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Compliance and
Enforcement Framework
Discussion Paper
APRIL 2012
APRIL 2012
This is an APVMA publication released to support the delivery of the Australian Government’s Better
Regulation Reform Agenda.
Australian Pesticides and Veterinary Medicines Authority (APVMA) 2012
10 April 2012
This work is copyright. Requests and enquiries concerning reproduction and rights can be made to:
The Manager, Public Affairs
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Australia
Email: communications@apvma.gov.au
This document is published by the APVMA. In referencing this document the APVMA should be cited as both author and
publisher.
Website: This publication is available from the APVMA website: www.apvma.gov.au
Comments and enquiries may be directed to:
Better Regulation Taskforce
Australian Pesticides & Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Australia
Telephone: +61 2 6210 4877
Fax: +61 2 6210 4813
Email: betterregulation@apvma.gov.au
CONTENTS iii
CONTENTS
1 INTRODUCTION 1
1.1 Background 1
Better Regulation reform 2
1.2 Purpose 2
1.3 Scope 3
2 APVMA PHILOSOPHY AND PRINCIPLES 5
2.1 Philosophy 5
2.2 Guiding principles 5
Proportional and consistent response 5
Focussed and effective intervention 5
Support compliance while deterring non-compliance 6
Professional conduct 6
Responsive to emerging risks and stakeholder expectations 6
Compliance and enforcement risk priority 7
2.3 The SELF Test 7
3 COMPLIANCE AND ENFORCEMENT APPROACH 9
3.1 Objectives of the compliance and enforcement regime 9
3.2 Regulatory posture 10
3.3 The nature of compliance interactions 10
Case study — Penalty Infringement Notices 12
4 SCOPE OF REGULATION 13
4.1 Definitions of agricultural and veterinary chemical products 13
4.2 How to identify registered agricultural or veterinary chemical products 13
4.3 Legislation 14
4.4 Offences and civil penalties 14
4.5 False and/or misleading information 15
Case study — Criminal prosecution 18
4.6 Levy evasion 19
4.7 Access to other Commonwealth statutes 19
5 COMPLIANCE ANDENFORCEMENT FUNCTIONS 21
5.1 Compliance and enforcement 21
5.2 Monitoring and investigation 21
Case study — APVMA intervention only 22
5.3 Manufacturing quality and licensing 22
5.4 Adverse experiences 23
5.5 Field activities 23
iv APVMA OPERATING FRAMEWORK
Case study — APVMA intervention only 24
6 INDUSTRY’S RESPONSIBILITIES 26
6.1 What the APVMA expects of industry 26
6.2 Product stewardship and co-regulation 26
Case study — Enforceable undertaking 27
7 INVESTIGATING CONTRAVENTIONS 29
7.1 APVMA compliance investigations 29
7.2 Visiting premises during investigations and inspections 30
Obligations 30
Rights 31
7.3 Use of non-intrusive investigative and monitoring powers 31
8 RESPONDING TO CONTRAVENTIONS 33
8.1 Compliance and enforcement options 33
8.2 Regulatory response 33
Regulatory sanction and regulatory action 33
8.3 Responsibility for unregistered chemical products 35
8.4 Responsibility for registered chemical products 35
8.5 Court proceedings 36
Civil 37
Criminal 37
Individual and corporate responsibility 38
Case study — Civil penalty order 39
‘Double jeopardy’ 40
8.6 Alternatives to court proceedings 40
8.7 Penalty Infringement Notices 41
9 REPORTING, MONITORING AND DETECTION 43
9.1 Reports of non-compliance 43
9.2 How to report non-compliance 43
9.3 How the APVMA manages reports of non-compliance 44
9.4 Outcomes from reports of non-compliance 44
9.5 Monitoring and detection 45
10 DISCLOSURE OF INFORMATION 47
10.1 Disclosure framework 47
10.2 Notices and information the APVMA will publish 47
11 RECALLS ANDCOMPLIANCE NOTICES 48
11.1 Recalls 48
Voluntary recall 48
CONTENTS v
Compulsory recall 49
Restriction on market authorisation 49
Case study — Restriction of market authorisation 50
11.2 Types of compliance notices 51
12 COMPLIANCE ANDENFORCEMENT PRACTICE NOTES 54
Abbreviations 55
Glossary 56
COMPLIANCE AND ENFORCEMENT FRAMEWORK 1
1 INTRODUCTION
1.1 Background
The Australian community has an expectation that agricultural and veterinary (agvet) chemicals registered
for supply in Australia or exported overseas are effective and can be used safely. The Australian Pesticides
and Veterinary Medicines Authority (APVMA) is the Australian Government agency responsible for regulating
the manufacture and supply of agvet chemicals in Australia (including the point of sale). Once sold, the use
of agvet chemicals is regulated by control-of-use legislation of each state and territory.
The APVMA compliance and enforcement regime is governed by a suite of legislation including the:
Agricultural and Veterinary Chemicals Act 1994 (the Agvet Act)
Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act)
The Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code)
Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.
This suite of legislation (and some associated Acts and Regulations) gives effect to a national framework for
1
regulating agvet chemicals to ensure their quality and safety for people or animals, the environment or
international trade.
The Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) includes
penalties for non-compliant activities and provides the APVMA with authority and tools to investigate and
respond to non-compliant issues and activities. A non-compliant activity is an allegation reported to the
APVMA or detected by the APVMA which suggests a person or company has breached their responsibilities
under the agvet laws.
Actions or penalties applied by the APVMA are tailored to the seriousness of the non-compliance and can
range from a warning letter, an enforceable undertaking, a Penalty Infringement Notice (a fi ne), or criminal
prosecution.
The APVMA believes engaging early with industry is important to establishing the confidence of stakeholders
in Australia’s chemical regulatory system. The APVMA is involved at all points in the market, including
importation, wholesale, distribution, transport and retail sale, and across urban and rural areas.
Persons and companies operating in the agvet industry who do not comply with the obligations of the Agvet
Code can expect a response from the APVMA. This includes providing false or misleading information to the
APVMA.
The APVMA also has an ongoing role in educating people and companies of responsibilities relating to
agvet chemicals. When appropriate, the APVMA supports industry self-regulation functions (such as the
Manufacturing Licensing Scheme auditing).
1
Agvet chemicals are registered by the APVMA, which deems them safe and effective in accordance with their approved instructions
of use.
2 APVMA OPERATING FRAMEWORK
Better Regulation reform
As part of its Better Regulation reform agenda, in 2012 the Australian Government will introduce reform
measures relating to the agvet chemical industry aimed at reducing the regulatory burden on business while
continuing to protect human health and the environment.
The reforms, as proposed in the Exposure Draft of the Agricultural and Veterinary Chemicals Legislation
Amendment Bill 2011, extend the range of compliance and enforcement options available to the APVMA.
The reforms help ensure that when non-compliance is suspected or confirmed, the APVMA intervention
appropriately balances regulatory action (ensuring compliance into the future) with regulatory sanction
(addressing past non-compliance).
In addition to this Compliance and Enforcement Framework, the APVMA also provides accompanying
Practice Notes on routine aspects of compliance and enforcement operations as required. The APVMA also
reports annually on compliance and enforcement outcomes as well as emerging areas of risk and details of
potential response options.
The APVMA will regularly review this Compliance and Enforcement Framework and associated documents
to incorporate lessons learned and advances in government policy, and to reflect amendments to agvet law
or the introduction of new legislation.
1.2 Purpose
This Compliance and Enforcement Framework sets out the objectives of the APVMA, the philosophy and
principles that guide its activities, and the approach it takes to compliance and enforcement.
It explains how to identify agvet products regulated by the APVMA and the different compliance and
enforcement activities the APVMA undertakes.
Responsibilities of industry when supplying agvet chemicals to Australia and overseas are detailed, and the
different actions that will be available to the APVMA when conducting investigations are explained.
Different factors the APVMA considers when selecting the most appropriate response to a non-compliance
issue or event are outlined.
How to report suspected non-compliance to the APVMA is detailed, along with how the APVMA manages
reports of non-compliance, including how it approaches product recalls and compliance notices.
To further understand the APVMA decision-making process, a series of case study scenarios are included
throughout this Compliance and Enforcement Framework. These case studies provide a broad explanation
of APVMA compliance responses and the expectations of how the APVMA will approach non-compliance.
Note that names of companies in case studies are fictional and do not refer to any specific Australian or
international businesses.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 3
1.3 Scope
This Compliance and Enforcement Framework was drafted in context of the Better Regulation reforms
committed to by the Australian Government in 2011, and in expectation of the passage of new legislation
through the Australian Parliament in 2012.
It is intended for information purposes only, and is not intended to provide legal guidance or advice and
should not be relied on for such.
Information presented here does not limit the discretion of the APVMA to take any appropriate action under
legislation it administers. It reflects current and expected future operational practices, which may be
amended from time to time.
The APVMA cannot provide advice relating to whether a particular person or company may face civil or
criminal proceedings. Persons and companies should obtain their own legal advice on these matters.
4 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 5
2 APVMA PHILOSOPHY AND PRINCIPLES
2.1 Philosophy
The APVMA philosophy is that strategic application of the range of compliance and enforcement
mechanisms provides an effective and flexible regulatory system.
The aim is to move non-compliant persons and companies into a state of sustained compliance and to deter
future non-compliance through visible application of compliance powers and authority. The APVMA prefers
to use education and persuasion to establish a meaningful and lasting commitment to compliance. More
punitive measures are generally reserved for higher-risk, deliberate, widespread and longer-term non-
compliance.
Each non-compliance issue or incident is unique. The APVMA considers all aspects of each incident or issue
to ensure it takes the most appropriate action.
2.2 Guiding principles
The APVMA is committed to procedural fairness and the presumption of innocence. It has a set of guiding
principles for its compliance and enforcement operations, which are described below.
Proportional and consistent response
The APVMA works to ensure a consistent approach to how it responds to non-compliance. It considers the
extent and seriousness of the risk and potential or actual harm as well as any mitigating circumstances, and
the ‘compliance’ history of a person or company.
As part of the Better Regulation reforms the APVMA will have a graduated compliance system and an
enhanced ability to ‘tailor’ compliance and enforcement responses to the particular circumstances. The
APVMA will be able to take a range of action in response to non-compliance, from formal warnings to
criminal prosecution—with regulatory action options ranging from education activities to cancelling market
authorisation.
Focussed and effective intervention
The APVMA recognises that third parties may be affected when administering compliance and enforcement.
The APVMA works to identify third parties quickly when investigating non-compliance and engaging parties
responsible for non-compliance.
After identifying the relevant parties, the APVMA takes the necessary regulatory action to return all parties to
compliance. It will also consider and decide on whether further sanctions are required to deter future
non-compliance. While the APVMA will consider the impact of its actions on third parties, this will not be
grounds for the APVMA to take no action in response to non-compliance. The APVMA will consider
pathways to mitigate the impact of its actions on third parties when appropriate.
Resolving compliance and enforcement matters can take an extended time, particularly when enforceable
undertakings and court proceedings are used. While the APVMA works toward efficient resolutions, it is also
committed to see matters to completion.
