The Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 (the bill) comprises two schedules, the first containing 20 parts and the second, one part (which primarily relates to the establishment of a governance board).
As noted in Chapter 1, the bill comprises measures which were previously included in two bills which lapsed in April 2019. The committee's February 2019 report provided a detailed overview of the key provisions of the Streamlining Regulation bill. Given that the measures contained in the bill do not substantially differ from those in the Streamlining Regulation bill, the following chapter will provide an overview of its key provisions. The newly introduced provisions – which propose the establishment of a Board for the APVMA – will be examined in more detail in Chapter 3.
Provisions of the bill
Schedule 1 – Main improvements
Part 1 – Information to be taken into account in determining applications
Part 1 of Schedule 1 proposes to amend the Agvet Code to provide the APVMA and industry with more flexibility to deal with "certain types of information given while the APVMA is determining an application". It is noted that specifics (regarding the kinds of information to be prescribed) are proposed to be included in regulations.
Currently, under section 8C of the Agvet Code, the APVMA is restricted from considering new information provided by, or on behalf of, the applicant during the assessment period for the application. It is noted that despite section 8C, the APVMA may, at its discretion, issue a notice to an applicant under Section 159 of the Agvet Code seeking additional clarifying information. The first such notice compulsorily triggers a one-off extension to the statutory time period in which the application must be assessed. This extension is typically equivalent to one third of the statutory assessment period for the original application (rounded up to the nearest whole month) plus an additional month.
While the fixed extension period is intended to provide certainty to the applicant about when the application will be determined, this period may be excessive for requests calling for simple clarifying information (related to information that has already been provided in the original submission). The only alternative for an applicant to provide such information is to do so in a variation application made after the active constituent or label has been approved or the product has been registered. It is argued that this can create inefficiencies for the APVMA and the applicant (adding costs, time and administrative burden). The amendment seeks to address these concerns.
Part 2 – Approval and registration for prescribed active constituents, chemical products or labels
Part 2 of Schedule 1 proposes amendments to the Agvet Code which would provide the APVMA with greater flexibility to manage applications and to align regulatory effort with risk. This is similar to the APVMA's existing streamlined options for prescribed variations to approvals or registrations. The amendments propose that this will be achieved by providing for both:
prescribed approvals of active constituents and labels; and
prescribed registrations of chemical products.
Division 2A (prescribed variations of relevant particulars) of Part 2 of the Agvet Code provides for streamlined variations to the relevant particulars of approvals and registrations. These processes provide for variations with reduced information requirements and lighter-touch 'assessments'. For example, where the risks associated with a variation warrant such an approach, there will be no requirement for a preliminary assessment. This amendment will reduce the time and effort for industry and the APVMA to deal with specific variations.
The Agvet Code provides for a person to apply for a new registration of a chemical product, or an approval of an active constituent or label for containers for a chemical product. Currently, however, there is no means to provide for approvals and registrations to be made by the APVMA (through a simplified model, similar to prescribed variations). The proposed amendments will allow both the Code Regulations and a disallowable legislative instrument made by the APVMA to specify the kinds of approvals and registrations that the APVMA can determine, as either prescribed approvals or prescribed registrations.
These proposed amendments will be similar to existing provisions for prescribed variations to approvals and registrations (including no requirement for a preliminary assessment). The amendment includes safeguards to ensure that only safe and effective products continue to be available.
Part 3 – Limits on use of information
Part 3 of Schedule 1 amends the Agvet Code to provide incentives for the chemicals industry to seek approval of certain kinds of active constituents with new, desirable features, or to register certain uses (priority uses) of chemical products. This amendment extends the period of time (up to a maximum of five additional years) during which the APVMA must not use an innovator's information to support the registration, variation or reconsideration of another chemical product or active constituent.
The Agvet Code currently provides for two kinds of data restriction:
'Protected information' refers to certain kinds of information (that relate to either an active constituent that has been approved or a chemical product that has been registered) provided in response to a request from the APVMA as part of a reconsideration (sometimes referred to as a chemical review).
'Limits on use of information' relates to information provided to the APVMA as part of an application made under Sections 10 or 27 of the Agvet Code or as relevant information under section 161 of the Agvet Code. If the information is relied on by the APVMA in making a decision, it receives a 'limitation period'.
The period during which any information (whether protected or with limits on use) cannot be used is frequently referred to as a 'data restriction period'. It has been suggested that the APVMA's existing 'data restriction period' is not sufficient; particularly in relation to those active constituents and uses (minor uses) that are not expected to produce sufficient economic return to offset the cost of approval or registration (including the costs associated with data generation).
