Proposed extensions to the Application Requirements Instrument

This consultation closed on 15 May 2022

Consultation period

29 March 2022 to 15 May 2022
The APVMA has considered all submissions received as part of this consultation and decided not to make any changes to the Application Requirements Instrument. More information about this decision is available in the submissions received and outcome of public consultation sections below.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is seeking feedback on proposed extensions to the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (the Application Requirements Instrument) to support implementation of the Agricultural and Veterinary Chemicals Code (Conditions of Approval or Registration) Order 2021 (the Order).

The Order, which commenced on 29 October 2021, requires (as a condition of approval or registration) that active constituents for use in agricultural chemical products and agricultural chemical products must not be supplied if the manufacture of the active constituent or chemical product contravenes, or fails to comply with, any manufacturing law of the country, or part of the country, in which it is manufactured. The Order does not apply to veterinary active constituents or veterinary products because the existing ‘Good Manufacturing Practice (GMP)’ system requires overseas veterinary product manufacturers to comply with at least equivalent standards to the Australian GMP system.

To support the Order, which imposes a post-market condition on the supply of active constituents for use in agricultural chemical products and agricultural chemical products, the APVMA plans to require applications for agricultural active constituent approval and agricultural chemical product registration to include a declaration from the applicant that the active constituent or agricultural chemical product will meet this condition. We propose to do this by amending the Application Requirements Instrument. This was anticipated in the Explanatory Statement to the Order.

The APVMA considers that requiring a declaration upon application will place minimal additional administrative burden on applicants and holders because the applicant should already have this information or it is readily available from the manufacturer. Requiring this information on application will support the condition of approval or registration applied by the Order.

As an example, a declaration could be as simple as using the words from the Application Requirements Instrument:  

‘I declare on behalf of Chemical Co Pty Ltd that the active constituent X manufactured by Pesticides Manufacturer India does not contravene, or fail to comply with, any manufacturing law of the country, or part of the country, in which it is manufactured.’

The APVMA will provide a template for this declaration to be made.

Submissions are sought from interested parties on the proposed amendments to the Application Requirements Instrument, including if the proposed wording is clear. An exposure draft of the amending instrument is available on our website.

The APVMA is not seeking views on the Order as this has already been made.

The APVMA has taken the opportunity to update references to the Quarantine Act 1908 with the Biosecurity Act 2015.

Please note: submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential, or if the APVMA chooses at its discretion not to publish any submissions received (refer to the public consultation coversheet).

How to make a submission

Please lodge your submission using the public consultation coversheet, which provides options for how your submission will be published.

Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.

Please send your written submission and coversheet by email or post to:

Email: enquiries@apvma.gov.au

Post:

Reform and Engagement
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001

Submissions received

The APVMA sought feedback on proposed amendments to the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (the Application Requirements Instrument) to support implementation of the Agricultural and Veterinary Chemicals Code (Conditions of Approval or Registration) Order 2021 (the Order). The APVMA planned to require applications for agricultural active constituent approval and agricultural chemical product registration to include a declaration from the applicant that the active constituent or agricultural chemical product will meet this condition. We proposed to do this by amending the Application Requirements Instrument.

A total of 3 submissions were received from industry groups. A copy of the published submissions (where consent to publish was provided) is available on our website.

Summary of submissions

The 4 main themes of the submissions received were:

  • It is unnecessary to amend the Application Requirements Instrument.
  • A need for clarification around the wording, specifically
    • present or future tense for the declaration
    • ANY or A law
    • who should be responsible for the declaration (applicant or manufacturer)
    • would it apply to just new registration/approval applications or also variations.
  • This requirement would represent increased administrative burden.
  • How are applicants expected to substantiate the declaration.

The submissions are summarised in Table 1.

Table 1: Summary of submissions received

Submitter

Issue

Response

Accord

 

The Order has been misguided and is impractical in its current form.

The APVMA’s public consultation was not about the Order

The Order is not clear about the nature of the manufacturing laws that are covered.

The APVMA’s public consultation was not about the Order

Further guidance is sought on how applicants and holders will substantiate this declaration – the APVMA should supply a list of acceptable documentation.

The APVMA has an expectation that registrants have appropriate systems and processes in place to ensure they meet their legal requirements. The nature of the evidence held will depend on the circumstances and registrants will have to satisfy themselves in this regard.

 

The APVMA has decided to not proceed with changes to the Application Requirements Instrument, so there will be no declaration as part of applications.

CropLife

 

Question if the declaration wording should be present tense (product does comply) compared to future tense (product will comply) as in some cases registration is required before a manufacturing licence is granted.

The APVMA has decided to not proceed with changes to the Application Requirements Instrument, so there will be no declaration as part of applications.

 

The APVMA notes this will not prevent registrations or approvals where a registrant does not intend to supply the product or active constituent.

Suggest that instead of a declaration, there could be a check box in the application form for applicants to acknowledge the Order will apply if their product or active constituent is registered/approved.

The APVMA has considered this suggestion, and based on stakeholder feedback has determined it is the preferred option.

 

The APVMA has decided to not proceed with changes to the Application Requirements Instrument, so there will be no declaration as part of applications.

Name withheld

Suggest that the proposed amendment is not necessary due to the current ability of the APVMA to request written evidence of the conditions of the order.

The APVMA has decided to not proceed with changes to the Application Requirements Instrument, so there will be no declaration as part of applications.

 

The APVMA retains the ability to request evidence if it considers it necessary.

This requirement will increase administrative, legal, regulatory and quality assurance burden.

The APVMA has decided to not proceed with changes to the Application Requirements Instrument, so there will be no declaration as part of applications.

Clarity is sought on if this requirement will apply to new registrations and approvals only or also to variation applications.

The condition in the Order applies to all agricultural chemical products and active constituents.

 

APVMA has decided not to proceed with the changes to the Application Requirements Instrument, so this issue is no longer relevant.

Clarity is sought on person or entity to provide the declaration. Suggest manufacturers make the declaration, or allow for either the applicant or the manufacturers to make the declaration

APVMA has decided not to proceed with the changes to the Application Requirements Instrument, so this issue is no longer relevant.

Outcome of public consultation

The APVMA has considered the issues raised in public consultation. Based on stakeholder feedback, the APVMA considers that amending the Application Requirements Instrument as proposed would result in additional regulatory burden and would not improve compliance with the Order.

Instead, the APVMA has decided to amend the application form to require applicants to acknowledge that the manufacturing conditions will apply if their product is registered or active constituent approved. No change to the Application Requirements Instrument is required for this to occur. This will not change the way that compliance with the conditions is monitored and enforced.

The APVMA intends to add the following acknowledgment to the application form as part of the myAPVMA project. Until myAPVMA is launched, applicants will continue to be advised of the manufacturing condition in the Order as part of the APVMA’s notice of approval or registration.

Acknowledgement:

I acknowledge at the time this active constituent is supplied it must comply with the conditions of the Agricultural and Veterinary Chemicals Code (Conditions of Approval of Registration) Order 2021.

OR

I acknowledge at the time this product is supplied it must comply with the conditions of the Agricultural and Veterinary Chemicals Code (Conditions of Approval of Registration) Order 2021

Any questions should be directed to enquiries@apvma.gov.au.

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