BILLS DIGEST NO. 53, 2018–19              11 February 2019

Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018

Paula Pyburne
Law and Bills Digest Section

Date introduced: 18 October 2018

House:  House of Representatives

Portfolio: Agriculture and Water Resources

Commencement: various dates as set out in the body of this Bills Digest

Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill’s home page, or through the Australian Parliament website.

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the Federal Register of Legislation website.

All hyperlinks in this Bills Digest are correct as at February 2019.

The Bills Digest at a glance

The Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018 amends various statutes which regulate agricultural and veterinary chemical products (known as agvet chemical products) in order to make changes to the regulatory process.

Changes to the way the APVMA works

This Bill contains some amendments which will have far reaching impacts on the way that the Australian Pesticides and Veterinary Medicines Authority (APVMA) works, such as:

•       creating a streamlined process for approvals and registrations where minimal or no assessment of technical information occurs. Those new processes will be set out in Regulations which have not yet been published. The streamlined approval process will be in addition to the existing, more exacting process which will only apply to certain applications

•       placing limits on the use of information for particular applications (of a kind prescribed in Regulations) where those applications also satisfy any requirements that may be prescribed by the Regulations. It is anticipated that these applications would relate to products with new, desirable features. For example, products with minor or priority uses, where the costs of registering these uses are not otherwise justified by the additional commercial returns to chemical manufacturers

•       permitting the APVMA to use computer programs to make decisions and

•       allowing the APVMA to make a legislative instrument which will prescribe a scheme to allow applicants and/or the APVMA to use accredited third party providers to undertake assessment services.

Minor amendments

The remaining amendments in the Bill address existing anomalies, create efficiencies or provide clarity.

Stakeholder comments

Many stakeholders have been supportive of the amendments in the Bill, particularly, the introduction of a streamlined process for approvals and registrations and permitting the APVMA to use computer programs to make decisions.

However, others express concern at the slow pace of change, especially in the light of amendments which were enacted in 2013 and which failed to produce promised efficiencies. For example, CropLife stated that the Bill fails to ‘deliver reform that will deliver genuine regulatory efficiency’. Nevertheless, it concedes that the Bill contains ‘necessary technical corrections and minor adjustments to the legislation’.

Above all stakeholders stressed the need for the Government to introduce sufficient incentives to bring newer and safer chemicals to market, particularly in cases where there may not be a commercial incentive for manufacturers due to the small Australian market.

Purpose of the Bill

The purpose of the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018 (the Bill) is to amend various statutes which regulate agricultural and veterinary chemical products (known as agvet chemical products) in order to make changes to the regulatory process.

Structure of the Bill

The Bill comprises two Schedules.

Schedule 1 to the Bill has 14 Parts each of which (with the exception of Part 13) amend the Agricultural and Veterinary Chemicals Code Act 1994 (the Code Act) as well as other statutes as set out below:

•       Part 1 relates to the approval and registration for prescribed active constituents, chemical products or labels

•       Part 2 is about the information to be taken into account in determining applications             

•       Part 3 details the lmits on use of information

•       Part 4 relates to computerised decision-making

•       Part 5 introduces the rules for the accreditation of third party assessors into the Code Act and Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act)

•       Part 6 is about voluntary recalls of chemical products

•       Part 7 relates to the notification of new information

•       Part 8 inserts a new definition of registered chemical product             

•       Part 9 provides for the suspension or cancellation of approval or registration for provision of false or misleading information

•       Part 10 relates to the supply of registered chemical products with unapproved label

•       Part 11 provides for the variation of approval or registration during suspension

•       Part 12 relates to the safety, efficacy, trade and labelling criteria

•       Part 13 amends the Administration Act to amend requirements about the Corporate plan

•       Part 14 sets out other amendments to the Administration Act, the Code Act and the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 (2013 Amending Act).

Schedule 2 to the Bill has two Parts—Part 1 contains minor amendments to the Code Act; whilst Part 2 repeals the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014 (2014 Amending Act) in its entirety.

Schedule 1 of the Code Act contains the Agricultural and Veterinary Chemicals Code (Agvet Code). For the purposes of this Bills Digest, amendments to Acts will be identified by way of section numbers. Amendments to the Agvet Code will be identified by way of clause numbers.

Background

Regulation of chemical products

The regulatory framework for managing pesticides and veterinary medicines in Australia is collectively referred to as the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). The NRS is a partnership between the Commonwealth and the states and territories.[1] Assessment and registration of agricultural and veterinary (agvet) chemicals, as well as control of supply activities up to the point of retail sale, is undertaken by the Australian Pesticides and Veterinary Medicines Authority (APVMA).[2] Control of the use of agvet chemicals after sale is the responsibility of individual states and territories.[3]

The Agvet Code is contained in a Schedule to the Code Act. Under the NRS, the Code operates, together with the Code of each participating jurisdiction (that is, each of the state and territories) to constitute a single national Code applying throughout Australia.[4]

Functions of the APVMA

·    assess the suitability for sale in Australia of active constituents for proposed or existing chemical products, registered chemical products, and labels for containers for chemical products

·    ensure that approvals and registrations for active constituents for chemical products and labels for containers for chemical products comply with the Agvet Code and the Agvet Code Regulations

·    provide information to the Australian Government and its agencies, and the states and territories, about approved active constituents for proposed or existing chemical products, registered chemical products and approved labels for such products, and cooperate with federal, state and territory governments on matters relating to the management and control of chemical products

·    collect and publish relevant information and statistics on approvals and registrations granted, and permits and licences issued under the Agvet Code

·    with the Australian Government and its agencies, and the states and participating territories, facilitate a consistent approach to the assessment and control of agvet chemicals

·    exchange information relating to chemical products and their use with overseas and international bodies that have similar functions to those of the APVMA and

·    report to or advise the Minister on matters relating to the performance of the APVMA’s functions.[5]

Some of the agvet chemicals approved and registered by the APVMA are crop protection products (CPP). These include herbicides,[6] insecticides,[7] fungicides[8] and other pesticides and chemical agents.[9] The key reasons for use of CPP include:

•       to decrease and control pests and diseases

•       to reduce the need for crops and plants to compete with weeds and other invasive plants

•       to increase the yield of crops or protect biodiversity and

•       to protect and maintain infrastructure such as buildings and roads through pest or weed control.

Deloitte Access Economics has estimated the contribution of CPP to the Australian economy as:

•       the economic contribution was $2.3 billion, which is associated with 9,225 full-time equivalent jobs[10] and

•       $20.6 billion of Australian agricultural output in 2015–16.[11]

History of legislative amendments

The regulation of chemical products has been the subject of considerable amendment during the course of the last five years.

2013 Amending Act

The 2013 Amending Act was a response to the Labor Government’s 2010 election promise to improve the regulation of agricultural and veterinary chemicals in Australia—based on recommendations of the Australian National Audit Office and the Productivity Commission.[12]

Primarily, it amended the Agvet Code:

•       using a risk-based approach, to improve the consistency and transparency of the process for making, and assessing, applications for:

–      approval of an active constituent for a chemical product

–      the registration of a chemical product and

–      the approval of a label for the containers of a chemical product

•       to insert a new requirement that existing approvals and registrations operate for a finite period and, when that period has elapsed, a new application must be lodged for re-approval or re-registration and

•       to update existing offences, create new offences and insert civil penalty provisions.

In addition, amendments were made to the Administration Act to insert extensive monitoring and investigation powers, and include updates to entry, search and seizure provisions to bring them into line with contemporary standards.[13] The purpose of these particular amendments was to create a graduated range of compliance and enforcement powers, such as infringement notices and enforceable undertakings, so that regulatory sanctions could be tailored to the seriousness of any non-compliance.[14]

Despite the lengthy consultation which led to the 2013 Amending Act, it was not without its critics and it was unclear whether the relevant amendments would lead to the greater efficiencies which they were intended to create. Of greatest concern were the following:

•       the potential for increased costs for registrants and applicants

•       an increased complexity in the regulatory system which might result in the loss of existing agricultural chemical products and discourage the introduction of newer, modern chemistry and biological products and

•       the potential loss from the Australian market of useful products that were safe and effective to use due to the need to obtain re-approval or re-registration of those products.[15]

2014 Amending Act

The 2013 Amendment Act received Royal Assent on 29 June 2013.[16] One of the purposes of that Act was to insert into the Code Act a requirement that, first, existing approvals and registrations of active constituents and chemical products operate for a finite period and, second, when that period elapsed, a new application was to be lodged for re-approval or re-registration.[17] The primary purpose of the 2014 Amending Act was to remove the requirement for re-approval or
re-registration of active constituents and chemical products.