The requirements for extending these periods include technical detail, so Part 2 of the bill provides (through amendments to the Agvet Code) that the regulations will specify most of the details of extending limitation and protection periods.
Part 4 – Annual returns and record keeping
Part 4 of Schedule 1 amends both the Levy Act and the Administration Act to simplify reporting requirements for annual returns. Mandatory reporting will be restricted to total chemical product quantities supplied for the previous financial year. It is argued that these amendments will reduce the regulatory burden on industry for reporting requirements. At the same time, they will ensure that appropriate data is provided to the Government to support functions such as policy development and to meet international reporting requirements.
Part 5 – Computerised decision-making
Currently, all decisions – including those of a largely administrative nature – require the direct involvement of an APVMA staff member. Part 5 of Schedule 1 amends the Agvet Code to provide that the APVMA may use computerised decision-making as part of its processes, thereby increasing efficiency. Computerised decision-making could, for example, be used for decisions involving an administrative check of an application.
This proposed amendment would align the Agvet Code with other Commonwealth legislation that also authorises computerised decision-making (for example, the therapeutic goods legislation).
Part 6 – Preliminary assessments
Currently, the APVMA is required to refuse an application if it contains minor errors (and it does not meet the application requirements). Applicants are then required to make a new application – a process which is administratively inefficient for industry and time consuming for the APVMA. Part 6 of Schedule 1 amends the Agvet Code to provide the APVMA with a greater level of flexibility, and allow it to manage application errors during the preliminary assessment of applications.
The proposed amendment will allow the APVMA to notify an applicant of minor errors in their application, and provide them with one opportunity to address the errors or submit missing information. It is noted that providing applicants with the opportunity to address errors (or provide missing information) can address situations where the applicant simply failed to attach information (or attached the wrong piece of information) to an application.
Part 7 – Variation of relevant particulars and conditions
Part 7 of Schedule 1 proposes amendments to the Agvet Code which would allow the APVMA to vary the relevant particulars or conditions of an approval of an active constituent, a registration of a chemical product, or an approval of a label for containers for a chemical product (in a way other than as set out in the original application for variation). This may also include granting part of a variation application.
The proposed amendments provide the APVMA with the flexibility to vary relevant particulars or conditions in a way other than as set out in the original application for variation (including providing an applicant with the opportunity to provide written submissions on such a variation).
Part 8 – Variation of approval or registration during suspension
Under the Agvet Code, the APVMA can suspend an approval (including an approval for a label for containers for a chemical product) or registration. It also provides that an approval or registration is taken, for the purposes of the Agvet Code (other than Sections 74 and 75) not to be in force during any period in which it is suspended. Division 3 of Part 2 of the Agvet Code currently sets out matters in relation to varying relevant particulars and conditions of approvals and registrations. Under the current arrangements, the APVMA cannot, however, amend a label approval or product registration to address a problem that leads to the requirement to suspend the label approval (or product registration) without first revoking the suspension.
Part 8 of Schedule 1 amends the Agvet Code to enable the APVMA to introduce practical measures to deal with suspended label approvals or registrations and to address the reason for suspension.
These amendments are proposed to remedy what is described as an 'unintended administrative barrier'. They underpin the appropriate rectification of issues in relation to suspended label approvals (or product registrations) which frequently prevent the holder of a label approval (or product registration) from dealing with the suspension problem.
Part 9 – False and misleading information
Currently, under Section 69ER of the Administration Act and Section 146 of the Agvet Code, a person commits an offence if they give false or misleading information or produce false or misleading documents. Unlike other provisions contained in the Administration Act and the Agvet Code, section 69ER of the Administration Act and Section 146 of the Agvet Code do not subject that conduct to civil pecuniary penalties.
Part 9 of Schedule 1 amends the Administration Act and the Agvet Code to establish civil pecuniary penalties for contraventions of provisions relating to false or misleading information. It is submitted that the creation of civil pecuniary penalties will encourage compliance with both the Administration Act and the Agvet Code and provide the APVMA with more flexibility when responding to circumstances of non-compliance.
Part 10 – Suspension or cancellation of approval or registration for provision of false or misleading information
Part 10 of Schedule 1 proposes the introduction of more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading in a material particular.
The new Section 38A of the Agvet Code addresses deficiencies in the current Agvet Code and improves the APVMA's ability to respond to false or misleading information (after a product has been registered or a label or active constituent has been approved).
