatory Newsletter, April 2023

• Directors update: Mr Hugh Dawick and Dr Gary Dorr
• New product registrations
• 6A guidelines review
• Useful information for industry
• Guidance for active constituent applications
• Possible timeframe and fee savings for international/overseas assessments
• Tips and tricks for preparing information lists
• Defect notices
• Tips to avoid disclosure of CCI in application summaries
• APVMA 2023 Stakeholder Survey

Directors update: Mr Hugh Dawick and Dr Gary Dorr

Welcome to the April 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 our review of section 6A Guidelines and information about the new module descriptors that took effect from 1 February 2023, plus guidance for active constituent applications, possible timeframe and fee savings for international/overseas assessments, and tips and tricks for preparing information lists.

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 by contacting the APVMA Case Management Team. If you have any suggestions or requests for future editions of the APVMA’s Pesticides Regulatory Newsletter, please send them through to the APVMA Communications Team.

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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 registrations of agricultural chemical products, based on new active constituents, 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 consultations page on our website for consultation opportunities.

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6A guidelines review

Section 6A of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) states that the APVMA may make written guidelines for performing its functions and exercising its powers under the Code.

Section 6A Guidelines are intended to assist APVMA staff in making decisions in a consistent and transparent way. They are therefore not guidelines intended for applicants; however, applicants may find them useful in preparing their applications, to understand what our staff will consider when making their decisions. The Agvet Code stipulates that all s 6A guidelines must be published.

Section 6A Guidelines are specific in that if the APVMA makes an s 6A guideline, APVMA decision-makers must have regard to it in performing the functions and exercising the powers of the APVMA under the Agvet Code.

The APVMA is currently reviewing its suite of s 6A guidelines, to ensure they are relevant to the decision-making process of APVMA staff and are suitable as an s 6A guideline compared with information and guidance for applicants.

Current s 6A guidelines are published on the APVMA website; however, the content will be progressively updated in the coming months to refine the information. An additional update will be provided in our next newsletter with details of the changes made.

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Useful information for industry

New module descriptors

New modules came into effect on 1 February 2023 as part of the APVMA’s new Cost Recovery Implementation Statement. We have created these new modules to capture assessment types where a reduced timeframe and fee is considered appropriate.

Changes to the module descriptors include:

• Toxicology and Work and Health Safety modules being combined and relabelled ‘Health’.
• Additional modules in Chemistry and Environment where a reduced timeframe and fee was deemed appropriate.
• Changes to the Residues modules to remove permit specific modules and redistribute work across all 5 modules.
• Relabelling the modules from numbers to more meaningful names.

The changes also include timeframe and fee reductions for applications where appropriate overseas assessments are submitted, along with supporting data. Pre-application assistance and a project plan are required to use this pathway. See our update on international assessments in this newsletter for further information.

There are no changes to fixed fee applications or to levies or other charges.

For pesticide product and active constituent applications, the following new modules have been introduced for applications submitted from 1 February 2023 onwards:

• Chemistry 4 and Chemistry 5 modules now have reduced timeframe and assessment fees, compared to previous Chemistry level 1 to 3 modules.
• A new Health 6 module has been included, with a reduced timeframe and assessment fee (noting previous Toxicology and Work Health and Safety modules have been combined and renamed as Health).
• Inclusion of Residues 3 and Residues 5 modules as part of the redistribution of work – these modules previously only applied to permit applications.
• A new Environment 4 module with a reduced timeframe and fee.

The module descriptors document is intended to be read from the top down when looking at which modules apply. Once your application meets a module-level descriptor, the intent is that your application should be submitted with that module and level. If no module level has been described for the application type, it is likely that module is not necessary. All applicants are encouraged to apply for pre-application assistance (PAA) to ensure they have the right modules for their application.

Note, only applications submitted after 1 February 2023 will be able to be assessed under the new module descriptors. Applicants are requested to note the modules they would like to include in the Executive Summary of their application if they are not available to choose on the application form. For application forms drafted (but not submitted) prior to 1 February 2023, the new modules will not appear.

Note, for Item 17 and 18 applications, applicants are required to mention the preferred module, Chemistry 4 or Chemistry 5, in the Executive Summary, if applicable.

A summary of timeframes and fees, including for the new modules, is available on our website.

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Guidance for active constituent applications

Prior to 1 February 2023, applicants had the choice of an Item 17 or Item 18 application to approve a new source of active constituent or vary the relevant particulars of an approved active, respectively. These application types have a fixed fee and timeframe and do not allow use of the new lower fee and timeframe chemistry modules.

From 1 February 2023, applicants can now access an Item 24 application to utilise the new modules.

What is an Item 24?