Rationale for the 2014 Amending Act

The originating Bill for the 2013 Amendment Act was referred to the House of Representatives Standing Committee for Agriculture, Resources, Fisheries and Forestry (the House of Representatives Committee) for inquiry and report.[18] Whilst the majority report of that Committee recommended that the Bill be passed,[19] the Coalition Members provided a dissenting report which stated:

… this Bill as is drafted provides a substantial increase in regulatory burden and costs that will have a negative impact on industry without significantly improving the efficiency of regulation and the re-registration process will slow down rather than increase the review of suspect chemistries. To achieve genuine efficiencies within the system that allow for a more timely review of suspect chemistries it is vital that the proposed re-registration process be removed from the Bill.[20]

The provisions of the originating Bill for the 2013 Amendment Act were also referred to the Senate Rural and Regional Affairs and Transport Legislation Committee (Rural and Regional Affairs and Transport Committee) for inquiry and report.[21] Whilst the majority of the Rural and Regional Affairs and Transport Committee recommended that the Bill be passed, the Coalition Senators[22] again provided a dissenting report recommending that it should not.[23]

In the lead up to the 2013 Federal election, the Coalition signalled its intention (if elected) to reform the agriculture and veterinary chemicals legislation to improve efficiencies by, amongst other things, removing re-registration.[24] The 2014 Amendment Act delivered on that election promise.

2017 Amending Bill

The Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 (2017 Amending Bill)[25] was introduced into the House of Representatives on 25 October 2017. The purpose of the 2017 Amending Bill was to amend the various statutes relating to agvet chemical products to:

•       simplify reporting requirements for annual returns

•       increase the ability of the APVMA to manage errors in an application at the preliminary assessment stage

•       enable the APVMA to grant part of a variation application under clause 27 of the Code

•       enable a person to apply to vary the relevant particulars or conditions of a label approval that is suspended, to the extent that the variation relates to the grounds for suspension

•       establish civil pecuniary penalties for contraventions of provisions relating to providing false or misleading information

•       amend the notification requirements in clause 8E of the Code

•       amend the definition of expiry date in the Code to mean the date after which a chemical product 'must not' be used and

•       make minor and technical amendments including the repeal of redundant provisions.[26]

The 2017 Amending Bill was not referred to Committee for inquiry and report.[27] Importantly though, during the passage of the Bill through the House of Representatives, the Government introduced amendments to the Administration Act to ‘establish a governance board for the APVMA’ and ‘cease the existing APVMA Advisory Board’.[28] This is consistent with one of the recommendations of the House of Representatives Standing Committee on Agriculture on Water and Resources report of May 2018 which is discussed below.

At the time of writing this Bills Digest, the 2017 Amending Bill had been debated in the House of Representatives and introduced into the Senate. However, it had not been the subject of debate in that Chamber.[29]

Relevant inquiries

ANAO report

In June 2017, the Australian National Audit Office (ANAO) published a performance audit report on the implementation of pesticide and veterinary medicine regulatory reform.[30] The report concluded that, amongst other things:

The Australian Pesticides and Veterinary Medicines Authority’s implementation of agvet chemical legislative reform has been mixed. While key legislative reforms were implemented by the legislated timeframe of July 2014, the full scope of the reform program is yet to be implemented more than four years since the legislative amendments were developed. Further, the Authority is not well placed to determine the extent to which reform objectives have been met in the absence of a robust set of performance measures. There is considerable scope for the APVMA to improve its management of major reform projects, particularly in the context of the Government’s decision to relocate the Authority over the next two years.[31] [emphasis added]

House of Representatives Committee inquiry

In May 2018, the House of Representatives Standing Committee on Agriculture on Water and Resources published a report which was based on the ANAO report.[32] The Committee made a number of recommendations—in particular that the Auditor-General undertake a further audit of the APVMA in 2019, to assess its ongoing implementation of regulatory reforms and its management of its program to relocate to Armidale.[33]

Consultation

Public consultation on an exposure draft of the current Bill occurred during the period 11 July to 22 August 2018.[34] A total of 17 submissions were received in response to the Exposure Draft.[35]

The Department of Agriculture and Water Resources responded to the consultation by making several changes. The current Bill:

•       omits the proposal for provisional registration

•       simplifies the proposed legislation for accrediting persons and removes the aggravated offence for contravening conditions of accreditation

•       aligns voluntary recalls more closely with the Australian Consumer Law

•       provides for internal review of an APVMA decision that is substituted for a computer-based decision and

•       simplifies the provisions for extending ‘data protection’ periods.

Committee consideration

Senate Rural and Regional Affairs and Transport Committee

The Bill has been referred to the Senate Rural and Regional Affairs and Transport Committee (Rural and Regional Affairs Committee) for inquiry and report by 11 February 2019.[36] At the time of writing this Bills Digest, 13 submissions had been received. Comments by submitters are canvassed under the heading ‘Key issues and provisions’ below.

It should be noted that some of the submitters to the Rural and Regional Affairs Committee made reference to provisions which were included in the Exposure Draft and subsequently omitted.

Senate Standing Committee for the Scrutiny of Bills

The Senate Standing Committee for the Scrutiny of Bills (Scrutiny of Bills Committee) commented on two aspects of the Bill—reliance on delegated legislation and the incorporation of external material into the law.[37] Further discussion of the comments made by the Scrutiny of Bills Committee is below.

Policy position of non-government parties/independents

At the time of writing this Bills Digest, none of the non-government parties or independents had commented on the contents of the Bill.

Position of major interest groups

According to CropLife, ‘a streamlined, effective regulator capable of delivering timely risk assessments, approvals and registration is essential for Australia agriculture.’[38] Some submitters to the Rural and Regional Affairs Committee opined that the reforms set out in the Bill do not go far enough.

For instance, CropLife stated that the Bill fails to ‘deliver reform that will deliver genuine regulatory efficiency’. Nevertheless, it concedes that the Bill contains ‘necessary technical corrections and minor adjustments to the legislation’.[39]

Grain Producers Australia (GPA) supports some—but not all—of the proposed amendments.[40] It points to ‘the key deficiency of the proposed changes’ [being that] ‘it does not address the declining commercial pesticide investment into Australia’.[41]

The National Farmers’ Federation (NFF) commented in a similar vein:

Policy reforms should also be underpinned with sufficient incentives to bring newer and safer chemicals to market, particularly in cases where there may not be a commercial incentive for manufacturers due to the small Australian market.[42]

Financial implications

According to the Explanatory Memorandum, the Bill will have no financial impact on the Australian Government Budget.[43]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.[44]

Parliamentary Joint Committee on Human Rights

The Parliamentary Joint Committee on Human Rights considered the Bill but made no comment on the grounds that it did not raise human rights concerns—either because the Bill does not engage or promotes human rights, and/or permissibly limits human rights.[45]

Key issues and provisions

Part 1—approval and registration

Quick guide to Part 1

The amendments in Part 1 of Schedule 1 of the Bill establish a streamlined process for approvals and registrations where minimal or no assessment of technical information occurs.

The new processes will be set out in Regulations or other instruments made by the APVMA.

The changes are intended to better align regulatory effort with risk by:

·    reducing red tape and

·    reducing some of the costs associated with approval and registration.

The amendments are consistent with the commitments made in the Government’s Agricultural Competitiveness White Paper of 2015.[46]

Commencement

The amendments in Part 1 of Schedule 1 to the Bill commence six months after Royal Assent.

Current law

Part 2 of the Agvet Code contains provisions relating to:

•       the approval of active constituents for proposed or existing chemical products

•       registration of chemical products and

•       approval of labels for containers for chemical products.[47]

Within Part 2, Division 2 (comprising clauses 9A–26) relates to approving active constituents for chemical products, registering chemical products and approving labels for containers of chemical products. Essentially, the Division works as follows:

•       clause 10 provides for applications to be made

•       applications must meet the application requirements specified in clause 8A

•       the APVMA must complete a preliminary assessment of an application. If the application passes preliminary assessment, the APVMA must notify the applicant and publish a summary of the application[48]

•       before determining certain applications that have passed preliminary assessment, the APVMA must publish a notice inviting public submissions[49]

•       the APVMA must approve an active constituent or label, or register a chemical product, if specified criteria are met[50]

•       clauses 14A–16 set out special rules about approvals and registrations

•       the APVMA must keep a Record of Approved Active Constituents for Chemical Products and a Register of Agricultural and Veterinary Chemical Products[51]

•       clauses 19–21 set out how approvals and registrations take place

•       clause 22 deals with dates of approval and registration

•       approvals and registrations may be subject to conditions[52]

•       clause 26 provides for incorrect relevant particulars and conditions of a kind prescribed by the regulations to be corrected.