Part 11 – Voluntary recalls
The APVMA receives some notifications from industry regarding voluntary recalls. The APVMA may, at its discretion, publish this information on its website. The Agvet Code does not, however, currently specify notification and publication requirements (if an agvet chemical product is being voluntarily recalled). It is therefore left to the person recalling the product to determine how stakeholders are notified and how the recall is conducted.
Part 11 of Schedule 1 amends the Agvet Code to require persons to inform the APVMA when they are undertaking certain voluntary recalls and requires the APVMA to publish such recalls. There are various different points in the supply chain (of a chemical product) where a voluntary recall may occur, and the person need not be the holder of an approval or registration.
The measures in the bill will ensure that the APVMA must be informed if certain voluntary recalls are being conducted, where these relate to matters set out in the Agvet Code – that is, the safety, efficacy, trade and labelling criteria. The APVMA will be required to publish such recalls, which will improve transparency and ensure a baseline of information is available to stakeholders.
Part 12 – Notification of new information
Part 12 of Schedule 1 amends the Agvet Code to ensure that obligations to provide relevant information to the APVMA apply to holders of label approvals and applicants for both label approvals and variations to approvals or registrations (as they do in relation to holders of active constituent approvals and product registrations).
Under the current legislation, information is 'relevant information' if it shows the active constituent or chemical product may not meet the statutory criteria, or if it contradicts information in the application or information the APVMA has recorded in the record or the register.
These provisions are intended to ensure the regulator is aware of the latest information that is available. This provides safeguards to protect public, animal and plant health and the environment from potential damage where new information about an agvet chemical comes to light.
Part 13 – Annual operational plans
Part 13 of Schedule 1 simplifies the APVMA's corporate reporting requirements by removing the need for the APVMA to develop and seek approvals of an operational plan in addition to a corporate plan.
It is proposed that removing the requirement for the APVMA to prepare an annual operating plan would remove duplicative reporting that is required under the PGPA Act.
Part 14 – Definition of registered chemical product
Part 14 of Schedule 1 amends the Agvet Code definition of a registered chemical product so it is consistent with variations authorised under Section 83 of the Agvet Code.
These provisions propose to amend an anomaly in the Agvet Code. Currently, for the offences and civil penalty provisions (in Part 4), the chemical product formulation must align exactly with the concentrations of constituents in the register, irrespective of any variation in constituent concentration that is provided by the regulations made for Section 83.
The amendments in the bill address these inconsistencies by providing, through the definition of registered chemical product, prescribed standards for the concentration range of constituents, the kinds of constituents, and the composition and purity of constituents in chemical products to apply for all offences and civil penalty provisions in the Agvet Code.
Part 16 – Safety, efficacy, trade and labelling criteria
Part 16 of Schedule 1 amends the Agvet Code to address anomalies in relation to prescribing matters for the labelling criteria and for overseas trials and experiments (including international assessments and data) in relation to the safety, efficacy, trade and labelling criteria.
Part 17 – Maximum Residue Limits Standard
Part 17 of Schedule 1 amends:
the Agvet Code to simplify, and provide flexibility on the timing of, the notification that must be provided to FSANZ by the APVMA in relation to an approval, registration, variation or permit under the Agvet Code which would, if given, made or issued be likely to require a corresponding variation to the Maximum Residue Limits Standard; and
the 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.
Part 18 – Expiry date
Part 18 of Schedule 1 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. The proposed amendment ensures that the expiry date reflects the timeframe in which the use of a chemical product is safe, effective and does not cause unmanageable risk.
Part 18 of Schedule 1 will commence on the day after the bill receives Royal Assent.
Part 19 – Other amendments
Part 19 of Schedule 1 proposes to 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; and
making 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.
Part 20 – Repeals
Part 20 of Schedule 1 repeals the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014, because all the transitional provisions for this Act are no longer required.
Schedule 2 – Australian Pesticides and Veterinary Medicines Authority Board
The provisions contained in Schedule 2, as explained in the Explanatory Memorandum (EM) relate specifically to the establishment of a governance board for the APVMA. The main provisions are summarised below.
Items 1–10 include minor amendments to the Administration Act. These provisions repeal various definitions, such as appointed Board member and Board and insert new definitions such as paid work. The provisions also repeal various sections and subsections of the Administration Act which are obsolete, or captured under a new subsection.