6 APVMA OPERATING FRAMEWORK
Support compliance while deterring non-compliance
When determining its response to non-compliance issues and events, the
APVMA employs a combination of regulatory action and any regulatory
sanction available to it. Regulatory actions will be employed and are intended
to return circumstances to compliance. Regulatory action will not be used
punitively. The APVMA will also consider as a separate matter any regulatory
sanction that may be appropriate to address past non-compliance before its A graduated
intervention occurred.
compliance
The approach and attitude of persons and companies and their willingness to
engage in regulatory action will, to an extent, inform how the APVMA will system that allows
consider and apply regulatory sanctions.
regulatory
The APVMA will continue to support compliance education programs, and be responses to be
involved in appropriate industry self-regulation (such as the Manufacturing
Licensing Scheme). However, the APVMA will intervene if it considers these aligned with the
tools are ineffective.
severity and
Professional conduct
deliberateness of
APVMA compliance and enforcement staff conduct themselves and their
activities in a manner of the highest standard. The APVMA employs a four- an offence.
step process (the SELF Test) as the operational measure for staff and
compliance and enforcement responses. An explanation of the SELF Test is
provided at the end of this chapter.
Compliance and enforcement activities are conducted in accordance with the
objectives established by the suite of legislation (the Agvet Act, Agvet Code
and the Collection Levy Act) with transparency and fairness. APVMA
compliance and enforcement responses preserve the presumption of
innocence, and seek to address similar instances of non-compliance in a
similar manner. In legal proceedings the APVMA will act as a ‘model litigant’.
The APVMA supports and guides interested parties in their compliance
obligations, within the constraints of its legislative obligations.
Responsive to emerging risks and stakeholder expectations
The expectations of APVMA stakeholders (including government, the
chemical industry, chemical users and the general public) are diverse and
often counter to each other. The APVMA continually engages with
stakeholders to help it stay informed of emerging areas of concern and to aid
it with prioritising its compliance and enforcement resources, and planning
future development of the APVMA’s capabilities.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 7
Compliance and enforcement risk priority
In establishing the risk priority of non-compliant activity or behaviour the APVMA will:
verify that a contravention of agvet legislation is likely to have occurred (non-compliant behaviour or
activity)
consider the seriousness of the non-compliance, including potential for harm
consider the history of compliance and enforcement interactions of a person and/or the company
consider the level of response necessary to prevent similar incidents by the person and/or the
company or others.
The APVMA generally takes a higher-level response to non-compliance in the event of:
the death of humans or animals
actual or potential harm to humans, animals or the environment
unrestricted exposure to the public
prolonged or deliberate action
a person or company gaining significant financial benefit or commercial gain from non-compliant
behaviour or activity.
The APVMA generally takes a lower-level response when non-compliance:
arises from inadvertent action
poses limited, or constrained, exposure to the public
provides no financial benefit or commercial gain.
2.3 The SELF Test
APVMA staff (including APVMA Inspectors and authorised auditors) conducting compliance and
enforcement activities measure their actions (before, during and at completion) against the SELF Test. The
four elements of the SELF test are described below.
Scrutiny Does it actively withstand scrutiny from the community, media, industry groups, APVMA
executive management and government?
Ethical Is it truly impartial and without bias or prejudice? Have personalities or personal loyalties been
properly considered and managed?
Lawful Is it according to the law? Is it likely to be supported by the courts?
Fair Is it fair to those involved? Is it consistent with policy and practice? Is it effective, proportionate
and respectful of individual and company reputations? Is it in any way unduly prejudicial or
detrimental to other stakeholders?
8 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 9
3 COMPLIANCE AND ENFORCEMENT APPROACH
This chapter explains the objectives the APVMA works to achieve and the approach it takes to compliance
and enforcement, including its regulatory posture of ‘firm and fair’.
3.1 Objectives of the compliance and enforcement regime
The main objective of the APVMA compliance and enforcement regime is to ensure that non-compliers move
into sustained compliance, and do so swiftly from the time the APVMA intervenes. Another key objective for
the APVMA compliance and enforcement regime is to deter people and companies from novel
non-compliance. Options the APVMA may adopt to establish sustained compliance include educational
activities, enforceable directions, recall notices and ultimately, suspending or cancelling market
authorisation.
The APVMA can impose a range of enforcement sanctions in its response to breaches of legislation or
program requirements (non-compliance). These sanctions may include warnings, fines, injunctions, civil
penalties or criminal prosecution.
The objectives of the APVMA compliance and enforcement regime are adapted from the Food and
Agricultural Organization of the United Nations, which describes 10 core compliance principles relevant to
2
pesticides regulatory programs.
These 10 UN principles are:
aiming for full and continuous compliance as a primary goal
seeking to enhance industry’s culture of compliance providing clear and well-understood requirements
having an expectation of self-initiated compliance
wanting industry to understand that detection of violations is likely
providing a fair and predictable government response
using compliance intervention as a mechanism to support the principle of a level playing field
using the visibility of compliance interventions for message sending and deterrence
acting to ensure comparable treatment for public and private sectors
acting in a way that shows transparency and accountability.
When relevant and appropriate, the APVMA works with partner agencies and co-regulators to ensure an
appropriate whole-of-government approach on compliance and enforcement matters. Information is shared
with other investigating agencies when required or permitted by law.
2
UN International Code of Conduct on the Distribution and Use of Pesticides, Revised Edition: Guidelines on Compliance and
Enforcement of a Pesticide Regulatory Programme, 2006.
10 APVMA OPERATING FRAMEWORK
3.2 Regulatory posture
The balance between delivering on statutory obligations and facilitating industry and community interactions
with a regulator represents an agency’s regulatory posture. More information about the APVMA wider
regulatory posture will be provided in the Risk Compendium — Regulatory Posture.
The foundation of the APVMA’s regulatory posture is to be a ‘firm and fair’ regulator in delivering on its
mission to protect people and animals, the environment and international trade.
The APVMA will intervene when evidence exists that behaviour of persons or companies does not meet
legislative requirements (is non-compliant). The APVMA will intervene swiftly and with appropriate strength
when credible evidence of culpable harm is suspected or confirmed.
Stronger enforcement actions provide incentives for those involved in the manufacture, supply and
management of agvet chemicals to ensure their systems, products and controls are high quality and comply
with the law. The APVMA will take a strong stance on accountability with industry and the marketplace.
3.3 The nature of compliance interactions
The APVMA conducts its compliance activities to ensure the presumption of innocence is supported, and
that reputations of people and companies are respected, and company operations are not unduly prejudiced.
With the exception of education and the self-regulation aspect of veterinary product manufacture, all APVMA
compliance and enforcement activities are provided for in agvet legislation (see Chapter 8: Responding to
contraventions below, which sets out intervention options available to the APVMA). The APVMA conducts
compliance activities in a manner that is sufficiently robust to ensure evidence collected is relevant and
admissible. This, in conjunction with the need to withstand review, means a degree of formality is necessary
and desirable.
There are specific reasons why formality and strict processes are required. Firstly, the use of some form of
power or application of a sanction based on legislation can generally be disputed in a relevant court or
tribunal. For example:
decisions about the issuance of recall notices can be disputed in the Administrative Appeals Tribunal
(AAT)
APVMA applications for civil penalties can be resisted in the Federal Court
culpability for criminal sanctions sought through the Commonwealth Director of Public Prosecutions
can be resisted in court.
As well as legal review, persons or companies may also complain about the conduct of APVMA compliance
investigations or particular actions of APVMA Inspectors and other staff. This may be on the basis of
perceived bias, unfair or inappropriate behaviour. Complaints of this nature may be made to the APVMA for
internal consideration or to the Commonwealth Ombudsman. The Ombudsman is the independent authority
tasked with safeguarding the community in its dealings with Australian Government agencies
(www.ombudsman.gov.au).
COMPLIANCE AND ENFORCEMENT FRAMEWORK 11
Further, the Australian Government Investigation Standards (AGIS) outline the standards required of
Australian Government agencies, such as the APVMA, in the identification of, and adherence to, the
operational framework, legislation and powers they operate under. The APVMA manages all compliance
investigations according to the AGIS and other relevant Australian Government guidelines and best practice
requirements.
The APVMA will select the most appropriate approach available to it when collecting evidence at each stage
of an investigation which may include:
seeking the voluntary provision of information to assist the APVMA
physically attending premises to conduct monitoring, or investigative activities at any point of
manufacture or at any point in the supply chain, either through consent or by use of legislated
powers (such as via statutory requirement, monitoring or search warrant)
mandatory requirements through ‘Notice to Attend or Produce’ provisions
seizing or purchasing goods reasonably believed to provide evidence that is relevant to the alleged
non-compliance.
The APVMA will send a formal notice to explain if information or records are being sought voluntarily or if the
APVMA is exercising a legislated power to request information. When a legislative power is utilised, the
relevant provision of the legislation will be referenced and explained and the consequences of non-
compliance outlined.
When an APVMA Inspector exercises legislative powers to physically visit a site, they will identify themselves
by showing their authorised officers’ identity card. They will provide information about the basis for exercising
their rights, and inform the occupier of their rights and responsibilities. For more information on rights and
responsibilities see the Practice Note Compliance Monitoring—rights and responsibilities.
APVMA Inspectors and other staff may use video, audio (digital tape recorder) and other recording systems
to ensure an accurate record of their actions. At a minimum, this may take the form of a recorded audio exit
interview. This will involve the APVMA Inspector summarising their activities at the site, their interactions with
people on the site and any responses provided to them during their visit. The ‘adoption’ occurs when the
accuracy is confirmed by the person(s) present. If the person or company disagrees with the APVMA
Inspector as to the accuracy of events occurring during an inspection, these inaccuracies must be mentioned
on the audio recording.
While this may seem overly formal, this process is necessary to accurately record the actions of APVMA
compliance staff as well as the people on the site they are interacting with.
More information on APVMA compliance investigations is provided below in Chapter 7: Investigating
contraventions.
12 APVMA OPERATING FRAMEWORK
Case study — Penalty Infringement Notices
Scenario
A wholesaler, A-Co, imports and distributes a product to small retailers as a household insecticide. The
product is freely available for supply and does not contain any instructions for use or safety directions. All
writing on the product label is in a language other than English. The product has not been assessed by the
APVMA (i.e. the product is unregistered). The use pattern (dispersed granules) and potential for exposure (if
swallowed by children or animals) presents a high risk. Neither A-Co nor the retailers it sells to are familiar
with their obligations under the Agvet Code. The supply of material is reported to the APVMA by local council
compliance officers.
APVMA response
An APVMA Inspector visits the local council and establishes that supply is widespread and not restricted to a
single council area. The APVMA Inspector and compliance staff conduct monitoring visits to retailers in the
wider area and identify unregistered material. Identified material is seized to ensure public health and restrict
future supply. At the time of the visit and in future communication, the retailers are advised of their
obligations under the Agvet Code. In light of the cooperation provided by retailers, the APVMA issues a
formal warning relating to the supply of an unregistered chemical product to each retailer.
Visits to retail outlets identify that A-Co is the common wholesaler to all identified retailers, and is the
potential source of the product. APVMA Inspectors attend the premises of A-Co and confirm it was
responsible for importing as well as distributing the product within the state. The APVMA issues a recall
notice requiring the withdrawal from the market and recovery of product from people who had purchased the
item. This recall is advertised in local and state-wide newspapers. All returned stocks are destroyed. After an
initial reluctance to cooperate, A-Co fulfils all regulatory actions required by the APVMA.
