Bills Digest No.
63, 2019–20
PDF version [925KB]
Paula Pyburne
Law and Bills Digest Section
21 January 2020
This Bills Digest replaces an earlier
version dated 2 December 2019 to include comments of the Senate Rural and Regional Affairs and Trade
Committee in relation to the Bill.
Contents
History of the Bill
Purpose of the Bill
Structure of the Bill
Background
Committee consideration
Policy position of non-government
parties/independents
Position of major interest groups
Financial implications
Statement of Compatibility with Human
Rights
Schedule 1—key issues and provisions
Other amendments in Schedule 1
Schedule 2—key issues and provisions
Concluding comments
Date introduced: 18
September 2019
House: House of
Representatives
Portfolio: Agriculture
Commencement: Various
dates as set out in 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 January 2020.
History of the Bill
The Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019 (the Bill) comprises measures from two Bills which
were introduced during the 45th Parliament but which lapsed when the Parliament
was prorogued in April 2019 being:
- the Agricultural and Veterinary Chemicals Legislation Amendment
(Operational Efficiency) Bill 2017 (Operational Efficiency Bill)—including a
government amendment[1]
and
- the Agricultural and Veterinary Chemicals Legislation Amendment
(Streamlining Regulation) Bill 2018 (Streamlining Bill).[2]
A Bills Digest was published in respect of each of the
Bills.[3]
The Bills Digest for this Bill replicates much of the
information in the earlier Bills Digests and indicates whether the provisions
are equivalent to, or depart from, the text of the earlier Bills.
Purpose of
the Bill
The purpose of the Bill is:
- to amend various statutes to improve the effectiveness and
efficiency of the national system for regulating agricultural and veterinary
(agvet) chemical products and
- to establish a governance Board for the Australian Pesticides and
Veterinary Medicines Authority Board (APVMA) and formally cease the existing
APVMA Advisory Board.
Structure of
the Bill
The Bill comprises two Schedules.
The amendments in Schedule 1 relates to the earlier Bills
which are detailed above. Schedule 1 to the Bill has 20 Parts most of which
amend the Agricultural
and Veterinary Chemicals Code Act 1994 (the Code Act) as well as
other statutes as set out below:
- Part 1 is about the information to be taken into account by the
regulator—the APVMA—in determining applications
-
Part 2 relates to the approval and registration for prescribed
active constituents, chemical products or labels
- Part 3 details the limits on use of information
-
Part 4 amends the Agricultural and
Veterinary Chemical Products (Collection of Levy Act) 1994 (Collection
of Levy Act) and the Agricultural and
Veterinary Chemicals (Administration) Act 1992 (Administration Act)
in relation to annual returns and record-keeping
-
Part 5 relates to computerised decision-making
- Part 6 is about the preliminary assessment of applications
for approval
- Part 7 allows for the variation or relevant particulars and
conditions
- Part 8 provides for the variation of an approval or registration
during suspension
- Part 9 amends the Administration Act and the Code Act
to make the provision of false and misleading information in specified
circumstances subject to a civil penalty
- Part 10 provides for the suspension or cancellation of
approval or registration for provision of false or misleading information
- Part 11 is about voluntary recalls of chemical products
- Part 12 provides for the notificatin of new information
- Part 13 amends the Administration Act in relation to
annual operational plans
-
Part 14 contains a new definition of the term registered
chemical product
-
Part 15 relates to the supply of registered chemical products
with an unapproved label
- Part 16 relates to the safety, efficacy, trade and labelling
criteria
- Part 17 amends the Administration Act and the Code Act
with respect to notification about variation to the Maximum Residue Limits
Standard and
-
Part 18 clarfies the expiry date of certain products
-
Part 19 makes other amendments to the Administration Act
and the Code Act
-
Part 20 repeals the Agricultural and
Veterinary Chemicals Legislation Amendment (Removing Re-approval and Re-registration)
Act 2014 (2014 Amending Act) in its entirety.
The amendments contained in Schedule 2 to the Bill were not
included in the original form of the earlier Bills which are detailed
above. Rather, they were Government
amendments which were circulated to Senators prior to the debate on the
Operational Efficiency Bill. Those amendments related to the functions and
powers of the Board.
Schedule 2 amends the Administration Act in similar
but not identical terms to the proposed Government amendments the Operational
Efficiency Bill.
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 are identified by way of section
numbers. Amendments to the Agvet Code are 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.[4]
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 APVMA.[5]
Control of the use of agvet chemicals after sale is the responsibility of
individual states and territories.[6]
The Agvet Code is contained in a Schedule to the Code
Act. Under the NRS, the Agvet 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.[7]
Functions of the APVMA
The Administration Act sets out the functions of
the APVMA as follows:
- 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.[8]
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Some of the agvet chemicals approved and registered by the APVMA are crop
protection products (CPP). These include herbicides,[9]
insecticides,[10]
fungicides[11]
and other pesticides and chemical agents.[12]
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[13]
and
- $20.6 billion of Australian agricultural output in 2015–16.[14]
Early reviews of the APVMA
The APVMA was the subject of reviews by the Australian
National Audit Office in 2006[15]
and by the Productivity Commission in 2008.[16]
Both of those reviews made recommendations for improvement.
In response to the reviews and to complaints about the
performance of the APVMA,[17]
the Government enacted the Agricultural and
Veterinary Chemicals Legislation Amendment Act 2013 (2013 Amendment
Act).[18]
The 2013 Amendment Act represented a significant modernisation of the
APVMA’s regulatory activities. The key reforms which were required to be
implemented from 1 July 2014 included:
- new regulatory guidance to industry under the reformed
legislative arrangements
- a structured, upfront pre-application assistance scheme for
applicants
- a system to electronically receive all applications online
-
stricter preliminary assessment arrangements that focus on basic
application requirements (restricting the ability of the applicant to rectify a
defect in their application during this phase of assessment)
- revised maximum assessment timeframes based on the type of
application being made, with increased time for the assessment of certain
products and chemical applications
- additional requirements for the review of registered products and
chemicals (such as the development of work plans for each review) and statutory
timeframes for completing chemical reviews and
- procedural, technical and transitional arrangements, including
limiting the acceptance of additional material from applicants and introducing
requirements to provide notices of certain proposed decisions to applicants.[19]
The reforms in the 2013 Amendment Act were intended
to:
... encourage the development of newer and safer chemicals by
providing more flexible and streamlined regulatory processes with higher levels
of transparency and predictability for business seeking approval for agvet
chemicals to enter the market. The reforms should result in a more
straightforward assessment process that is easier to understand and more cost
effective to administer. In many cases, particularly for products of low
regulatory concern, the reformed system as established by these amendments should
be faster, deliver more predictable outcomes and result in improved health and
environmental protection for the broader community.[20]
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.[21]
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.[22]
Despite the lengthy consultation which led to the 2013
Amendment 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.[23]
2014 Amending Act
The 2013 Amendment Act received Royal Assent on 29
June 2013.[24]
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.[25]
The primary purpose of the Agricultural and
Veterinary Chemicals Legislation Amendment (Removing Re-approval and
Re-registration) Act 2014 (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.[26]
Whilst the majority report of that Committee recommended that the Bill be
passed,[27]
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.[28]
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 (RRAT Committee) for inquiry and report.[29]
Whilst the majority of the RRAT Committee recommended that the Bill be passed,
the Coalition Senators[30]
again provided a Dissenting Report recommending that it should not.[31]
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.[32]
The 2014 Amending Act gave effect to that election
promise.
Agricultural
Competitiveness White Paper
On 4 July 2015, the Government released its Agricultural
Competitiveness White Paper which promised ‘a fairer go for farm businesses by
creating a better business environment with better regulation ....’[33]
The White Paper acknowledges that ‘Australian agricultural
and veterinary (agvet) chemical regulation imposes a large regulatory burden’
that is ‘often disproportionate to the risks these products pose’.[34]
Accordingly it sets out the Government’s intention to lower the regulatory
burden in the following ways:
The Government is putting in place a new approach for the
APVMA to streamline access to products and better manage the risks these
products can pose, while ensuring human health protection.
Working with industry, the Government will limit pre-market
assessments of low- and medium-risk products. The Government will focus its
attention on products that pose the highest risk. The Government will recognise
assessments from accredited third party suppliers and trusted chemical
regulators to reduce the paper work. Where products are available in trusted
overseas countries, the Government will examine risks that are different in the
Australian market, such as where we have different human health requirements,
agricultural practices or environmental assets. In collaboration with industry
and the States and Territories, the Commonwealth will explore opportunities to
improve post-market compliance and national control of chemical use.[35]
Further inquiries
Productivity
Commission
In November 2015, the Treasurer requested the Productivity
Commission to undertake an inquiry into the regulatory burden imposed on
Australian farm businesses, focussing on regulation with a material impact on
domestic and international competitiveness.[36]
The Productivity Commission’s final report, published in
March 2017[37]
noted that, despite numerous reviews and subsequent reforms, concerns remain
about:
- unnecessarily lengthy, complex and duplicative registration
procedures and
- interjurisdictional inconsistencies, particularly in control-of-use
regimes,[38]
which can make it costly and confusing to comply with regulatory requirements.[39]
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.[40]
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.[41]
[emphasis added]
House of Representatives Committee inquiry
In May 2018, the House of Representatives Standing
Committee on Agriculture and Water Resources published a report which was based
on the ANAO report.[42]
The Committee made a number of recommendations. Relevant to this Bills Digest,
the Committee recommended
... the establishment of a Board of Directors for the
Australian Pesticides and Veterinary Medicines Authority. The Committee
recommends that, if a Board is to be established, the Minister for Agriculture
should be consulted in relation to the appointment of Members to provide
additional oversight and further links between the Minister and the APVMA.[43]
As set out under the heading ‘History of the Bill’ above,
the government subsequently introduced the Operational Efficiency Bill (which
included a government amendment to establish a Board) and the Streamlining
Bill.
However, both of the Bills lapsed when the 45th Parliament
was prorogued.
Committee
consideration
Senate Rural
and Regional Affairs and Transport Committee
The Bill was referred to the RRAT Committee for inquiry
and report by 28 November 2019.[44]
The RRAT Committee received ten submissions to its inquiry.