What the Bill does

According to the Minister for Agriculture and Water Resources, David Littleproud:

The Bill makes changes to enable the use of new, simpler processes for chemical product assessment based on risk. These changes support improved access to safe and effective chemical products and reduce costs associated with their registration…

The Bill specifically provides for new prescribed approval and registration processes that will be quicker and less costly than those currently available, while also ensuring these products remain safe and effective.[53]

According to the Explanatory Memorandum to the Bill:

This change will introduce a system change to enable the use of new, simpler regulation processes for these approvals and regulations where minimal or no assessment of technical information occurs.[54]

How this is achieved

The Bill operates to create new subdivisions within Division 2 as an aid to interpretation. Item 3 repeals and replaces subclauses 9A(2)–(5) of the Agvet Code to provide an updated explanation of the operation of Division 2 which is consistent with amendments outlined below.

Item 5 inserts proposed Subdivision C—Approval and registration for prescribed active constituents, chemical products or labels. It is new Subdivision C that introduces an additional streamlined pathway to the approval and registration process.

Proposed clause 14C provides that a person may apply to the APVMA for approval of a prescribed active constituent—being an active constituent that is for a proposed or existing chemical product; and is of a kind that either is prescribed by the regulations or determined by the APVMA.[55]

Instrument-making powers

A broad Regulation making power is contained in section 6 of the Code Act. Essentially it allows the Governor-General to make Regulations in relation to anything required or permitted by the Code to be so prescribed.

In addition to the existing Regulation making powers, the Bill empowers the APVMA to make two separate legislative instruments which relate to the approval of a prescribed active constituent. These instruments:

•       determine a kind of active constituent which will be captured by proposed clause 14C.[56] The APVMA must not make such a determination unless it is satisfied that the kind of active constituent meets the safety criteria[57] and

•       determine disqualifying criteria that apply to an application for approval under clause 14C.[58]

According to the Explanatory Memorandum to the Bill:

These [disqualifying] criteria could, for example, set out the circumstances to allow the APVMA to have regard to the regulatory history of the applicant, or consider if applicants have been convicted of an offence, ordered to pay a civil pecuniary penalty or had a registration or approval cancelled or suspended for breaching a condition or providing false or misleading information. Applicants disqualified through this mechanism will still be able to apply for approvals and registrations under section 10 of the Agvet Code.[59]

Decision-making process

In the event that such regulations and determinations have been made the decision-making process operates as follows:

•       an application which meets the application requirements is received[60]

•       the APVMA must approve the active constituent if the application meets the application requirements, the active constituent is a prescribed active constituent and none of the circumstances which have been determined to be disqualifying circumstances apply[61]

•       otherwise the application must be refused.[62]

Proposed clauses 14D and 14E of the Code relate to applications for registration of prescribed chemical products and applications for approval of prescribed labels for containers for chemical products respectively. They are set out in equivalent terms to proposed clause 14C in that they first, provide for the APVMA to make legislative instruments which prescribe certain kinds of chemical products and container labels and second, provide for the APVMA to determine the circumstances which would disqualify an application under the relevant clauses.

Limits on use of information

Currently, Division 4A of Part 2 of the Agvet Code limits the use of information which has been given to the APVMA as part of the application process.

Item 7 of Part 1 in Schedule 1 to the Bill inserts proposed subclause 34G(1AA) into the Agvet Code to limit the use of information given to the APVMA when it is making an assessment or decision under the streamlined approval and registration processes in proposed clauses 14C, 14D or 14E. According to the Explanatory Memorandum to the Bill:

By limiting the use of information, the original producer of that information (the ‘innovator’) can prevent competitors (such as producers of generic products) from using the innovator’s data, or can seek compensation from the competitors for the information it has produced. This benefits the innovator, who has incurred the cost of generating this information and testing the market, and so promotes innovation.[63]

Review and appeal

Item 9 amends subparagraph 166(1A)(b)(i) of the Code so that a decision to refuse an application under the abbreviated approval and registration process in proposed clauses 14C, 14D or 14E may be subject to an internal review. Consistent with that provision, items 10 and 11 of Part 1 in Schedule 1 to the Bill amend subclause 167(1) of the Agvet Code so that a decision to refuse such an application, or approve it subject to conditions, may be subject to a review by the Administrative Appeals Tribunal.

Stakeholder comments

Stakeholders generally supported the measure in Part 1 on the grounds that it ‘represents a better alignment of regulatory effort with risk for low-risk products’.[64]

The (NFF) opined that ‘any measure to make the approval process more efficient and cost effective is welcomed by the NFF, particularly when the application is for a low or medium risk product’.[65]

On the other hand, Gene Ethics opposed the proposal stating that its inherent flaw was ‘the lack of objective measures and a general paucity of good data to establish that certain chemicals are of low enough risk to justify simpler regulatory processes’.[66]

Part 2—information to be taken into account             

Quick guide to Part 2

The amendments in Part 2 of Schedule 1 to the Bill amend existing rules which operate inefficiently where the APVMA is seeking simple clarifying information from an applicant during the assessment period.

The amendments allow Regulations to prescribe certain kinds of information that the APVMA may consider during the assessment period.

The measure is intended to ‘provide the APVMA and industry with more flexibility in this regard, to reduce costs, time and administrative burdens’.[67]

Commencement

The provisions in Part 2 of Schedule 1 to the Bill commence six months after Royal Assent.

Current law—seeking simple information

Currently, subclause 8C(1) of the Agvet Code sets out the information that must be taken into account in determining applications such as:

•       information in, or accompanying, an application that is required under section 8B or any other provision of the Code

•       information given to the APVMA as required by clauses 157 (samples given for analysis), 159 (information, reports or samples) or 160A (new information) of the Code

•       submissions made in response to an invitation given by the APVMA in relation to the application and

•       any other matter that the APVMA thinks is relevant.

Subclause 8C(2) of the Agvet Code sets out the information that must not be taken into account in determining applications.

Together those provisions operate to restrict the APVMA’s ability to consider new information provided by an applicant during the assessment period for the application. The APVMA has the discretion to issue a notice to an applicant seeking additional clarifying information.[68] However, the notice compulsorily triggers a one-off extension to the statutory time period in which the application must be assessed.[69]

The rules may operate inefficiently where the APVMA is seeking simple clarifying information.

What the Bill does

Item 13 inserts proposed subclause 8C(2A) into the Agvet Code. The new subclause operates so that Regulations may prescribe the type of information and/or the circumstances in which that information is given. Such information will not be subject to the prohibition in existing subclause 8C(2) of the Agvet Code.

Importantly, under the application provision in item 14 of Part 2, the amendment will apply to applications lodged before the commencement of this item but not yet determined by the APVMA.

Part 3—limits on use of information

Quick guide to Part 3

The Agvet Code contains general and specific rules about the use of information. The specific rules relate to:

·    information which is protected information and is subject to a protection period and

·    information that is subject to a limitation period.

The amendments in Part 3 of Schedule 1 to the Bill extend, by up to five years, the period during which information that was used to assess an application or reconsideration for a chemical product or active constituent is protected from use by other applicants.

Commencement

The provisions in Part 3 of Schedule 1 to the Bill commence on the earlier of a single day to be fixed by Proclamation or six months after Royal Assent.

Current law—information from a trial or laboratory experiment

Division 4A in Part 2 of the Agvet Code limits the use of information which has been provided to the APVMA in connection with an application under clause 10 (the general application provision)[70] or clause 27 (application for variation) or under clause 161 (new information).[71] The relevant provisions of Division 4A are:

•       clause 34G sets out general rules about the use of information

•       clause 34H provides that a breach of the rules does not affect the validity of the APVMA’s actions

•       clauses 34J, 34K and 34L set out exceptions to the general rules—including where protected information is subject to a protection period which has since ended and

•       clause 34M sets out limitation periods for certain information. 

Clause 3 of the Agvet Code defines the term protected information as information or results given to the APVMA as required under paragraph 32(1)(b)[72] or 33(1)(a) or (c),[73] or subparagraph 159(1)(d)(i), (ii) or (iii),[74] that have been obtained because of a trial or laboratory experiment and which relate to an active constituent that has been approved or a chemical product that has been registered.

The term protection period, in relation to protected information, means the period of eight years after the APVMA makes a decision on the reconsideration of the information.