Item 11 repeals Divisions 2, 3 and 4 of Part 3 to the Administration Act, which contain provisions relating to the APVMA Advisory Board. Repealing these provisions ceases the Advisory Board.
This Item also inserts – into Part 3 to the Administration Act – a new Division 2, which sets out the provisions of the Board. These provisions are grouped into subdivisions A to K, detailed below.
Subdivision A – sets out the creation (and functions) of the Board, and includes the following sections:
Section 14 – establishes the Board of the APVMA.
Section 15 – sets out the functions and powers of the Board, which include:
ensuring the proper, efficient and effective performance of the APVMA's functions;
determining the objectives, strategies and policies to be followed by the APVMA; and
doing anything incidental to, or conducive to, the performance of these functions.
Section 16 – makes clear that the Board is a separate entity from the legal body corporate that is the APVMA, and specifies that the functions and powers of the Board do not include making decisions under agvet chemical legislation (other than under certain parts of the Administration Act).
Subdivision B – sets out the Board membership requirements as follows:
Section 17 – notes that the Board will consist of a Chair, the APVMA CEO and three other members. The CEO is included as an ex officio Board member to support informed and collective decision making and ensure the Board's policies are effectively integrated into day-to-day operations.
Section 18 – allows for the Minister to appoint Board members by written instrument, noting that they will be appointed on a part-time basis. Under this provision, the Minister will also appoint one of the appointed members as Chair.
Section 18 provides that the Minister ensure (to the extent practicable) that there is sufficient diversity in the skills, qualifications and experience on the Board. Further, it also provides that a person cannot be appointed as a Board member unless the Minister is satisfied they have appropriate qualifications, skills or experience in one or more of the following:
public sector governance;
science (including agricultural science and veterinary science); and
public health or occupational health and safety.
Subdivision B – goes on to provide the following in relation to the Board:
Section 19 – specifies that an appointed Board member holds office for the period specified in their instrument of appointment – a period which cannot exceed four years. While Board members may be eligible for reappointment for a second term, they cannot be appointed for longer than eight consecutive years.
Section 20 – empowers the Minister to appoint, by written instrument, a Board member to act as the Chair, or a person to act as a member of the Board:
during a vacancy in the office of Chair or appointed Board member;
during a period when the Chair or appointed Board member is absent from duty or from Australia; or
during a period where the Chair or the appointed Board member is, for any reason unable to perform the duties of office.
Section 21 – requires appointed Board members to be paid the remuneration that is determined by the Remuneration Tribunal or, if no determination is in operation, the member is to be paid the remuneration that is prescribed by the regulations.
Section 22 – restricts Board members from engaging in any paid work that, in the opinion of the Minister, conflicts or could conflict with the proper performance of their duties.
Section 23 – provides that the Minister may grant the Chair a leave of absence, subject to terms and conditions determined by the Minister. It also provides that the Chair may grant a leave of absence to an appointed Board member, subject to terms and conditions determined by the Chair.
Section 24 – allows for an appointed Board member to resign by giving the Minister a written resignation.
Section 25 – sets out the grounds upon which the Minister may terminate the appointment of an appointed Board member.
Section 26 – allows for the Minister to determine the terms and conditions on which an appointed Board member holds office for matters not provided for in this bill.
Subdivision C – includes Sections 27, 27A, 27B, 27C, 27D, 27E and 27F, and sets out requirements for Board meetings, including convening meetings, presiding at meetings, quorum, voting at meetings, conduct of meetings, minutes and decisions without meetings.
Subdivision D – includes Section 27G, and allows for the Minister to give a direction, in writing, to the Board about the performance of its functions or the exercise of its powers. The Board must comply with a direction made by the Minister, unless the direction relates to its obligations as the accountable authority under the PGPA Act.
Subdivision E – includes Section 27H, which sets out requirements for the Board to provide certain documents to the Secretary of the Department.
Subdivision F – includes Section 27J, which provides an express power for the Board to establish committees.
Subdivision G – includes Section 27K, and sets out the requirement that the Minister undertake a review of the functions and operations of the Board. The review is to be finalised within four years of the commencement of this section.
It is noted that this is not a standard provision (and it is not included in the enabling legislation for other Australian Government bodies). Further, the EM notes that it is considered necessary to ensure an independent mechanism to review the APVMA's governance arrangements.
Items 12-43 – include a range of minor amendments which repeal or amend a number of sections and subsections of the Administration Act. Some of these provisions have been included to provide clarity and consistency, some are transitional provisions, and several represent minor technical amendments and updates to the Administration Act.