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Australian Pesticides and Veterinary Medicines Authority—Report for 2020-21


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Annual Report 2020-21

Australian Pesticides and Veterinary Medicines Authority 2021

ISSN: 1449-0862 (print); 2209-4407 (electronic)

ISBN: 978-1-925390-08-7 (print); 978-1-925390-07-0 (electronic)

Ownership of intellectual property rights in this publication Unless otherwise noted, copyright (and any other intellectual property rights) in this publication is owned by the Australian Pesticides and Veterinary Medicines Authority (APVMA). When referencing this document, the APVMA should be cited as author and publisher.

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Comments and enquiries Assistant Director, Communications Australian Pesticides and Veterinary Medicines Authority GPO Box 3262 Sydney NSW 2001 Australia Telephone: +61 2 6770 2300 Email: enquiries@apvma.gov.au

This publication is available from the APVMA website: apvma.gov.au/node/11031

13 September 2021

The Hon David Littleproud MP Minister for Agriculture and Northern Australia Parliament House Canberra ACT 2600

Dear Minister

In accordance with subsection 46(1) of the Public Governance, Performance and Accountability Act 2013 and section 61 of the Agricultural and Veterinary Chemicals (Administration) Act 1992, I am pleased to approve and submit the Annual Report on the activities of the Australian Pesticides and Veterinary Medicines Authority (APVMA) for the 2020-21 reporting year.

The report has been prepared in accordance with our legislative obligations.

In accordance with the Public Governance, Performance and Accountability Rule 2014, I certify that:

(i) fraud risk assessments and fraud control plans have been prepared for the APVMA

(ii) appropriate mechanisms that meet the needs of the APVMA are in place for preventing, detecting incidents of, investigating or otherwise dealing with, and recording or reporting fraud

(iii) all reasonable measures have been taken to deal appropriately with fraud relating to the APMVA.

Yours sincerely

Ms Lisa Croft Chief Executive Officer

Contents

Chapter 1 Summary and outlook ................................................................................................................................3

Regulatory performance.................................................................................................................................................4

Stakeholder engagement and collaboration ......................................................................................................4

Core business ......................................................................................................................................................................5

Looking ahead .....................................................................................................................................................................5

Chapter 2 Organisation overview ................................................................................................................................7

Corporate profile and purpose ...................................................................................................................................8

Responsible minister .......................................................................................................................................................8

Enabling legislation ...........................................................................................................................................................8

Functions and powers .....................................................................................................................................................9

Organisation structure ................................................................................................................................................. 10

Funding .................................................................................................................................................................................13

Staff profile ......................................................................................................................................................................... 14

Ministerial directions and government policy orders .................................................................................20

Significant activities and changes ........................................................................................................................20

Chapter 3 Strategic framework and reporting ......................................................................................23

Measuring our performance ..................................................................................................................................... 25

Results against performance criterion ............................................................................................................... 25

Variation from the APVMA Portfolio Budget Statement ............................................................................ 25

Statement of preparation by the Chief Executive Officer ........................................................................26

Strategy 1: Continue to be a world-class leader in agvet chemical regulation ........................... 27

Strategy 2: Deliver high-quality decision making that is timely, science-based and proportionate to risk .....................................................................................................................................................32

Strategy 3: Improve regulatory delivery and feedback systems ..........................................................36

Australian Pesticides and Veterinary Medicines Authority iv

Chapter 4 Corporate governance and management ...................................................................41

Corporate and operational plans ........................................................................................................................... 42

Governance ........................................................................................................................................................................ 42

Consultation and collaboration ............................................................................................................................... 47

Accountability .................................................................................................................................................................... 52

Judicial decisions and reviews by outside bodies ....................................................................................... 57

Chapter 5 Financial performance ...........................................................................................................................59

Summary of financial performance ......................................................................................................................60

ANAO Letter ........................................................................................................................................................................64

Statement by the accountable authority and the Chief Financial Officer .......................................66

Financial statements .................................................................................................................................................... 67

Acronyms and abbreviations ...................................................................................................100

Glossary ................................................................................................................................................................ 102

Compliance index ....................................................................................................................................104

Index ...........................................................................................................................................................................106

List of figures

Figure 1: APVMA strategy map 2020-21 ...................................................................................................... 24

Figure 2: Performance measure rating scale............................................................................................... 25

Figure 3: Timeframe performance by application type, per quarter in 2020-21 ...................33

v Annual Report 2020-21

List of tables

Table 1: APVMA organisation structure as at 30 June 2021 ........................................................... 10

Table 2: APVMA office locations ........................................................................................................................ 14

Table 3: APVMA employee substantive positions as at 30 June 2021 ...................................... 14

Table 4: Ongoing APS employees employed at the APVMA during the current reporting period ........................................................................................................................................15

Table 5: Ongoing employees employed at the APVMA during the previous reporting period ........................................................................................................................................15

Table 6: Non-ongoing APS employees employed at the APVMA during the current reporting period ........................................................................................................................................ 16

Table 7: Non-ongoing APS employees employed at the APVMA during the previous reporting period ................................................................................................................... 16

Table 8: Key management personnel ............................................................................................................. 17

Table 9: Summary of key management personnel remuneration ...................................................18

Table 10: Key management personnel remuneration ..............................................................................19

Table 11: Applications processed - 1 July 2020 to 30 June 2021 .................................................33

Table 12: Summary of activities related to regulatory decisions from 1 July 2020 to 30 June 2021 ......................................................................................................................................34

Table 13: Accountable authority ........................................................................................................................... 42

Table 14: Details of the APVMA’s accountable authority in 2020-21 ...........................................43

Table 15: APVMA governance committees .....................................................................................................44

Table 16: 2020-21 Audit Committee membership and attendance ..............................................45

Table 17: Related entity transactions ...............................................................................................................46

Table 18: APVMA participation in stakeholder engagement forums ...............................................48

Table 19: APVMA participation in international forums ..........................................................................49

Table 20: APVMA engagement with visiting international delegations ........................................... 52

Table 21: Activities related to APVMA regulatory decisions .................................................................54

Table 22: Summary of adverse experience reports received by the APVMA in 2020-21 ..55

Table 23: Summary of serious adverse experience reports received in 2020-21 by classification ........................................................................................................................................55

Table 24: APVMA income, 2020-21 ..................................................................................................................60

Table 25: Agency Resourcing Statement, 2020-21 ................................................................................. 61

Table 26: APVMA expenditure, 2020-21 (including comparison with PBS) ................................ 61

Table 27: Expenses for Outcome 1 ....................................................................................................................62

Table 28: Purchasing - number of quotes required ..................................................................................63

Australian Pesticides and Veterinary Medicines Authority vi

Purpose We regulate agricultural and veterinary chemicals to manage the risks of pests and diseases for the Australian community and to protect the health and safety of animals, humans and the environment.

Vision To be a global leader in agricultural and veterinary chemicals regulation for the benefit of Australia.

Chapter 1

Summary and outlook

Summary and outlook

In 2020-21 the Australian Pesticides and Veterinary Medicines Authority (APVMA) prioritised delivery of high-quality decision making and strengthening regulatory services and feedback systems, to achieve our vision to be a global leader in agricultural and veterinary chemicals regulation for the benefit of Australia.

Regulatory performance

This year we delivered further improvements in the on-time assessment of agricultural and veterinary chemical products, permits and active applications. We finalised 94% of applications within timeframe in 2020-21, increasing from 88% in 2019-20. This included finalising 99% of pesticides applications (up from 92% in 2019-20), and 99% of veterinary medicines applications (up from 89% in 2019-20) within timeframe.

We responded to the outbreaks of pests and diseases by prioritising the assessment of emergency permits to support Australian producers. This included the timely approval of applications in response to the mouse plague, incursions of fall armyworm and khapra beetle and the outbreak of grasshoppers, and for use in the eradication of Mediterranean and Queensland fruit fly.

Stakeholder engagement and collaboration

In September 2020 we published the APVMA Stakeholder Engagement Framework, which sets out our strategic approach to stakeholder consultation and collaboration for the 2020-23 period. We established and reinvigorated a number of stakeholder forums and working groups, including the APVMA Consultative Forum, Cost Recovery Working Group and Registration Liaison Forum, to strengthen our engagement with industry and further our engagement objectives.

We released our final tailored guidance pathway in October 2020, which marked the end of our ‘Top 20’ project to develop and improve guidance material for stakeholders and make the registration process for industry easier and more efficient.

In March 2021 we undertook our Client and Stakeholder Survey to determine current stakeholder satisfaction with our performance and services and identify opportunities for improvement. The results of the survey indicated the overall level of stakeholder satisfaction with our performance has improved significantly since the last survey was undertaken in 2018, with the proportion of respondents who were either ‘very satisfied’ or ‘satisfied’ increasing by approximately 50%.