Under the Agvet Code there are additional limits on the use of information given to the APVMA in connection with an application made under section 10 (general application provision) or if the information was given under section 161 (new information). This information is subject to a limitation period. The limitation periods are set out in table form in clause 34M. Importantly, the limits on use of information provisions do not apply to information if it is information to which a limitation period applies and the limitation period has ended.[75]

If the information is provided to the APVMA in connection with such an application, and the application is not granted (for example, it is refused by the APVMA or withdrawn by the applicant), that information does not have a limitation period and it remains subject to the limitation on use of information provisions (that is, its use is limited indefinitely).[76]

What the Bill does

Existing clause 34J allows the APVMA to use information under certain conditions—for instance where the authorising party has given written consent to the use of the information[77] or where the APVMA is satisfied that the use of the information is in the public interest.[78]

Relevant to this Bills Digest, existing subclause 34J(5A) of the Agvet Code permits the APVMA to use information that is protected information where the relevant protection period has expired.

Item 22 of the Bill inserts proposed clause 34KA into Division 4A in Part 2 of the Code to extend the existing protection periods in certain circumstances. The clause allows Regulations to be made about extending the protection period for protected information and/or ending such an extension. The total length of all extensions of a protection period must not be more than five years.[79]

No application for extension will be required.[80] However, unless an application is made in accordance with the requirements of the Regulations at least three years before the protection period will end, an extension of a protection period must not occur.[81]

Accordingly, item 21 of the Bill repeals and replaces subclause 34J(5A) of the Agvet Code to permit the APVMA to use protected information where the protection period, or an extended protection period (in accordance with Regulations made under proposed clause 34K) has ended.

Item 25 of the Bill inserts proposed clause 34MA into the Agvet Code to allow Regulations to be made to extend a limitation period or to end an extended limitation period.[82] The terms of proposed clause 34MA are in near equivalent terms to those of proposed clause 34KA—that is:

•       an application for extension is not required 

•       no extension of a limitation will occur unless an application is made at least three years before that limitation period will end and

•       the maximum extension of a limitation period is five years.

The reference to no application being required is unclear. However, according to the Explanatory Memorandum to the Bill:

… an extension is a consequence that follows when particular applications (of a kind prescribed in regulations) are lodged and these applications also satisfy any requirements that may be prescribed by the regulations. It is anticipated that these applications would relate to products with new, desirable features. For example, products for minor or priority uses, where the costs of registering these uses are not otherwise justified by the additional commercial returns to chemical manufacturers. In addition, the application must be lodged while there is at least three years of the existing protection period remaining. The purpose of this three year period is to reduce the impact on potential applicants, allowing them to have certainty as to when a protection period will end, and they can consider entering the market based on the protected information.[83]

Stakeholder comments

The submission from the Herbicide Consortium expressed concern that this may well be a double-edged sword for growers in that it ‘provides an incentive for chemical companies to develop and register new chemistry that will aid growers and negate the need for minor use permits but will (likely) keep prices higher for longer’.[84]

Part 4—computerised decision-making

Quick guide to Part 4

The amendments in Part 4 are intended to permit the APVMA to use computer programs which will make decisions.

Although other Commonwealth statutes allow the use of such computer programs, this is new for the APVMA.

In order to comply with the rules of natural justice, decisions which have been made using a computer program may be reviewed at first instance by an officer at the APVMA.

Commencement

The provisions in Part 4 of Schedule 1 to the Bill commence on the earlier of a single day to be fixed by Proclamation or six months after Royal Assent.

Background

In 2004, the Administrative Review Council (ARC) prepared a report for the Attorney-General on Automated Assistance in Administrative Decision Making.[85] The report acknowledged:

Expert systems can play a significant and beneficial role in administrative decision making, particularly in areas where high volumes of decisions are made. Their potential to offer cost savings and improve efficiency and accuracy means it can be expected that the systems will become increasingly important tools of government.[86]

To that end the ARC set out what it considered to be best-practice principles for computerised decision making.

Whilst other agencies have adopted computerised decision making, for instance the Therapeutic Good Administration,[87] this has not been the case with the APVMA. However, the APVMA’s relocation to Armidale has presented an opportunity to create ‘a new business operating model, supported by modern technology’.[88] According to the APVMA its

… present information and communication technology (ICT) environment is at the point of critical failure. Investment in the authority’s infrastructure, applications and core business systems is vital to support the transition to Armidale, New South Wales, and underpins future efficiencies in application assessment and registration.[89]

This measure is consistent with the APVMA’s proposed digital strategy for the period 2018–22.

What the Bill does

Item 28 of the Bill inserts proposed clause 5F into the Agvet Code to authorise the APVMA to use computer programs to make decisions. Under proposed subclause 5F(1) the APVMA may arrange for the use of computer programs to make a decision, exercise a power or comply with any obligation under the Code or do anything else arising from those matters. In that case, the APVMA is deemed to have made the decision, exercised the power or complied with the obligation.

The APVMA may substitute a decision for a computer generated decision (the initial decision) if the APVMA is satisfied that the initial decision is incorrect—provided that the substituted decision is made within 60 days of the day the initial decision is made.[90]

Review and appeal

Items 29–34 of the Bill amend clause 166 of the Agvet Code to ensure that, where a decision has been made by a computer program, a person who is affected by the decision may request the APVMA to reconsider that initial decision.

Any subsequent decision made by a member of the staff of the APVMA will be a reviewable decision which will be able to be reviewed by the Administrative Appeals Tribunal.

This is consistent with the ARC best-practice principles which state that decisions made by or with the assistance of expert systems must comply with administrative law standards in order to be legally valid.[91]

Stakeholder comments

Animal Medicines Australia (AMA) supports this measure in principle, but considers that ‘any computerised decision-making systems and processes will need to be carefully and routinely validated to ensure that the correct decisions are being made’.[92]

The Grains Research and Development Corporation (GRDC) is similarly supportive, stating that it would:

… see this as the first of other reforms to move away from paper-based systems to electronic. This will allow for the easy transfer of information across Australia and integrate the regulatory system into the digital age and the fast approaching autonomous machine age.[93]

According to Grain Producers Australia:

There is an urgent need for the chemical industry to transform from current 19th century paper based systems into a 21st century smart digital agriculture system. There is also the additional need for further legislative reform that allows for the outcome of the decision making process to result in an electronic label as an alternative to the current paper based output.[94]

Part 5—accreditation of assessors

Quick guide to Part 5

The APVMA currently outsources elements of its technical assessments to third party external assessors who are experts in the fields of human health, environment, efficacy and target animal and crop safety risk assessment.[95]

The amendments in Part 5 in Schedule 1 to the Bill allow for the APVMA to make a legislative instrument which will prescribe a scheme to allow applicants and/or the APVMA to use accredited third party providers to undertake assessment services.

Commencement

The provisions of Part 5 in Schedule 1 to the Bill commence 12 months after Royal Assent.

What the Bill does

Item 43 of the Bill inserts proposed clause 6G into the Agvet Code so that the APVMA may accredit certain persons.

Proposed subclause 6G(1) empowers the APVMA to prescribe matters, by way of legislative instrument, relating to:

•       the accreditation of persons by the APVMA for the purposes of the Agvet Code and

•       those persons performing roles prescribed in the instrument.

A reference to a person includes a body politic or a corporation.

This measure was recommended in the December 2017 report Independent Review of Assessment Performance of the Australian Pesticides and Veterinary Medicines Authority.[96] The report compares the APVMA’s performance in competing applications within the statutory timeframe (69%) with that of New Zealand (100%)—citing the New Zealand model as ‘an example of the use of independent third party data assessors enabling much shorter legislative time frames’.[97]

However, these powers are extremely broad. Although proposed subclause 6G(2) lists certain matters that may be dealt with in such an instrument they are examples only and do not limit the extent of the power. Essentially the amendments in Part 5 will allow the APVMA to establish a scheme which would allow it to approve third parties either in Australia or offshore to undertake assessments of applications under the Agvet Code. The manner of operation of the scheme is unknown at the time of writing this Bills Digest. However, the breadth of the legislative power is such that, into the future, it is possible that much of the assessment will be carried out by persons other than those employed by the APVMA.

Proposed subclause 6G(3) operates to remove the fetters on the instrument making power in subsection 14(2) of the Legislation Act 2003, so that an instrument made under proposed subclause 6G(1) may make provision about any matter by adopting or incorporating the contents of an instrument or other writing as in force or existing from time to time.

