APVMA Board and Improvements Act

4

Annual returns and record-keeping: Amends the Levy Act and the Administration Act to simplify reporting requirements for annual returns, by restricting mandatory reporting to total chemical product quantities supplied for the previous financial year.

Commenced 7 December 2021.

Persons who are liable to pay a levy will be required to report leviable disposals of chemical products, rather than active constituents as was previously the case, by 30 November in the next financial year.

This will apply for annual returns in November 2022 and instructions will be provided to relevant persons before this time.  

13

Annual operational plans: This amendment simplifies the APVMA’s corporate reporting requirements by removing the need for the APVMA to prepare an annual Operational Plan.

Commenced 1 January 2022.

N/A

14

This amendment addresses an inconsistency in the Agvet Code definition of a registered chemical product for the purposes of what constituents a reasonable variation in a product’s composition.

Previously, the offences and civil penalties in ss 75 and 78 did not allow for any variation in composition, while s 83 allowed for the APVMA to prescribe the limits within which a product could vary and remain a registered chemical product.

Commenced 8 December 2021.

Removes uncertainty where a reasonable variation in composition might be acceptable for the purposes of s 83 but not for ss 75 or 78.  

15

This amendment replaces the requirement for labels to include all ‘relevant particulars’ with a requirement to include ‘minimum information’. This is to recognise that not all relevant particulars are required on a label (e.g. a holder or nominated agent). It also includes provisions for APVMA to deal with earlier labels that contain information that is no longer required.

Commenced 8 December 2021.

No significant impact. The APVMA still approves product labels.

16

This covers 2 amendments to the Agvet Code. Both are intended to address minor inconsistencies in wording between the Agvet Code and the Regulations.

Labelling Criteria: Clauses 5A, 5B, and 5C of the Agvet Code all compel the APVMA to have regard to matters prescribed in the Regulations when determining that a product meets the safety, efficacy, and trade criteria. Clause 5D does not include a similar provision and, as a result, there is no overt requirement for the APVMA to have regard to matters prescribed in the Regulations when determining if a label meets the labelling criteria. This amendment to the Agvet Code will address this omission.

Overseas data: Section 160 of the Agvet Code was amended in 2014 to state that the APVMA may consider the results of overseas trials and/or international regulators; however, s 5A-C (and now s 5D) allow the Regulations to prescribe matters that the APVMA must have regard to. This amendment addresses the anomaly whereby the use of “may” in s 160 could potentially be in conflict with the use of “must” in s 5A, s 5B, s 5C, and (now) s 5D.

Commenced 8 December 2021.

N/A

17

Maximum Residue Limits Standard: This amends the:

• Agvet Code, to simplify and provide flexibility on the timing of the notification provided to Food Standards Australia New Zealand by the APVMA in relation to an approval, registration, variation or permit under the Agvet Code which would be likely to require a corresponding variation to the Maximum Residue Limits Standard
• Administration Act, to clarify that the requirement to publish an APVMA legislative instrument for residues of chemical products in protected commodities under section 7A of the Administration Act also provides the authority for this legislative instrument to be made and amended as required. 

Commenced 8 December 2021.

N/A

18

This measure amends the definition of expiry date in section 3 of the Agvet Code to clarify that the expiry date is the date after which a chemical product must not be used.

Commenced 8 December 2021.

The definition of expiry date, as it applies to agvet chemicals, has been strengthened to prohibit the use of agvet chemicals beyond the expiry date listed on the container.

19

Other amendments: This measure will improve the operation of the Administration Act and the Agvet Code by:

• removing redundant and unnecessary provisions (including unnecessary transitional provisions)
• clarifying how ‘classes’ of matter are dealt with to ensure consistency with both subsection 33(3A) of the Acts Interpretation Act 1901 and subsection 13(3) of the Legislation Act 2003
• authorising the APVMA to reconsider (internally review) decisions on its own initiative to improve the ability of the APVMA to respond where errors are made and reduce the onus on other persons to request the APVMA to internally review a decision
• make a number of minor amendments to the Administration Act and the Agvet Code to improve the operation of these laws and remove redundant and unnecessary provisions.

Commenced 8 December 2021.

These amendments have limited impact on stakeholders.

Items 118 and 119 amend section 69D of the Administration Act, which deals with export certificates. The amendment clarifies that the fee for Certificates of Export is to be paid to the Commonwealth, like all other fees.

The APVMA can reconsider a decision of the APVMA to refuse to give a certificate under subsection (1).

The measures related to Items 129 to 152 and 156 remove unnecessary provisions for exceptions and determinations that the APVMA could make about approvals and registrations that had ceased under sections 74, 75, 76 and 78.