Australian Pesticides and Veterinary Medicines Authority 4

CHAPTER 1 Summary and outlook

Core business

Our revised Cost Recovery Implementation Statement (CRIS) took effect on 1 July 2020. The CRIS ensures full cost recovery of all regulatory functions we provide to industry through the efficient implementation of cost recovered activities, consistent with the Australian Government Cost Recovery Guidelines.

A key focus in 2020-21 has been to maintain operations and continue to serve the Australian community and stakeholders throughout the COVID-19 pandemic, with many facing unprecedented circumstances and challenges.

We implemented business continuity arrangements to ensure our staff were equipped to work remotely with no impact to the important services we provide.

To support holders and manufacturers of veterinary medicines, we developed guidance to allow those audited by the APVMA to demonstrate compliance with Good Manufacturing Practice while travel restrictions and other measures were in place.

Looking ahead

In the year ahead, we will continue to prioritise the timely assessment of agricultural and veterinary chemicals and reinforce the quality and consistency of our decision making processes.

We will continue to collaborate and liaise with a broad range of stakeholders to achieve our purpose and support effective implementation of Australia’s National Registration Scheme.

We will continue to actively identify and implement innovations to strengthen the regulatory services we provide, and be ready to contribute to the Australian Government’s response to the Independent Review of the Agvet Chemicals Framework.

I would like to thank and congratulate APVMA staff for their contributions to our continued high performance at a time when it is critical we deliver timely access to safe and effective products and continue to provide stakeholders with innovative, science-based chemical regulation.

Ms Lisa Croft Chief Executive Officer September 2021

5 Annual Report 2020-21

Chapter 2

Organisation overview

Organisation overview

Corporate profile and purpose

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the independent statutory authority responsible for the assessment, registration and regulation of agricultural and veterinary (agvet) chemicals in Australia.

Agvet chemical products must be evaluated and registered, or authorised under permit, by the APVMA before they can be legally sold, supplied or used in Australia.

Responsible minister

The APVMA is within the portfolio of the Hon David Littleproud MP, who was appointed Minister for Agriculture, Drought and Emergency Management on 6 February 2020.

Enabling legislation

The APVMA is established under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act). The Administration Act sets out our role to administer the National Registration Scheme for Agricultural and Veterinary Chemicals in partnership with state and territory governments, and the scheme’s legislation.

Functions and powers are conferred on the APVMA by the Administration Act, the Agricultural and Veterinary Chemicals Code (Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations), and the Agvet Codes and Agvet Regulations of each state or participating territory.

We are a corporate Commonwealth entity under the Public Governance, Performance and Accountability Act 2013 (PGPA Act). A corporate Commonwealth entity is a corporate body that is legally separate from the Commonwealth.

Australian Pesticides and Veterinary Medicines Authority 8

Functions and powers

The APVMA operates under an intergovernmental agreement between the Australian Government and all states and territories. Under this agreement we are responsible for regulating agvet chemicals up to and including the point of sale. The states and territories are responsible for regulating agvet chemicals after they are sold, a process that is known as ‘control of use’.

Our key functions, which are set out in section 7 of the Administration Act, are to:

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

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

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

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

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

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

¤ report to or advise the minister on matters relating to the performance of the APVMA’s functions.

9 Annual Report 2020-21

CHAPTER 2 Organisation overview

Organisation structure

Our organisation structure (Table 1) supports effective operation, communication and strategic understanding at all levels of the APVMA.

Table 1: APVMA organisation structure as at 30 June 2021

Chief Executive Officer ¤ Office of the Chief Executive Officer

Deputy Chief Executive Officer

¤ Office of the Chief Regulatory Scientist

¤ Registration Management

¤ Risk Assessment Capability

Chief Operating Officer

¤ Assurance and Risk

¤ Business Intelligence and Improvement

¤ Finance

¤ Human Resources

¤ Information and Communication Technology (ICT)

¤ Parliamentary and Communications

¤ Procurement and Infrastructure

Executive Director, Risk Assessment Capability

¤ Chemical Review

¤ Chemistry and Manufacture

¤ Efficacy and Safety

¤ Environment

¤ Health

¤ Residues and Trade

Executive Director, Registration Management

¤ Permits

¤ Pesticides

¤ Pre-Evaluation and Quality

¤ Veterinary Medicines

Chief Regulatory Scientist

¤ Adverse Experience Reporting Program

¤ Assessment, Investigations and Monitoring

¤ Learning and Development

¤ Manufacturing Quality and Licensing

¤ Science Quality

General Counsel ¤ Legal services

Australian Pesticides and Veterinary Medicines Authority 10

Ms Lisa Croft Chief Executive Officer

The Chief Executive Officer (CEO) is the accountable authority responsible for governance, performance and management of the APVMA, and the exercise of the authority’s powers and functions. The CEO consults with key stakeholders to set the organisation’s vision, objectives and strategies to meet its legislative responsibilities. The CEO approves the APVMA’s Corporate and Operational Plans and budgets, monitors financial and operational performance, and oversees program performance.

Dr Jason Lutze Deputy Chief Executive Officer (acting)

The Deputy CEO provides strategic advice to the CEO and executive oversight of the regulatory science, post-market and reform functions of the APVMA. Key responsibilities include oversight of Risk Assessment Capability, Registration Management, Compliance, and reform and stakeholder engagement.

Mr Brendan Wright Chief Operating Officer (acting)

The Chief Operating Officer supports the delivery of the APVMA’s strategic objectives through the oversight of the agency’s enabling services, including corporate planning, performance and risk, information and communications technology, human resources, finance and procurement, media and communications, parliamentary services, and security.

11 Annual Report 2020-21

CHAPTER 2 Organisation overview

Dr Sheila Logan Executive Director, Risk Assessment Capability (acting)

The Executive Director, Risk Assessment Capability manages the expert assessment areas of the APVMA, including chemical review, chemistry and manufacture, efficacy and safety, environment, health, and residues and trade assessment.

Dr Rachel Chay Executive Director, Registration Management

The Executive Director, Registration Management manages the assessment process for agricultural chemicals and veterinary medicines. Responsibilities include managing pre-application assistance, preliminary assessment and evaluation of product registration, permits, export certificates, and import consents.

Dr Maggie Hardy Chief Regulatory Scientist

The Chief Regulatory Scientist ensures the continued high quality of the APVMA’s scientific decision making through 2 functions: science quality (responsible for the Learning and Development Framework) and post-market activities (including the Adverse Experience Reporting Program, compliance and monitoring, and manufacturing quality and licensing).

Ms Susan Hynes General Counsel

The General Counsel provides legal advice to the CEO, Executive and staff on all aspects of the APVMA’s administrative and regulatory functions.

Australian Pesticides and Veterinary Medicines Authority 12

Funding

The APVMA is a cost-recovered agency with the majority of our funding received from levies and a smaller proportion from fees and charges.

Levies are collected based on the wholesale value of chemical products sold. Fees and charges include, but are not limited to:

¤ registration renewal fees

¤ application fees (product, active constituent, permits)

¤ Good Manufacturing Practice licensing fees.

The APVMA also receives some additional funding through government appropriations.

Financial performance The APVMA’s total income for 2020-21 was $43.423 million. This included:

¤ industry fees and charges of $38.829 million

¤ government appropriation of $4.400 million

¤ own-source income of $194,000.

Total industry income derived from fees and charges of $38.829 million, government appropriated funding of $1.613 million, and own-source income of $194,000 (including $54,000 of resources received free of charge and a grant of $135,000 from the Department of Agriculture, Water and the Environment for minor use) was available to fund the APVMA’s business-as-usual activities. Normal business operational activities excludes specific appropriated funding of $2.787 million.

The specific appropriation funding of $2.787 million was assigned to relocation ($2.570 million) and Enabling Technologies ($0.217 million).

Multi-year contracts and commitments have necessitated carry-overs of $3.080 million for relocation activities and $3.420 million for Enabling Technologies. The $17.735 million for Appropriation Act (No. 5) 2019-2020 has not been drawn down in 2020-21 but held as a receivable from government. It is likely these funds will not be fully drawn down, with the potential for a large reduction in income in subsequent years when the receivable is reversed.

The net cost of APVMA services for 2020-21 was $36.191 million. The cost of the APVMA’s industry-related expenses for 2020-21 was $35.164 million, excluding expenses related to the information technology renewal and relocation, some of which were funded by the carry-forward of funds from 2019-20.