Part 5 of Schedule 1 to the Bill does not create offences or penalties. Instead these, too, are to be prescribed by Regulation—although they are likely to relate to breaches of the conditions of accreditation. Financial penalties for breaching the relevant Regulations will be no more than 50 penalty units for an individual and 250 penalty units for a corporation.[98]

Scrutiny of Bills Committee

Reliance on delegated legislation

The Scrutiny of Bills Committee expressed concern that a scheme to accredit persons to perform functions in relation to the Agvet Code is to be determined in accordance with delegated, rather than primary, legislation.[99]

The issue with such use of delegated legislation, in the Committee’s view, is that it is not subject to the full range of Parliamentary scrutiny inherent in bringing proposed changes in the form of an amending Bill. Whilst the Explanatory Memorandum makes some comment in relation to the relevant provisions, the Scrutiny of Bills Committee did not consider that it provided a sufficient account as to ‘why it would not be appropriate to include such requirements in primary legislation’.[100]

Ministerial advice

Accordingly, the Scrutiny of Bills Committee requested the Minister's advice in relation to:

•       why it is considered necessary and appropriate to leave all of the content of the proposed accreditation scheme to delegated legislation

•       the appropriateness of amending the Bill so as to include at least high-level guidance as to the requirements of the proposed accreditation scheme and

•       whether specific consultation obligations can be included in the legislation.[101]

In relation to the question about why it was considered necessary and appropriate to leave all of the content of the proposed accreditation scheme to delegated legislation, the Minister stated:

Before registering a chemical product, the APVMA must reach satisfaction in relation to the safety, efficacy, trade and labelling criteria. The proposed scheme will provide flexibility in how the APVMA may efficiently obtain a robust assessment of applicant's data to assist it to reach this satisfaction (or, alternatively, refuse the application). This may, for example, include specifying the particular types of applications that may be suitable for external assessment. For instance, third-party assessments could involve detailed scientific assessments of complex data for new products, or they could be limited to essentially administrative assessments of applications for products of low regulatory concern with well understood chemistries. Different requirements could also apply in relation to different aspects of assessments, such as toxicology, environmental safety, residues or chemistry. The APVMA is best placed to determine these requirements for any third-party accreditation scheme.

In addition, rather than creating a significant regulatory scheme, the accreditation scheme will be constrained and will, in effect, supplement and formalise existing practices … [to] provide a more rigorous and transparent framework that would provide a greater basis for public confidence about the assessment of chemicals …

The use of third party accreditation schemes by Commonwealth regulators is not unusual, nor is it unusual for the content of such schemes to be set out in delegated legislation. For example, the Australian Maritime Safety Authority (AMSA), as a national regulator, relies on the recommendations of marine surveyors to determine whether a vessel meets safety standards … The creation of a pool of experienced third-party assessors will not just assist the APVMA, it will also assist industry in preparing applications, particularly emerging or new participants. However, there will be no requirement for industry to engage accredited assessors.[102]

In addition, the Minister rejected the notion that the Bill should be amended to include high-level guidance as to the requirements of the proposed accreditation scheme. He also rejected the suggestion that specific consultation obligations should be included in the legislation on the grounds that ‘mandating consultation requirements in the primary legislation may limit the APVMA's ability to respond to urgent situations’.[103]

Stakeholder comments

It is this measure which attracted most negative comments from stakeholders. For instance, the Department of Primary Industries and Regional Development in Western Australia (DPIRD) supported all of the proposed amendments in the Bill but this one.[104] The DPIRD acknowledged that the APVMA has used independent assessors under contract for many years so as to extend the technical ability of the APVMA but warned:

Allowing chemical companies to pay accredited third party providers to undertake assessment services directly on their behalf could lead to real or preceived conflict of interest ... there is a risk to the credibility and reputation of the registration process.[105]

Dr Ian Musgrave of the School of Medicine at the University of Adelaide had this to say:

The APVMA not only must be independent, but must been seen to be independent for there to be public trust in the registration process. The evaluation process must be at arm’s length from the sponsors (as with the TGA approval of medicines) and they should not be paid by the sponsors. Given the recent publicity over the potential conflicts of interests of the APVMA itself for funding its assessment activities via sponsor payment, the perceived conflict of interest in the case will be substantial (even though the assessors are professionals of the highest integrity, it is the perceived conflict of interest that is the issue).[106]

The Community and Public Sector Union (CPSU) expressed its concern that ‘allowing chemical companies to fund outsourced assessment services could lead to real or perceived conflicts of interest and undermine public trust in the APVMA’.[107]

The GRDC conditionally supported the measure and stated:

Under the current system the assessors of the regulatory packages are not known to the registrants. Under the proposed system, an accredited assessor would be selected by the registrant. This may put undue pressure on assessors to approve data packages that are marginal in meeting the regulatory requirements.[108]

Other stakeholders were less critical. Grain Producers Australia noted that ‘there is significant opportunity for implementation of third party APVMA approved certifiers rather than the current APVMA monopoly’. However, it suggested that ‘limitations of liability from negligence will need to be in place, otherwise the cost of insurance premiums for external assessors are likely to make the program unviable’.[109]

The NFF also supported this measure but noted ‘the need for rigour in the quality of external assessors and their assessments and the importance of consultation with industry on details of the accreditation scheme prior to its introduction’.[110]

Part 6—voluntary recalls

Quick guide to Part 6

The amendments in Part 6 of Schedule 1 to the Bill establish a voluntary recall scheme for persons who have stocks of chemical product in their possession. The Scheme will specify notification and publication requirements in respect of a chemical product that is being voluntarily recalled. This is not currently required.

The recall scheme will be in addition to the product recall scheme which is set out in Part 3-3 of the Australian Consumer Law (which is contained in Schedule 2 to the Competition and Consumer Act 2010).

Commencement

The amendments in Part 6 of Schedule 1 to the Bill commence three months after Royal Assent.

Current law

Currently Part 6 of the Agvet Code sets out various circumstances in which the APVMA may issue recall notices requiring persons who have, or have had, stocks of chemical products in their possession to stop supplying the products and to take action in relation to the products as directed by the APVMA. These powers are said to be ‘in addition to the recall powers conferred on the Australian Competition and Consumer Commission under the Competition and Consumer Act’.[111]

Existing clause 106 of the Agvet Code cross references those powers.

What the Bill does

Items 48 and 49 of the Bill amend clause 100 of the Code to provide for the voluntary recall of chemical products.

Item 50 repeals and replaces clause 106 to set out in detail the manner in which the voluntary recall power will operate. In particular, the new provisions apply if a person voluntary recalls a chemical product on the grounds that:

•       the chemical product does not meet the safety criteria, trade criteria or the efficacy criteria or a label for the container of a chemical product does not meet the labelling criteria and/or

•       the chemical product is not registered.[112]

In particular, where a person takes voluntary action to recall a chemical product in specified circumstances, the person must notify the APVMA within two days, in the appropriate manner and form, of the recall action.[113]

The APVMA is to publish a copy of that notice on its website within three days of its receipt and publish an additional copy in the Gazette within 14 days of its receipt.[114]

Proposed subclause 106(4) provides that where a person is required to give such a notice to the APVMA, the person commits an offence of strict liability if he, or she, refuses of fails to give the notice.[115] This is also a civil penalty provision.

Stakeholder comment

Stakeholders generally supported this measure.[116] For instance the NFF endorsed the need for an approval form to be completed to advise the APVMA of the recall.[117]

Part 7—notification of new information             

Quick guide to Part 7

The amendments in Part 7 of Schedule 1 to the Bill extend the obligations to provide relevant information to the APVMA by persons in respect of applications lodged but not yet determined for:

·    label approvals and

·    variations to approvals and registrations.

These requirements already apply to holders of active constituent approvals and product registrations.

Commencement

The amendments in Part 7 of the Bill commence three months after Royal Assent.

Current law

Existing subclause 160A(1) of the Agvet Code applies if an application has been lodged with the APVMA for:

•       approval of an active constituent for a proposed or existing chemical product

•       registration of a chemical product

•       a permit in respect of such an active constituent or in respect of a chemical product or

•       a licence in respect of the manufacture of a chemical product.

If the APVMA has not determined the application and the applicant becomes aware of any relevant information in relation to the constituent, or in relation to the product or any of its constituents then he, or she, must give the information to the APVMA as soon as the applicant becomes aware of it.[118]

Under existing clause 161 of the Agvet Code, the requirement to give new information to the APVMA also applies to:

•       the holder of an approval of an active constituent and

•       the holder of a permit in relation to an active constituent of a chemical product.

What the Bill does

Item 53 of Part 7 in Schedule 1 to the Bill inserts proposed subparagraphs 160A(1)(a)(vi) and 160A(1)(a)(vii) into paragraph 160A(1)(a) of the Agvet Code to expand the requirement to give relevant information to applicants for label approvals and applicants for variations of approvals or registrations.

Item 57 of Part 7 in Schedule 1 to the Bill inserts proposed paragraph 161(1)(c) into the Agvet Code to extend the requirements of clause 161 to the holder of the approval of a label for containers for a chemical product.

These amendments address minor inconsistencies in the Agvet Code.

Part 8—definition of registered chemical product             

Quick guide to Part 8

The amendments in Part 8 of Schedule 1 to the Bill address an inconsistency in the Agvet Code.