The chemical posed significant risk to children or small animals if swallowed, and was available to the
general public. On this basis the APVMA prepares to seek a civil penalty. However, in light of A-Co’s
cooperation in completing the recall and other requirements, the APVMA issues Penalty Infringement
Notices (fines) totalling $137 500. A-Co pays the amount owed, and with the completion of the recall the
APVMA response is finalised.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 13
4 SCOPE OF REGULATION
This chapter provides information on the scope of agvet regulation, including which agvet chemicals are
regulated by the APVMA. It lists key legislation relating to agvet chemical products and defines what will
constitute a breach of the Agvet Code (non-compliance).
4.1 Definitions of agricultural and veterinary chemical products
Sections 4 and 5 of the Agvet Code specifically define agricultural or veterinary chemical products
respectively.
There are four broad reasons why chemical products may meet the definition of an agvet chemical product
and thus be regulated by the APVMA:
1. The product’s effect.
2. Claims made about an effect of the product.
3. The product’s ingredients (formulation).
4. The product is specifically declared an agricultural or veterinary chemical product by legislation.
A product does not have to be used in an agricultural or veterinary setting to meet a legislated definition of
an agvet chemical product under the Agvet Code. For example, household insecticides, personal insect
repellents and pool and spa chemicals (amongst other non-traditional ‘agricultural’ chemicals) are included in
the Agvet Code.
Similar broad concepts to meet the definition of veterinary chemical products apply, such as medicated
foods. More details on products declared as agricultural or veterinary chemical products are provided in Part
2 of Schedule 3 and Schedule 3AA of the Regulations to the Agvet Code.
Regulations to the Agvet Code also define chemical products expressly excluded from APVMA regulatory
oversight, such as cosmetic treatments for animals. Full details on these products are provided in Part 3 of
Schedule 3 and Schedule 3AA of the Regulations to the Agvet Code.
4.2 How to identify registered agricultural or veterinary chemical
products
Agvet chemical products registered by the APVMA feature the words ‘APVMA Approval No’, followed by a
unique number printed at the bottom of the product label. (Some older products may continue to be labelled
‘NRA Approval Number’. The APVMA was previously known as the National Registration Authority for
Agricultural and Veterinary Chemicals — NRA).
Only registered chemical products may be supplied (including gifts, sales, offers for sale, exchange or
provide under contract).
Current registration status of chemicals and other basic information is provided by the Public Chemical
Registration Information System (PUBCRIS), accessed via the APVMA website (www.apvma.gov.au).
14 APVMA OPERATING FRAMEWORK
The APVMA is developing applications to allow access from tablet or smart phone technology. These
applications will provide portable and ready access to the PUBCRIS system and allow fast confirmation of
the registration status of chemical products.
4.3 Legislation
The APVMA administers a suite of agvet legislation that provides for a cooperative national statutory scheme
between the Australian Government, states and territories as well as for the evaluation, registration and
control of agvet chemical products. The agvet legislation:
establishes the APVMA as an independent statutory authority of the Australian Government,
responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale
provides the functions and powers of the APVMA
provides for the control of the import and export of chemicals
establishes constitutional and other legal provisions that enable the Agvet Code to have effect in the
states and territories covered by the national cooperative scheme
provides for the APVMA to recover operating costs through the collection of application fees and sales
levies.
For most practical purposes, the suite of agvet legislation has the general characteristics of federal rather
than state or territory laws. In particular, this ‘federalisation’ allows the Commonwealth’s Acts Interpretation
Act 1901 to apply for the purposes of interpreting the various iterations of the Agvet Code (Commonwealth,
state and territory legislation) to ensure a consistent interpretative regime. The Commonwealth Director of
Public Prosecutions is empowered to prosecute for any offences against the suite of agvet legislation even
though these are offences against the laws of the states or territories concerned. The Australian
Government’s administrative law package allows exclusive rights of review of APVMA decisions taken under
the Agvet Code as though the decisions were made under Commonwealth law.
Enforcement tools referred to in this Compliance and Enforcement Framework are found in the series of
agvet laws administered by the APVMA:
the Agvet Code of each participating jurisdiction
the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994
the Agricultural and Veterinary Chemicals (Administration) Act 1992.
Penalties may be imposed for non-compliance with the provisions of these Acts and supporting Regulations.
It is the responsibility of agvet industry operators to be aware of any changes to legislation and other
regulatory arrangements affecting the industry.
It should be noted that offence provisions in other Commonwealth statutes (such as the Crimes Act 1914)
may be accessed in certain circumstances. More information on this is provided below in 4.7 Access to other
Commonwealth statutes.
4.4 Offences and civil penalties
The legislative reforms that underpin the Australian Government’s Better Regulation reform agenda extend
the scope of the APVMA’s access to and use of penalties. Changes in the suite of agvet legislation provide
COMPLIANCE AND ENFORCEMENT FRAMEWORK 15
the APVMA with access to civil penalties, where previously there were none. More information on provisions
to impose civil penalties is provided below in 8.5 Court Proceedings — Civil.
Some of the civil and criminal offence penalties provided for in the current suite of agvet legislation and the
draft legislation are listed below. While not a complete list of penalty provisions that will be available to the
APVMA, it provides a broad understanding of the areas when an obligation for compliance rests on industry
or the wider marketplace.
Unless a specific exemption, defence or reasonable excuse applies, the Agvet Code makes it unlawful to:
supply or possess for supply an agricultural or veterinary chemical that has not been approved or
registered by the APVMA or for which a permit has not been issued by the APVMA — s. 78
fail to comply with conditions of registration, permit or licence — ss. 79, 116A, 121B
provide false or misleading information — ss. 145(2), 145(4)
manufacture or supply of counterfeit agricultural or veterinary chemicals — ss. 95A, 95B
supply a date-expired agricultural or veterinary chemical registered by the APVMA — s. 91A
advertise an agricultural or veterinary chemical that has not been registered by the APVMA — s. 88
supply an agricultural or veterinary chemical product without, or make claims inconsistent with, the
label approved by the APVMA — ss. 84, 85, 86, 89
fail to comply with a direction or requirement of an Inspector — ss. 130B, 132G, 138D, 145GB, 145H
fail to adhere to regulatory instructions or requirements — ss. 32(3), 33(2), 45A(6), 54(3), 56X(3),
56ZI(7), 56ZQ(3), 56ZR(4), 105
undertake a step in the manufacture of a veterinary chemical in premises not licensed (refer
Manufacturers’ Licensing Scheme) by the APVMA — s. 121A
manufacture a prohibited chemical product — s. 121
fail to provide updated regulatory information in respect of registrations — ss. 26, 56R(1), 160A, 161
use a protected name or symbol of the APVMA without authority — s. 170A.
Unless a specific exemption, defence or reasonable excuse applies, under the Agricultural and Veterinary
Chemicals (Administration) Act 1992 it is unlawful to:
import unregistered chemical products or unapproved active constituents — s. 69B
fail to provide updated information — s. 69CD(1), s. 69E
provide false or misleading information — s. 69CD(3)
breach conditions in respect of international conventions — s. 69C
fail to maintain records — s. 69EA
fail to comply with a direction or requirement of an Inspector — s. 69EB(6), s. 69EN(3).
Unless a specific exemption, defence or reasonable excuse applies, under the Agricultural and Veterinary
Chemical Products (Collection of Levy) Act 1994 it is unlawful to:
fail to advise the APVMA of the leviable value of a product — s. 15
fail to keep records of supplied agvet chemicals — s. 36.
4.5 False and/or misleading information
Like all regulators, the APVMA has a degree of trust in people who submit applications and other information
to the APVMA.
16 APVMA OPERATING FRAMEWORK
Many market authorisation processes are informed by a desk-based analysis of the dossier of documents
provided to the APVMA by an applicant or manufacturing site operators. Whilst genuine mistakes can occur,
providing false or misleading information to an Australian Government agency is a very serious breach of the
Agvet Code and wider criminal law. The public expects chemical companies to be honest with all regulators.
‘False information’ is information that includes incorrect or inaccurate details. ‘Misleading information’
includes data that whilst not incorrect, does not convey a full and accurate picture of the situation it is
purporting to represent.
The deliberate or negligent supply of false or misleading information is a serious attack on the integrity of the
regulatory system as it undermines industry, consumer and community confidence. The APVMA regards
such dishonesty as fraud, and it undermines its efforts to protect people and the environment.
All APVMA Inspectors and staff are required to report any suspected fraud (including when they believe the
APVMA has been supplied false and/or misleading information).
All reports of the supply of false or misleading information are investigated.
The APVMA may pursue criminal prosecution or administration action of a person or company that it
believes has supplied false or misleading information.
The maximum criminal penalties for supplying false or misleading information under the Agvet Code include
fines of up to:
$33 000 for a person
$165 000 for a company.
If appropriate, instances of false or misleading information may be investigated under other Commonwealth
statutes such as the Commonwealth Criminal Code 1995 and Crimes Act 1914. More details on this are
provided below in 4.7 Access to other Commonwealth statutes.
Administrative response options when the APVMA suspects that false or misleading information has
influenced its decision-making include suspending or cancelling active constituent approvals, product
registrations or permits.
The APVMA may pursue court proceedings, administrative action or a combination of both when a person or
a company provides it with false or misleading information.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 17
18 APVMA OPERATING FRAMEWORK
Case study — Criminal prosecution
Scenario
B-Co has submitted information to the APVMA in support of market authorisations (a total of 100 approvals,
registration and permits) detailing the manufacturing process and supporting analytical results. The
information has been generated by an analytical facility operating under contract to B-Co. The information is
fundamental to the APVMA’s satisfaction for the market authorisations.
Donna is an ex-employee of B-Co. Donna advises the APVMA that B-Co routinely directs the contracted
analytical facility on the results it requires to satisfy APVMA requirements. Donna says the results the
analytical facility presents should not be considered factual. They provide correspondence between B-Co
and the analytical facility clearly stating that results for numerous tests should be changed to be in line with
APVMA tolerances. Donna states that all market authorisations granted by the APVMA to B-Co in the past
decade are affected.
APVMA response
APVMA Inspectors visit Donna and seek a formal statement, for potential use in court proceedings. Donna
agrees to serve as a potential witness and provides a formal statement. The statement includes various
examples of the fraudulent activities.
The examples are validated against APVMA records and it is considered the statement is reliable. APVMA
Inspectors seek, and are granted, search warrants for the head office and manufacturing facilities of B-Co.
Searches are conducted by APVMA Inspectors, assisted by IT specialists, and full copies of business
records and email traffic of B-Co are taken. After review of these records it is established that all market
authorisations are supported by a level of fraud.
APVMA Inspectors prepare a brief of evidence, including recorded interviews with B-Co company directors
and key staff, for the Commonwealth Director of Public Prosecutions (CDPP) to consider criminal
prosecution of the persons and B-Co for submitting fraudulent information to the APVMA. The CDPP starts
court proceedings, seeking a conviction and penalties for each offence against each market authorisation
(100 in total).
Following the review of records obtained through the search warrants, the APVMA seeks to suspend all
market authorisations held by B-Co. B-Co provides an inadequate response. The APVMA is satisfied the
market authorisations are invalidated by fraud and suspends all market authorisations for B-Co.
The APVMA considers the risk posed by the product in the marketplace and issues recall notices as
required for some broad acre products. As B-Co provides analytical results in support of the registrations,
the APVMA considers these and cancels the suspensions when its statutory satisfaction is achieved.