3

This amendment extends the period of time (up to a maximum of 5 additional years) during which the APVMA must not use information subject to data restrictions (protected information and information with limits on use) to support the registration, variation or reconsideration of another chemical product or active constituent without the owner of the information providing consent.

This provides an incentive for the holders to register certain uses (priority uses) of chemical products.

The priority uses have been identified by growers and other stakeholders.

A legislative instrument has been developed by the Department of Agriculture, Fisheries and Forestry that details these priority use patterns.

7

Applications for variation of an active constituent or chemical product: This amendment enables the APVMA to vary, as part of a variation application, the relevant particulars or conditions of an active constituent, a chemical product, or a label for containers for a chemical product, in a way other than as set out in the original application for variation.

This may include granting part of a variation application.

In practice, the APVMA works with applicants to vary their applications where an application might otherwise be refused.

If the APVMA proposes to vary an active constituent, product or label in a way other than what was set out in a variation application, an applicant would have the opportunity to provide a written submission.

This situation already applies for registration applications and is very rarely used.

8

This amendment enables the APVMA to deal with suspended label approvals or registrations and to address the reason for a suspension.

It will also allow holders to request a suspension of an approval or registration.

A holder can apply to vary the relevant particulars and conditions for a label approval or product registration that is suspended, provided the application relates to the reasons for the suspension.

This means that the issues with a label or product that led to its suspension can be rectified prior to a suspension being lifted.

Previously, holders could only request cancellation of their approval or registration. This amendment allows them to request a suspension if this is needed.

9

This clarifies the offence of providing false or misleading information or documents to the APVMA, orally or in writing, and allows the APVMA to seek civil penalties.

Clarification of the law and the prospect of civil penalties for relevant contraventions. This is expected to encourage compliance with the Administration Act and Agvet Code and provides the APVMA greater flexibility to respond to circumstances of non-compliance.

10

This amendment provides the APVMA with more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading. This includes information provided in certain applications that were not previously covered and by persons other than the holder.

The provision of false or misleading information may lead to suspension or cancellation of active constituent approvals and product registrations in more circumstances.

The APVMA will still provide the holder with a notice of reasons for a proposed decision and review processes continue to apply.

11

This amendment to the Agvet Code requires persons to inform the APVMA when they are undertaking certain voluntary recalls and requires the APVMA to publish such recalls.

This person need not be the holder of an approval or registration, as there are a number of different points in the supply chain of a chemical product where a voluntary recall may occur.

Persons undertaking certain voluntary recalls will be required to inform the APVMA.

12

This amendment requires holders of label approvals, and applicants for label approvals and variations to provide relevant information to the APVMA.

Relevant information is information that shows an active constituent, chemical product or label may not meet the statutory criteria or contradicts information already provided or held by the APVMA.

This will ensure the APVMA has access to the latest information related to an active constituent, chemical product or product label to ensure it continues to meet safety, efficacy and trade criteria.

This provision extends requirements that already apply to applicants and holders of product registrations and active constituent approvals. Holders of approval of a label for containers now have the same obligations to provide relevant information as other holders.

1

The APVMA can request certain information from an applicant while it is determining an application, without making a request under s 159 of the Agvet Code.

The Regulations prescribe this information as information that clarifies or updates information given in relation to the application (e.g. provided in the application or under s 159).

The information must be provided within 14 days of the request being made, and will not result in an extension to the application timeframe.

This provides applicants with the ability to provide clarifying or updating information during an application, at APVMA’s request, without triggering a timeframe extension under s 159.

2

This amends the Agvet Code to provide the APVMA with the ability to make a legislative instrument prescribing certain types of low-risk applications for approval of active constituents and labels, and registration of chemical products.

This is similar in intent to the existing Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 which allows for simple, low-risk variation applications.

No immediate impact.

The APVMA may make a legislative instrument setting out the types of prescribed approvals and registrations.

The APVMA is developing a framework for how low regulatory concern products and active constituents might be identified to be registered/approved in this way. Industry stakeholders will be consulted on this framework and on the instrument when it is developed.

5

This amends the Agvet Code to provide that the APVMA may choose to use computerised decision-making as part of its processes. For example, computerised decision-making might be used for decisions involving an administrative check of an application.

N/A

6

This amends the Agvet Code to provide the APVMA with the ability to manage minor application errors during preliminary assessment.

Previously, if an application did not meet the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 it would have had to have been refused at preliminary assessment. This amendment allows the APVMA and the applicant to rectify minor defects in an application for registration or approval of an active constituent.

This process already existed for permit applications.

Applicants can now rectify minor defects in their application, at the preliminary assessment stage, rather than having an application refused.