The majority view of the Committee was that the Bill
should be passed.[45]
However, Australian Labor Party (ALP) Senators expressed their ‘deep concerns
about the policy rationale for the implementation of a Governance Board’
because, amongst other things:
The APVMA Governance Board will not have the power to
independently set the APVMA’s strategic direction, drive its operational
performance, set an appropriate risk management framework and ensure greater
accountability. Under the proposed legislation the Minister will continue to
have the power to direct the APVMA and will be provided with the power to
direct the board in the performance of its functions. Therefore, it appears the
Governance Board will just be another layer of regulation which will add
additional cost to Australian farmers.[46]
The Australian Greens (the Greens) Senators did not agree
that the Bill should be passed.[47]
What is not included in the Bill?
A number of submitters to the first Committee’s inquiry
into the Streamlining Bill, including the Western Australian Department of
Primary Industries and Regional Development, the Grains Research and
Development Corporation, and the Community and Public Sector Union, expressed
concerns about amendments which would have allowed the APVMA to make a
legislative instrument to prescribe a scheme in the future that would allow
applicants and the APVMA to use accredited third party providers to undertake
assessment services.[48]
Both Australian Labor Party Senators and Australian Greens
Senators who were members of the first Committee prepared Dissenting Reports
in which they expressed concerns about that measure and recommended either
that the Bill be passed without the measure[49]
or that the Bill be opposed.[50]
Importantly this measure has not been replicated in
the current Bill.
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As stakeholder comments about the amendments in Schedule 1 have been canvassed
in an earlier Bills Digest, they have not been included in this Bills Digest.
Stakeholder comments in relation to the proposed APVMA
Board are set out under the heading ‘Schedule 2’ below.
Senate
Standing Committee for the Scrutiny of Bills
The Senate Standing Committee for the Scrutiny of Bills (Scrutiny
of Bills Committee) made reference to an element in Part 5 of the Bill.[51]
This matter is discussed under the relevant heading below.
Policy
position of non-government parties/independents
As stated above, the Greens Senators on the RRAT Committee
inquiry into the Bill did not support it. They were particularly concerned
about the proposed APVMA Board as they ‘believe greater detail is required to
justify the need for the new Board, and appropriate provisions are required to
ensure community engagement’.[52]
Position of
major interest groups
Submitters to the RRAT Committee were generally in support
of the measures in Schedule 1 to the Bill. However, according to the Grains
Research and Development Corporation (GRDC):
Australia is missing out on productivity improvements through
a lack of commercial investment in novel crop protection solutions including
new or emerging chemical, biological and biochemical technologies. It is
essential that Australian grain growers have access to the same pesticide
technologies to remain internationally competitive with overseas producers.[53]
Similarly Grain Producers Australia (GPA) expressed
disappointment that the Bill addresses:
... a small number of the issues identified, or in some cases
created through previous rounds of legislative reforms. There is clearly a need
for further legislative reform to deliver technology access outcomes for
Australian agriculture including grains.[54]
Financial implications
According to the Explanatory Memorandum,
the Bill will ‘have no impact on the Australian Government Budget’.[55]
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.[56]
Parliamentary
Joint Committee on Human Rights
At the time of writing this Bills Digest the Parliamentary
Joint Committee on Human Rights had not commented on the Bill.
Schedule 1—key
issues and provisions
Part 1—information
to be taken into account
Quick guide to Part 1
The provisions in Part 1 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 amendments in Part 1 of the Bill are identical to
those that were set out in Part 2 of Schedule 1 to the Streamlining Bill.
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Commencement
The provisions in Part 1 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 clause 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.[57]
However, the notice compulsorily triggers a one-off extension to the statutory
time period in which the application must be assessed.[58]
The rules may operate inefficiently where the APVMA is
seeking simple clarifying information.
What the Bill does
Item 2 of Part 1 to the Bill 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 3
of Part 1, the amendment will apply to applications lodged before the
commencement of this item but not yet determined by the APVMA.
Part 2—approval
and registration
Quick guide to Part 2
The amendments in Part 2 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.[59]
The amendments in Part 2 of the Bill are identical to
those that were set out in Part 1 of Schedule 1 to the Streamlining Bill.
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Commencement
The amendments in Part 2 of Schedule 1 to the Bill
commence on the day after the end of the period of 6 months beginning on the
day this Act receives the 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.[60]
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[61]
- before determining certain applications that have passed
preliminary assessment, the APVMA must publish a notice inviting public
submissions[62]
-
the APVMA must approve an active constituent or label, or
register a chemical product, if specified criteria are met[63]
-
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[64]
- 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[65]
- 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 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.[66]
How this is achieved
The Bill operates to create new subdivisions within
Division 2 as an aid to interpretation. Item 6 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 8 inserts proposed Subdivision C—Approval and registration for
prescribed active constituents, chemical products or labels into the Agvet Code.
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.[67]
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.[68]
The APVMA must not make such a determination unless it is satisfied that the kind
of active constituent meets the safety criteria[69]
and
- determine disqualifying criteria that apply to an
application for approval under clause 14C.[70]
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.[71]
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[72]
- 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[73]
- otherwise the application must be refused.[74]
Proposed clauses 14D and 14E of the Agvet 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 10 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.[75]
Review and appeal
Item 12 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 13 and 14
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.
Part 3—limits
on use of information
Quick guide to Part 3
The amendments in Part 3 of Schedule 1 to the Bill extend
the period of time (up to a maximum of five additional years) during which
the APVMA must not use an innovator’s information to support the
registration, variation or reconsideration of another chemical product or
active constituent.
The amendments in Part 3 of the Bill are in equivalent
terms to those set out in Part 3 of Schedule 1 to the Streamlining Bill—with
the exception of items 16 and 17 which are consequential amendments to the
definitions of protected active constituent and protected
chemical product.
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Commencement
The amendments in Part 3 of Schedule 1 to the Bill
commence on the earlier of a single day to be fixed by Proclamation or three
months after Royal Assent.
Current law
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.
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[76]
or where the APVMA is satisfied that the use of the information is in the
public interest.[77]
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.
What the
Bill does
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.[78]
No application for extension will be required.[79]
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.[80]
Accordingly, item 21 in Part 3 of Schedule 1 to 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 in Part 3 of Schedule 1 to 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.[81]
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.
Clarifying the reference to no application being required,
the Explanatory Memorandum to the Bill states:
... 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 priority uses
(including minor 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, (whose
applications would rely on the protected information), allowing them to have
certainty as to when a protection period will end.[82]
Part 4—annual
returns and record‑keeping
Quick guide to Part 4
The provisions in Part 4 amend the Collection of Levy
Act and the Administration Act to simplify reporting requirements
for annual returns. They restrict mandatory reporting to total chemical
product quantities supplied for the previous year.
The amendments in Part 4 are in near equivalent terms to
the amendments in Part 1 of the Operational Efficiency Bill with some
additional clarification of the Constitutional basis for the provisions.
|
Commencement
The amendments in Part 4 of Schedule 1 to the Bill
commence on the day after Royal Assent.
Current law
Currently, levies under the agvet scheme are payable based
on the dollar value of sales (known as leviable disposals)
of registered products.[83]
The interested person in relation to the chemical product is
liable to pay the levy.[84]
For the purposes of the Collection of Levy Act, the
interested person, in relation to a registered chemical product,
is:
- the person (the original applicant) who applied for
the registration or, in the case of a chemical product whose registration has
been renewed, applied for the renewal, or the last renewal of the registration
- if the original applicant has entered into a contract with
another person in relation to the product so that the other person
will or may apply to the APVMA to have the other person’s name entered in the
relevant particulars in relation to the product, or to have a label approved in
relation to containers for the product—the other person
- if the person who would be the interested person was an
individual who has died or is an individual whose affairs are being lawfully
administered by another person—their legal personal representative or the
person’s administrator or
- if the interested person was a body corporate—a successor in law
of that body corporate.[85]
Annual returns
The requirement for annual returns is contained in section
69E of the Administration Act. Under that section a person who imports
into, manufactures in, or exports from Australia, chemical products or active
constituents for proposed or existing chemical products during a financial year
must give the APVMA a return, setting out the respective quantities of
those active constituents, or of the active constituents contained in those
products. The return must be provided to the APVMA within three months after
the end of the year concerned.
Together, these provisions require companies to collate
information on both quantities of active constituents contained in products and
sales of product and to report those matters to the APVMA at different times.
What the
Bill does
Lodging
returns
Item 32 of Part 4 of the Bill repeals section 69E
of the Administration Act.
Item 29 of Part 1 of the
Bill inserts proposed section 35 into the Collection of Levy Act
to align the requirement to lodge a return with the requirement to pay levies.
Proposed subsection 35(1) of
the Collection of Levy Act requires the interested person in
relation to a chemical product who is liable to pay a levy in respect of leviable
disposals of the product to give the APVMA a return. The return must
set out the total quantity of chemical product that was disposed of anywhere in
Australia at any time during a financial year. The return must be provided
before 30 November in the next financial year.
A failure to give the APVMA the required return gives rise
to an offence of strict liability.[86]
The maximum penalty for the offence is 50 penalty units.[87]
In addition, proposed subsection 35(1) is a civil penalty provision.[88]
This is consistent with the APVMA’s existing power (and the position under
section 69E of the Administration Act) to apply to a court of competent
jurisdiction for an order that a person who is alleged to have contravened a
civil penalty provision must pay the Commonwealth a pecuniary penalty.[89]
There is an exception to the general rule about providing
an annual return: a return is not required for a quantity of product that is
less than the quantity prescribed by the Regulations or for a chemical product
that is prescribed by the Regulations.[90]
This exception is in similar terms to the exception in existing subsection
69E(2), which is to be repealed. According to the Explanatory Memorandum to the
Bill, the Regulation may:
... prescribe low quantities of chemical products for which an
interested person is exempt from the requirements to provide an annual return...
[and may also] ... prescribe a limited range of ‘low regulatory concern’ chemical
products that could be exempted from the annual return reporting requirements.[91]
The APVMA must give the Secretary of the Department a
statement setting out the total quantities of each active constituent for each
chemical product covered by those returns before the end of the next financial
year.[92]
For the purposes of this requirement, item 28 of Part 4 in Schedule 1 to
the Bill inserts the definition of the term active constituent
into subsection 3(1) of the Collection of Levy Act.[93]
Keeping
records
Item 30 of Part 4 in Schedule 1 to the Bill inserts proposed
section 37 into the Collection of Levy Act to require an interested
person who is liable to pay a levy in respect of leviable
disposals of the product to keep records. The relevant records are those
that are reasonably necessary to enable the APVMA to find out whether the
requirement to give an annual return has been complied with. The records are to
be retained for six years.