At the end of the suspension period the APVMA seeks to cancel all market authorisations that have not
been satisfactorily addressed. B-Co seeks to have the APVMA extend the suspension by 12 months to
provide time for the generation of data. B-Co proposes, and the APVMA accepts, an enforceable
undertaking that B-Co will conduct the required analyses at accredited facilities in Australia and will provide
all results to the APVMA. At the end of the continued period it is agreed that all market authorisations that
remain under suspension will be cancelled.
The APVMA may also choose to conduct further investigation into the operations of the analytical facility
involved in this scenario.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 19
4.6 Levy evasion
Levy evasion is when a person or company has not paid a levy (or levies) due, or when they have
deliberately misled the APVMA about their activities to reduce their levy liability. Levy evasion is taken very
seriously as it reduces the amount of revenue available to fund APVMA programs and services, and
provides an unfair competitive advantage to a person or company.
Other examples of levy evasion include failing to declare sales, manipulating sales data to remain under
recovery thresholds and failing to register products whilst continuing to supply them after the APVMA has
intervened.
Offence provisions are included in the Agricultural and Veterinary Chemical Products (Collection of Levy) Act
1994 and associated regulations, and within other Commonwealth statutes. Significant penalties, including
imprisonment, can be applied by courts for levy evasion.
4.7 Access to other Commonwealth statutes
Because the APVMA is an Australian Government agency and breaches of the Agvet Code (non-
compliance) are treated as Commonwealth offences, the APVMA can also seek to access the enforcement
provisions of other legislation. This includes the Crimes Act 1914 and Commonwealth Criminal Code 1995.
When APVMA investigations confirm serious, systemic or otherwise flagrant breaches that constitute levy
evasion or dishonest conduct, the APVMA may ask the Commonwealth Director of Public Prosecutions to
consider starting proceedings under other legislation (rather than the Agvet Code).
The maximum penalties under the Criminal Code (see 4.5 False and/or misleading information above) for
levy evasion or dishonest conduct include:
1 year of imprisonment for each time false or misleading information is submitted to a Commonwealth
entity
10 years of imprisonment for possessing or submitting forged documents with intent to dishonestly
induce a Commonwealth entity.
As an Australian Government agency, the APVMA may also refer a matter to the Australian Federal Police
(AFP) if it considers a sufficiently serious breach has occurred. The proceeds of crime confiscation and
forfeiture regime may be considered by the AFP and Commonwealth Director of Public Prosecutions in any
instance of referral for wider statutes.
The APVMA may also seek assistance or advice from the AFP about any investigation being conducted into
suspected breaches of agvet law.
20 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 21
5 COMPLIANCE ANDENFORCEMENT FUNCTIONS
This chapter sets out the variety of compliance and enforcement activities the APVMA undertakes, and
details APVMA sections responsible for compliance and enforcement functions.
5.1 Compliance and enforcement
The APVMA includes a Compliance and Enforcement team to support its role as regulator of the agvet
chemical industry. Core activities of the Compliance and Enforcement team include conducting compliance
audits, assessing allegations of non-compliance, and investigating for the purposes of criminal prosecution.
There are three main components to compliance activities of the APVMA: education, engagement and
enforcement.
‘Education’ of industry sectors is the foundation level compliance activity undertaken by the particular
APVMA section responsible for issuing market authorisations or statutory approvals.
Statutory approvals include:
agvet chemical product registrations
approval of sites of manufacture for active constituents
permits to supply agvet chemical products
licences to manufacture veterinary chemical products.
Contact details for these APVMA sections are provided on the APVMA website
(www.apvma.gov.au/about/contact).
The APVMA is a cost-recovered agency with defined resources. Compliance and enforcement interventions
are resource-intensive and so the APVMA must be prudent when applying these resources.
5.2 Monitoring and investigation
The APVMA Compliance and Enforcement team reports directly to the Program Manager of Regulatory
Strategy and Compliance (RS&C) and is primarily responsible for conducting APVMA monitoring programs
(audits of registrants and the marketplace for compliance with statutory obligations) and investigations for
court proceedings for agvet chemicals.
The APVMA Compliance and Enforcement team also responds to reports (allegations) of non-compliance
submitted to the APVMA, including reports of the supply of unregistered chemical products. The APVMA
may also purchase agvet chemical materials from a suspected non-complier to establish an evidence brief to
support its enquiries.
The monitoring functions of the APVMA include the ability to act swiftly to secure material if it poses a
potential health or safety risk to people or animals, the environment or international trade. The Compliance
section of the APVMA may also conduct scientific product and active constituent testing.
22 APVMA OPERATING FRAMEWORK
You can contact the APVMA Compliance section on the Compliance Hotline 1300 700 315 during business
hours or via email at compliance@apvma.gov.au
Information on how to report non-compliance is provided on the APVMA website
(www.apvma.gov.au/compliance ).
Case study — APVMA intervention only
Scenario
C-Co seeks and is granted a permit by the APVMA for the supply and use of an unregistered chemical
product. In supplying and advertising the product, C-Co includes a copy of the permit. In conducting a desk-
based audit of the permit, an APVMA Inspector identifies that C-Co has not kept records on who was
supplied with the product, the quantities supplied and the location of use. All these requirements are
conditions of the permit for C-Co to supply and use the product. The APVMA suspects that C-Co has
breached the permit.
APVMA response
An APVMA Inspector telephones C-Co to identify the extent and seriousness of the non-compliance. C-Co
acknowledges it has not complied with record-keeping requirements. C-Co says its staff are unfamiliar with
permits, and the agricultural chemical represents a small component of the business. C-Co states it does
have records establishing total quantities imported and supplied. The quantities represent less than 10 per
cent of that allowed within the permit.
C-Co undertakes to prepare new operating procedures and protocols to ensure accurate records. Copies of
these are provided to the APVMA within a week of the initial phone call from the APVMA. C-Co also agrees
not to supply any material until the procedures are reviewed by the APVMA.
Based on the limited risk posed by the breach of conditions, and the response of C-Co, the APVMA does
not impose a regulatory sanction. Future permit audits are conducted over the next 2 years to monitor
compliance.
5.3 Manufacturing quality and licensing
The Manufacturing Quality and Licensing (MQL) section of the APVMA conducts specialist compliance
activities for veterinary chemical products. The MQL section is located within the Compliance and
Enforcement team, and reports to the Program Manager of the APVMA Veterinary Medicines Program
(VMP).
The MQL section manages two veterinary product manufacturing schemes:
The Manufacturers’ Licensing Scheme for veterinary products manufactured in Australia
The Overseas GMP Scheme for veterinary products manufactured overseas.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 23
Ultimate responsibility for meeting these quality objectives lies with company
senior management, but the participation and commitment of all staff, at all
levels within the manufacturing organisation is vital. To achieve quality
objectives, the manufacturer must have in place a comprehensive,
adequately-resourced and correctly implemented system of quality
assurance that incorporates the principles of the GMP.
Working with
The MQL section also monitors the GMP compliance status of Australian and
overseas agvet chemical manufacturers. Manufacturer compliance with GMP industry at each
is a necessary prerequisite to gain and maintain veterinary product
registration and to gain relevant export certificates. The MQL section may point in the supply
choose when to intervene if non-compliance is identified or refer the matter
to the Compliance section of the APVMA for further consideration. chain to ensure
More information on the MQL section and programs it administers is
the agvet
provided at the APVMA website (www.apvma.gov.au/supply/veterinary ).
chemicals
supplied to the
5.4 Adverse experiences
Australian market
The APVMA operates an Adverse Experience Reporting Program (AERP).
This program has no formal compliance and enforcement function. It aims to meet quality
provide the APVMA with feedback about the quality and performance of
pesticides and veterinary medicines in the field. This information helps standards and do
ensure registration decisions the APVMA makes remain appropriate and
promote and maintain public confidence in the National Registration not pose undue
Scheme. Reports may also focus compliance and enforcement resources to
areas of emerging concern. risk to people or
Reports of adverse experiences or an unintended effect from the use of
the environment.
registered agricultural or veterinary chemicals can be made on the APVMA
website online form, by email (aerp@apvma.gov.au ) or
telephone (1800 700 583 — business hours).
5.5 Field activities
Staff from the APVMA Compliance and Enforcement team can be deployed
to respond to instances of non-compliance anywhere in Australia. The
APVMA may also seek assistance from other Australian Government, state
or territory departments and agencies to increase its resources to ensure an
effective response to serious instances of non-compliance.
24 APVMA OPERATING FRAMEWORK
Case study — APVMA intervention only
Scenario
John owns and operates a company, D-Co, that manufactures flea treatments registered by the APVMA.
Following a routine audit, the APVMA Inspector (auditor) discovers D-Co has released batches of the flea
treatment before testing is complete, and against release specifications. While the quality control test
results demonstrated compliance with product specifications, the process was not consistent with the
standard operating procedures provided to the APVMA (during registration) covering release for supply.
The releases were invariably made in response to product shortages and limited storage capacity within D-
Co’s manufacturing facility. Despite the potential seriousness of this non-conformance, the APVMA audit
report indicates the quality system was effective.
APVMA compliance and enforcement intervention
Following receipt of the audit report, the Manufacturing Quality and Licensing (MQL) section of the APVMA
sends a formal warning to John reminding him of the obligations of D-Co under Regulation 61 (6) of the
Agvet Code to maintain an effective quality function. As part of the audit closure process, John works with
his staff to address this non-conformance by strengthening the role of D-Co’s Quality Nominee in the
release process. John recognises the underlying root cause behind D-Co’s non-conformance related to
storage capacity and seeks and obtains a licence for an off-site distribution warehouse so quarantined
material can be shipped and stored pending final release.
The corrective actions are completed within the timeframe specified by the APVMA and the audit is closed.
No further compliance action is taken.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 25
26 APVMA OPERATING FRAMEWORK
6 INDUSTRY’S RESPONSIBILITIES
This chapter sets out the expectations the APVMA has of agvet chemical industry operators, including
approval holders, registrants, manufacturers, wholesalers and retailers.
Note that obligations and controls relating to the use of agvet chemical products once they are sold is the
responsibility of each state and territory.
6.1 What the APVMA expects of industry
With such a broad range of agvet chemicals available in Australia, the singular term ‘industry’ is used to
cover a diverse range of entities. The suite of agvet legislation is primarily focussed on the import,
manufacture and/or supply of agvet chemicals. The APVMA thus considers the term ‘industry’ to include
importers, manufacturers, distributors, wholesalers and retailers.
The APVMA and the Australian community expects industry competence in manufacturing, importing and
supplying agvet chemicals and products. This competence includes:
being aware of (or having the ability to become aware of) obligations under agvet legislation that
governs industry activities
complying with agvet legislation and other relevant Commonwealth, state and territory legislation
maintaining accurate records relating to agvet chemical products
maintaining appropriate licences to manufacture veterinary medicines and abide by licence conditions
maintaining appropriate manufacturing and formulation standards for agvet chemicals
handling chemicals responsibly and in accordance with Commonwealth, state and territory
requirements.