Commencement

The amendments in Part 8 of the Bill commence on the day after Royal Assent.

Current law

Currently clause 3 of the Code defines a registered chemical product as a chemical product that is registered and complies with the relevant particulars entered in the Register for the product.

What the Bill does

Item 63 of Part 8 in Schedule 1 to the Bill repeals that definition and inserts a new cross reference to proposed clause 5AA.

Item 64 inserts proposed clause 5AA into the Code to provide a fuller definition of the term registered chemical product. The new definition reiterates the contents of the current definition[119] and adds additional requirements about:

•       the constituents of the chemical product

•       the concentration of the constituents of the chemical product

•       the composition of the constituents of the chemical product and

•       the purity of the constituents of the chemical product.

The updated definition is consistent with variations which may be authorised under clause 83 of the Agvet Code and which currently interact in an inconsistent way with the offences and civil penalties which relate to possessing with the intention of supply, or supplying an unregistered chemical product.[120]

Part 9—suspension or cancellation of approval or registration

Quick guide to Part 9

The amendments in Part 9 of Schedule 1 to the Bill create more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading in a material particular.

Commencement

The amendments in Part 9 of Schedule 1 to the Bill commence on the day after Royal Assent.

Current law

At present clause 38A of the Code provides for the APVMA to suspend or cancel an active constituent approval, or a product registration, where false or misleading information has been provided. However, clause 38A does not currently apply if the false or misleading information was provided:

•       in an application for variation of an approval of an active constituent or variation of a registration of a chemical product

•       in an application for approval, or variation of an approval, of a label for containers for a chemical product

•       by a person other than the holder, such as through subclause 27(2) of the Code.[121]

What the Bill does

Part 9 of Schedule 1 to the Bill introduces more comprehensive grounds for suspending or cancelling approvals or registrations where information is provided that is false or misleading in a material particular.

Item 66 of the Bill repeals and replaces clause 38A of the Code. Proposed clause 38A addresses the deficiencies outlined above and improves the capability of the APVMA to respond to false or misleading information after a product has been registered or a label or active constituent has been approved. Specifically, it broadens the circumstances where a more proportionate APVMA response (suspension or cancellation) is available, rather than the APVMA only being able to rely on the offences and civil penalty provisions in clause 146 of the Code for providing false or misleading information.

Part 10—supply with unapproved label

Quick guide to Part 10

The amendments in Part 10 of Schedule 1 to the Bill address an inconsistency in the Agvet Code by clarifying what information must be included in a label attached to the container for a chemical product.

Commencement

The amendments in Part 10 of Schedule 1 to the Bill commence on the day after Royal Assent.

Current law

Currently clause 21 of the Code sets out how approval of a label takes place. The clause provides that approval of a label takes place when the APVMA does all of the following:

(a)              determines the particulars prescribed by the regulations that are appropriate to be contained on the label

(b)              gives a distinguishing number to the label

(c)              records the following information in the relevant APVMA file:

(i)              the name of the person who applied for the approval as the holder of the approval

(ii)              the name of any nominated agent for the approval

(iii)              the distinguishing number

(iv)              the instructions and any particulars that are to be contained on the label

(iva) any other particulars prescribed by the regulations and

(v)              any conditions of the approval imposed by the APVMA.

The Bill recognises that stating all of the relevant particulars in a label is not necessary, for instance, the name of the nominated agent and the holder of the approval.

However, under clause 81 of the Agvet Code, a person commits an offence if he, or she, supplies a registered chemical product in a container if the label attached to the container does not state the relevant particulars.

The term relevant particulars is defined in clause 3 of the Agvet Code as meaning, in relation to the approval of a label—the information required to be recorded in the relevant APVMA file by subparagraphs 21(c)(i) to (iva) (as set out above) and includes particulars of variations of relevant particulars.

What the Bill does

Items 68–71 in Part 10 of Schedule 1 to the Bill substitute existing references to relevant particulars in clause 81 with references to minimum information. Item 73 inserts proposed subclause 81(5) which states that the term minimum information means the information covered by subparagraphs 21(c)(iii) and (iv) (including that information as varied under Part 2).

Item 72 in Part 10 repeals and replaces paragraphs 81(3)(a), (b) and (c) of the Agvet Code. The new provisions allow a registered chemical product to be supplied for a limited period of two years (or another period allowed by the APVMA) if the information on the label is different from that required when supply occurs, but is information that was required to be on the label at a time before supply took place.

The Explanatory Memorandum provides the following rationale for the change:

Information required on a label may change. It is therefore necessary to enable the APVMA to deal with products containing information that was previously required but is different from the information that is currently required (that is, to allow trade out of a product with previously required information in the label). The amendments … allow the APVMA to deal with this by allowing a product (with the previously required information in the label) to be supplied, where the APVMA considers that is appropriate.[122]

Part 11—variation of approval or registration during suspension

Quick guide to Part 11

The amendments in Part 11 of Schedule 1 to the Bill introduce measures to deal with suspended registrations and to address the reason for the suspension.

Commencement

The amendments in Part 11 of Schedule 1 to the Bill are contingent on the commencement of Part 4 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Act 2018.[123] If those provisions do not commence then the amendments in Part 11 of this Bill do not commence.

Current law

The Agvet Code provides for:

•       the making, and assessment of, applications for approval of an active constituent for a proposed, or existing, chemical product

•       the registration of a chemical product and

•       approval of a label for the containers of a chemical product.

Clause 15 of the Agvet Code provides that the APVMA must not register a chemical product unless each active constituent of the product, as well as a label for the container of the product, have been approved. The APVMA must not approve a label for the container of a chemical product unless it also registers the product.

Division 5 of Part 2 of the Agvet Code provides for suspending and cancelling approvals and registrations. It sets out the procedure to be followed by the APVMA before it takes action to suspend; and the circumstances in which it may exercise that power.

In particular, the APVMA may suspend an approval for a label for containers for a chemical product. This may be because, amongst other things, there has been a contravention of a condition of the approval,[124] the label does not meet the labelling criteria, or it does not comply with a requirement prescribed by the regulations.[125] The Agvet Code operates so that an approval is taken not to be in force during any period in which it is suspended.[126] The suspension is made by entering the information, including the period of the suspension, into the APVMA file.[127]

The effect of these provisions is that where the problem with the label may be addressed by an amendment to or variation of the label, the APVMA must first revoke the suspension.

Part 4 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 is intended to address much of this problem, by allowing the APVMA to vary a label approval while the approval is suspended.[128] The current Bill has been drafted on the basis that the Operational Efficiency Bill will have already commenced.[129]

What the Bill does

The Bill makes further amendments to Division 5 of Part 2 of the Agvet Code to extend the approach proposed in the amendments in the Operational Efficiency Bill, by allowing the holder of a product registration that is suspended to apply to the APVMA to vary relevant particulars and conditions of that registration, while the registration is suspended. (Rather than requiring the suspension to be revoked before any variations to the registration can be made, as is the case at present.) It will also enable a holder to have their approval or registration suspended while they deal with any issues with that approval or registration. The measure is ‘aimed at reducing the administrative and cost burden’.[130]

Stakeholder comments

GPA acknowledged the ‘need for a more pragmatic mechanism to vary a suspended chemical product registration’.[131]

Nevertheless, GPA expressed its:

… significant concern that this reform may result in a weakening of registrants taking timely responsibility for the registration of their products. There is a risk that some registrants may continue to manage these situations after the effect. There is a need for a restriction or penalty to use this mechanism if there is continued suspension situations arising.[132]

Part 12—safety, efficacy, trade and labelling criteria

Quick guide to Part 12

The amendments in Part 12 of Schedule 1 to the Bill address existing anomalies in the Agvet Code in relation to the safety, efficacy, trade and labelling criteria.

Commencement

The amendments in Part 12 commence on the day after Royal Assent.

Current law

Each of clauses 5A, 5B and 5C of the Agvet Code operate so that in working out whether a product meets the safety criteria, the efficacy criteria and the trade criteria respectively the APVMA must have regard to matters prescribed in Regulations.

Currently clause 5D of the Agvet Code, which relates to whether a label meets the labelling criteria, is different. Subclause 5D(1) provides that a label must contain adequate instructions for use and sets out those matters which will satisfy that requirement. In particular a label will contain adequate instructions for use—and thereby meet the labelling criteria—if the label also contains instructions about matters that are prescribed by Regulations. Under subclause 5D(2) the APVMA must have regard to certain specified matters in making a determination about whether a label meets the labelling criteria.

Unlike clauses 5A, 5B and 5C, there is no overt requirement for the APVMA to make its decision on a label by having regard to matters prescribed in regulations.