The final comprehensive income position for the APVMA was $7.038 million. The equity balance of $40.346 million is $31.346 million above the APVMA’s targeted equity position of 3 months expenditure, being $9 million; however, it includes $6.499 million in carry-forward funding for the projects described above and $17.735 million of receivable from government as well as employee leave entitlements and payables.

13 Annual Report 2020-21

CHAPTER 2 Organisation overview

Compliance with finance law Section 19 of the PGPA Act requires, among other things, that entities notify their responsible minister and the Finance Minister, as soon as practicable, of any significant issue that has affected the entity.

There were no significant instances of non-compliance with the finance law in 2020-21.

Staff profile

The APVMA has offices at 2 locations within Australia: Armidale and Canberra. Details of our office locations are provided in Table 2.

Table 2: APVMA office locations

Street address Postal address

Armidale office 102 Taylor Street

Armidale NSW 2350

GPO Box 3262 Sydney NSW 2001

Canberra office Level 1, 11 Faulding Street Symonston ACT 2609 GPO Box 3262 Sydney NSW 2001

Table 3 provides details of Australian Public Service (APS) employees employed at the APVMA under the Public Service Act 1999 in 2020-21.

Table 3: APVMA employee substantive positions as at 30 June 2021

Classification

Full-time (ongoing)

Part-time (ongoing) Non-ongoing and casual Total

Senior Executive officer 3 0 0 3

EL2 21 0 1 22

EL1 39 8 0 47

APS6 46 1 1 48

APS5 29 3 9 41

APS4 8 1 4 13

APS3 2 0 4 6

APS2 0 0 0 0

Trainee 0 0 0 0

Total 148 13 19 180

EL = Executive Level

Australian Pesticides and Veterinary Medicines Authority 14

Table 4 provides detail about the ongoing APS employees employed at the APVMA in 2020-21.

Table 4: Ongoing APS employees employed at the APVMA during the current reporting period

Male Female Indeterminate

Full-time

Part-time

Total male

Full-time

Part-time

Total female

Full-time

Part-time

Total

indeterminate

Total

NSW 52 1 53 67 9 76 0 0 0 129

ACT 21 2 23 18 1 19 0 0 0 42

Total 73 3 76 85 10 95 0 0 0 171

Table 5 provides detail about the ongoing APS employees employed at the APVMA during the previous reporting period, 2019-20.

Table 5: Ongoing APS employees employed at the APVMA during the previous reporting period

Male Female Indeterminate

Full-time

Part-time

Total male

Full-time

Part-time

Total female

Full-time

Part-time

Total

indeterminate

Total

NSW 42 0 42 58 11 69 0 0 0 111

ACT 19 2 21 19 2 21 0 0 0 42

Total 61 2 63 77 13 90 0 0 0 153*

* 35 employees accepted a voluntary redundancy on 1 July 2019 due to the relocation of the APVMA from Canberra to Armidale. These employees are not included in Table 5.

15 Annual Report 2020-21

CHAPTER 2 Organisation overview

Table 6 provides detail about the non-ongoing APS employees employed at the APVMA in 2020-21.

Table 6: Non-ongoing APS employees employed at the APVMA during the current reporting period

Male Female Indeterminate

Full-time

Part-time

Total male

Full-time

Part-time

Total female

Full-time

Part-time

Total

indeterminate

Total

NSW 11 0 11 14 5 19 0 0 0 30

ACT 1 0 1 0 1 1 0 0 0 2

Total 12 0 12 14 6 20 0 0 0 32

Table 7 provides detail about the non-ongoing APS employees employed at the APVMA during the previous reporting period, 2019-20.

Table 7: Non-ongoing APS employees employed at the APVMA during the previous reporting period

Male Female Indeterminate

Full-time

Part-time

Total male

Full-time

Part-time

Total female

Full-time

Part-time

Total

indeterminate

Total

NSW 9 0 9 5 2 7 0 0 0 16

ACT 4 0 4 0 1 1 0 0 0 5

Total 13 0 13 5 3 8 0 0 0 21

Australian Pesticides and Veterinary Medicines Authority 16

Key management personnel During the reporting period, the APVMA had the following executives who met the definition of key management personnel (KMP). Their names and length of term as KMP are summarised in Table 8. Their remuneration is shown in Tables 9 and 10.

Table 8: Key management personnel

Name Position Term as key management personnel

Ms L Croft

Chief Executive Officer (CEO) Appointed 8 October 2020

Acting CEO 17 August 2020 to 7 October 2020

Deputy CEO 1 July 2020 to 16 August 2020

Dr C Parker Chief Executive Officer Term ended 16 August 2020

Dr J Lutze

Acting Deputy CEO 21 December 2020 to 30 June 2021

Executive Director, Risk Assessment Capability

Substantive

Mr B Wright

Acting Chief Operating Officer 15 June 2021 to 30 June 2021

Director, Parliamentary and Communications Substantive

Dr S Logan

Acting Executive Director, Risk Assessment Capability 13 January 2021 to 30 June 2021

Dr R Chay

Executive Director, Registration Management Appointed 22 October 2020

Acting Executive Director, Registration Management 1 July 2020 to 21 October 2020

Dr M Hardy Chief Regulatory Scientist Full year

Ms S Hynes General Counsel Full year

Mr K Lockyer

Acting Executive Director, Corporate Services 17 August 2020 to 15 January 2021

Director, Corporate Services Substantive

Mr S Harris Acting Chief Regulatory Scientist Short-term acting during 2020-21

Mr G Edmunds Acting Chief Regulatory Scientist Short-term acting during 2020-21

Ms P Oxford Acting Chief Regulatory Scientist Short-term acting during 2020-21

Mr P MacLeod Acting Executive Director, Registration Management Short-term acting during 2020-21

Ms B Battisson Acting Executive Director, Registration Management Short-term acting during 2020-21

17 Annual Report 2020-21

CHAPTER 2 Organisation overview

Table 9: Summary of key management personnel remuneration

2020-21 $

2019-20 $

Short-term employee benefits:

Base salary 1 732 759 1 928 875

Bonuses 3 015 64 360

Other benefits and allowances 0 24 180

Total short-term employee benefits: 1 735 774 2 017 415

Post-employment benefits

Superannuation 246 069 285 752

Total post-employment benefits: 246 069 285 752

Long-term employee benefits

Long service leave accrued 46 218 44 299

Total other long-term employee benefits: 46 218 44 299

Terminations

Terminations 0 182 047

Total terminations: 0

Total key management personnel remuneration: 2 028 061 2 529 513

Senior Executive personnel The APVMA had no Senior Executive staff earning more than $230,000 this financial year, not included in Table 10.

Other highly paid staff The APVMA had no other highly paid staff earning more than $230,000 this financial year.

Senior Executive Remuneration Policy

Chief Executive Officer

As a statutory officer, the CEO is remunerated in accordance with determinations made by the independent Remuneration Tribunal under the Remuneration Tribunal Act 1973.

Senior Executive officers

The terms and conditions of employment for the APVMA’s Senior Executive officers are established under subsection 24(1) of the Public Service Act 1999 and outlined in the respective employee’s determination. Factors used by the CEO to determine the relevant remuneration are experience and level of responsibility, taking comparable salaries for senior executives across the APS into consideration. The APVMA Enterprise Agreement is also considered.

Australian Pesticides and Veterinary Medicines Authority 18

Table 10: Key management personnel remuneration

Short-term benefits Post-employment benefits Other long-

term benefits

Name Position title

Base salary

Annual leave accrued

Bonuses

Other benefits and allowances

Superannuation contributions

Long service leave

Other long-term benefits

Termination benefits

Total remuneration

Ms L Croft

Chief Executive Officer/ Deputy Chief Executive Officer

324 093 24 835 0 0 47 801 7 991 0 404 720

Dr C Parker Chief Executive Officer 43 566 3 336 0 0 7 372 1 074 0 55 348

Dr J Lutze

Acting Deputy Chief Executive Officer/ Executive Director, Risk Assessment Capability 224 477 17 201 0 0 39 129 5 535 0 286 342

Mr B Wright

Acting Chief Operating Officer/ Director, Parliamentary and Communications 150 474 15 182 3 015 0 20 921 6 832 0 196 424

Dr S Logan Acting Executive Director, Risk Assessment Capability 91 852 7 039 0 0 12 770 3 167 0 114 828

Dr R Chay

Executive Director, Registration Management/ Acting Executive Director, Registration Management 199 661 15 300 0 0 27 590 4 923 0 247 474

Dr M Hardy Chief Regulatory Scientist 207 467 15 898 0 0 38 570 5 116 0 267 051

Ms S Hynes General Counsel 162 623 12 461 0 0 24 194 4 010 0 203 288

Mr K Lockyer Acting Executive Director, Corporate Services/ Director, Corporate Services 178 127 15 182 0 0 25 049 6 832 0 225 190

Mr S Harris Acting Chief Regulatory Scientist 7 949 609 0 0 1 062 274 0 9 894

Mr G Edmunds Acting Chief Regulatory Scientist 3 975 304 0 0 429 137 0 4 845

Ms P Oxford Acting Chief Regulatory Scientist 1 699 130 0 0 263 59 0 2 151

Mr P MacLeod Acting Executive Director, Registration Management 3 795 291 0 0 429 131 0 4 646

Ms B Battisson Acting Executive Director, Registration Management 4 929 304 0 0 490 137 0 5 860

Total:

1 604 687 128 072 3 015 0 246 069 46 218 0 0 2 028 061

19 Annual Report 2020-21

CHAPTER 2 Organisation overview

Ministerial directions and government policy orders

The following government policy orders made under section 22 of the PGPA Act applied to the APVMA during the reporting period:

¤ Public Governance, Performance and Accountability (Charging for Regulatory Activities) Order 2017

¤ Public Governance, Performance and Accountability (Location of Corporate Commonwealth Entities) Order 2016

There were no instances of non-compliance with ministerial directions or government policy orders in the reporting period.