The APVMA also expects industry to be good corporate citizens by:
providing feedback to the APVMA Compliance and Enforcement team about obligations to comply
with agvet legislation
notifying the APVMA when necessary and to fulfil obligations under agvet legislation in an honest and
transparent way
using the appropriate mechanism to advise the APVMA within the required timeframe of any variations
to the details of an agvet product, its label or intended use
providing reasonable assistance for voluntary calls for the provision of information, data or records to
the APVMA
providing timely cooperation with all lawful requirements and directions from APVMA Inspectors
alerting the APVMA Adverse Experience Reporting Program (AERP) to any adverse experiences
alerting the APVMA to potential non-compliance, including the provision of any information to the
APVMA suspected to be false and/or misleading, and alerting the APVMA of any suspected
fraudulent activity
not seeking to misuse non-compliance reports for financial benefit or commercial gain.
6.2 Product stewardship and co-regulation
COMPLIANCE AND ENFORCEMENT FRAMEWORK 27
The APVMA expects the agvet chemical industry to demonstrate a high level of product stewardship and
adhere to all relevant Commonwealth, state or territory legislation.
The APVMA also acknowledges that strong industry practices may potentially augment government
regulatory arrangements when underpinned by agvet legislation. On this basis, the APVMA encourages the
development of industry-wide codes of practice that complement the legislation and promote compliance.
Certain offence provisions include sections providing that an offence has not occurred when a ‘reasonable
excuse’ exists. It rests with the person or company alleged to have committed the breach (non-compliance)
to establish a ‘reasonable excuse’. As industry develops codes of practice, the APVMA will consider
submissions as to their standing in respect of ‘reasonable excuse’ provisions for offences under the Agvet
Code.
Case study — Enforceable undertaking
Scenario
A veterinary chemical product manufacturer, E-Co, submits its product to a contract laboratory, Lab-1, for
release specification testing. Lab-1 is not normally used by E-Co, and does not routinely undertake product
testing and therefore is not licensed. E-Co has been involved with veterinary chemical products for 20 years
and is aware of the obligations of Good Manufacturing Practice (GMP) and the conditions imposed upon
licensed manufacturers.
The matter is identified during a GMP audit by an APVMA Inspector, who reports it to the APVMA.
APVMA response
Manufacturing, Quality and Licensing (MQL) staff in consultation with APVMA Inspectors request
information from E-Co and Lab-1 on testing and quantity of material. It is established that Lab-1 is unaware
of GMP and is not interested in pursuing product release specification testing as the commercial value is
not significant. Lab-1 admits it conducted a step in the manufacture process and it is not licensed. A formal
warning is issued to Lab-1.
E-Co proposes to the APVMA an enforceable undertaking requiring adherence to the licence conditions and
the use of appropriate facilities for all future steps of manufacture.
In the absence of any adverse reports the APVMA accepts the undertaking of E-Co and takes no further
regulatory action.
28 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 29
7 INVESTIGATING CONTRAVENTIONS
This chapter sets out how the APVMA conducts compliance investigations once it has received and
assessed a report (an allegation) of non-compliance.
7.1 APVMA compliance investigations
All reports and detections of potential breaches of agvet legislation are subject to an initial assessment by
the relevant APVMA section to ascertain their priority for further compliance and enforcement action.
Priorities are set to ensure investigative resources of the APVMA are used most effectively.
Initial assessment typically includes a preliminary examination and analysis of the non-compliance report or
allegation to decide the likelihood that non-compliance with agvet legislation has occurred and to assess its
seriousness and likely consequences. If possible, the APVMA will act to prevent non-compliance and
discourage ongoing and future non-compliance.
In certain circumstances, the APVMA may refer suspected contraventions to the Australian Federal Police or
other enforcement agencies for investigation. During these investigations, the APVMA supports the relevant
investigating agencies on matters relating to administration of the Agvet Code.
Based on the outcome of the initial assessment and the relevant provisions of legislation, the APVMA will
determine the appropriate level of intervention (if any). Depending on the results of the initial assessment,
the APVMA may elect to:
1. Not pursue the matter further (having regard to its jurisdiction, priorities, if a breach of legislation has
occurred, and how best to achieve the objects of the legislation or program).
2. Seek more information from the person or company that reported the non-compliance as well as the
marketplace or the person or the company the non-compliance report relates to.
3. Proceed with a detailed investigative action (reserved for non-compliance reports identified as high
risk).
Once the APVMA has completed its investigations it may choose to:
1. Not pursue the matter further if no law has been broken.
2. Take no further intervention action, but take steps to increase awareness and encourage compliance
(such as providing educational material and engaging relevant stakeholder groups).
3. Take further intervention, and implement a mid-range compliance response such as
seizing a product (for evidentiary or safety purposes)
issuing a Penalty Infringement Notice (a fine)
conducting scientific or other testing
recalling the product from market
suspending or cancelling an agvet licence, permit or registration.
4. Escalate the intervention to a detailed investigative action with a view to court proceedings.
When the APVMA elects not to proceed with a particular matter at a particular time, this is subject to review if
further reports or additional information is received.
30 APVMA OPERATING FRAMEWORK
The APVMA’s enquiries and investigations aim to:
determine if the law has been broken
gather evidence that will be admissible (allowed) in civil or criminal
proceedings, or that may facilitate regulatory action
improve controls to prevent contraventions
deter further or similar action
improve public confidence in the integrity of the regulatory system Taking a strong
achieve an appropriate outcome within a reasonable time and at a
reasonable cost, according to the law and the nature of the stance on
investigation.
In certain circumstances, the APVMA may refer suspected contraventions to non-compliance,
the Australian Federal Police or other enforcement agencies for
investigation. During these investigations, the APVMA supports the relevant driving industry
investigating agencies on matters relating to administration of the Agvet
Code.
accountability and
7.2 Visiting premises during investigations and assuring the
inspections
Inspections, investigations and the associated collection of evidence can be integrity in the
an intrusive and sometimes stressful process. APVMA Inspectors and other
staff will approach these activities in a way that will withstand scrutiny, is National
ethical, lawful and fair (see chapter 3: Compliance and enforcement
approach above).
Registration
The APVMA will endeavour to conduct investigations in ways that:
ensure the presumption of innocence is supported Scheme.
respect the reputations of people and companies and do not unduly
prejudice company operations
mitigate the impact on third parties
do not prejudice a person or a company’s right to a fair hearing.
Obligations
Under the law, APVMA Inspectors can enter premises and require
documents or information in certain circumstances. When an Inspector
intends to exercise this legislated power, they are required to identify
themselves and present their authorised officers’ identity card. This is usually
done when the Inspector first enters a property.
Inspectors may give warnings about the consequences of refusing a
legislative requirement to provide information. It may be a defence for a
person to refuse a requirement to provide information or produce documents:
if the information required or documents produced would tend to
incriminate the person
if there is a reasonable excuse.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 31
However, these claims may not necessarily be accepted at the time and the person may be required to
prove these defences apply to them in court at a later date. Further, these protections are not usually
afforded when a body corporate (such as a company) is the focus of APVMA enquiries.
The law also provides for an APVMA Inspector to give certain direction if items are seized or detained.
These actions are intended to ensure the health and safety of the public. An Inspector may give warnings
about the consequences of refusing to follow these requirements, and may again show their APVMA
authorised officers’ identity card to remind people of their legal power to provide directions.
It may be a defence to refuse such a direction if there is a reasonable excuse, however, a claim of
‘reasonable excuse’ may not necessarily be accepted at the time and the person may be required to prove
these defences apply to them in court later.
Rights
If an APVMA Inspector is confronted with evidence during compliance monitoring activities or investigations
they reasonably believe shows that a particular person or a company has committed an offence under agvet
legislation, the Inspector may ‘caution’ people. This ‘caution’ states the person is not obliged to answer
questions nor take certain actions.
People ‘cautioned’ may include people suspected of having committed offences (often called suspects) and
persons believed to have knowledge of matters under investigation (often called persons of interest).
If an inspection or search is undertaken via a warrant issued by a Magistrate, a copy of the warrant and a
‘Notice to Occupier’ will be provided to persons at the premises around the time of entry. The ‘Notice to
Occupier’ will contain information about specific rights relating to the inspection or search.
More information (including examples of the actions allowed for and by an APVMA Inspector during an
authorised visit) is provided in the Practice Note—Compliance Monitoring—Rights and Responsibilities.
7.3 Use of non-intrusive investigative and monitoring powers
APVMA compliance and enforcement operations occur throughout all Australian states and territories. Travel
for limited enquiries or enquiries into low-risk matters may not be an efficient or effective use of APVMA
resources. The Better Regulation reforms introduced provisions for APVMA Inspectors to require certain
information is provided via a written notice. Penalties for non-compliance with requests for information are
similar to those when an Inspector physically visits a site and requests information from a person.
Written notices also provide time for the responsible person to locate the specific information requested and
to provide written context surrounding the item(s).
32 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 33
8 RESPONDING TO CONTRAVENTIONS
Once the APVMA has substantially advanced or completed an investigation it considers a range of factors
when selecting the most appropriate response or responses. This chapter explains these factors as well as
how the APVMA views responsibility for behaviour and the liability for multiple penalties.
8.1 Compliance and enforcement options
Consistent with the philosophy of encouraging and supporting compliance, the APVMA seeks to use the
most appropriate response (regulatory sanction, regulatory action or a combination of these). The range of
responses available to the APVMA is shown in Figure 1. Note that it shows only key responses: higher level
graduations available within each response are not included.
Responses may range from: education or warnings; Penalty Infringement Notices (fines); testing orders;
suspension or cancellation of permits, approvals or registrations; injunctions; remediation orders; seizure of
goods; and civil or criminal proceedings.
Figure 1 –Enforcement measures available to the APVMA
8.2 Regulatory response
Regulatory sanction and regulatory action
When determining the appropriate response to non-compliance, the APVMA considers all relevant factors.
Most instances will see a combination of the regulatory sanction (addressing previous non-compliance) and
regulatory action (ensuring future compliance).
34 APVMA OPERATING FRAMEWORK
Factors that inform APVMA decision-making include:
the type and level of risk posed such as:
o the seriousness of the risk the non-compliance poses for people or animals, the environment
or international trade
o the cost of the non-compliance to the regulator, the Australian Government or general
community
o general consistency with international regulatory practices or Australia’s obligations under
relevant international agreements
the type and severity of the harm, or potential harm:
o the seriousness of the harm caused to people or animals, the environment or international
trade
o the financial benefit derived through the non-compliance, including levies evaded
o the cost of the non-compliance to the regulator, the Australian Government or general
community
o general consistency with international regulatory practices or Australia’s obligations under
relevant international agreements
the law in terms of:
o objectives of the legislation and the specific penalty provisions
o legal precedents affecting the case
o the precedent and deterrent value of specific responses
o the standard of evidence collected
o the time elapsed since the contravention
o the availability and willingness of witnesses to support litigation
the integrity of the regulatory system measuring:
o the prevalence of the type of non-compliance
o the likely public concern about the seriousness of the non-compliance
o the efficacy of the proposed response option
o if the proposed response is likely to promote compliance and promote confidence in the
regulatory system
any aggravating or mitigating circumstances such as:
o if the level of malice or culpability of the non-compliance was or was not intentional,
reckless, negligent, or a mistake
o the apparent commercial value of the non-compliance
o the history of previous non-compliances under the same or similar legislation (excluding
spent convictions)
o the likelihood of the non-compliance continuing or being repeated at a later date
o the type and speed of implementation of voluntary responses by the company
o if the matter was self-reported
o the level of cooperation with authorities.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 35
8.3 Responsibility for unregistered chemical products
Agvet chemical products not registered by the APVMA have not been evaluated as being safe or appropriate
3
for the Australian marketplace. They thus represent a potential and unacceptable risk to people and
animals, the environment and international trade.