An Item 24 is a modular application item made under section 10 or 27 of the Agvet Code and requires a technical assessment, other than those covered by Items 1 to 18. An Item 24 can be used for applications of active constituent approvals or variations to existing approvals. For existing approvals, it is also referred to as an Item 24V. While Item 24 is effectively a miscellaneous application item to cover situations not picked up by others, it can now be used more widely for active constituent approvals.

There are a number of scenarios where an Item 24 and 24V will be appropriate for an active constituent application. Some example scenarios are included in Table 2.

How do I submit an Item 24?

The decision tree and Online Services Portal have now been updated to include the ability to submit both Item 24 and Item 24V applications. You will see in the decision tree several new questions for active constituents under both the approval and variation pathway to give Item 24 a decision ID. These questions are labelled with Item 24 in addition to providing examples of what is submitted under Item 24 to make them easy to differentiate.

The same application form is used for both Item 24 and 24V applications and our administration staff will correctly assign them as Item 24 or 24V applications. If you are submitting a variation, please make sure to include the active number of the active constituent you wish to be varied as part of your submission.

If you have an unpaid draft application currently in progress in the Online Services Portal as an Item 17 or Item 18 application that meets the Item 24 criteria, please clearly state in the Executive Summary that you want your application to be an Item 24 application and list the modules required. If you have submitted an application and it has not passed preliminary assessment, please forward the request for consideration as an Item 24 or 24V to the APVMA Enquiries Team.

The APVMA has also recently updated our tailored guidance pathways with information about all options to approve or vary an active constituent. If you have further questions, please contact the APVMA Enquiries Team.

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Possible timeframe and fee savings for international/overseas assessments

The APVMA acknowledges the work of trusted overseas regulators and international scientific bodies. We recognise that by using assessments from these bodies, it eases the assessment workload for the APVMA, and in some situations, we are able to offer applicants timeframe and fee reductions whilst maintaining the quality and independence of the APVMA’s decisions.

Information about these potential fee and timeframe savings, including examples, is available on our website. More information relating to pre-application assistance (PAA) can also be found on our website.

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Tips and tricks for preparing information lists

The APVMA receives many applications with large data lists and a large amount of supporting data. In order to pass preliminary assessment, an Administration or Case Management Officer must match each file received against its corresponding data/information list entry to ensure all data items have been received. This can be quite time consuming, particularly if data item descriptions and file names do not match. Furthermore, data lists will not upload if entries are not provided for mandatory fields. This can often result in delays to the assessments for applications.

We’ve compiled the following tips and tricks to help applicants avoid issues with data lists and prevent delays:

• Use a unique reference code under 25 characters for each data item.
• If possible, incorporate the reference code into the file name. This allows us to easily match received data items with the data/information list. If you are asked for a ‘missing data item’ please ensure this reference code is incorporated for easy identification.
• Ensure the date in the data list is in the correct format – YYYY Month Date; Date Month YYYY; or DD/MM/YYYY. Variations, including abbreviating the month/year, or adding a ‘th’ (e.g. 12th) will prevent files from importing correctly to the APVMA system.
• Do not use diacritics (e.g. é, œ, ŭ) in any section of the data list as they are incompatible with our system and will prevent the data item being imported into our internal database.
• If data items are to be shared between modules, please consider providing a separate reference table titled ‘Instructions for data list’ with an outline of which data items are to be shared. Alternatively, for a small number of items, please add an explanation into the Executive Summary of the application. This will prevent duplicate files being imported as separate data items.

Further guidance on preparing information lists and using the information list editor is available on our website.

Please contact your Case Manager or our Data Team if you require assistance.

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Defect notices

Defect notices can now be issued at preliminary assessment.

In line with the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021, the APVMA has now introduced defect notices for registration and variation applications at preliminary assessment that do not appear to meet the application requirements in section 8A of the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). Previously, defect notices could only be issued during preliminary assessment of applications for minor use permits.

Defect notices, referred to as 11(3), 28(3) and 110A(3) ‘Notices of defects in application’ provide applicants with an opportunity to address errors or missing information in cases where the issue(s) can be reasonably rectified within the one-month preliminary assessment timeframe.

Further information about updating or clarifying application defect notices is available on our website.

I have received a defect notice, what does it mean for me?

The APVMA is committed to working with applicants to progress applications to register new products, approve active constituents, and approve variations to registered products. However, in some situations, applications can have errors that need to be fixed before the application can be assessed.

As part of standard processes, we conduct an initial check of incoming applications, which is called a preliminary assessment. This check is to confirm if, upon lodgement, your application meets the application requirements as outlined in Section 8A of the Agvet Code and, in particular, the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014. As part of this check, we will also confirm that other key legislative requirements are met from other parts of the Agvet legislation, for example, if it is the correct item number.