Significant activities and changes

In October 2020, the Minister for Agriculture, Drought and Emergency Management, the Hon David Littleproud MP announced the appointment of Ms Lisa Croft as CEO. This announcement followed the departure of Dr Chris Parker in August 2020.

In June 2021, the APVMA began an organisational restructure with the appointment of Mr Brendan Wright to the position of acting Chief Operating Officer, and the transfer of the Chemical Review function to Risk Assessment Capability.

Australian Pesticides and Veterinary Medicines Authority 20

Chapter 3

Strategic framework and reporting

Strategic framework and reporting

The APVMA Corporate Plan 2020-21 and Operational Plan 2020-21 established 3 strategies to support us to achieve our purpose (Figure 1):

Figure 1: APVMA strategy map 2020-21

Outcome 1

Protection of the health and safety of people, animals, the environment, and agricultural and livestock industries through regulation of pesticides and veterinary medicines.

Portfolio Budget Statements

Program 1.1 Australian Pesticides and Veterinary Medicines Authority

Objective: The APVMA regulates agricultural and veterinary chemicals up to and including at the point of sale to protect the health and safety of people, animals and crops, the environment and trade, and support Australian primary industries.

Key performance indicator: Registered chemicals are available for product registrations, actives and permits.

2020-21 target: 100% of applications were completed within timeframes.

Corporate strategies

1. Continue to be a world-class leader in agvet chemical regulation

2. Deliver high-quality decision making that is timely, science-based and proportionate to risk

3. Improve regulatory delivery and feedback systems

Corporate/Operational Plan

Targets:

¤ Participation in expert

working groups, international and domestic activities, and training activities

¤ Continuous engagement

with regulators and relevant international organisations

¤ Ongoing development of

MoUs with international and domestic partners

Targets:

¤ 90% of regulatory decisions

completed within timeframes

¤ 60% of emergency use permits

finalised within 14 days and 95% within 28 days

¤ No regulatory decisions are

overturned by external bodies such as the Administrative Appeals Tribunal

¤ Reconsiderations commenced,

progressed, and concluded in alignment with risk-based program plans

Targets:

¤ Fees and charges align

with the efficient cost of regulation

¤ Implementation

of inspection and monitoring program as per program plan

¤ Stakeholder

engagement activities are commenced, progressed and concluded as per program plans

Australian Pesticides and Veterinary Medicines Authority 24

CHAPTER 3 Strategic framework and reporting

Measuring our performance

Each of the 3 strategies have associated activities and performance measures to ensure:

¤ our business continues to transform with industry, science and environmental factors

¤ we make evidence-based regulatory decisions to protect the health and safety of people, animals and the environment

¤ we maintain the quality and timeliness of our decisions, while applying our scientific expertise to align the effort of regulatory intervention with the risks being managed

¤ we enable our operations to deliver effective regulatory evaluation and registration of agvet chemical products.

Results against performance criterion

This chapter provides the results of our performance against the:

¤ APVMA Portfolio Budget Statement (PBS)

¤ measures listed in the APVMA Corporate Plan 2020-21

¤ activities listed in the APVMA Operational Plan 2020-21.

Results against these measures, including analysis of performance, are presented in this annual performance statement in tables. Achievement of each performance measure is rated using the scale in Figure 2.

Figure 2: Performance measure rating scale

Performance results

Performance met expectations

Performance partially met expectations Performance did not meet expectations

Variation from the APVMA Portfolio Budget Statement

There have been no variations from the APVMA PBS in 2020-21.

25 Annual Report 2020-21

Statement of preparation by the Chief Executive Officer

I, as the accountable authority of the APVMA, present the 2020-21 annual performance statement of the APVMA, as required under paragraph 39(1)(a) of the Public Governance, Performance and Accountability Act 2013 (PGPA Act). In my opinion, these annual performance statements are based on properly maintained records, accurately reflect the performance of the entity, and comply with subsection 39(2) of the PGPA Act.

Ms Lisa Croft Chief Executive Officer 13 September 2021

26

CHAPTER 3 Strategic framework and reporting

Strategy 1 Continue to be a world-class leader in agvet chemical regulation

Summary of performance Performance measure Result

Participation in expert working groups, international and domestic activities, and training activities

Continuous engagement with regulators and relevant international organisations

Ongoing development of MoUs with international and domestic partners

Focus areas and activities ¤ Ensure risk assessment procedures align where applicable with international standards

¤ Participate in and lead global reviews

¤ Deliver robust and independent compliance and monitoring activities, in line with international best practices

¤ Enhance collaboration with international and domestic partners

Results against corporate performance measures Activity Ensure there is an adequate level of capability available within the APVMA and through scientific networks to inform the regulatory assessment process

Measure Participation in expert working groups, international and domestic activities, and training activities

Source Operational Plan 2020-21

Result Performance met expectations

During 2020-21 we maintained high levels of capability through our continued participation and engagement in international expert groups, as well as ongoing training activities internally and externally via international seminars, workshops and conferences. Examples of these activities include:

¤ participation in Organisation for Economic Co-operation and Development (OECD) working groups, including the Residue Definition Working Group (both on the residues and toxicology subgroups), the Minor Use Working Group, and the Drafting Group on Pesticides Residue in Honey

¤ participation as monographers (expert writers) in the Joint Meeting on Pesticides Residues Toxicology and Residues groups, completing the 2020 meeting cycle with the evaluation of several compounds (both for new chemicals and periodic reviews) and contributing to the 2021 meeting cycle

27 Annual Report 2020-21

¤ participation in parallel with the United States Environmental Protection Agency (US EPA) and the Health Canada Pest Management Regulatory Agency (PMRA) in industry-led work towards the future use of non-animal models and clarification of problem statements

¤ attendance at the Australasian College of Toxicology and Risk Assessment (ACTRA) webinars on risk assessment across Risk Assessment Capability and Registration Management areas

¤ presentation of ACTRA webinars demonstrating the leading role the APVMA plays in regulatory toxicology

¤ delivery of training on residues processes at international level through activities within the Asia-Pacific Economic Cooperation (APEC) group

¤ attendance at seminars and working groups on kinetically derived maximum dose work, as well as completion of a university course on toxicokinetics and toxicodynamics by an EL2 in Risk Assessment Capability

¤ participation in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Due to COVID-19 travel restrictions the APVMA participated virtually in international activities, which afforded more staff the opportunity to take part in meetings and working groups.

Our participation in technical working groups increased awareness for our staff of current issues and challenges experienced by other regulators. This close interaction with comparable international regulators has increased the capability of our staff to undertake, or conduct peer review of international-quality assessments. Strengthening these scientific networks facilitates cooperative efforts allowing further consultation on difficult technical issues, particularly where assessments are undertaken in a similar timeframe.

Our ongoing participation in international activities, particularly through the OECD, helps ensure that technical material developed and adopted internationally reflects the requirements of the Australian regulatory environment.

Australian Pesticides and Veterinary Medicines Authority 28

CHAPTER 3 Strategic framework and reporting

Case study: Data harmonisation The agvet chemical sector is a global industry, with products being developed for sale into multiple international markets. Each market is regulated by a different set of rules, not just for the safety of products but also the standards and guidelines used for submitting data for assessment. These differences can increase the cost of preparing data and limit the ability for international regulators to collaborate on reviews and registrations.

To help minimise these barriers and improve access to safe and effective agvet products, the APVMA actively participates in the harmonisation of data guidelines with our international counterparts through organisations such as the OECD and VICH.