When APVMA enquiries identify agvet chemicals suspected of being unregistered (or unapproved for active
constituents) these will be secured pending confirmation. This will usually mean a written prohibition on
continued supply of the material and directions for storage. When a high risk is posed by a chemical, the
notice may extend to removal of material to appropriate storage facilities.
Once it has confirmed that material is unregistered, the APVMA will take action to ensure public safety. This
may include requiring existing materials or products are destroyed (and potential recall of previously supplied
products), export of materials or products to another jurisdiction, or storage of them pending registration.
In all cases, costs associated with these actions will be borne by the party the APVMA identifies as primarily
responsible for releasing the materials or product into the Australian marketplace. It should be noted the
costs of chemical disposal or export can be significant and may be calculated on a per-item basis. When little
or no information on the constituents of a product is known, the cost of disposal will reflect the potential
hazard.
When disposal, export or storage is required, the APVMA will detail the timeframe that actions must occur
within, as well as the broad principles that must be complied with (such as the requirement to use a licensed
chemical disposal operator). In rare circumstances, the APVMA may act of its own initiative to dispose of
material and seek recovery of costs from responsible parties (and this may include legal proceedings).
In the first instance, the point of supply the APVMA identifies (including a retail outlet) will be considered as
the initial party of responsibility. If information (such as deeds of sale, wholesale invoices, etc.) is provided
that establishes another party as responsible for supplying the material or product to the Australian market,
the APVMA will consider this when determining who bears the burden of removal. It should be noted that
while responsibility for cost may be transferred to a third party, the APVMA may still address the actions of
the point of supply initially identified.
8.4 Responsibility for registered chemical products
The person or company responsible for a registered chemical product within the Australian marketplace is
normally referred to as ‘the registrant’. This is the person or company listed within the Register of Chemical
Products for a specific product (either as the original party applying for registration of that product, or
accepting ownership through subsequent registration transferal). The registrant is responsible for all aspects
3
Agvet chemicals are registered by the APVMA, which deems them safe and effective in accordance with their approved instructions of
use.
36 APVMA OPERATING FRAMEWORK
of the product within the Australian marketplace including quality, efficacy,
stability and broadly advertised claims.
When issues relating to a registered product are brought to the APVMA
attention, the initial point of contact for the Compliance and Enforcement
team is with the registrant. The extent of the registrant’s involvement in the
matter can then be determined. For instance, it is possible that claims may New civil penalty
be made about a product that are independent of, and not supported by, the
registrant. In these instances, the APVMA will focus on the author of the provisions that
claim.
provide immediate
When materials or products are identified as counterfeit, the APVMA
acknowledges that responsibility is not appropriately applied to the registrant consequences for
of the ‘real’ product. The person or company responsible for counterfeit
products is determined by the APVMA in a similar manner to how it responds
industry
to unregistered chemical products (described above). misconduct and
The Manufacturer Licensing Scheme (MLS) applies responsibility for the encourage
manufacture of veterinary products to the manufacturer. Non-compliances
arising from Good Manufacturing Practice (GMP) audits of veterinary chemical
manufacturers are generally unlikely to result in formal action, unless the
non-compliance is reported and represents an offence or breach of licence companies to
conditions, or the non-compliance is wilful or places animals or the public at
risk. When any risk criteria are met, the matter is considered as a potential
operate within the
non-compliance and treated accordingly.
law.
8.5 Court proceedings
The Agvet Code (and related legislation) contains civil and criminal penalty
provisions. A person found guilty of committing a criminal offence may
receive a criminal record or be ordered to pay an amount set by a court (a
fine). Certain provisions of the Agvet Code include imprisonment upon
conviction, although these offences apply solely to employees or agents of
the APVMA. A person found to have contravened a civil penalty provision
may be ordered to pay an amount the court defines, but no criminal
conviction against them is recorded.
Initiating court proceedings (civil penalty or criminal prosecution) is a serious
matter and represents the extreme of response options available to the
APVMA. The APVMA or Commonwealth Director of Public
Prosecutions (CDPP) may choose to proceed against companies as the
responsible legal entities, or certain individuals as natural persons, or people
as executive directors or other senior managers of a company, or a
combination of these.
The APVMA may initiate court action if:
executive directors or other senior managers have acted intentionally or with a high degree of
recklessness
COMPLIANCE AND ENFORCEMENT FRAMEWORK 37
the person or company staff have previously had APVMA warnings directed to them
the person or company has a history of non-compliance
the person or company resists regulatory intervention, adopts an antagonistic or adversarial stance
the APVMA regards efforts to come into compliance as inadequate
the Australian Government or Australian public expects the conduct to be prosecuted
due to the nature or magnitude of the non-compliant action or behaviour it is important to deter
potential other offenders.
The APVMA will consider a variety of matters when deciding if it will seek redress under civil or criminal
provisions (when they are available to it).
Civil
The standard of proof for civil litigation is the ‘balance of probabilities’ which differs from the ‘beyond
reasonable doubt’ of criminal prosecutions. Civil penalty provisions of agvet legislation do not require that
knowledge of the breach (non-compliance), or state of mind at the time of the breach, is established. The
APVMA need only to establish the breach occurred and to confirm the identity of the person or company
responsible for that breach.
When deciding if to start civil proceedings, the APVMA will have regard to the Commonwealth Legal
Services Directions and is committed to the ‘model litigant’ principles.
The APVMA may proceed with civil proceedings if:
the obligation of a Penalty Infringement Notice has not been discharged correctly (i.e. failure to pay
the
fine), or when a Penalty Infringement Notice is challenged
the APVMA regards the matter as particularly serious due to volume of material or risk posed by the
activity
the activity in question was driven by anticipated, or actual, commercial benefit for the party.
Criminal
If the APVMA considers criminal prosecution the most appropriate response to an alleged offence it will
prepare a brief of evidence. The brief is then referred to the Commonwealth Director of Public Prosecutions
(CDPP), who has ultimate responsibility for prosecuting offences against Commonwealth law. The CDPP’s
decision will be taken in accordance with the Prosecution Policy of the Commonwealth, which lists a number
of criteria, including if prosecution is in the public interest.
The CDPP normally expects agencies referring a brief of evidence to include whom the agency proposes is
the defendant to answer any charge(s).
The APVMA may seek criminal proceedings if:
false and/or misleading information is provided to the APVMA
the offence involves levy evasion or other dishonest behaviour
the APVMA regards the matter as particularly serious due actual or potential for harm to people,
animals or the environment.
38 APVMA OPERATING FRAMEWORK
Individual and corporate responsibility
Sections 145CD, 145CE and 151 of the Agvet Code define the liability of employees, agents or officers of a
body corporate relative to the liability of the body corporate itself.
An executive officer liability generally relates to:
if the executive knew the non-compliance would occur
if they were in a position to stop the non-compliance
if they failed to act to stop the non-compliance.
In these instances, the APVMA response targets both a person and their company.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 39
Case study — Civil penalty order
Scenario
A company, F-Co, is granted a permit for the manufacture, supply and use of a chemical product in
response to a plague of locusts. The permit restricts supply to 150t of active constituent and limits the sites
of manufacture to a single location. The permit also requires assessment of the site by state or territory
workplace or occupational health & safety authorities before manufacture starts. The restrictions are
necessary to ensure the safety of workers, users and the environment and to control off-target species
damage and risks of residues in trade commodities.
F-Co imports 1000t of material and releases it for manufacture in all states. The importation, manufacture
and supply to the market are made under the auspices of the permit. F-Co conducts a national advertising
campaign, through regional papers and media outlets, offering the material for supply.
A local farm group accessing the product reads the permit and realises it does not apply to their state.
They contact the APVMA seeking information on the legality of use and potential risks posed to their crops.
APVMA response
APVMA Inspectors review advertising material to identify potential sites of supply and immediately attend
various states and territories to validate the report. After confirming that manufacture and supply is
occurring outside the conditions of the permit, investigative warrants are sought and F-Co is notified of the
intent to suspend the current permit. Searches and seizure of product and records are conducted at all sites
of manufacture, transport companies and the head office of F-Co.
F-Co is provided 7 days to show cause why the APVMA should not suspend the permit. This timeframe is
considered appropriate due to the high-risk behaviour F-Co has displayed. The response displays a
disregard for F-Co’s legislative obligation with a justification of commercial benefit alone. In reviewing the
material seized under warrant it is established that before seeking a permit, F-Co had taken orders for
1000t and made arrangements for manufacture in all states. The APVMA considers all information and
suspends the permit.
APVMA Inspectors start the investigation, gathering statements and recording interviews with relevant
people, including staff from the manufacturing sites as well as company directors of F-Co. The APVMA
prepares a brief of evidence for civil proceedings relating to the breach of permit conditions and the
importation of an unregistered chemical product. Criminal proceedings also begin relating to the supply of
false or misleading information to the APVMA. In its brief of evidence, the APVMA highlights the high risk
posed to people and animals, the environment and international trade by the conduct of F-Co and seeks the
court’s consideration of a civil penalty of up to $1.65 million for all matters.
40 APVMA OPERATING FRAMEWORK
F-Co is issued with a notice requiring the storage of material pending the completion of court proceedings.
All consideration of permits relating to this matter is suspended while the matter is before the courts.
To formalise a future monitoring program, the APVMA seeks a monitoring warrant for all F-Co premises and
routinely visits its premises to ensure compliance is maintained.
The APVMA will, in conjunction with cancelling the permit, require the destruction of material in the event
that a civil penalty is imposed and/or F-Co is convicted in relation to the false and misleading information.
When these findings are made the APVMA considers if F-Co should hold any permits and may cancel any
or all permits it holds.
‘Double jeopardy’
Introducing civil penalties in addition to criminal offence provisions will allow the APVMA to consider both
pathways. Sections 145B, 145BA and 145BB of the exposure draft Agricultural and Veterinary Chemicals
Amendment Bill 2011 detail the circumstances when the APVMA may, and may not seek sanctions for non-
compliant behaviour through civil and criminal proceedings.
The APVMA must not seek a civil penalty order if a person has previously been convicted in the criminal
jurisdiction for substantially the same conduct (see s. 145B of the Agvet Code).
If criminal prosecution for the same conduct starts while civil proceedings are pending, the civil proceedings
are stayed pending the outcome of criminal proceedings. If the criminal prosecution does not proceed or
does not result in a conviction, the APVMA may resume civil proceedings and seek a civil penalty order (see
s. 145BA of the Agvet Code).
Similarly, the APVMA may also start civil proceedings after criminal proceedings are complete (with no
conviction recorded).
The APVMA may seek criminal prosecution for substantially the same conduct the Federal Court has
previously awarded a civil penalty order for (see s. 145BB of the Agvet Code).
8.6 Alternatives to court proceedings
The APVMA may determine that the most appropriate response to non-compliance is not to proceed with
court action (civil or criminal). The Better Regulation reforms are introducing a range of alternate response
options under the Agvet Code.
Formal warnings about an activity, enforceable directions, enforceable undertakings, and/or Penalty
Infringement Notices (fines) are all mechanisms to provide a proportional and rapid response to certain
situations or incidences of non-compliance. It is important to note that due to the unique nature of each non-
compliant action or behaviour, the proportional and appropriate response may be court proceedings. The
APVMA is not obliged to utilise alternative options.