If you receive a defect notice, it will be because an error has been identified in your application, but we believe the error can be corrected within a reasonable period (one month).

What types of errors can be corrected?

We will email you to clarify small errors, such as spelling mistakes or errors in contact details. A defect notice will be issued for issues such as the following examples:

• The manufacturer details listed in Section 13 (Active Constituent Manufacturers) of the application form do not match an approved source of that active constituent – particularly for Item 7 applications that otherwise fail Schedule 6 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations).
• The data list does not contain a brief description of each piece of information provided for the assessment.
• The application has missing information that is required under the Application Requirements Instrument.

What types of applications cannot be corrected?

You will receive an email from the APVMA advising if your application does not pass preliminary assessment and must be refused, in situations including where:

• the application is an incorrect item number as defined under Schedule 6 of the Agvet Code Regulations
• a proposed variation does not involve a change of relevant particulars.

If I receive a notice, what happens next?

The defect notice allows you one month to provide the requested information to the APVMA. Once the information is provided, we will then reassess your application to see if it passes preliminary assessment.

If the information is not provided within the one month period, or the APVMA finds the response unsatisfactory, the application will be refused. There is no right of review for this refusal decision.

What should I do if I don’t understand the defect or what I need to do?

Please contact us and ask to speak to the officer named on your defect notice. It is important the defect is corrected as quickly as possible. Extensions to the one-month period are not permitted.

How do I provide the requested information?

Information less than 10 MB can be emailed to our Enquiries Team. If the size of the data exceeds 10 MB, you should contact us so we can arrange alternative data transfer methods.

Please note, you will not be able to upload or submit the information through your online user registration account or update your original submitted application.

Will this delay my application?

Not necessarily, but it will depend on the circumstances and when the defect(s) is rectified. The assessment period for the application only commences once the application has passed preliminary assessment and all fees are paid. The APVMA will invoice for outstanding fees once an application passes preliminary assessment.

Can I withdraw the application and receive a refund of fees paid?

You can withdraw your application at any time after the application is made and before it is determined, under section 8D of the Agricultural and Veterinary Chemicals Code Act 1994. Any withdrawal request should be submitted to the APVMA. Any request for a refund would be considered by an APVMA financial delegate on a case-by-case basis after withdrawal of the application.

Any additional questions can be referred to our Enquiries Team or your Case Manager.

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Tips to avoid disclosure of CCI in application summaries

Division 2.1 and Division 2.2 of the Agricultural and Veterinary Chemicals Code Regulations 1995 require the APVMA to publish certain information about an application. These application summaries are published on our website after an application has passed preliminary assessment into evaluation, and are removed 2 weeks after an application is finalised.

Please note, divisions 2.1 and 2.2 do not apply to applications for pre-application assistance and requests for technical advice (Item 25). Summaries are also not produced for Item 13A (Prescribed Variation) applications or for Notifiable Variations that do not undergo preliminary assessment.

‘Application purpose and description of use’

One of the fields in an application summary is the ‘application purpose and description of use’ field. The APVMA system extracts the contents of this field from the information entered by the applicant in the Executive Summary of the application form. An example image from the Online Service Portal is featured below with additional text in red showing what information is placed in the application summary, and what is not included.

Confidential Commercial Information (CCI) entered in the top field in the Executive Summary will automatically be published in the application summary on our website, should the application pass preliminary assessment.

APVMA staff will inform applicants if CCI is identified at preliminary assessment and can amend the application form if consent is provided. However, there is a risk APVMA Administration Officers may not identify the information as CCI. Examples of CCI that have been identified by APVMA staff include product formulation information, and the names and addresses of manufacturers.

The description should include all requested changes to be made in the application but should only include details that are known, or will become known, to the public. Sample text is provided on the application form for applicants to amend. Other examples of appropriate text are outlined below:

• Registration of a 100 g/L active for the control of broadleaf weeds.
• Variation to the relevant particulars of a registered chemical product and label approval to add additional uses.
• Application to approve a new source of the active constituent X.

Common questions and answers relating to application summaries can be found on our website.

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APVMA 2023 Stakeholder Survey

The APVMA conducts surveys of our stakeholders to determine your level of satisfaction with our performance and services. The results of the survey provide us with a benchmark to assist with measuring our performance and provide insights into what is working well and identify opportunities for improvement.

The APVMA’s 2023 Stakeholder Survey will be launched later this month. If you are subscribed to our mailing list, you will receive an invitation to participate in this anonymous survey. Alternatively, you will be able to access the survey when it becomes available.

If you have any questions relating to the survey, please contact our Enquiries Team.

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