We have been a contributor to the development and updating of a wide range of guidelines, including:

¤ internal and external parasiticides

¤ residues definitions and establishment

of maximum residues limits

¤ developmental neurotoxicity

¤ the selection of doses in cancer studies

and the application of kinetically derived maximum dose principles to dose selection.

We have aligned many areas of our guidelines with international standards (available at apvma.gov.au/node/19991), and support the submission of data generated according to many international guidelines, including:

¤ OECD and VICH test guidelines

¤ Food and Agricultural Organization

of the United Nations (FAO) and World Health Organization (WHO) guidelines for data generation

¤ test guidelines published by the:

• US EPA

• PMRA

• European Food Safety Authority for plant protection (pesticide) products

• EU Biocidal Products Regulations, the European Medicines Agency for veterinary medicine products

• United States Food and Drug Administration (US FDA).

Our participation in harmonisation activities on data guidelines and utilisation of international guidelines continues to benefit the Australian agvet sector by:

¤ ensuring a risk-based approach

is incorporated where appropriate, avoiding predominance of a primarily hazard-based approach

¤ simplifying the assembly and submission

of data packages by industry

¤ expanding the use of common

international methodology to align with international best practice and improve the consistency of decision making

¤ facilitating the use of international

assessments, resulting in considerable time-savings for companies that opt to utilise them

¤ ensuring the level of data required to

satisfy our legislative requirements is proportionate to risk.

The use of harmonised data guidelines and assessment promotes Australia’s ability to participate in international sharing of work and global joint reviews. The ability to use comparable data packages to overseas regulators has assisted companies in approaching Australia as the first global site of registration for a number of products, in some cases building on the Australian evaluation to facilitate overseas approvals.

29 Annual Report 2020-21

Activity Collaborate with domestic jurisdictions and international counterparts to contribute to the improvement of regulatory processes

Measure Continuous engagement with regulators and relevant international organisations

Source Operational Plan 2020-21

Result Performance met expectations

The APVMA engaged with regulators and relevant international organisations throughout the reporting period. During 2020-21 we:

¤ verified acceptance of satisfactory application of Good Manufacturing Practice (GMP) assessment of compliance and maintained the European Union Mutual Recognition Agreement

¤ met regularly with counterparts at the Therapeutic Goods Administration in relation to technical and operational matters

¤ met regularly with comparable regulators, such as Canada’s PMRA, to discuss common regulatory challenges and explore regulatory best practice

¤ participated in monthly meetings with regulators of veterinary medicines from New Zealand, Canada, the United Kingdom and the United States

¤ engaged with relevant state authorities to ensure the information held by each authority is up-to-date and applied according to law

¤ continued stakeholder engagement through the Manufacturers’ Licensing Scheme - Industry Liaison Consultative (MLS - ILC) Forum.

The APVMA and Europol met monthly to discuss counterfeit and illicit chemical products. Where necessary, we liaised with other Commonwealth agencies and regulators and developed several Memoranda of Understanding (MoUs).

A regular monthly meeting was established with the Australian Competition and Consumer Commission to discuss and collaborate on product recalls and other regulatory matters.

The APVMA chairs quarterly meetings with Australian state and territory agvet chemical regulators. This encourages regular communication on mutual topics of interest, ensures communication channels are strong and remain open, and supports streamlining the regulatory process through the removal of duplicated processes.

The APVMA became a corporate member of the Australia and New Zealand School of Government National Regulators Community of Practice (NRCoP) in February 2021. NRCoP is an active network of public sector regulators from all 3 levels of government and from every regulatory sector. The APVMA’s membership allows us to share knowledge, insights and experiences with other regulators and to participate in regular educational events featuring Australian and international thought leaders on aspects of regulatory best practice.

The regular interaction with partner international regulators has allowed issues around chemical review, legislative processes, registration and reporting to be discussed, leading to increased awareness of other regulatory practices and opportunities to improve our standard practices.

Australian Pesticides and Veterinary Medicines Authority 30

CHAPTER 3 Strategic framework and reporting

Activity Collaborate with domestic jurisdictions and international counterparts to contribute to the improvement of regulatory processes

Measure Ongoing development of MoUs with international and domestic partners

Source Operational Plan 2020-21

Result Performance met expectations

In 2020-21 we finalised MoUs between the APVMA and:

¤ the Office of the Gene Technology Regulator (OGTR)

¤ Harness Racing Victoria

¤ Racing New South Wales

¤ Racing and Wagering Western Australia

¤ State of New South Wales through Harness Racing New South Wales

¤ Canada’s PMRA.

The APVMA has formal information sharing arrangements with the US FDA.

These MoUs and arrangements set out the cooperative agreements between the APVMA and relevant entities to achieve our respective organisational objectives. They provide a framework that supports high level collaboration and information exchange to facilitate safe and effective agvet chemical regulation and international trade.

31 Annual Report 2020-21

Strategy 2 Deliver high-quality decision making that is timely, science-based and proportionate to risk

Summary of performance

Performance measure Result

90% of regulatory decisions completed within timeframes

100% of regulatory decisions are completed within timeframes

60% of emergency permits finalised within 14 days, and 95% finalised within 28 days

No regulatory decisions are overturned by external bodies such as the Administrative Appeals Tribunal

Reconsiderations commenced, progressed and concluded in alignment with risk-based program plans

Focus areas and activities ¤ Deliver decisions that are based on the most up-to-date scientific evidence

¤ Improve the timeliness of regulatory decisions

¤ Support and develop our people to enhance a high-performing culture

¤ Embed our quality management and enterprise risk management frameworks

Results against corporate performance measures Activity Undertake timely and objective assessment of information provided

Measure 90% of regulatory decisions completed within timeframes 100% of regulatory decisions are completed within timeframes

Source Operational Plan 2020-21 Portfolio Budget Statement 2020-21

Result Performance met expectations Performance did not meet expectations

A total of 94% of regulatory decisions for products, permits and active constituents were completed within statutory timeframes between 1 July 2020 and 30 June 2021.

An ongoing focus on building capability within the APVMA, strengthening stakeholder engagement, and delivering continuous process improvements has contributed to achieving our improved timeframe performance.

Ensuring the APVMA meets its legislated timeframes creates surety for applicants with the regulatory process and facilitates the timely provision of agvet chemicals to the Australian community.

Australian Pesticides and Veterinary Medicines Authority 32

CHAPTER 3 Strategic framework and reporting

Table 11: Applications processed - 1 July 2020 to 30 June 2021

Type Commenced Finalised

Finalised within timeframe

2019-20 in

timeframe

In

progress

In progress still within timeframe

Pesticides 1 336 1 466 99% 92% 387 97%

Veterinary medicines

1 008 1 051 99% 89% 230 96%

Total products

2 344 2 517 99% 91% 617 97%

Permits 580 622 74% 81% 248 81%

Actives 263 307 96% 85% 143 94%

Total 3 187 3 446 94% 88% 1 008 92%

Figure 3: Timeframe performance by application type, per quarter in 2020-21

98%

98%

98%

78%

96%

94%

99%

99%

99%

75%

100%

96%

99%

99%

99%

70%

96%

92%

99%

100%

99%

70%

99%

93%

Pesticides Veterinary

medicines

Total Permit

applications

Active

applications

Total

applications

Product applications Others Total

% Finalised

Sep Qtr 20

% Finalised

Dec Qtr 20

% Finalised

Mar Qtr 21

% Finalised

Jun Qtr 21

33 Annual Report 2020-21

Table 12: Summary of activities related to regulatory decisions from 1 July 2020 to 30 June 2021

Type of regulatory decisions Commenced Finalised/issued In progress

Pre-application assistance 244 169 39

Product registration - pesticides 1 336 1 466 387

Product registration - veterinary medicines 1 008 1 051 230

Permits 580 622 248

Actives 263 307 143

Items 8L, 8M, 8P 1 004 826 210

Technical assessment (Item 25) 12 11 9

Notifiable variations 1 011 1 011 0

Import consents 697 674 5

Certificates of export 479 492 21

Total 6 634 6 629 1 292

Activity Undertake timely and objective assessment of information provided

Measure 60% of emergency permits finalised within 14 days, and 95% finalised within 28 days

Source Operational Plan 2020-21

Result Performance did not meet expectations

We finalised 74 emergency use permits between 1 July 2020 and 30 June 2021. Of these:

¤ 54% were finalised within 14 days (up from 41% in 2019-20)

¤ 84% were finalised within 28 days (up from 50% in 2019-20).

During the reporting period, the APVMA’s Permits and Minor Use Team assessed a large number of emergency permit applications to support Australian producers through several serious pest incursions and outbreaks across Australia, including mice, fall armyworm, khapra beetle and grasshoppers. These applications can be complex and require extensive consultation across a number of expert areas internally and externally.