The APVMA may issue formal warnings relating to conduct when reasonable grounds exist to suspect the
conduct contravenes agvet law.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 41
An enforceable undertaking is in effect a contract a party enters into with the APVMA. The contract states
the party will undertake, or cease certain actions, to ensure compliance with agvet law.
An enforceable direction may be issued relating to conduct when reasonable grounds exist to suspect the
conduct breaches agvet law and the direction is necessary to protect people and animals, the environment
and international trade. The direction will require a person or company to take action (do something or cease
doing something) to comply with agvet law. Penalty Infringement Notices (fines) may be issued by an
APVMA Inspector when they have reasonable grounds to believe an enforceable provision of the agvet
legislation has been breached in the previous 12 months.
8.7 Penalty Infringement Notices
Court proceedings represent the high-end response options appropriate to high-risk or high-impact non-
compliance matters. For low to medium-risk matters, the APVMA will consider applying Penalty Infringement
Notices. These represent an efficient and effective way to address non-compliance and provide a viable
alternative to court proceedings.
The APVMA will start court proceedings as necessary to support any Penalty Infringement Notice. This will
include dispute by the recipient of a notice or a failure to discharge the financial liability. The APVMA will
establish sufficient evidence to produce a comprehensive brief in the event court proceedings are necessary.
42 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 43
9 REPORTING, MONITORING AND
DETECTION
This chapter outlines how to make a report of non-compliance to the APVMA
and how the APVMA will assess the significance of alleged or suspected
non-compliance with agvet law.
Modern legislation
9.1 Reports of non-compliance that gives the
The APVMA recognises the value of information provided by industry and the APVMA the tools
community, and welcomes reporting of suspected breaches of legislation and
product requirements. This includes reports on: and authority to
the advertising and supply of unregistered and unapproved chemicals
better protect the
inappropriate or incorrect agvet chemical product manufacture
products that don’t meet conditions and/or standards safety of people
the promotion of products inconsistent with approved labels.
and animals, the
The APVMA may also become aware of non-compliance through its own
investigations, networks and activities. This can include Good Manufacturing environment and
Practice (GMP) audit reports, market surveillance and intelligence-sharing
between Australian, state, territory and local government agencies. Non-
international
compliance identified through these pathways is administered in the same
trade.
manner as reports received from external sources.
9.2 How to report non-compliance
Details of what, where, when, how and who are vital information when
considering reports of non-compliance. To help establish the relevance and
importance of each report, the APVMA has developed a non-compliance
reporting form. This form can be downloaded from the APVMA website
(www.apvma.gov.au/compliance/report.php).
General concerns not readily identifiable as particular offences may be
referred to other sections of the APVMA to assist with assessment to or to
manage.
Incomplete reports of non-compliance or reports not submitted through the
appropriate mechanisms may not be identified as compliance matters, and
the APVMA may not act on them.
44 APVMA OPERATING FRAMEWORK
9.3 How the APVMA manages reports of non-compliance
Information received on non-compliance is initially handled on a confidential basis and assessed to
determine if further investigative action is required. If prosecution or litigation occurs, the APVMA is required
to disclose all relevant information, which may include the identity of people who have made reports of non-
compliance.
All reports of non-compliance submitted using the form are acknowledged upon receipt and prioritised for
action on the basis of ‘chemical risk’. Chemical risk is based on the potential or actual harm to people and
animals, the environment and international trade.
Reports are streamed to the appropriate section of the APVMA. For instance, reports submitted primarily
relating to veterinary manufacture will initially be considered by the Manufacturing Quality and Licensing
(MQL) section. Reports relating to offences outside the Manufacturer Licensing Scheme (MLS) are routinely
handled by the APVMA Compliance and Enforcement team.
In accordance with regulatory risk principles in the Compliance and Enforcement Framework, the APVMA
responds to the non-compliance that poses the greatest risk. The APVMA is unlikely to respond to
complaints with little public interest (or risk) that are largely driven by commercial motives.
All reports that pose a potential high-risk are assessed and if there is a possibility that high-risk behaviour
has occurred or will continue to occur, the report is prioritised quickly with immediate intervention. This
intervention may involve a formal investigation and the outcome of this could include court proceedings (civil
or criminal) as well as Penalty Infringement Notices, product suspension and/or product control measures
(such as a market recall).
When the assessment establishes that high risk behaviour is likely to occur in the near future, immediate
administrative intervention is taken. This may take the form of compliance audits, suspending or cancelling
market authorisation, product control measures (recall notice) or enforceable undertakings.
Reports assessed as low to medium risk which result from deliberate, repeated or sustained non-compliance
are prioritised and pursued through active formal intervention. Actions the APVMA will take will aim to
motivate people or companies to genuinely commit to long-term compliance while addressing their past
behaviour. Options can include product control measures (recall notice) as well as Penalty Infringement
Notices (fines), enforceable directions and suspension of market authorisation.
Reports assessed as representing a low to medium risk that are not cases of deliberate, repeated or
sustained non-compliance are primarily dealt with through warnings, enforceable undertakings, Penalty
Infringement Notices or other negotiation to achieve compliance
9.4 Outcomes from reports of non-compliance
COMPLIANCE AND ENFORCEMENT FRAMEWORK 45
The APVMA, like many Australian Government agencies, has a performance benchmark for processing non-
compliance reports. The APVMA benchmark is to attempt resolution within 90 days of receiving and
acknowledging a report of non-compliance.
The APVMA cannot normally comment on specific compliance and enforcement activities, including
providing any details of its investigations to the initial complainant. This is to preserve the rights of all parties
(such as the presumption of innocence) while investigations are underway. Notwithstanding this limitation,
the APVMA will endeavour to respond to correspondence in accordance with its Service Charter
(www.apvma.gov.au/about/reporting/service_charter.php) to the extent that confidentiality and privacy
considerations permit.
More information on the disclosure of compliance investigation outcomes is provided below in chapter 10:
Disclosure of information.
9.5 Monitoring and detection
The APVMA conducts activities designed to monitor compliance with and to detect breaches of agvet
legislation. These activities include market surveillance (including up to the point of retail sale), analysis of
information from sources such as the industry, the general public, government agencies (Australian and
international) and non-government organisations.
Monitoring and detection activities may be strategic, targeted or random and may consist of:
Australian Code of Good Manufacturing (GMP) or marketplace audits
sample collection and product testing
site visits and inspections
call-in of evidence from holders of statutory approvals, registrations or licences to verify ongoing
compliance
observations by the APVMA or other agencies
intelligence analysis of information, data and reports.
These monitoring activities may be conducted under statutory powers of entry or through the use of
monitoring warrants. A monitoring warrant requires the APVMA to seek judicial approval to enter premises
(including residential premises) to ensure compliance. These warrants are used when the primary place of
business is a home-office or similar and when a formal prolonged monitoring program is required.
The APVMA seeks to constantly improve its capacity to detect and respond to non-compliance, and works
with other agencies to enhance this capacity. When appropriate (for example, when APVMA monitoring
responsibilities overlap with those of other agencies), the APVMA builds strategic partnerships to enhance
the effectiveness of agvet chemical regulation. Information and evidence may be shared with other agencies
when required and permitted by law.
46 APVMA OPERATING FRAMEWORK
COMPLIANCE AND ENFORCEMENT FRAMEWORK 47
10 DISCLOSURE OF INFORMATION
The APVMA does not comment on investigations underway. It upholds the presumption of innocence and
where possible, avoids any disclosure that may prejudice future actions. The APVMA will disclose
information about non-compliance incidents as required by law or in support of a wider regulatory response.
This chapter explains the transparency and disclosure principles that guide compliance and enforcement
activities of the APVMA.
10.1 Disclosure framework
People who submit reports of suspected non-compliance to the APVMA are always interested in how their
report is being, or has been, managed. This information is generally not provided as it may be unfair or
prejudicial to a person or company.
In particular, the APVMA will not comment if to do so would prejudice a person’s or a company’s right to a
fair hearing or legal process, impinge upon the privacy or safety of others involved in the investigation (such
as complainants, witnesses and suspects) or prejudice past, current or future actions of the APVMA.
Details of investigative activities normally remain confidential. However, most court proceedings are open to
the public. Enforcement outcomes are publicised when appropriate.
Information may be shared with co-regulators for law enforcement purposes and when this occurs, the
relevant information security and privacy provisions apply, as provided in the Information Privacy Principles
of the Privacy Act 1988 (Privacy Act).
Responses to information requests about general compliance and enforcement matters are handled in
accordance with the APVMA’s Service Charter, subject to any confidentiality obligations and legislative
requirements relating to information security and privacy. The Service Charter is provided on the APVMA
website (www.apvma.gov.au).
Media enquiries are handled by the APVMA Public Affairs unit and the APVMA Compliance and
Enforcement spokesperson.
10.2 Notices and information the APVMA will publish
The APVMA publishes certain information relating to compliance and enforcement activities on its website
(www.apvma.gov.au/compliance), including monitoring activities, enforcement actions and the value of
Penalty Infringement Notices issued. The APVMA also reports on performance in compliance and
enforcement activities its Annual Report.
Requests for information relating to compliance or enforcement, or to matters made pursuant to the Freedom
of Information Act 1982 (FOI Act) are handled in accordance with the process set out in the FOI Act. Any
decision to release or refuse to release information is considered on a case-by-case basis in accordance
with the provisions of the FOI Act and the Privacy Act.
48 APVMA OPERATING FRAMEWORK
11 RECALLS ANDCOMPLIANCE NOTICES
As part of responding to non-compliance incidents, there may be risks best-managed by the APVMA
arranging for the removal of a product (either specific batches of the product or the entire product) from the
market, or preventing future supply to the market.
This chapter details how the APVMA makes recall decisions and the range of compliance notices available
to the APVMA.
11.1 Recalls
The ability to recall defective or non-compliant (including unregistered) products is fundamental to assuring
quality and safety of agvet chemicals in the Australian market and compliance with Australian laws relating to
agvet chemicals. The term ‘recall’ does not refer just to the retrieval or return of products from the
marketplace and/or consumers. ‘Recalls’ may also include ‘not to supply’ or ‘stop supply’.
The full suite of powers available to the APVMA for recalls are found in s. 101 (recall of unregistered
products), s. 102 (recall of registered products) and s. 103 (recall of products with unapproved labels) of the
Agvet Code.
Recalls and similar powers are used solely as a cautionary protective measure, and although their issuance
can impose burdens, they are not used as a form of punishment.
The APVMA has issued Guidelines for the Recall of Agricultural and Veterinary Chemicals to help people
and companies determine if a recall is required and how to effectively recall affected products. The
guidelines are recommended to all involved in the manufacture or supply of agricultural and veterinary
chemicals. The guidelines are available on the APVMA website
(www.apvma.gov.au/compliance/docs/recall_guidelines_feb_2009.pdf).
Costs associated with any aspect of a recall (voluntary or compulsory) are the responsibility of the person or
company. This includes costs for advertising required as part of a compulsory recall.
When deciding if advertising a product recall is required, the APVMA considers the ability of the responsible
company to contact all affected parties.
For instance, when a recall relates to a chemical product with an identified lack of efficacy, and this is
distributed by mail-order direct to end-users, the APVMA will likely require direct correspondence from the
supplier to each customer, rather than advertisements in national media. If the product is distributed through
retail outlets to the general public, the APVMA will likely require notices at point-of-sale and advertisements
in print media to ensure an effective recall.