A failure to comply with that requirement gives rise to an
offence of strict liability. The maximum penalty for the offence is 50 penalty
units.[94]
In addition, proposed subsection 37(1) is a civil penalty provision.[95]
Constitutional
basis
Item 30 also inserts proposed sections 37 and
37B into the Collection of Levies Act to set out the Constitutional basis
for sections 35 and 37. These are:
- the census and statistics power: section 51(xi)
-
the incidental matters power: section 51(xxxix)
- the trade and commerce power which relates to trade and commerce
between Australia and places outside Australia; among the States; or within a
Territory, between a State and a Territory or between two Territories: section
51(i)
-
the corporations power in relation to a leviable disposal by a
corporation: section 51(xx) and
-
the Territories power in relation to a leviable disposal that
occurs in a Territory: section 122.
Part 5—computerised
decision‑making
Quick guide to Part 5
The amendments in Part 5 of Schedule 1 to the Bill 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.
The amendments are identical to those set out in Part 4 of
Schedule 1 to the Streamlining Bill.
|
Commencement
The provisions in Part 5 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.[96]
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.[97]
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,[98]
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’.[99]
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.[100]
This measure is consistent with the APVMA’s proposed digital strategy for the period
2018–22.
What the Bill does
Item 36 in Part 5 of Schedule 1 to 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.[101]
Review and appeal
Items 37–41 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.[102]
Scrutiny of Bills Committee comments
The Scrutiny of Bills Committee noted that proposed clause
5F of the Agvet Code would allow the APVMA to arrange for the use of
computer programs for any purpose for which it may make a decision,
exercise a power or comply with an obligation, or do anything related to those
matters.[103]
The Committee’s particular concern was that where
decisions are made by computer rather than by a person there are risks that the
process may operate as a fetter on discretionary power, by inflexibly applying
predetermined criteria to decisions. This was considered to be especially
relevant in the case of more complex or discretionary decisions. For example, the
APVMA may be required to consider or take into account:
- any recommendations made by a co-ordinator
- whether there are reasonable grounds for issuing the permit
pending determination of the application or
- whether there are exceptional circumstances that justify issuing
the permit.
The Scrutiny of Bills Committee concluded that ‘it may be
appropriate for more complex decisions to be made by a person, rather than by a
computer’.[104]
As the Explanatory Memorandum did not address this matter
in a manner that the Committee considered to be adequate, it requested Minister's
more detailed advice as to:
- why it is considered necessary and appropriate to permit the
APVMA to arrange for the use of computer programs for any purpose for which the
APVMA may or must take administrative action
- whether consideration has been given to how automated
decision-making processes will comply with administrative law requirements (for
example, the requirement to consider relevant matters and the rule against
fettering of discretionary power) and
- whether consideration has been given to requiring that certain
administrative actions (for example, complex or discretionary decisions) be
taken by a person rather than by a computer.[105]
The Minister for Agriculture, Senator McKenzie, responded
to the Scrutiny of Bills Committee stating:
The APVMA's decisions about
implementing computerised decision-making will be
guided by the best
practice principles developed by the Administrative
Review Council.
This will ensure that decision-making done by or with the
assistance of computer systems is consistent with the administrative law values
of lawfulness, fairness, rationality, transparency and efficiency ...
Decisions that require interpretation or evaluation of
evidence—such as where fact finding or weighing evidence is required—would not
be made by automated systems. Complex decisions such as these will continue to
be determined by a human decision maker.[106]
The Scrutiny of Bills Committee noted the Minister’s
advice but referred to the absence of ‘limitation on the types of decisions
that will be subject to computerised decision-making on the face of the primary
legislation’.[107]
Accordingly, the Committee recommended that the Bill be amended to limit the
types of decisions that can be made by computers. The Committee also
recommended amendments to the Bill to provide that the APVMA must, before
determining that a type of decision can be made by computers, be satisfied that
it is appropriate for the type of decision to be made by a computer rather than
a person.
Given their concerns the Scrutiny of Bills Committee has
requested further advice from the Minister as to whether the recommended
amendments will be introduced.[108]
Part 6—preliminary
assessments
Quick guide to Part 6
The measures in Part 6 of Schedule 1 to the Bill are
intended to provide the APVMA with greater flexibility to manage application
errors during the preliminary assessment of applications for:
- approval
or registration and
- variation
of approval of registration.
The amendments are in equivalent terms to those which were
previously set out in Part 2 of the Operational Efficiency Bill.
|
Commencement
The measures in Part 6 of Schedule 1 to the Bill commence 12
months after Royal Assent.
Current law—approvals and variations
Prior to the enactment of the 2013 Amendment Act,
the Department of Agriculture was concerned that the APVMA had to:
... go back to registrants with every small defect it finds
with an application ... They have to continually do this and it takes an
inordinate amount of time, and lots of letters back and forth to be able to
accept the application, because of these small deficiencies.[109]
In order to remedy this perceived defect in the process,
the 2013 Amendment Act did two things. First, it prescribed what
it meant to meet the application requirements.[110]
Second, it gave the APVMA one month to complete a preliminary assessment
of an application.[111]
An application meets the application requirements
if:
- it is lodged with the APVMA in the approved manner and form, is
accompanied by the prescribed fee and contains the required information
- the constituent, product or label in relation to which the
application is made complies with any requirement prescribed by the Regulations
- any requirement prescribed by another provision of the Agvet Code
in relation to the application has been complied with and
- any amount (including an amount in respect of a tax or penalty)
that is due and payable by the applicant to the APVMA has been paid.
Where the application appears to meet the
application requirements, the APVMA must notify the applicant that the
application has passed the preliminary assessment, in writing, within 14 days
of making that preliminary assessment. The notice must state, amongst other
things, that the application has passed preliminary assessment, and it must set
out any matters prescribed by the Regulations.[112]
In addition, the APVMA must publish a summary of the application that includes
any details prescribed by the Regulations.[113]
Where the application does not appear to meet the
application requirements, the APVMA must refuse the application.[114]
The requirement for an application to undergo a
preliminary assessment was a key feature of the 2013 Amendment Act—an
application for a variation of an approval or registration is the subject of a
preliminary assessment process in equivalent terms.[115]
What the Bill does
The requirement that the APVMA complete a preliminary
assessment of the application within one month after it is lodged remains.
However, the Bill removes the requirement that the APVMA refuse an application
at first instance if it does not appear to meet the application
requirements.
Application for approval
Item 46 of Part 6 repeals subclause 11(3) and
inserts proposed subclauses 11(3) and 11(3A) into the Agvet Code. Under proposed
subclause 11(3) where it appears to the APVMA, after completing a
preliminary assessment of the application, that the application does not
meet the application requirements but that the defects in the application can
reasonably be rectified, the APVMA must give written notice to the applicant
within 14 days setting out the relevant defects and requiring that they are
rectified within one month.
Item 45 of Part 6 of the Bill amends subclause
11(2) of the Agvet Code so that where an applicant who has been given a notice
to rectify a defect does so within the specified time, the APVMA must give the
applicant a written notice that the application has passed the preliminary
assessment and will be determined under the relevant provisions of the Agvet
Code.
Proposed subclause 11(3A) of the Agvet Code
provides that where the APVMA is not satisfied that defects in the application
can reasonably be rectified, or the defects are not rectified within the specified
time, the APVMA must refuse the application.
Application for variation
The Agvet Code allows a holder[116]
to apply to the APVMA for a variation of the relevant particulars or conditions
of:
- the approval of an active constituent
- the registration of a chemical product or
- the approval of a label for containers for a chemical product.[117]
An application for such a variation must meet the
application requirements.[118]
Clause 28 of the Agvet Code sets out the requirement for a
preliminary assessment of such an application in equivalent terms to clause 11.
Items 47 and 48 of Part 6 in Schedule 1 to the Bill amend subclauses
28(2) and 28(3) in equivalent terms to items 45 and 46, as discussed above,
where a holder makes an application for a variation, and the application
contains defects that can reasonably be rectified.
Current law—permits
All agricultural and veterinary chemical products sold in
Australia must be registered by the APVMA. In addition:
The APVMA administers a permits scheme that allows for the legal
use of chemicals in certain ways that are contrary to the label instructions
or, in certain circumstances allows for the limited use of an unregistered
chemical product.[119]
A person may apply to the APVMA for a permit in respect of
an active constituent for a proposed or existing chemical product, or in
respect of the chemical product.[120]
The application must meet the application requirements.[121]
Like approvals and variations, applications for permits
are subject to a preliminary assessment process. However, the process differs
because it already contains the right for the APVMA to give notice to an
applicant to rectify defects.[122]
What the Bill does
Items 49 and 50 of Part 6 in Schedule 1 to
the Bill make minor amendments to the wording in existing subclauses 110A(2) and
110A(3) of the Agvet Code so that they are in equivalent terms to the
preliminary assessment provisions for applications for approval which are
discussed above.
Part 7—variation of relevant particulars and conditions
Quick guide to Part 7
The amendments in Part 7 of Schedule 1 to the Bill amend
the Agvet Code to enable the APVMA to vary the relevant particulars or
conditions of an approval of an active constituent, a registration of a
chemical product, or an approval of a label for containers for a chemical so
that they are different from the original application.
The amendments are in equivalent terms to those which were
previously in Part 3 of the Operational Efficiency Bill.
|
Commencement
The provisions of Part 7 of Schedule 1 to the Bill commence
on the day after the end of the period of three months after Royal Assent.
Current law
A stated above, a holder may apply to the
APVMA for a variation of the relevant particulars or conditions of:
- the approval of an active constituent
- the registration of a chemical product or
-
the approval of a label for containers for a chemical product.[123]
Under existing subclause 29(1) of the Agvet Code, the
APVMA must vary the relevant particulars or conditions if it is
satisfied that the application meets the application requirements and that the
variation would meet applicable statutory criteria and established standards as
required by paragraphs 29(1)(b)–(d) of the Agvet Code. If the application does
not satisfy those provisions, the APVMA must refuse the application.[124]
Essentially those paragraphs only give the APVMA the
authority to approve the variation precisely as it is set out in the relevant
application.