Through the issuing of 74 emergency use permits we contributed significantly to Australia’s biosecurity response and supported Australia’s trade by approving permits to control the outbreaks of pests.

Australian Pesticides and Veterinary Medicines Authority 34

CHAPTER 3 Strategic framework and reporting

Activity Make transparent and proportionate regulatory decisions in accordance with the legislation, using a risk-based approach

Measure No regulatory decisions are overturned by external bodies such as the Administrative Appeals Tribunal

Source Operational Plan 2020-21

Result Performance did not meet expectations

On 15 December 2020 an application was made to the Federal Court of Australia that sought judicial review of our internal review decision on 20 November 2020 to affirm our original decision under section 41 of the Agvet Code to cancel the approvals of certain swimming and spa pool sanitiser products containing hydrogen peroxide and polyhexanide hydrochloride.

In February 2021 we signed orders consenting to the setting aside of both the internal review and original decisions to cancel the relevant products on natural justice grounds.

See the Judicial decisions and reviews by outside bodies section of this Annual Report for more information.

Activity Reconsiderations under Division 4 of Part 2

Measure Reconsiderations commenced, progressed and concluded in alignment with risk-based program plans

Source Operational Plan 2020-21 Agvet (Admin) Regulations, Part 1, Section 1A.3 (a), (b), (c)

Result Performance partially met expectations

We continue to progress reconsiderations under Division 4 of Part 2 of the Act and take a risk-based approach to regulatory action through the existing legislation, including label reviews under Division 5.

In September 2020 the reconsideration of 2,4-D was finalised and prior labels were cancelled.

See the Chemical review section of this Annual Report for more information.

35 Annual Report 2020-21

Strategy 3 Improve regulatory delivery and feedback systems

Summary of performance

Performance measure Result

Fees and charges align with the efficient cost of regulation

Implementation of inspection and monitoring program as per program plan

Stakeholder engagement activities are commenced, progressed and concluded as per program plans

Focus areas and activities ¤ Engage with internal and external stakeholders and consider feedback to improve our operations

¤ Increase industry and community awareness of regulatory requirements

¤ Improve the efficiency of our operations

¤ Implement new enabling technologies in line with our digital strategy

Performance against corporate performance measures Activity Ensure the costs of regulation are measured and regulatory fees are used efficiently

Measure Fees and charges align with the efficient cost of regulation

Source Operational Plan 2020-21

Result Performance met expectations

Our revised Cost Recovery Implementation Statement (CRIS) came into effect on 1 July 2020 and introduced revised fees to ensure we continue to recover the full, efficient cost of regulation in accordance with the requirements of the Australian Government Charging Framework.

Australian Pesticides and Veterinary Medicines Authority 36

CHAPTER 3 Strategic framework and reporting

Activity Monitor the compliance of approvals with the requirements of the legislation through a program of inspections and regular monitoring

Measure Implementation of inspection and monitoring program as per program plan

Source Operational Plan 2020-21

Result Performance met expectations

We maintain a program of risk-based auditing and a review of audits of manufacturers against GMP standards in Australia and overseas.

With assistance from Department of Agriculture, Water and the Environment (DAWE) officers, who were re-deployed due to COVID-19, we assessed approximately 10,000 labels during an audit of marketed product labels.

Our Compliance and Monitoring function monitors the importation of agvet chemicals in collaboration with the Australian Border Force and publishes an annual compliance plan. We use proactive analysis of contraventions to shape the annual compliance plan for the next financial year.

During the reporting period we:

¤ published our Compliance Case Categorisation and Prioritisation Model and Enforcement Guidelines in August 2020

¤ published educational material for suppliers in February 2021, to support compliance with the legislation

¤ published an Infringement Notice Guideline under section 6A of the Agvet Code in April 2021

¤ issued infringement notices to 2 companies for failing to comply with an APVMA-issued notice

¤ attended the Primex Field Day in Casino, New South Wales from 19 to 22 May 2021

¤ continued audits of hormonal growth promotant suppliers in Katherine and Darwin in the Northern Territory, and Atherton, Mareeba, Malanda, Townsville, and Charters Towers in Queensland.

During 2020-21 we developed and reviewed remote auditing and hybrid audit models to ensure continued supply of ingredients and products to stakeholders during COVID-19 restrictions.

We strengthened our stakeholder engagement and worked towards an agreed approach to auditing during the pandemic, which contributed positively to achieving this activity.

37 Annual Report 2020-21

Case study: Introducing remote and hybrid auditing models An audit against a GMP standard is required to provide sufficient evidence for the APVMA to assess whether the legislative requirements in relation to GMP have been satisfied.

The GMP compliance assessment for manufacturers of veterinary chemical products was extended by up to 12 months as a result of COVID-19 restrictions. In response to this, we developed and implemented remote and hybrid auditing models that complied with the APVMA GMP Audit Procedure, which enabled the safe conduct of GMP compliance audits and ensured manufacturers and manufacturing sites remained compliant with legislative requirements.

To support the assessment of these sites, we:

¤ conducted workshops to work with

auditors and manufacturers to identify the best ways to move forward with audits

¤ developed risk-based audit options

(in-person, remote or hybrid) for manufacturers

¤ streamlined the acceptable evidence

manufacturers could produce to demonstrate compliance with GMP, further increasing our use of international assessments and documentation in support of compliance assessments

¤ conducted desk assessments of all

licenced manufacturers to prolong the inter-audit interval where appropriate, to support the Australian biosecurity

initiatives to prevent the spread of COVID-19

¤ finalised training of new auditors,

including witness audits, to ensure sufficient auditors to manage workload.

The parameters we developed for conducting remote or hybrid audit ensured the appropriate options were made available to domestic and international audits throughout the pandemic.

By the end of the reporting period we had initiated 93 new audits and completed 60 audits, including domestic and international manufacturing sites.

The remote and hybrid auditing models contributed to:

¤ the Australian industry retaining supply

chains that otherwise might have been disrupted, and increased the number of supply chains available while maintaining confidence in the assessments of these sites in supplying Australian manufacturers and holders

¤ enabling the assessment of overseas

manufacturers of veterinary chemicals and ingredients for the production of veterinary chemicals in Australia

¤ maintaining trade with existing and new

overseas suppliers, thereby ensuring sufficient ingredients for the production and supply of veterinary chemicals in Australia

¤ enabling the audit of low-risk domestic

manufacturers to ensure business continuity and confidence in the Australian GMP program.

Australian Pesticides and Veterinary Medicines Authority 38

CHAPTER 3 Strategic framework and reporting

Activity Promote compliance with regulatory requirements educating holders and stakeholders about legislation

Measure Stakeholder engagement activities are commenced, progressed and concluded as per program plans

Source Operational Plan 2020-21

Result Performance met expectations

We continued our engagement with stakeholders to promote compliance with regulatory requirements and education about the legislation.

We conducted the following stakeholder engagement activities during the 2020-21 reporting period:

¤ The APVMA Consultative Forum with representatives from key industry groups, including Accord, Animal Medicines Australia (AMA), CropLife, the National Farmers’ Federation (NFF), and the Veterinary Manufacturers and Distributors Association (VMDA).

¤ The APVMA Cost Recovery Working group with representatives from key industry groups, including Accord, AMA, CropLife, the NFF, the VMDA and DAWE.

¤ The MLS - ILC Forum with representatives from key industry groups, including AMA, the Feed Ingredients and Additives Association of Australia and the VMDA.

¤ The quarterly Interagency Regulators Forum with state and territory entities, including chemical coordinators, environmental protection agencies and departments of primary industry and health, to promote compliance with regulatory requirements and uphold the intent of the Intergovernmental Agreement.

¤ The Registration Liaison Forum with state and territory chemical coordinators.

¤ The APVMA Users Forum with key industry user groups, including the Aerial Application Association of Australia, Australian Meat Industry Council, Ausveg, Cattle Council of Australia, Grain Producers Australia (GPA), Grain Trade Australia, Growcom and Hort Innovation.

¤ Participation in agricultural field days continued to highlight the importance of compliance with regulatory requirements and to educate stakeholders about the legislation. This year we attended a COVID-safe field day hosted by Primex with 30,000 attendees.

See the Consultation and collaboration section of this Annual Report for more information.

39 Annual Report 2020-21

Chapter 4

Corporate governance and management

Corporate governance and management

Corporate and operational plans

The APVMA’s planning and reporting requirements are set out in the Public Governance, Performance and Accountability Act 2013 (PGPA Act) and the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act).

Our primary planning document is the APVMA Corporate Plan, which defines the principal objectives of the APVMA and outlines the strategies to achieve these objectives.