Voluntary recall
Voluntary recalls may begin when a person or company becomes aware of a quality or labelling issue in a
specific batch of a product and alerts the APVMA. Reporting the potential for a voluntary recall to the
APVMA as soon as an issue is identified establishes a high level of product stewardship. Additionally it
provides opportunity for engaging with the APVMA and industry.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 49
When the APVMA receives a report, it considers if a wider response (such as audits of manufacturing
facilities or escalating the matter to a compulsory recall to provide additional rigor and regulatory control) is
required. If the matter is not escalated, the APVMA monitors the activities of the person or company to
complete the recall and provide input and direction as required.
The APVMA records and publishes information about voluntary recalls.
Compulsory recall
A compulsory recall of a product is instigated and overseen by the APVMA. Compulsory recalls are
undertaken to ensure the safety of people and animals, the environment and international trade, or in any
other instance when a greater degree of regulatory control of chemical material is required.
Compulsory recalls are issued by the APVMA when:
a risk to the public or environmental health exists
the product in question is unregistered
voluntary action is insufficient or increased regulatory oversight is required.
A recall notice lists the actions a person or company must take, including:
the level of application (wholesale, retail or end-user)
the future fate of the material (disposal, export etc.)
the advertising or dissemination of the recall notice (local, national advertising including newspapers
or trade publications)
the form and wording of any correspondence or advertisement informing affected parties
the timeframe for actions.
Restriction on market authorisation
The Agvet Code provides for the APVMA to suspend or cancel any market authorisation it has provided
(such as active constituent approval, product registration or a permit). These response options form a
valuable and viable component of compliance and enforcement activities. They are also integral to the
operation of the chemical reconsideration (commonly called Chemical Review) and permit assessment. For
more information on Chemical Review or Permit restrictions to market authorisation please see the relevant
sections of The Risk Compendium.
When issuing a restriction of market authorisation the APVMA will consider the need for a related recall
notice or permit. As a minimum, any restriction on market authorisation will prohibit further entry of material
into the supply chain. Limited permits addressing material already in the supply chain or in current use are
considered on a case-by-case basis. When the APVMA restricts market authorisation based upon imminent
risk to public health the APVMA will facilitate (and thus continue the risk) continued supply, or use, of the
chemical and will actively work to withdraw the product from the market.
In determining the need for action, the APVMA will consider the public exposure to the active constituent or
product, the likelihood of harm to people, animals, the environment or international trade. The APVMA will
also consider the legislated obligation of industry to provide information to the APVMA, comply with the
conditions and conform to assessed criteria as detailed in s. 41 of the Agvet Code.
The Agvet Code provides that the APVMA may suspend a market authorisation in instances of:
imminent risk to public health or occupational health
50 APVMA OPERATING FRAMEWORK
breaching a condition of approval or registration
failing to give information, samples, results of trials or experiments when requested by the APVMA
providing false or misleading information to support, or in connection with, an approval or registration
use of protected information where arbitration is unsuccessful
chemical reconsideration decisions
non-compliance with criteria for approval or registration.
When the grounds for suspension relate to failing to provide required information, breaching a condition, or
non-compliance with criteria, the APVMA may revoke the suspension once compliance with requirements
has been established.
The APVMA may as part of the suspension give consideration to the future cancellation of the market
authorisation.
All provisions within the Agvet Code that provide for a suspension are extended to grounds for cancellation.
The APVMA is not obliged to suspend a product prior to cancellation. When the APVMA believes it is
necessary, it will seek to cancel a market authorisation. In determining the need for action the APVMA will
consider the public exposure to the active constituent or product, the likelihood of harm to people, animals,
the environment or international trade.
Case study — Restriction of market authorisation
Scenario
A licensed manufacturer of veterinary chemical products, C1, is purchased by another company, C2, which
then enters into a partnership with a third company, C3, to form an amalgamated entity, C4. C4 is not
reflected on the licence, and C4 continues to manufacture products without a valid licence. Although the
APVMA is advised of the change through a routine audit by an APVMA Inspector, the nature of the
partnership is unknown. No application had been received from C2 or C3 and the provisions for being an
exempt person in the Agvet Regulations had apparently not been met.
APVMA compliance and enforcement intervention
On receiving the audit report, the Manufacturing Quality and Licensing (MQL) section of the APVMA writes
to the identified managers at C4’s manufacturing facility and requests more information about the identity of
the responsible company and copies of relevant documents such as the partnership or joint venture
agreement. This letter also contains a formal warning of penalties associated with manufacturing without a
licence and advises C4 to cease manufacture until a suitable licence is issued. Parallel enquiries are made
through the Australian Security and Investments Committee (ASIC) and with the original licence holder with
a view to progressing cancellation of that licence. From the information obtained it is confirmed that C4 is
not covered by the original licence. Although an application for a licence is subsequently provided, the
application cannot be progressed due to the number and seriousness of outstanding non-conformances
arising from the previous APVMA audit. C4 makes no apparent attempt to comply with APVMA
manufacturing standards and obtain a licence. The non-conformances raises concerns with the underlying
quality of the products being manufactured and the clear risk to animal health.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 51
After providing C4 an opportunity to show cause why restrictions on market authorisation should not occur,
the APVMA is satisfied a recall of all batches of manufactured product from end users is required. The
recall also requires C4 to discontinue supply of the product. C4 resists all actions within the recall, with final
compliance achieved through further consideration of increased restrictions to market authorisation
(cancellation of registration).
APVMA Inspectors prepare a brief of evidence, including recorded interviews with company directors and
key staff of C4 for the Commonwealth Director of Public Prosecutions (CDPP) to consider criminal
prosecution of the relevant persons and C4 for submitting fraudulent information to the APVMA. The CDPP
commences proceedings, seeking a conviction and penalties for each offence.
11.2 Types of compliance notices
The different types of APVMA compliance notices and their purposes are listed below. The term ‘agvet
product’ here includes registered and unregistered products, approved and unapproved active ingredients,
and market access through listed registration and permits. More than one notice may be issued in any given
circumstance.
Compulsory ‘Not to Supply’ Notice: a notice that requires a person or company not supply a specified
agvet product. Generally these are considered when the material is identified before its release to the
market.
Compulsory ‘Stop Supply’ Notice: a notice that requires a person or company to compulsorily stop
supplying a specified agvet product. These are generally considered after supply to the market to avoid
further release by the controlling entity (registrant, manufacturer or importer). An accompanying recall notice
may also be considered.
Compulsory ‘Recall Notice’: a notice that requires an entity to recover agvet product from the Australian
market to the level specified in the notice (wholesaler, retailer or end-user).
Product Suspension Notice: a notice that suspends the registration or approval of an agvet chemical
product, active constituent or label.
Product Cancellation Notice: a notice that cancels the registration or approval of an agvet chemical
product, active constituent or label.
Notice of Licence Suspension or Cancellation: a notice that a licence to manufacture veterinary chemical
products is suspended or cancelled.
Notice of Licence Variation: a notice that conditions of a licence to manufacture veterinary chemical
products are varied or amended.
Compulsory Information Provision Notice: a notice that requires the provision of further information in
relation to a product.
52 APVMA OPERATING FRAMEWORK
Compulsory Testing Order Notice: a notice that requires a registrant to compulsorily test an agvet product
at the direction of the APVMA, with testing at the expense of the company listed in the notice.
Notice to Produce: a notice that requires a registrant or approval holder to provide the APVMA information
or documents, or to appear before an APVMA Inspector to answer questions.
Penalty Infringement Notice: a notice that applies a monetary penalty for a breach of a civil penalty or
criminal offence provision (a fi ne).
Substantiation Notice: a notice that requires a person who supplies or makes claims in relation to an agvet
chemical product to provide information on the quantity, place or period of supply and information supporting
the claim(s).
COMPLIANCE AND ENFORCEMENT FRAMEWORK 53
54 APVMA OPERATING FRAMEWORK
12 COMPLIANCE ANDENFORCEMENT PRACTICE NOTES
The APVMA has developed a suite of Practice Notes to inform stakeholders about compliance priorities and
how certain compliance powers may be exercised. These are provided in Volume 2 of the Risk
Compendium.
Additional Practice Notes are created as areas requiring further clarity in the community or for industry are
identified. Practice Notes aim to provide practical guidance to the agvet chemical industry. They are intended
as stand-alone documents that form a library of information to support parties in dealing with the APVMA on
various topics.
Failure to follow the guidance of Practice Notes may be used in any legal proceedings for breaches of agvet
chemical legislation
Practice Notes include:
Compliance with the Law
Compliance Monitoring—Rights and Responsibilities
Reporting Non-compliance to the APVMA
Formal Warnings
Penalty Infringement Notices
Enforceable Undertakings
Use of Optical Surveillance
Compliance Obligations of ‘Permits’ and ‘Exemptions’
APVMA Processes to Support Levy Auditing
APVMA Handling of Complaints of a Commercial Nature
APVMA Handling of Complaints Regarding Advertising
Acceptable Publications for Scientific Research or Technical Material Relating to an Unregistered
Product or ‘Off label’ Use of Registered Products.
COMPLIANCE AND ENFORCEMENT FRAMEWORK 55
Abbreviations
AAT Administrative Appeals Tribunal
Active The active constituent in a product
AERP Adverse Experience Reporting Program
AFP Australian Federal Police
AGIS Australian Government Investigation Standards
Agvet Agricultural and veterinary
Agvet Code Schedule to the Agricultural and Veterinary Chemicals Code Act 1994
Agvet law Agricultural and veterinary chemicals legislation containing enforcement provisions:
• Agricultural and Veterinary Chemicals Act 1994 (the Agvet Act)
• Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code)
• Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994
• Agricultural and Veterinary Chemicals (Administration) Act 1992.
Agvet legislation Agricultural and veterinary chemicals legislation incorporating the Acts, Regulations and
Instruments
APVMA Australian Pesticides and Veterinary Medicines Authority
CDPP Commonwealth Director of Public Prosecutions
FAO United Nations Food and Agriculture Organisation
GMP Good Manufacturing Practice
MQL Manufacturing Quality and Licensing
RS&C APVMA’s Regulatory Strategy and Compliance Program
56 APVMA OPERATING FRAMEWORK
Glossary
Compliance The full implementation of legal requirements.
culpable harm The component of an agricultural or veterinary chemical product responsible for its
physiological When it is reasonable to hold a person or company legally responsible for
loss and/or damage resulting from their action or failure to act.
Enforcement Set of actions that governments or others take to achi eve compliance by the regulated
community with pesticide regulatory requirements and/or to halt situations that may
endanger public health. Government enforcement usually includes activities like
investigations, negotiations and legal actions.
Market authorisation Includes active constituent approvals, product registration, listed registration, or permits
issued by the APVMA providing access for agricultural or veterinary chemicals to the
Australian marketplace.
regulatory action Primarily administrative actions required by the APVMA to return a non-compliant system
to compliance, and ensure continued compliance into the futur e. While not punitive in
nature costs may be associated with addressing APVMA requirements.
Regulatory activities Activities involved in administering regulations.
regulatory sanction Punitive measures intended to as a response to non-compliant action or behaviour for the
purposes of deterrence. Usually applied in conjunction with regulatory action.