What the
Bill does
Item 54 of Part 7 in Schedule 1 to the Bill amends
paragraphs 29(1)(b)–(d) of the Agvet Code by deleting references to a variation
‘in accordance with the application’ and substituting references to a variation
of particulars or conditions ‘in a particular way (which may not be the same
way as set out in the application)’. This will allow the APVMA to vary an
approval or registration in a way which differs from the application.
Items 52 and 53 of Part 7 of the Bill make
consequential amendments to the notice provisions in existing clause 8S to
require the APVMA to give an applicant a written notice of its intention—prior
to approving a variation of an approval or registration in a way other than
that set out in the application. The effect of the amendments is to provide the
applicant with the opportunity to make submissions to the APVMA about the
proposal.
Item 55 of Part 7 of the Bill is also a
consequential amendment. It inserts proposed paragraph 167(1)(ca)
into the Agvet Code so that a decision to vary relevant particulars or
conditions in a way other than set out in the application for variation is
subject to review by the Administrative Appeals Tribunal.
Part 8—variation of approval or registration during suspension
Quick guide to Part 8
The provisions of Part 8 in Schedule 1 to the Bill amend
the Agvet Code so that the APVMA may implement practical measures to deal
with suspended label approvals or registrations and address the reason for
that suspension.
The amendments in items 60–63 are in equivalent
terms to those which were previously set out in Part 4 of the Operational
Efficiency Bill. The amendments in items 57–59 and items 64–65
are in equivalent terms to those which were previously in Part 11 of Schedule
1 to the Streamlining Bill.
|
Commencement
The provisions of Part 8 of Schedule 1 to the Bill commence
on the day after the end of the period of three months after Royal Assent.
Current law
The Agvet Code provides for both:
- 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,[125]
the label does not meet the labelling criteria, or it does not comply with a
requirement prescribed by the Regulations.[126]
The Agvet Code provides that an approval is taken not to be in force during any
period in which it is suspended.[127]
The suspension is made by entering the information, including the period of the
suspension, into the APVMA file.[128]
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.[129]
What the Bill does
Items 57–59 of Part 8 of Schedule 1 to the Bill
amend clause 42 of the Agvet Code. The amendments allow 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.
Item 61 of Part 8 of Schedule 1 to the Bill inserts
proposed subclauses 43(4) and (5) into the Agvet Code to address this
problem.
In particular, proposed subclause 43(4) provides
that the suspension of an approval[130]
of a label for containers for a chemical product does not prevent a person from
requesting a variation of the relevant particulars of the approval, provided
that the variation relates to the reasons for the suspension of the approval.
This means that suspended label approvals may be rectified without first
revoking the suspension.
Part 9—false and misleading information
Quick guide to Part 9
The provisions in Part 9 of Schedule 1 to the Bill amend
both the Administration Act and the Agvet Code to establish civil
pecuniary penalties for contraventions of the prohibition against giving
false or misleading information.
The amendments are in equivalent terms to those which were
previously set out in Part 5 of the Operational Efficiency Bill.
|
Commencement
The provisions of Part 9 in Schedule 1 to the Bill commence
three months after Royal Assent.
Current law
Importation offence
Subsection 69B(1) of the Administration Act
prohibits a person from importing into Australia:
- an active constituent for a proposed or existing chemical product
that is not approved or
- a chemical product that is not a registered chemical product, a reserved
chemical product or an exempt chemical product.
Similarly, a person is prohibited from arranging such
importation into Australia, on behalf of another person who, at the time of the
arrangements, is neither a resident of, nor carrying on business in, Australia.
Subsection 69B(1AA) of the Administration Act
provides that a person who contravenes these prohibitions commits an offence
(known as an importation offence)—the maximum penalty for which is 300 penalty
units.[131]
However, an offence will not be committed if the person has the APVMA’s written
consent for the relevant importation.[132]
False and misleading information
Subsection 69ER(1) of the Administration Act provides
that where a person who has applied to the APVMA for written consent (as above)
gives information (whether orally or in writing) that the person knows to be
false or misleading in a material particular, the person commits an offence. In
the alternative, the offence arises if the person produces a document that the
person knows to be false or misleading in a material particular without:
- indicating to the person to whom the document is produced that it
is false or misleading and the respect in which it is false or misleading and
- providing correct information to that person if the person
producing the document is in possession of, or can reasonably acquire, the
correct information.
Similarly to the importation offence, the maximum penalty
for the offence is 300 penalty units.[133]
Lesser offence
Subsection 69ER(2) of the Administration Act provides
that a person commits an offence if, when complying with a requirement made by
an inspector under, or for the purposes of, or in connection with any provision
of Part 7A,[134]
Part 7AA or Part 7AB of the Administration Act the person gives
information that the person knows to be false or misleading in a material
particular. An offence is also committed if the person produces a document that
the person knows to be false or misleading in a material particular without:
- indicating to the person to whom the document is produced that it
is false or misleading and the respect in which it is false or misleading and
- providing correct information to that person if the person
producing the document is in possession of, or can reasonably acquire, the
correct information.
In this case, the maximum penalty for the offence is 60
penalty units.[135]
What the Bill does
The 2013 Amendment Act introduced a range of
enforcement options for the APVMA which included seeking civil penalty orders,
issuing infringement notices, accepting and enforcing undertakings, seeking
injunctions, requiring claims to be substantiated and issuing formal warnings.
However, while it created two offences in section 69ER of
the Administration Act, it did not create equivalent rights to seek
civil penalty orders.
Item 68 of Part 5 of the Bill addresses this
problem by inserting proposed subsections 69ER(3)–(5) into the Administration
Act.
Proposed subsections 69ER(3) and (4) are in
equivalent terms to existing subsections 69ER(1) and (2) respectively. Proposed
subsection 69ER(5) of the Administration Act specifies that those
subsections are civil penalty provisions. Accordingly if they are breached, the
APVMA may apply to a court of competent jurisdiction for an order that a person
pay the Commonwealth a pecuniary penalty.[136]
Item 70 of Part 9 in
Schedule 1 to the Bill amends the equivalent offences for false and misleading
information in the Agvet Code by inserting proposed subclauses 146(3)–(5)
which are in similar terms to proposed subsections 69ER(3)–(5) being
inserted into the Administration Act. The difference between the
provisions is that proposed subsection 146(3) makes reference to matters
referred to in clause 5A,[137]
5B,[138]
5C[139]
or 5D[140]
or subclause 123(1)[141]
of the Agvet Code rather than to Part 7A, Part 7AA or Part 7AB of the Administration
Act.
Amount of civil penalty
The amount of the pecuniary penalty is worked out under
section 69EJA of the Administration Act. Importantly, it applies not
only to persons but to bodies corporate.[142]
By a body
corporate
Subsection 69EJA(1) of that Act provides that the
pecuniary penalty for a contravention of a civil penalty provision by a body
corporate must not exceed five times the amount of the maximum monetary penalty
that could be imposed by a court if the body corporate were convicted of an
offence constituted by the same conduct. Subclause 145AA(1) of the Agvet Code
is in equivalent terms.
This means that for a contravention of proposed
subsection 69ER(3) of the Administration Act or proposed subclause
146(3) of the Agvet Code, a body corporate would be liable for a maximum
penalty of 1,500 penalty units—being $315,000. For a contravention of proposed
subsection 69ER(4) of the Administration Act or proposed subclause
146(4) of the Agvet Code, a body corporate would be liable for a maximum
penalty of 300 penalty units—being $63,000.
By an
individual
Subsection 69EJA(2) of the Administration Act and
subclause 145AA(2) of the Agvet Code provide that the penalty for an individual
for contravening a civil penalty provision must not exceed three times the
amount of the maximum monetary penalty that could be imposed by a court on an
individual convicted of an offence constituted by the same conduct.
This means that for a contravention of proposed
subsection 69ER(3) of the Administration Act or proposed subclause
146(3) of the Agvet Code, an individual would be liable for a maximum
penalty of 900 penalty units—being $189,000. For a contravention of proposed
subsection 69ER(4) of the Administration Act or proposed subclause
146(4) of the Agvet Code, an individual would be liable for a maximum
penalty of 180 penalty units—being $37,800.
Problems that are addressed by
civil penalties
Prior to the enactment of the 2013 Amendment Act
all of the offences in the Agvet Code were criminal offences—most (but not all)
of which were strict liability offences. The standard of proof in a criminal
case is ‘beyond a reasonable doubt’. To establish an offence of strict
liability it is only necessary to prove that the relevant conduct or event took
place. However the defence of ‘mistake of fact’ (honest and reasonable mistake)
is open to those who mistakenly but reasonably believe certain facts to exist
which, if true, would have shielded them from liability. Those offences, if
proven, generally allowed for financial penalties to be paid rather than
imposing a term of imprisonment.
Unfortunately, the APVMA had limited success in
prosecuting holders of registrations and approvals in circumstances where
alleged breaches of the Agvet Code had occurred.[143]
That being the case, the 2013 Amendment Act provided for existing
offence provisions to also be civil penalty provisions to enable the APVMA to apply
to the court for a civil penalty order against a person who has contravened a
civil penalty provision. In that case, the standard of proof is lower being ‘on
the balance of probabilities’.
The tension within the Agvet statutes, then, is that a pecuniary penalty may be higher than an amount payable as a fine were
the person prosecuted under a criminal offence, even though the conduct is
essentially the same.[144]
Part 10—suspension or cancellation of approval or
registration
Quick guide to Part 10
The amendments in Part 10 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.
The amendments are in equivalent terms to those which were
previously set out in Part 9 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 10 of Schedule 1 to the Bill
commence three months after Royal Assent.
Current law
At present, clause 38A of the Agvet 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.[145]
What the Bill does
Part 10 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 73 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 Agvet Code for providing false or
misleading information.
Part 11—voluntary recalls
Quick guide to Part 11
The amendments in Part 11 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).
The amendments are in equivalent terms to those which were
previously contained in Part 6 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 11 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’.[146]
Existing clause 106 of the Agvet Code cross references
those powers.
What the Bill does
Items 75 and 76 of the Bill amend clause 100
of the Agvet Code to provide for the voluntary recall of chemical products.
Item 77 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.[147]
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.[148]
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.[149]
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 or fails to give the notice.[150]
This is also a civil penalty provision.
Part 12—notification of new information
Quick guide to Part 12
The amendments in Part 12 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.