What the Bill does

Item 85 in Part 12 inserts proposed paragraph 5D(2)(d) into the Agvet Code to address that anomaly.

Subclause 160(2) (which is not amended by the Bill) provides that in determining matters about active constituents and/or chemical products (including their label) the APVMA may take into account the following information:

(a)              the results of any trials or experiments already carried out in a foreign country in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or any of its constituents

(b)              any decisions or evaluations made by regulators of agricultural or veterinary chemicals in a foreign country and

(c)              any information on which a decision or evaluation mentioned in paragraph (b) is based

to the extent that those results, decisions or evaluations are, or that information is, relevant having regard to any matters the APVMA thinks appropriate.

Item 86 in Part 12, inserts proposed clause 5E into the Agvet Code. Essentially it ties the provisions of clause 160 into the decision-making processes in clauses 5A–5D by allowing regulations to prescribe that the APVMA must have regard to the matters in paragraphs 160(2)(a), (b) or (c) of the Agvet Code.

Stakeholder comments

The submission by GPA to the Rural and Regional Affairs Committee does not support this measure on the grounds that there is no ‘need to introduce a legislative requirement for compulsory consideration of international data’.[133]

The NFF agreed that ‘it is unnecessary to introduce a legislative requirement’, ‘as the APVMA is already maximising the use of international standards, assessments and data’.[134]

Part 13—annual operational plans

Quick guide to Part 13

The amendments in Part 13 of Schedule 1 to the Bill amend the Administration Act to remove the need for the APVMA to develop and seek approval of an annual operational plan in addition to a corporate plan.

Commencement

The amendments in Part 13 of Schedule 1 to the Bill commence on 1 January 2020.

Current law

Currently Part 6 of the Administration Act requires the Chief Executive Officer of the APVMA to give a corporate plan to the Minister for approval on or before 1 June of each year, or such other date that the Minister allows.[135] That report must be prepared in accordance with the requirements of section 35 of the Public Governance, Performance and Accountability Act 2013 (PGPA Act).

In addition, the Administration Act requires that an annual operational plan must be prepared and approved by the Minister.[136] The operational plan must:

•       set out particulars of the action that the APVMA intends to take in order to give effect to the objectives set out in the corporate plan

•       include such performance indicators as the Chief Executive Officer considers appropriate against which the APVMA’s performance can be assessed during the period to which the plan relates and

•       include such other information (if any) as is prescribed by the regulations.

What the Bill does

Item 89 of Part 13 of Schedule 1 to the Bill repeals sections 55–57 of the Administration Act so that there will no longer be a requirement to provide an annual operational plan. The requirement for a corporate plan, prepared in accordance with the PGPA Act, is unchanged.

Items 90–92 amend section 61 of the Administration Act to make consequential amendments to the matters which are to be included in the APVMA’s Annual Report.

Other provisions

Part 2 of Schedule 2 to the Bill repeals the Agricultural and Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration) Act 2014. Some stakeholders have misunderstood the effect of the repeal—believing it to reinstate the amendments in the 2013 Amending Act.[137] That is not the case.

Subsection 7(2) of the Acts Interpretation Act 1901 states that if an Act, or an instrument under an Act, repeals or amends an Act (the affected Act) or a part of an Act, then the repeal or amendment does not revive anything not in force or existing at the time at which the repeal or amendment takes effect.

The Bill does no more than repeal legislation which is no longer required.

Concluding comments

Many of the measures in the Bill have been welcomed by stakeholders, some of whose submissions to the Rural and Regional Affairs Committee display a level of frustration and fatigue at the cycle of reviews and legislative amendments that have occurred over the last five years—and their failure to deliver real reform with genuine improvements to the APVMA’s efficiency.

One insistent message from stakeholders was the need for the Government to implement policy reform which provides incentives to bring new and safer chemicals to market, particularly where there may not be a commercial incentive for manufacturers due to the small Australian market.[138] The amendments in the Bill to streamline certain approval processes and to extend data protection periods may help to address these concerns.

Seen in its best light, the Bill builds on the recommendations of a number of reviews to establish a plan for the future of the APVMA—and in particular to make changes to the APVMA’s way of working, for example by allowing for decisions to be made by computer.

On a less positive note, the major changes wrought by the Bill, being the streamlined approval process and the move to third party assessors, are to be set out in Regulations which have not yet been circulated. That being the case it is not possible to speculate on their breadth and reach. The danger is that, particularly the use of third party assessors could operate in such a way as to undermine the independence of the APVMA and/or to remove some decision making from APVMA assessors altogether. If that is the case, it may diminish the confidence of stakeholders in the quality of the APVMA’s overall performance.

The APVMA plays an important gate-keeper role in assessing the suitability for sale in Australia of active constituents for proposed or existing chemical products, registered chemical products, and labels for containers for chemical products. Any undermining of the quality of its decisions would be a serious loss.

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[1].              Australian Pesticides and Veterinary Medicines Authority (APVMA), ‘Overview of agvet chemical regulation’, APVMA website, last updated 1 August 2017.

[2].              APVMA, ‘About the APVMA’, APVMA website, last updated 24 October 2018.

[3].              Explanatory Memorandum, Agricultural Pesticides and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 2.

[4].              APVMA, ‘Legislative framework’, APVMA website, last updated 28 September 2018.

[5].              Agricultural and Veterinary Chemicals (Administration) Act 1992, section 7.

[6].              Deloitte Access Economics, Economic activity attributable to crop protection products – commissioned by CropLife Australia, Deloitte, n.p., February 2018, p. 2. These are products intended to prevent or reduce the growth of weeds. These can be either: selective (chemicals which kill weeds specifically without harming crops); or non-selective (chemicals which stop the growth of plants indiscriminately).

[7].              Ibid. These are chemicals which aim to control insects in plants and crops.

[8].              Ibid. These are products whose purpose is to prevent or manage fungal diseases in plants.

[9].              Ibid.

[10].              Ibid., p. ii.

[11].              Ibid., p. iii.

[12].              For information about the originating Bill to the 2013 Amending Act see P Pyburne, Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012, Bills digest, 89, 2012–13, Parliamentary Library, Canberra, 2013.

[13].              The updated investigative powers are located in Part 7AA of the Administration Act.

[14].              The updated enforcement powers are located in Part 7AB of the Administration Act.

[15].              P Pyburne, Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012, op. cit., p. 62.

[16].              Parliament of Australia, ‘Agricultural and Veterinary Chemicals Legislation Amendment Bill 2013 homepage’, Australian Parliament website.

[17].              For details of the amendments see P Pyburne, Agricultural and Veterinary Chemicals Amendment Bill 2012, Bills digest, 89, 2012–13, Parliamentary Library, Canberra, 2013.

[18].              Details of the inquiry including the terms of reference, submissions from stakeholders and the Standing Committee for Agriculture, Resources, Fisheries and Forestry report are on the inquiry homepage.

[19].              House of Representatives Standing Committee on Agriculture, Resources, Fisheries and Forestry, Advisory report on the Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012, House of Representatives, Canberra, February 2013.

[20].              Ibid., p. 52.

[21].              Details of the inquiry including the terms of reference, submissions from stakeholders and the Rural and Regional Affairs and Transport Committee report are on the inquiry homepage.

[22].              Rural and Regional Affairs and Transport Committee, Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012 [Provisions], The Senate, Canberra, February 2013, pp. 27–30.

[23].              Ibid., p. 30.

[24].              Liberal Party of Australia and the Nationals, The Coalition’s policy for a competitive agriculture sector, Coalition policy document, Election 2013, p. 10.

[25].              Parliament of Australia, ‘Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 homepage’, Australian Parliament website.

[26].              Senate Standing Committee for the Scrutiny of Bills, Scrutiny digest, 13, 2017, 15 November 2017, p. 1.

[27].              Senate Standing Committee for Selection of Bills, Report, 1, 2018, 8 February 2018.

[28].              Supplementary Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017, p. 1.

[29].              For information about the Bill see P Pyburne, Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017, Bills Digest, 78, 2017–18, Parliamentary Library, Canberra, 2018.

[30].              Australian National Audit Office (ANAO), Pesticide and veterinary medicine regulatory reform: Australian Pesticides and Veterinary Medicines Authority, ANAO report, 56, 2016–17, ANAO, Canberra, 2017.

[31].              Ibid., p. 7.

[32].              House of Representatives Standing Committee on Agriculture and Water Resources, APVMA regulatory reforms: inquiry based on the Auditor-General report no. 56 (2016–17): Pesticide and Veterinary Medicine Regulatory Reform, House of Representatives, Canberra, May 2018.

[33].              Ibid., recommendation 1, p. ix.