In addition, each year we develop an Operational Plan that sets out the actions needed to achieve the objectives in the Corporate Plan. We measure our operational effectiveness annually through the performance indicators in the Operational Plan and the PBS.

Governance

As a corporate Commonwealth entity under the PGPA Act, the APVMA is a body corporate with a separate legal personality from the Commonwealth and can act in its own right exercising certain legal rights, such as entering into contracts and owning property. The CEO is the accountable authority for purposes of the PGPA Act and is appointed by the minister.

Details of the accountable authority during the reporting period are provided in Table 14.

Table 13: Accountable authority

Name Position held

Period as the accountable authority Date of commencement Date of cessation

Dr C Parker Chief Executive Officer 13 November 2017 16 August 2020

Ms L Croft Acting Chief Executive Officer 17 August 2020 7 October 2020

Ms L Croft Chief Executive Officer 8 October 2020 8 October 2025

Dr J Lutze Acting Chief Executive Officer 11 January 2021 26 January 2021

Australian Pesticides and Veterinary Medicines Authority 42

CHAPTER 4 Corporate governance and management

Table 14: Details of the APVMA’s accountable authority in 2020-21

Name Ms Lisa Croft

Qualifications Bachelor of Communications (Public Relations), University of Canberra

Experience Ms Lisa Croft was appointed Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority on 8 October 2020. Prior to her appointment as Chief Executive Officer, Ms Croft served as the APVMA’s Deputy Chief Executive Officer from February 2018.

Before joining the APVMA, Ms Croft held senior positions within the Department of the Prime Minister and Cabinet and the Department of Families, Community Services and Indigenous Affairs working in areas of grant and project management, service delivery, Commonwealth state relations, policy design and stakeholder engagement.

Ms Croft spent almost a decade working in Indigenous Affairs and remote service delivery and was awarded the Institute of Chartered Accountants Leadership in Government Award for her work on the National Partnership Agreement on Remote Indigenous Housing.

Prior to this Ms Croft held a number of Executive-level roles with the Australian Greenhouse Office, including strategic communications and media relations, international liaison and policy design.

The CEO is responsible for the governance and management of the APVMA, with the support of the Executive (see Chapter 2) and the Audit Committee (see Table 15). The CEO is also responsible for delivering against the performance measures listed in our planning documents.

Our governance structure aligns accountabilities to ensure decision making delivers best-practice scientific assessment and operational effectiveness.

Governance committees Our governance committees adhere to the principles of public sector governance to provide accountability, transparency, integrity, stewardship, efficiency and leadership and are listed in Table 15.

43 Annual Report 2020-21

Table 15: APVMA governance committees

Committee Description

Executive Committee The Executive Committee (EC) supports the CEO to lead, govern and set the strategic direction for the APVMA. The EC provides advice to the CEO

on the appropriateness of the APVMA’s decision-making processes and oversight and reporting arrangements, and helps to ensure the agency delivers efficient and effective regulation while complying with the law, regulations, published standards and community expectations of probity, accountability and openness. Previously known as the Executive Leadership Team (ELT), the Senior Leadership Team and Change Management and Science Quality Committee’s reported to ELT before it underwent a restructure in September 2020. On 8 September 2020, the Change Management and Science Quality Committee’s were disestablished and the responsibilities subsumed by the EC.

Audit Committee The Audit Committee reports to the CEO and assists the agency to discharge its responsibilities under the PGPA Act and the Administration Act regarding

financial reporting, performance reporting, risk oversight and management, internal control and compliance with relevant laws and policies.

Staff Consultative Committee

The Staff Consultative Committee provides a framework to allow employees to be consulted on significant decisions that affect their working lives and thereby contribute to a more efficient and productive organisation while enhancing the quality of the working life of individual employees.

Work Health and Safety Committee

The Work Health and Safety Committee provides a framework to allow workers to be consulted on significant work, health and safety decisions that affect their working lives. Consultation contributes to a safe and healthy workplace while enhancing the quality of the working life of individual workers.

Staff guidance We develop and publish guidance material to support operational effectiveness and help our staff adhere to the public sector values to be impartial, committed to service, respectful, accountable and ethical.

Guidance material includes policies relating to security, appropriate management of confidential information, financial and procurement practices, use of social media, conflicts of interest, travel, performance management and workplace safety. These policies operate in line with, and in addition to requirements under the APS Code of Conduct and legislative framework governing the conduct of APS employees.

In addition to our guidance material, the APVMA Core Training Policy requires all staff to complete training covering topics such as the APS ethical and legal framework, risk management, security, workplace diversity, and APS values and principles. This training ensures we fulfill our legislative obligations and that staff comply with the APS Code of Conduct and Values set out in the Public Service Act 1999.

Australian Pesticides and Veterinary Medicines Authority 44

CHAPTER 4 Corporate governance and management

Audit Committee The Audit Committee provides independent assurance and advice to the CEO on our accountability and control framework - particularly those aspects concerning performance and financial reporting and systems relating to risk and control.

The Audit Committee Charter is available on our website at apvma.gov.au/node/9526.

The Audit Committee met 4 times in 2020-21.

In 2020-21 the Audit Committee had 3 external members (including the independent Chair). Committee observers and advisers can include representatives from the Australian National Audit Office (ANAO), the internal auditor, and APVMA management representatives.

Table 16 provides detail about Audit Committee members during the 2020-21 reporting period.

Table 16: 2020-21 Audit Committee membership and attendance

Member name

Qualifications, knowledge, skills or experience (including formal and informal as relevant)

Number of meetings attended/ total number

of meetings

Total annual remuneration (incl GST)

($)

Peter Hoefer (Chair, independent member)

¤ Masters in Business Systems and Fellow

with the following bodies:

• CPA Australia

• Australian Institute of Company Directors and the Australian Computer Society

¤ Management consulting experience across

regulatory agencies and cost recovery, financial management, risk management, ICT and corporate and business systems

4 10 000.00

Narelle Sheppard (independent member)

¤ Certified Internal Auditor

¤ Certified Government Auditing Professional

¤ Certification in Risk

Management Assurance

¤ Certified Practicing Accountant, Bachelor

of Financial Administration

¤ Fellow of the Institute of Internal Auditors

• Australia and of CPA Australia

¤ Over 12 years’ private sector experience

and 17 years’ federal government experience in external audit, financial accounting, internal audit and consulting. Experience includes working within other regulatory bodies, including the Levies Revenue Service at the Department of Agriculture, Water and the Environment

4 13 727.80

45 Annual Report 2020-21

Member name

Qualifications, knowledge, skills or experience (including formal and informal as relevant)

Number of meetings attended/ total number

of meetings

Total annual remuneration (incl GST)

($)

Darren Schaeffer (independent member)

¤ Graduate of the Australian Institute of

Company Directors

¤ Fellow Certified Practicing Accountant

(FCPA)

¤ ACT CPA Divisional Council (2016-18)

¤ Professional Doctorate in Business

Administration (Research) - current

¤ MBA (Public Sector Administration)

¤ BBus (Accounting), DipFinPlan

¤ Institute of Internal Auditors

• Certified Government Auditing Professional

¤ Director, Curijo Pty Ltd

¤ CFO, Department of Agriculture, Fisheries

and Forestry (2008-13)

¤ Public Sector Management Boards

¤ CFO, Department of Environment and

Water Resources (2005-08)

4 6 600.00

Related entity transactions The APVMA procured goods and services from the related entities listed in Table 17 during 2020-21.

See Chapter 5 - Consultancies for further details on the APVMA’s decision making processes.

Table 17: Related entity transactions

Related entity No. of transactions Total amount ($)

Department of Agriculture, Water and the Environment

6 174 518.40

Comcare 1 104 529.50

Comcover 2 88 926.30

Australian Government Solicitor 9 61 727.05

Department of Defence 13 42 693.02

Department of Finance 4 33 525.58

Australian Public Service Commission 9 31 414.00

Comsuper 1 19 322.00

Australian Pesticides and Veterinary Medicines Authority 46

CHAPTER 4 Corporate governance and management

Related entity No. of transactions Total amount ($)

Department of Foreign Affairs and Trade 27 18 999.00

Department of Employment, Skills, Small and Family Business

1 9 437.97

Australia Post 12 5 177.05

Attorney-General’s Department 1 3 899.28

Australian Federal Police 11 1 344.00

Department of Infrastructure, Transport and Regional Development and Communications

1 1 214.04

Total 98 596 727.19

Consultation and collaboration

Effective consultation with our stakeholders is an essential component in supporting us to achieve our purpose and corporate objectives.