The amendments are in equivalent terms to those which were
previously contained in Part 7 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 12 of Schedule 1 to 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.[151]
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 80 of Part 12 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 84 of Part 12 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 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.
The amendments are in equivalent terms to those which were
previously contained in Part 13 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 13 of Schedule 1 to the Bill
commence on the first 1 January to occur after the day this Act receives
the Royal Assent.
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.[152]
That report must be prepared in accordance with the requirements of section 35
of the Public
Governance, Performance and Accountability Act 2013 (PGPA Act).
The Corporate Plan must include, amongst other things:
- how the entity will achieve its purposes[153]
- how the entity’s performance will be measured and assessed,
including for the purposes of preparing its annual performance statements[154]
- the key strategies and plans that the entity will implement in
each year covered by the plan to achieve its purposes[155]
- a summary of the risk oversight and management systems in place
for each year of the plan.[156]
In addition, Part 6 of the Administration Act
requires that an annual operational plan must be prepared and approved by the
Minister.[157]
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 91 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 92–94 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.
According to the Explanatory Memorandum to the Bill:
Removing the requirement for the APVMA to prepare an annual
operational plan would remove duplicative reporting that is required by the Public
Governance, Performance and Accountability Act 2013.[158]
Part 14—Definition of registered chemical product
Quick guide to Part 14
The amendments in Part 14 of Schedule 1 to the Bill
address an inconsistency in the Agvet Code.
The amendments are in equivalent terms to those which were
previously set out in Part 8 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 14 of the Bill commence on the day
after this Act receives the Royal Assent.
Current law
Currently clause 3 of the Agvet 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 96 of Part 14 in Schedule 1 to the Bill
repeals that definition and inserts a new cross reference to proposed clause
5AA.
Item 97 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[159]
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.[160]
Part 15—supply of registered chemical products with unapproved
label
Quick guide to Part 15
The amendments in Part 15 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.
The amendments are in equivalent terms to those which were
previously contained in Part 10 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 15 of Schedule 1 to the Bill commence
on the day after Royal Assent.
Current law
Currently clause 21 of the Agvet 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:
- determines
the particulars prescribed by the regulations that are appropriate to be
contained on the label
- gives a distinguishing
number to the label
- records the following
information in the relevant APVMA file:
- the
name of the person who applied for the approval as the holder of the approval
- the
name of any nominated agent for the approval
- the
distinguishing number
- the
instructions and any particulars that are to be contained on the label
- any
other particulars prescribed by the Regulations and
- 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 98–101 in Part 15 of Schedule 1 to the Bill
substitute existing references to relevant particulars in clause
81 with references to minimum information.
Item 103 inserts proposed subclause 81(5) into
the Agvet Code 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 102 in Part 15 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.[161]
Part 16—safety, efficacy, trade and labelling criteria
Quick guide to Part 16
The amendments in Part 16 of Schedule 1 to the Bill
address existing anomalies in the Agvet Code in relation to the safety,
efficacy, trade and labelling criteria.
The amendments are in equivalent terms to those which were
previously set out in Part 12 of Schedule 1 to the Streamlining Bill.
|
Commencement
The amendments in Part 16 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) of the Agvet Code, 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 105 in Part 16 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:
- 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
- any
decisions or evaluations made by regulators of agricultural or veterinary
chemicals in a foreign country and
- 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 106 in Part 16 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.
Part 17—Maximum Residue Limits Standard
Quick guide to Part 17
The provisions in Part 17:
- amend
the Agvet Code to simplify and provide flexibility in the timing of the
notification that must be provided to Food Standards Australia New Zealand (FSANZ)
by the APVMA in relation to an approval, registration, variation or person
under the Agvet Code that would require a corresponding variation to the
Maximum Residue Limits Standard
- make a
consequential amendment to the Administration Act.
Items 110 and 111 are in equivalent terms to those contained
in Part 6 of Schedule 1 to the Operational Efficiency Bill.
The amendments to the Administration Act were not
contained in either the Streamlining Bill or the Operational Efficiency Bill.
|
Commencement
The provisions of Part 17 in Schedule 1 to the Bill commence
on the day after Royal Assent.
Background
The APVMA registers and approves all agvet chemicals in
Australia and sets maximum residue limits (MRLs) for these chemicals. Levels
are set based on how much of the chemical is needed to control pests and/or
diseases. The product's chemistry, metabolism, analytical methodology and
residue trial data are also assessed.[162]
The MRLs apply to agvet chemicals in agricultural produce—particularly
produce entering the food chain. They are set at levels that are not likely to
be exceeded if the agricultural or veterinary chemicals are used in accordance
with approved label instructions.[163]
Current law
Existing subsection 8E(1) of the Agvet Code requires the
APVMA to notify FSANZ if an approval, registration, variation or permit
proposed under the Code would be likely to require a variation to the Maximum
Residue Limits Standard.[164]
Currently the notice must be given to FSANZ within 28 days after the APVMA
completes a preliminary assessment of the application.[165]
That notification triggers the process to be carried out
by FSANZ including the preparation of a dietary exposure assessment of the
proposed variation, any relevant consultation about the dietary exposure
assessment and the eventual publication of the variation.[166]
What the Bill does
Item 111 of Part 17 in Schedule 1 to the Bill
repeals and replaces paragraph 8E(2)(c) of the Agvet Code so that the notice is
to be given to FSANZ before the approval, registration, variation or permit is
given, made or issued.
According to the Explanatory
Memorandum to the Bill this will ‘provide the APVMA and FSANZ with the
flexibility to agree on appropriate timeframes for notification’.[167]
Item 109 of Part 17 in Schedule 1 to the Bill
repeals and replaces subsection 7A(1) of the Administration Act. Proposed
subsection 7A(1) specifies that the APVMA is authorised to approve standards
for residues of chemical products in protected commodities. Currently, the
subsection merely provides that the APVMA is to publish such standards.
Part 18—expiry date
Quick guide to Part 18
The amendment in Part 18 of Schedule 1 to the Bill amends
the definition of expiry date in the Agvet Code to make clear
that is a reference to the date after which a chemical product must not be
used.
The amendment is in equivalent terms to that in Part 7 of
the Operational Efficiency Bill.
|
Commencement
The provision in Part 18 of Schedule 1 to the Bill commences
on the day after Royal Assent.
What the
Bill does
Item 33 of Part 7 of the Bill amends the definition
of expiry date in section 3 of the Agvet Code to omit the
reference to ‘should’ and substitute a reference to ‘must’. This is intended to
ensure that the definition ‘reflects the timeframe in which the use of a
chemical product is safe, effective and does not cause unmanageable risks’.[168]
Other amendments in Schedule 1
The provisions in Part 19 of Schedule 1 the Bill are minor
consequential amendments to the Administration Act and the Agvet Code.
The amendment in Part 20 of Schedule 1 to the Bill repeals the 2014 Amending
Act.
The relevant amendments in Parts 19 and 20 commence on the
day after Royal Assent.
Schedule 2—key
issues and provisions
Commencement
The amendments in Schedule 2 commence on the earlier of a
single day to be fixed by Proclamation or 12 months after Royal Assent.
Background
As stated above, the House of Representatives Standing
Committee on Agriculture and Water Resources published a report in 2018 in
which it recommended:
... the establishment of a Board of Directors for the
Australian Pesticides and Veterinary Medicines Authority. The Committee
recommends that, if a Board is to be established, the Minister for Agriculture
should be consulted in relation to the appointment of Members to provide
additional oversight and further links between the Minister and the APVMA.[169]
The amendments in Schedule 2 to the Bill are consistent
with that recommendation.
Current law
Currently, Part 3 of the Administration Act
establishes an Advisory Board, the function of which is to provide advice and
make recommendations to the Chief Executive Officer in relation to the
performance of a function or the exercise of a power of the APVMA.[170]
Advisory Board members did not represent particular
interests, and were appointed by the minister based on experience in the
regulation of chemical products, the agricultural chemical industry, primary
production, environmental toxicology, consumer interests, public health, and
work health and safety.[171]
However, there are currently no members appointed to the Advisory
Board. Previous appointments expired in November 2015.[172]
Establishing
the Board
Item 11 of Schedule 2 to the Bill repeals Divisions
2, 3 and 4 of Part 3 of the Administration Act which currently provide
for the Advisory Board, the appointment of its members and the Advisory Board’s
procedures respectively.
Item 11 also inserts proposed Division 2—Board
of the APVMA.
Within new Division 2, proposed section 14
establishes the Board of the APVMA. Items 1–3 of Schedule 2 to the Bill
make consequential amendments to the definitions in section 4 of the Administration
Act to ensure that references to the Board are not references to the former
Advisory Board but to the Board established under proposed section 14.
The functions of the Board are:
- to ensure the proper, efficient and effective performance of the
APVMA’s functions which are contained in section 7 of the Administration Act
- to determine objectives, strategies and policies to be followed
by the APVMA and
- to do anything incidental to or conducive to the performance of
those functions.[173]
Board
members
The Board is to consist of the Chair, the Chief Executive
Officer and three other members.[174]
To assist in its work, the Board may establish committees which may consist of
those persons that it determines. Committee members may also be Board members.[175]
Board members are to be appointed by the Minister, in
writing, on a part-time basis[176]
for a period not exceeding four years.[177]
A person who is appointed to the Board is eligible to be reappointed on one
further occasion.[178]
A person must not be appointed as a Board member unless the
Minister is satisfied that the person has appropriate qualifications, skills or
experience in one or more of the following fields:
- financial management
- law
-
risk management
- public sector governance
-
science (including agricultural science and veterinary science)
-
public health or occupational health and safety.[179]
The Remuneration Tribunal is to determine the remuneration
to be paid to an appointed Board member.[180]
In the absence of such a determination the member is to be paid the
remuneration that is prescribed by the Regulations.
The Minister may terminate the appointment of a Board
member, amongst other things:
- for misbehaviour
- an inability to perform his or her duties because of physical or
mental incapacity
- where the member becomes bankrupt or applies to take the benefit
of any law for the relief of bankrupt or insolvent debtors
- if the person engages in paid work that conflicts or could
conflict with the performance of his or her member’s duties or
-
if the Minister is satisfied that the appointed Board member’s
performance has been unsatisfactory.[181]
Meetings of
the Board
The Chair may convene a meeting at any time but must
convene at least four meetings each calendar year.[182]
A quorum is constituted by a majority of Board members.[183]
The person presiding at the meeting of the Board has a
deliberative vote and, if the votes are equal, a casting vote.[184]
The Board must give the Secretary of the Department a copy
of the minutes and the Board papers within 20 business days of the date of the
meeting.[185]
In addition the Board must give the Secretary of the Department a copy of any
other document he, or she, has requested within 20 business days of the date
that the request was made.