[34].              Department of Agriculture and Water Resources (DAWR), ‘Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018’, DAWR website, last reviewed 5 December 2018.

[35].              Ibid.

[36].              The terms of reference, submissions to the Rural and Regional Affairs and Transport Committee and the Committee’s final report (when published) are available on the inquiry homepage.

[37].              Senate Standing Committee for the Scrutiny of Bills, Scrutiny digest, 13, 2018, 14 November 2018, pp. 1–5.

[38].              CropLife, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 21 December 2018, p. 6.

[39].              Ibid., p. 4.

[40].              Grain Producers Australia (GPA), Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018,
19 December 2018, pp. 3–4.

[41].              Ibid., 5.

[42].              National Farmers’ Federation (NFF), Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018,
20 December 2018, p. 5.

[43].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 2.

[44].              The Statement of Compatibility with Human Rights can be found at pages 46–59 of the Explanatory Memorandum to the Bill.

[45].              Parliamentary Joint Committee on Human Rights, Report, 12, 2018, 27 November 2018, p. 50.

[46].              Department of Agriculture, Agricultural competitiveness white paper: stronger farmers, stronger economy, Australian Government, Canberra, 2015.

[47].              Agvet Code, subclause 9(1).

[48].              Agvet Code, clause 11.

[49].              Agvet Code, clauses 12 and 13.

[50].              Agvet Code, clause 14.

[51].              Agvet Code, clauses 17 and 18.

[52].              Agvet Code, clause 23.

[53].              D Littleproud (Minister for Agriculture and Water Resources), ‘Second reading speech: Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018’, House of Representatives, Debates, 18 October 2018, p. 10398.

[54].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 7.

[55].              Agvet Code, proposed subclause 14C(4).

[56].              Agvet Code, proposed subclause 14C(6).

[57].              Agvet Code, proposed subclause 14C(5). Agvet Code, subclause 5A(1) sets out when active constituent or chemical product meets the safety criteria.

[58].              Agvet Code, proposed subclause 14C(9).

[59].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 9.

[60].              Agvet Code, proposed subclause 14C(2). Agvet Code, clause 8A sets out when an application meets the application requirements.

[61].              Agvet Code, proposed subclause 14C(7).

[62].              Agvet Code, proposed subclause 14C(8).

[63].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 10.

[64].              Animal Medicines Australia (AMA), Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 21 December 2018, p. 2.

[65].              NFF, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 20 December 2018, p. 7.

[66].              Gene Ethics, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 27 December 2018, p. 4.

[67].              DAWR, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 20 December 2018, p. 4.

[68].              Agvet Code, clause 159.

[69].              The relevant period is determined under Division 9.3 of the Agricultural and Veterinary Chemicals Code Regulations.

[70].              Agvet Code, clause 10 provides that a person may apply to the APVMA for approval of an active constituent for a proposed or existing chemical product; for registration of a chemical product; or for approval of a label for containers for a chemical product.

[71].              Agvet Code, clause 161 provides that where a holder of an approval of an active constituent or the holder of a permit relating to an active constituent becomes aware of any relevant information in relation to the constituent or in relation to the product or of any of its constituents, the holder must, as soon as the holder becomes aware of the information, give that information to the APVMA.

[72].              Agvet Code, paragraph 32(1)(b) relates to information provided by the holder of an approval or registration in response to a written notice from the APVMA because the approval or registration is being reconsidered.

[73].              Agvet Code, paragraphs 33(1)(a) and (c) permit the APVMA by written notice to the holder of an approval or registration to conduct, or cause to be conducted, trials or laboratory experiments and give the results of the trials or experiments to the APVMA.

[74].              Agvet Code, subparagraphs 159(1)(d)(i), (ii) and (iii) permit the APVMA to require further information by notice in writing in deciding whether to suspend or cancel an approval of an active constituent for a proposed or existing chemical product; the registration of a chemical product; or the approval of a label for containers for a chemical product.

[75].              APVMA, ‘Limitation periods’, APVMA website, Last updated 18 June 2018.

[76].              Ibid.

[77].              Agvet Code, subclause 34J(2).

[78].              Agvet Code, subclause 34J(3).

[79].              Agvet Code, proposed subclause 34KA(4).

[80].              Agvet Code, proposed subclause 34KA(2).

[81].              Agvet Code, proposed subclause 34KA(3).

[82].              Agvet Code, proposed subclause 34MA(1).

[83].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 15.

[84].              Herbicide Consortium, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 21 December 2018,
p. 2.

[85].              Administrative Review Council (ARC), Automated assistance in administrative decision making: report to the Attorney-General, ARC report, 46, ARC, Canberra, November 2004.

[86].              Ibid., p. vii.

[87].              Therapeutic Goods Act 1989, section 7C.

[88].              APVMA, ‘Digital strategy 2018–2022’, op. cit.

[89].              Ibid.

[90].              Agvet Code, proposed subclauses 5F(3) and (4).

[91].              ARC, Automated assistance in administrative decision making, op. cit., p. viii.

[92].              AMA, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 21 December 2018, p. 3.

[93].              Grains Research and Development Corporation, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, n.d., p. 6.

[94].              GPA, Submission, op. cit., p. 7.

[95].              DAWR, Submission, op. cit., p. 5.

[96].              Reason Group, Independent Review of Assessment Performance Report of the Australian Pesticides and Veterinary Medicines Authority, Reason Group, Canberra, 22 December 2017, p. 24.

[97].              Ibid., p. 36.

[98].              Proposed subclause 6G(4). Under section 4AA of the Crimes Act 1904, a penalty unit is equivalent to $210. This means that the maximum penalties are $10,500 and $52,500 respectively. Subclause 170(5) of the Agvet Code sets out the calculation of a pecuniary penalty for a corporation, which may be up to five times the penalty imposed on an individual.

[99].              Senate Standing Committee for the Scrutiny of Bills, Scrutiny digest, op. cit., p. 2.

[100].              Ibid., p. 3.

[101].              Ibid., pp. 3–4.

[102].              Senate Standing Committee for the Scrutiny of Bills, Scrutiny digest, 14, 2018, 28 November 2018, pp. 6–11.

[103].              Ibid., p. 9.

[104].              Department of Primary Industries and Regional Development (WA), Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 20 December 2018, p. 1.

[105].              Ibid., p. 2.

[106].              I Musgrave (School of Medicine, University of Adelaide), Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 26 November 2018, p. 3.

[107].              CPSU, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 17 January 2019, p. 1.

[108].              Grains Research and Development Corporation, Submission, op. cit., p. 5.

[109].              GPA, Submission, op. cit., p. 7.

[110].              NFF, Submission to the Senate Standing Committee on Rural and Regional Affairs and Transport, Inquiry into the Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, 20 December 2018, p. 7.

[111].              Agvet Code, clause 100.

[112].              Agvet Code, proposed subclause 106(1).

[113].              Agvet Code, proposed subclause 106(2).

[114].              Agvet Code, proposed subclause 106(6).

[115].              The imposition of strict liability means that a fault element does not need to be satisfied, but the offence will not criminalise honest errors and a person cannot be held liable if he, or she, had an honest and reasonable belief that they were complying with relevant obligations.

[116].              For instance, GPA, op. cit., p. 3; Animal Medicines Australia, op. cit., p. 3.

[117].              NFF, Submission, op. cit., p. 10.

[118].              Agvet Code, subclause 160A(2). Subclause 160A(4) states that information is relevant information if it: (a) contradicts any information that was given to the APVMA by the applicant in an application and relates to particulars prescribed by the regulations; or (b) shows that the constituent or product may not meet the safety criteria, the trade criteria or the efficacy criteria.

[119].              Agvet Code, proposed subclause 5AA(1).

[120].              Agvet Code, clauses 75 and 78.

[121].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 33.

[122].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 35.

[123].              As mentioned above, the Bill for that Act is currently before Parliament. See: Parliament of Australia, ‘Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017 homepage’, Australian Parliament website.

[124].              Agvet Code, clause 36.

[125].              Agvet Code, subclause 41(2).

[126].              Agvet Code, subclause 43(2).

[127].              Agvet Code, clause 45. Agvet Code, clause 21 sets out how approval of a label takes place.

[128].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill 2017, pp. 21–23.

[129].              Explanatory Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018, p. 37.

[130].              DAWR, Submission, op. cit., p. 10.

[131].              GPA, op. cit., p. 7.

[132].              Ibid.

[133].              GPA, op. cit., p. 8.

[134].              NFF, op. cit., p. 11.

[135].              Administration Act, section 51.

[136].              Administration Act, sections 55 and 56.

[137].              Gene Ethics, op. cit., p. 3.

[138].              NFF, op. cit., p. 5.