Ministerial directions
The Bill empowers the Minister to give written directions
to the Board about the performance of its functions or the exercise of its
powers,[186]
provided that the Minister:
- has first given the Board a written notice that the Minister is
considering giving the direction and
- has given the Board an adequate opportunity to discuss with the
Minister the need for the proposed direction.
In that case, the Board must comply with the direction.[187]
A copy of any direction given by the Minister to the Board in accordance with proposed
subsection 27G(1) of the Administration Act is to be laid before
each House of the Parliament within 15 sitting days of giving the direction.[188]
Other
matters relating to the Board
Under the Bill, the Board replaces the CEO as the accountable
authority under the PGPA Act.[189]
As a result the PGPA Act will impose general duties on Board members
(other than the CEO).[190]
Stakeholder
comments
Independence
of the Board
The NSW Farmers Association stated the ‘need for members
of the APVMA Board to be selected on a skills basis and continue to allow the
organisation to operate independently.[191]
Similarly, the National Farmers’ Federation (NFF) stated
that it:
... is not opposed to the establishment of a skills-based APVMA
governance Board, on the understanding that establishment of such a Board has
been recommended as the best mechanism to strengthen the APVMA’s governance
arrangements and assist the regulator to manage operational, financial and performance
matters—and drive improvement in those areas.[192]
However, it should be noted that this is a small Board.
Essentially, it has four members plus the CEO. If for some reason the CEO has
to recuse him, or herself, from voting on a matter, the person presiding,
probably the Chair, will have the casting vote. Whilst the Bill provides for
persons with a range of skills to be members, it remains to be seen what the
skill set of the Board in its final form will be; and whether the Board will
‘be effective and protect the independent evidence- and science-based
decision-making of the APVMA’.[193]
According to the Explanatory Memorandum to the Bill, ‘a
five member Board is appropriate as it balances the need to provide the
necessary skills to effectively govern the APVMA with the cost of maintaining
the Board’.[194]
The issue of cost was raised by some submitters to the RRAT Committee.
Cost of the
Board
Grain Producers Australia (GPA) expressed support for the
establishment of a governance board for the APVMA. However, it stressed that it
should be:
... a skills based board and independence of directors will be
essential. To ensure absolute public confidence in the independence of a skills
based APVMA board, the costs associated with the appointment and operation of
this board should be fully funded by the Australian Government in annual
appropriation budgets rather than funded through the APVMA by registrant levies
which are indirectly supported by producers through pesticide sales.[195]
CropLife Australia was also critical of the expected costs
of the Board stating:
The direct and associated costs of a Board should be fully
funded by government as an appropriate contribution to the effective operations
of the Regulator. Without government funding, the cost of a Governing Board would
be an additional direct cost to the farming sector, further limiting access to
crucial crop protection products by farmers. The $600,000 a year cost
attributed to the APVMA Governing Board, as referenced in Senate Estimates in
May 2018, is an exorbitant and unnecessary cost to what is already one of the
world’s most expensive agricultural chemical regulators for industry.[196]
Role of the Chief
Executive Officer
Currently, Part 4 of the Administration Act sets
out the terms and conditions of the Chief Executive Officer (CEO). The Bill
amends subsection 32(1) so that the CEO is ‘responsible for the day-to-day
management and decision making of the APVMA’. In carrying out his, or her,
duties the CEO is to act in accordance with the objectives, strategies and
policies determined by the Board as part of its functions.[197]
Importantly, the Board may give written directions to the
CEO about the performance of the CEO’s duties. However, the Board must not give
such a direction unless the Board has first:
- given the CEO a written notice stating that the Board is considering
giving the direction and
- given the CEO an adequate opportunity to discuss with the Board
the need for the proposed direction.[198]
Items 16–26, 28 and 30 make
consequential amendments to Part 4 of the Administration Act to
substitute references to Minister with references to the Board to make clear
that it is the Board who appoints the CEO. However, the Board must consult the
Minister before appointing the CEO[199]
or terminating that appointment. [200]
According to the Explanatory Memorandum:
The Bill will also establish a governance Board for the APVMA
and cease the existing APVMA Advisory Board. Establishing an APVMA Board will strengthen
the APVMA’s governance arrangements and provide the necessary oversight to
help the regulator manage operational, financial and performance matters.[201]
About corporate governance
In general terms, corporate governance encompasses the
arrangements by which the power of those who implement the strategy and
direction of an organisation is both delegated and limited to ensure the
organisation’s success, taking into account the environment in which the
organisation is operating ...
Generally, governance arrangements for statutory authorities
should strike a balance between providing flexibility to enable authorities
to undertake their legislated functions and the policies of the government of
the day ... the ability of an authority to act independently of government is
drawn by the authority’s legislative framework. The greater an organisation’s
independence, the greater is the need for robust governance mechanisms as a
means of ensuring that it is discharging its delegation appropriately. To the
extent that independence is combined with power, that need is heightened.
Given the independence of statutory authorities, this is a critical factor
for the public sector. Robust governance provides assurance, not only to
government, but also to the Parliament and the public, that those in the community
affected by the activities of an authority are protected from the
inappropriate exercise of power.
Governance should establish appropriate structures and
behaviour to enhance the capacity of government and statutory authorities to
achieve greater clarity in their relationship and in aligning expectations
with performance. Good governance structures also establish appropriate
processes to resolve any tensions which may emerge between the manner in
which authorities perform their legislated functions and the policies of the
Government of the day. They should also provide a mechanism for that part of
the community upon which an authority has impact to have input through
consultation of some kind. The benefits include greater openness in
decision-making and consequentially greater clarity for Parliament and the
public regarding government priorities and expectations and the performance
of statutory authorities.[202]
|
The APVMA has extensive functions including providing
information to the Governments and authorities of the Commonwealth, the States
and the participating Territories about approved active constituents for
proposed or existing chemical products, registered chemical products, reserved
chemical products and approved labels for containers for chemical products and
to co-operate with those Governments and authorities on matters relating to the
management and control of chemical products.[203]
Given the amount of legislative change in relation to
agvet chemicals over the last six years, and the criticisms of the
effectiveness of those changes, it is appropriate that a Board is established
to ensure the proper, efficient and effective performance of the APVMA. The
rationale for creating a Board is as valid today as it was when the House of
Representatives Standing Committee on Agriculture and Water Resources made its
recommendation in May 2018.[204]
The Bill imposes a high level of scrutiny by the Minister
and the Secretary on the activities of the Board. On the one hand this may give
the appearance of undermining the independence of the Board. However, this
needs to be balanced against the need to ensure that the APVMA is operating
optimally and that the Minister is fully informed if it is not.
On 5 September 2019 Minister for Agriculture, Senator
McKenzie, announced that there would be a review of ‘every facet of
agricultural and veterinary chemical regulation’ stating:
The independent review will tell us a lot about how we can
modernise our agricultural and veterinary chemical regulatory framework—and how
we can safely improve farmer and community access to agvet chemical products.[205]
It would be prudent to have the proposed Board in place to
assist in providing information to that review.
Concluding comments
The Bill contains most of the measures included in two previous
Bills—the Operational Efficiency Bill) and the Streamlining Bill. The measures
mostly have been widely welcomed by stakeholders.
The Bill establishes the APVMA Board. However, the size of
the Board and the oversight of the Board’s activities by the Government may not
deliver the level of independence that some stakeholders would prefer.
[1]. Parliament
of Australia, ‘Agricultural
and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill
2017 homepage’, Australian Parliament website.
[2]. Parliament
of Australia, ‘Agricultural
and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill
2018 homepage’, Australian Parliament website.
[3]. P
Pyburne, Agricultural
and Veterinary Chemicals Legislation Amendment (Operational Efficiency) Bill
2017, Bills digest, 78, 2017–18, Parliamentary Library, Canberra, 9
September 2018; P Pyburne, Agricultural
and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill
2018, Bills digest, 53, 2018–19, Parliamentary Library, Canberra,
11 February 2019.
[4]. Australian
Pesticides and Veterinary Medicines Authority (APVMA), ‘Overview of agvet chemical regulation’,
APVMA website, last updated 1 August 2017.
[5]. APVMA,
‘The role of the APVMA’, APVMA
website, last updated 24 October 2018.
[6]. Explanatory
Memorandum, Agricultural Pesticides and Veterinary Chemicals Legislation
Amendment (Streamlining Regulation) Bill 2018, p. 2.
[7]. APVMA,
‘Legislative framework’, APVMA
website, last updated 22 October 2019.
[8]. Agricultural and
Veterinary Chemicals (Administration) Act 1992, section 7.
[9]. 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).
[10]. Ibid.
These are chemicals which aim to control insects in plants and crops.
[11]. Ibid.
These are products whose purpose is to prevent or manage fungal diseases in
plants.
[12]. Ibid.
[13]. Ibid.,
p. ii.
[14]. Ibid.,
p. iii.
[15]. Australian
National Audit Office (ANAO), Regulation of
pesticides and veterinary medicines: Australian Pesticides and Veterinary
Medicines Authority, Audit report, 14, 2006–07, ANAO, Barton, ACT, 2006.
[16]. Productivity
Commission (PC), Chemicals
and plastics regulation, Research report, PC, Canberra, July 2008.
[17]. For
example, D Jopson and R Pollard, ‘Name
your poison—it’s legal’,
The Sydney Morning Herald, 22 October 2007, p. 1; D Jopson, ‘Banned
chemical on shelves despite fears it can harm health’, The Sydney Morning Herald, 22
October 2007, p. 15; M Denholm, ‘Regulator stalls on
review of weed killer’,
The Australian, 27 June 2008, p. 8.
[18]. Parliament
of Australia, ‘Agricultural
and Veterinary Chemicals Legislation Amendment Bill 2013 homepage’, Australian
Parliament website.
[19]. ANAO, Pesticide and
veterinary medicine regulatory reform: Australian Pesticides and Veterinary
Medicines Authority, Audit report, 56, 2016–17, ANAO, Barton, ACT, p. 17.
For further details of the amendments see P Pyburne, Agricultural
and Veterinary Chemicals Legislation Amendment Bill 2012, Bills digest,
89, 2012–13, Parliamentary Library, Canberra, 12 March 2013.
[20]. Revised Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
Bill 2013, p. 1.
[21]. The
updated investigative powers are located in Part 7AA of the Administration
Act.
[22]. The
updated enforcement powers are located in Part 7AB of the Administration
Act.
[23]. P
Pyburne, Agricultural
and Veterinary Chemicals Legislation Amendment Bill 2012, Bills digest,
89, 2012–13, Parliamentary Library, Canberra, 12 March 2013, p. 62.
[24]. Parliament
of Australia, ‘Agricultural
and Veterinary Chemicals Legislation Amendment Bill 2013 homepage’, Australian
Parliament website.
[25]. P
Pyburne, Agricultural
and Veterinary Chemicals Amendment Bill 2012, op. cit.
[26]. 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.
[27]. 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.
[28]. Ibid.,
p. 52.
[29]. Details
of the inquiry including the terms of reference, submissions from stakeholders
and the Rural and Regional Affairs and Transport Legislation Committee report
are on the inquiry
homepage.
[30]. Rural
and Regional Affairs and Transport Legislation Committee (RRAT Committee), Agricultural
and Veterinary Chemicals Legislation Amendment Bill 2012 [Provisions], The Senate,
Canberra, February 2013, pp. 27–30.
[31]. Ibid.,
p. 30.
[32]. Liberal
Party of Australia and the Nationals, The
Coalition’s policy for a competitive agriculture sector, Coalition
policy document, Election 2013, p. 10.
[33]. T
Abbott (Prime Minister) and B Joyce (Minister for Agriculture), Agricultural
Competitiveness White Paper—stronger farmers, stronger economy, joint
media release, 4 July 2015, p. 1.
[34]. Australian
Government, Agricultural
competitiveness white paper: stronger farmers, stronger economy, Commonwealth of Australia,
Canberra, 2015, p. 37.
[35]. Ibid.,
p. 38.
[36]. S
Morrison (Treasurer) and B Joyce (Minister for Agriculture and Water
Resources), Productivity
Commission to examine regulation of Australian agriculture, joint media
release, 20 November 2015.
[37]. PC,
Regulation
of Australian agriculture, Inquiry report, 79, PC, Canberra, 15 November
2016.
[38]. Control-of-use
regimes are regimes controlling the use of chemical products after retail sale.
[39]. Ibid.,
p. 291.
[40]. ANAO,
Pesticide and
veterinary medicine regulatory reform, op. cit.
[41]. Ibid.,
p. 7.
[42]. House
of Representatives Standing Committee on Agriculture on Water and Resources
[sic], 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.
[43]. Ibid.,
recommendation 2, p. ix.
[44]. The
terms of reference, submissions to the RRAT Committee and the Committee’s final
report are available on the
inquiry homepage.
[45]. RRAT
Committee, Agricultural
and Veterinary Chemicals Legislation Amendment (Australian Pesticides and
Veterinary Medicines Authority Board and Other Improvements) Bill 2019
[Provisions], Senate, Canberra, November 2019, p. 29.
[46]. Australian
Labor Party (Labor) Senators, Dissenting
comments, RRAT Committee, Inquiry into the provisions of the
Agricultural and Veterinary Chemicals Legislation Amendment (Australian
Pesticides and Veterinary Medicines Authority Board and Other Improvements)
Bill 2019, The Senate, Canberra, pp. 31–32.
[47]. Australian
Greens, Dissenting
report, RRAT Committee, Inquiry into the provisions of the Agricultural
and Veterinary Chemicals Legislation Amendment (Australian Pesticides and
Veterinary Medicines Authority Board and Other Improvements) Bill 2019, The
Senate, Canberra, pp. 33–35.
[48]. RRAT
Committee, Agricultural
and Veterinary Chemicals Legislation Amendment (Streamlining Regulation) Bill
2018 [Provisions], op. cit., pp. 13–14.
[49]. Labor
Senators, Dissenting
comments, RRAT Committee, Inquiry into the Agricultural and Veterinary
Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018
[Provisions], The Senate, Canberra, February 2019, p. 35.
[50]. Australian
Greens Senators, Dissenting
comments, RRAT Committee, Inquiry into the Agricultural and Veterinary
Chemicals Legislation Amendment (Streamlining Regulation) Bill 2018
[Provisions], The Senate, Canberra, February 2019, pp. 37–38.
[51]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny digest,
7, 2019, The Senate, 17 October 2019, pp. 1–4.
[52]. Australian
Greens, Dissenting
report, RRAT Committee, Inquiry into the provisions of the Agricultural
and Veterinary Chemicals Legislation Amendment (Australian Pesticides and
Veterinary Medicines Authority Board and Other Improvements) Bill 2019, op.
cit., p. 33.
[53]. Grains
Research and Development Corporation (GRDC), Submission
to the RRAT Committee, Inquiry into the Agricultural and Veterinary
Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines
Authority Board and Other Improvements) Bill 2019 [Provisions], [Submission
no. 4], 10 October 2019, p. 1.
[54]. Grain
Producers Australia (GPA), Submission
to the RRAT Committee, Inquiry into the Agricultural and Veterinary
Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines
Authority Board and Other Improvements) Bill 2019 [Provisions], [Submission
no. 3], 10 October 2019, p. 2.
[55]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 3.
[56]. The
Statement of Compatibility with Human Rights can be found at pages 83–125 of
the Explanatory
Memorandum to the Bill.
[57]. Agricultural
and Veterinary Chemicals Code (Agvet Code), clause 159.
[58]. The
relevant period is determined under Division 9.3 of
the Agricultural
and Veterinary Chemicals Code Regulations 1995.
[59]. Australian
Government, Agricultural
competitiveness white paper, op. cit.
[60]. Agvet
Code, subclause 9(1).
[61]. Agvet
Code, clause 11.
[62]. Agvet
Code, clauses 12 and 13.
[63]. Agvet
Code, clause 14.
[64]. Agvet
Code, clauses 17 and 18.
[65]. Agvet
Code, clause 23.
[66]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 12.
[67]. Agvet
Code, proposed subclause 14C(4).
[68]. Agvet
Code, proposed subclause 14C(6).
[69]. Agvet
Code, proposed subclause 14C(5). Agvet Code, subclause 5A(1) sets out
when an active constituent or chemical product meets the safety criteria.
[70]. Agvet
Code, proposed subclause 14C(9).
[71]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 14.
[72]. Agvet
Code, proposed subclause 14C(2). Agvet Code, clause 8A sets out when an
application meets the application requirements.
[73]. Agvet
Code, proposed subclause 14C(7).
[74]. Agvet
Code, proposed subclause 14C(8).
[75]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 15.
[76]. Agvet
Code, subclause 34J(2).
[77]. Agvet
Code, subclause 34J(3).
[78]. Agvet
Code, proposed subclause 34KA(4).
[79]. Agvet
Code, proposed subclause 34KA(2).
[80]. Agvet
Code, proposed subclause 34KA(3).
[81]. Agvet
Code, proposed subclause 34MA(1).
[82]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 19.
[83]. Collection
of Levy Act, subsection 12B(1). Section 12C sets out the formula for
calculating the amount of the levy based on the total leviable value in respect
of the product for the financial year and the rate of the levy. The rate of the
levy is set in
section 6A of the Agricultural
and Veterinary Products (Collection of Levy) Regulations 1995.
[84]. Collection
of Levy Act, subsection 12B(2).
[85]. Collection
of Levy Act, subsection 3(1).
[86]. Collection
of Levy Act, proposed subsection 35(3). 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.
[87]. Under
section 4AA of the Crimes
Act 1914 a penalty unit is equivalent to $210. This means that the
maximum penalty is $10,500. Subsection 4B(3) of the Crimes Act
provides that the maximum penalty that may be imposed on a body corporate is
five times the maximum penalty that could be imposed on an individual convicted
of the same offence. Accordingly, the maximum pecuniary penalty for a
corporation is $52,500.
[88]. Collection
of Levy Act, proposed subsection 35(4).
[89]. Administration
Act, subsection 69EJ(1). Subsection 69EJA(1) of the Administration Act sets
out the maximum amount of the penalty for a body corporate, which is five times
the maximum monetary penalty that could be imposed if the body corporate was
convicted of an offence constituted by the same conduct. As explained in
footnote 34, the maximum penalty that could be imposed on a corporation for an
offence against proposed subsection 35(1) is $52,500. This means that the
maximum civil penalty that can be imposed on a corporation is $262,500.
Subsection 69EJA(2) of the Administration Act sets out the maximum
amount of the penalty for an individual, which
is three times the maximum monetary penalty that could be imposed if the individual
was convicted of an offence constituted by the same conduct. This means that
the maximum civil penalty that can be imposed on an individual is $31,500.
[90]. Collection
of Levy Act, proposed subsection 35(2). See regulation 4.10 of the Agricultural and
Veterinary Chemicals (Administration) Regulations 1995.
[91]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 22.
[92]. Collection
of Levy Act, proposed subsection 35(5).
[93]. Active
constituent, in relation to a proposed or existing agricultural
chemical product or veterinary chemical product, means the substance that is,
or one of the substances that together are, primarily responsible for the
biological or other effect identifying the product as an agricultural chemical
product or a veterinary chemical product, as the case may be. See section 3 of
the Schedule to the Code Act.
[94]. Collection
of Levy Act, proposed subsection 37(2). See footnote 34 for more
information on penalties for individuals and corporations.
[95]. Collection
of Levy Act, proposed subsection 37(3). This replicates the existing
penalty which is imposed under section 69EA of the Administration Act in
respect of annual returns that are required under section 69E of the Administration
Act—which is to be repealed. See footnote 36 for more information on the
quantum of the penalties.
[96]. Administrative
Review Council (ARC), Automated
assistance in administrative decision making: report to the Attorney-General,
ARC report, 46, ARC, Canberra, November 2004.
[97]. Ibid.,
p. vii.
[98]. Therapeutic Goods
Act 1989, section 7C.
[99]. APVMA,
‘Digital strategy 2018–2022’,
last updated 8 May 2018.
[100]. Ibid.
[101]. Agvet
Code, proposed subclauses 5F(3) and (4).
[102]. ARC,
Automated
assistance in administrative decision making, op. cit., p. viii.
[103]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny digest,
7, 2019, op. cit., p. 2.
[104]. Ibid.,
p. 3.
[105]. Ibid.,
pp. 3–4.
[106]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, 8, 2019, The Senate, 13 November 2019, pp. 37–42.
[107]. Ibid.,
p. 41.
[108]. Ibid.
[109]. M
Kelly (Director, Reform Development and Implementation, Department of
Agriculture, Fisheries and Forestry), Evidence
to the Rural and Regional Affairs and Transport Legislation Committee, Inquiry
into the Agricultural and Veterinary Chemicals Legislation Amendment Bill 2012,
Senate, Hansard, 4 February 2013, p. 56.
[110]. Agvet
Code, clause 8A.
[111]. Agvet
Code, subclause 11(1).
[112]. Agvet
Code, paragraph 11(2)(a). Agvet Code, clause 156A operates so that if the APVMA
is required to give a person information in writing, the requirement will be
taken to have been met if the person consents to the information being given
electronically and it is so given, the information includes the Chief Executive
Officer’s electronic signature and, in the event of a breach of a civil penalty
provision (arising from a person’s failure to do, or not do, a thing set out in
the information), the APVMA has in place systems for proving the person
received the information.
[113]. Agvet
Code, paragraph 11(2)(b).
[114]. Agvet
Code, subclause 11(3).
[115]. Agvet
Code, clause 28.
[116]. Agvet
Code, subclause 3(1) defines a holder as (a) in relation to an
approval or registration: the person entered in the Record, Register or
relevant APVMA file as the holder of the approval or registration; if the
holder was an individual who has died or is an individual whose affairs are
being lawfully administered by another person—the legal personal representative
of the individual or the person administering the individual’s affairs or if
the holder was a body corporate—a successor in law of the body corporate or (b)
in relation to a permit or licence: the person to whom the permit or licence
was issued.
[117]. Agvet
Code, subclause 27(1).
[118]. Agvet
Code, subclause 27(3).
[119]. Australian
Pesticides and Veterinary Medicines Authority (APVMA), ‘Permits’, APVMA website, last updated
1 July 2014.
[120]. Agvet
Code, clause 110.
[121]. Agvet
Code, clause 110A.
[122]. Agvet
Code, subclauses 110A(3) and (4).
[123]. Agvet
Code, subclause 27(1).
[124]. Agvet
Code, subclause 29(2).
[125]. Agvet
Code, clause 36.
[126]. Agvet
Code, subclause 41(2).
[127]. Agvet
Code, subclause 43(2).
[128]. Agvet
Code, clause 45. Agvet Code, clause 21 sets out how approval of a label takes
place.
[129]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 19.
[130]. Agvet
Code, suspension of an approval or a registration may be made under clause 36,
subclause 41(2) or subclause 44(2).
[131]. Under
section 4AA of the Crimes
Act 1914, a penalty unit is equivalent to $210. This means that the
maximum penalty for the offence is $63,000. Subsection 4B(3)
of the Crimes Act provides that the maximum penalty that may be imposed
on a body corporate is five times the maximum penalty that could be imposed on
an individual convicted of the same offence. Accordingly, the maximum pecuniary
penalty for a corporation is $315,000.
[132]. Administration
Act, subsection 69B(1B).
[133]. Administration
Act, subsection 69ER(1). See footnote 73 for more information on penalties
for individuals and corporations.
[134]. Other
than section 69B, which is covered by subsection 69ER(1).
[135]. Administration
Act, subsection 69ER(2). The maximum penalty is equivalent to $12,600 for
an individual and $63,000 for a corporation.
[136]. Administration
Act, subsection 69EJ(1). The amount of the pecuniary penalty is worked out
under section 69EJA of the Administration Act (as discussed further
below).
[137]. Clause
5A of the Agvet Code sets out the matters to be considered in determining
whether an active constituent or chemical product meets the safety
criteria.
[138]. Clause
5B of the Agvet Code sets out the matters to be considered in determining
whether a chemical product meets the efficacy criteria.
[139]. Clause
5C of the Agvet Code sets out the matters to be considered in determining
whether a chemical product meets the trade criteria.
[140]. Clause
5D of the Agvet Code sets out the matters to be considered in determining
whether a label for containers of a chemical product meets the labelling criteria.
[141]. Subclause
123(1) of the Agvet Code sets out the matters to be considered in determining
whether a licence to carry out steps in the manufacture of chemical products at
particular premises must be issued.
[142]. Subsection
4B(3) of the Crimes Act states that, where a body corporate is convicted
of an offence against a law of the Commonwealth, a court may, if the contrary
intention does not appear and the court thinks fit, impose a pecuniary penalty
not exceeding an amount equal to five times the amount of the maximum pecuniary
penalty that could be imposed by the court on a natural personal convicted of
the same offence.
[143]. For
example Australian Pesticides and Veterinary Medicines Authority v
Administrative Appeals Tribunal, (2008) 216 FCR 405, [2008] FCA
1393 (12 September 2008).
[144]. Although
additional, non-monetary consequences, such as a criminal record, flow from
conviction for a criminal offence.
[145]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 46.
[146]. Agvet
Code, clause 100.
[147]. Agvet
Code, proposed subclause 106(1).
[148]. Agvet
Code, proposed subclause 106(2).
[149]. Agvet
Code, proposed subclause 106(6).
[150]. 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.
[151]. 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.
[152]. Administration
Act, section 51.
[153]. Public Governance,
Performance and Accountability Rule 2014, subsection 16E(2), table item 4.
[154]. Ibid.
[155]. Ibid.,
table item 5.
[156]. Ibid.,
table item 6.
[157]. Administration
Act, sections 55 and 56.
[158]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 55.
[159]. Agvet
Code, proposed subclause 5AA(1).
[160]. Agvet
Code, clauses 75 and 78.
[161]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 59.
[162]. Food
Standards Australia New Zealand (FSANZ), ‘Chemicals
in food—maximum residue limits’, FSANZ website, April 2018.
[163]. APVMA,
‘Pesticides and veterinary residues’,
APVMA website, 9 March 2017.
[164]. Subsection
82(3) of the Food
Standards Australia New Zealand Act 1991 contains equivalent similar
requirement.
[165]. Agvet
Code, subparagraph 8E(2)(c)(i).
[166]. FSANZ
Act, section 82.
[167]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 2.
[168]. Ibid.,
p. 64.
[169]. House
of Representatives Standing Committee on Agriculture on Water and Resources
[sic], APVMA
regulatory reforms: inquiry based on the Auditor-General report no. 56
(2016–17): Pesticide and Veterinary Medicine Regulatory Reform, op.
cit., recommendation 2, p. ix.
[170]. Administration
Act, sections 14 and 16.
[171]. APVMA,
Annual
Report 2015–16, Australian Government, 2016, p. 14.
[172]. Ibid.,
p. 13.
[173]. Administration
Act, proposed subsection 15(1).
[174]. Administration
Act, proposed section 17.
[175]. Administration
Act, proposed subsections 27J(1) and (2).
[176]. Administration
Act, proposed subsection 18(1).
[177]. Administration
Act, proposed subsection 19(1).
[178]. Administration
Act, proposed subsection 19(2).
[179]. Administration
Act, proposed subsection 18(2).
[180]. Administration
Act, proposed section 21.
[181]. Administration
Act, proposed section 25.
[182]. Administration
Act, proposed section 27.
[183]. Administration
Act, proposed section 27B.
[184]. Administration
Act, proposed subsection 27C(2).
[185]. Administration
Act, proposed section 27E.
[186]. Administration
Act, proposed subsection 27G(5) provides that the direction is a
notifiable instrument. This means that it will not be subject to disallowance
under the Legislation
Act 2003.
[187]. Administration
Act, proposed subsections 27G(1) and (2).
[188]. Administration
Act, proposed subsection 27G(6).
[189]. Administration
Act, proposed subsections 27G(3), inserted by item 11 of
Schedule 2 to the Bill.
[190]. PGPA
Act, sections 15–19.
[191]. NSW
Farmers’ Association, Submission
to the Rural and Senate Rural and Regional Affairs and Transport Committee, Inquiry
into the provisions of the Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019, 10 October 2019, p. 1.
[192]. NFF,
Submission
to the Rural and Senate Rural and Regional Affairs and Transport Committee, Inquiry
into the provisions of the Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019, 10 October 2019, p. 2.
[193]. CropLife
Australia, Submission
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into the provisions of the Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019, 10 October 2019, p. 2.
[194]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 72.
[195]. GPA,
Submission
to the Rural and Senate Rural and Regional Affairs and Transport Committee, Inquiry
into the provisions of the Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019, op. cit., p. 8.
[196]. CropLife
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into the provisions of the Agricultural and Veterinary Chemicals Legislation
Amendment (Australian Pesticides and Veterinary Medicines Authority Board and
Other Improvements) Bill 2019, 10 October 2019, p. 2. See, Senate Rural and
Regional Affairs and Transport Legislation Committee, Official
Committee Hansard, 23 May 2018, p. 95.
[197]. Administration
Act, proposed subsection 32(4), inserted by item 14 of
Schedule 2 to the Bill.
[198]. Administration
Act, proposed subsections 32(5) and (8), inserted by item 14
of Schedule 2 to the Bill.
[199]. Administration
Act, proposed subsection 33(1A), inserted by item 17 of
Schedule 2 to the Bill.
[200]. Administration
Act, proposed subsection 41A(2), inserted by item 31 of
Schedule 2 to the Bill.
[201]. Explanatory
Memorandum, Agricultural and Veterinary Chemicals Legislation Amendment
(Australian Pesticides and Veterinary Medicines Authority Board and Other
Improvements) Bill 2019, p. 2.
[202]. J
Uhrig, Review
of the corporate governance of statutory authorities and office holders,
Commonwealth of Australia, Canberra, June 2003, pp. 17–18.
[203]. Administration
Act, paragraph 7(1A)(b).
[204]. House
of Representatives Standing Committee on Agriculture on Water and Resources
[sic], APVMA
regulatory reforms: inquiry based on the Auditor-General report no. 56
(2016–17): Pesticide and Veterinary Medicine Regulatory Reform, op.
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[205]. B
McKenzie (Minister for Agriculture), Independent
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5 September 2019.
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