Stakeholder consultation is also a mandatory requirement for cost recovered agencies and guides our work to support Australia’s National Registration Scheme and ensure the safety of people, animals and the environment. We collaborate with stakeholders from the agvet industry, government and the community and encourage transparent and timely consultation to facilitate their feedback in our decision-making processes.

In September 2020 we published our Stakeholder Engagement Framework that sets out our strategic approach to stakeholder consultation and collaboration for the 2020-23 period.

In March 2021 we conducted our Client and Stakeholder Survey to seek feedback from stakeholders about their level of satisfaction with our performance and service delivery. The results of the survey provided us with an updated benchmark to assist with measuring performance, provided insights into what is working well and identified opportunities for improvement. A summary of the results from the 2021 survey, which indicated the overall level of stakeholder satisfaction with our performance has significantly improved, is available on our website at apvma.gov.au/node/82776.

At the conclusion of the 2020-21 reporting period we had conducted 27 public consultations on a range of topics, including Trade Advice Notices and Public Release Summaries.

In addition to ongoing informal engagements, the APVMA continued to engage with stakeholders in key forums throughout the reporting period (see Table 18).

47 Annual Report 2020-21

Table 18: APVMA participation in stakeholder engagement forums

Meeting Purpose Date Participants

Agvet Chemical Minor Use Prioritisation Forum

To develop a priority list of agvet chemical needs to inform DAWE’s assistance grants program

¤ 16 Nov 2020 ¤ DAWE

(Convenor)

¤ Representatives

from industry

APVMA Consultative Forum

To consult with and involve stakeholders to ensure their issues and concerns are understood and considered, and educate stakeholders on our regulatory activities

¤ 18 Aug 2020

¤ 9 Feb 2021

¤ Representatives

from peak industry bodies

APVMA User Forum

Liaison and high-level discussion with agvet product user groups

¤ 24 May 2021 ¤ Representatives

from user groups

Cost Recovery Working Group To seek feedback and input from industry

stakeholders on our cost recovery framework

¤ 26 Aug 2020

¤ 17 Dec 2020

¤ DAWE

¤ Representatives

from peak industry bodies

Harmonised Agvet Chemicals Control of Use Task Group

To consult with state and territory regulators to ensure their issues and concerns are understood and considered, and to share APVMA activities

¤ 18 Jun 2021 ¤ DAWE

(Convenor)

¤ Representatives

from state and territory regulators

Jurisdictional Spray Drift Working Group

To develop and implement spray drift policies

¤ 17 Nov 2020 ¤ DAWE

¤ Representatives

from state and territory regulators

Manufacturers’ Licensing Scheme - Industry Liaison Forum

To seek feedback and input from veterinary chemical product manufacturers on issues such as remote auditing during COVID-19

¤ 21 Sep 2020

¤ 26 Nov 2020

¤ 7 Dec 2020

¤ 21 Jun 2021

¤ Representatives

from veterinary chemical product manufacturers

Manufacturing Quality and Licensing Auditor Updates

To improve audit process, outcomes and opportunities for remote and hybrid audits

¤ Commenced Mar

2021

¤ APVMA Auditors

Australian Pesticides and Veterinary Medicines Authority 48

CHAPTER 4 Corporate governance and management

Meeting Purpose Date Participants

Registration Liaison Forum

To discuss common issues across the Commonwealth and the jurisdictions

¤ 4 Nov 2020

¤ 3 Feb 2021

¤ 5 May 2021

¤ DAWE

¤ Representatives

from state and territory regulators

Regulatory Science Network To discuss regulatory science issues and

improve interagency cooperation

¤ Ongoing

participation

¤ Representatives

from Commonwealth chemical regulators

Presentation on antimicrobial resistance and pesticide registration

¤ 4 Nov 2020

Veterinary Immunobiologicals Working Group

To discuss updated guidelines for autogenous vaccines

¤ 2 Sep 2020 ¤ Representatives

from industry

Veterinary Labelling Code presentation and workshop

To build a shared awareness and understanding of labelling issues

¤ 27 May 2021 ¤ Representatives

from peak industry bodies

International engagement We continued our program of international engagement in 2020-21, participating in key international scientific and regulatory forums (see Table 19) and hosting international visitors to the APVMA (see Table 20).

Table 19: APVMA participation in international forums

Meeting Contribution Date

Asia Pacific Association for Regulatory Science Steering Committee Participant ¤ Monthly from 12 Oct 2020

Asia-Pacific Economic Cooperation Workshop on Enforcement of Pesticide Maximum Residue Limits

Participant ¤ 16 to 17 Dec 2020

Bayer Operator Standards Workshop Participant ¤ 22 to 23 Apr 2021

Center of Excellence in Regulatory Science in Agriculture Unmanned Application Systems Spray Drift Workshop

Participant ¤ 2 to 4 Dec 2020

Codex Committee on Pesticide Residues electronic working groups Australian Representatives

¤ Ongoing participation

Codex Committee on Residues of Veterinary Drugs in Foods electronic working groups Australian Representatives

¤ Ongoing participation

49 Annual Report 2020-21

Meeting Contribution Date

Discussion of cannabidiol and hemp use with the Canadian Veterinary Drugs Directorate Participant ¤ 14 May 2021

FAO/WHO Joint Meeting on Pesticide Specifications Participant ¤ 12 to 16 Oct 2020

¤ 24 to 29 Jun 2021

FAO Meeting on Highly Hazardous Pesticides Information Participant ¤ 15 Jan 2021

Good Manufacturing and Distribution Practice International Working Group Meeting Member ¤ 11 Sep 2020

¤ 24 Nov 2020

¤ 2 to 5 Mar 2021

¤ 22 to 25 Jun 2021

Government-Industry Global Joint Review meeting (convened by Health Canada Pest Management Regulatory Agency)

Participant ¤ 29 Jun 2021

Health and Environmental Sciences Institute (HESI) Expert ¤ Ongoing

HESI Risk21 Scientific Advisory Board Meetings Member ¤ 22 Sep 2020

¤ 5 May 2021

HESI Transforming the Evaluation of Agrochemicals Committee Meeting Member ¤ 2 Feb 2021

Health Canada Pest Management Regulatory Agency Cooperation Participant ¤ Ongoing participation

International Regulator Forum Chair ¤ Ongoing participation

Introductory meeting on the World Organization for Animal Health-International Criminal Police Organization Emergency Management Exchange Programme

Participant ¤ 10 Feb 2021

Joint FAO/WHO Meeting of the Working Party of Chemicals, Pesticides and Biotechnology and the Chemicals Committee/Chemicals and Biotechnology Committee

Member ¤ 5 to 6 Nov 2020

¤ 8 to 10 Jun 2021

Joint FAO/WHO Meeting on Pesticides Residues - Residues Expert ¤ Ongoing participation

Joint FAO/WHO Meeting on Pesticides Residues - Toxicology Expert ¤ Ongoing participation

OECD Ad Hoc Expert Group on RNAi-based Pesticides Expert Working Group Member ¤ Ongoing participation

OECD Expert Group on BioPesticides Member ¤ 28 to 30 Jun 2021

OECD Expert Group on Electronic Exchange of Pesticide Data Participant ¤ Ongoing participation

Australian Pesticides and Veterinary Medicines Authority 50

CHAPTER 4 Corporate governance and management

Meeting Contribution Date

OECD Expert Group on Integrated Pest Management Member ¤ Ongoing participation

OECD Expert Group on Minor Uses Chair ¤ Ongoing participation

OECD International Uniform Chemical Information Database User Group Expert Panel Member ¤ 2 Oct 2020

¤ 30 Mar 2021

OECD Drafting Group on Pesticides Residue in Honey Member ¤ Ongoing participation

OECD Network on Illegal Trade of Pesticides Australian Representatives ¤ Ongoing participation

OECD Residues Chemistry Expert Group (RCEG) Chair ¤ Ongoing participation

OECD RCEG Drafting Group on Definition of Residues Member ¤ Ongoing participation

OECD Working Group of National Coordinators of the Test Guidelines Programme (WNT) Participant ¤ 20 to 23 April 2021

OECD WNT Expert Group on Developmental Neurotoxicity Member ¤ Ongoing participation

OECD Working Group on Pesticides - Drones Sub Group Member ¤ Ongoing participation

OECD Working Party on Biocides Member ¤ 14 to 15 Sep 2020

¤ 26 May 2021

OECD Working Party on Exposure Assessment Member ¤ Ongoing participation

Operation Silver Axe Briefing Participant ¤ 20 Jan 2021

Veterinary Medicines International Regulators Meeting Participant ¤ Ongoing participation

Veterinary Registration Meetings with New Zealand Participant ¤ 20 Aug 2020

¤ 19 Oct 2020

¤ 13 May 2021

¤ 25 May 2021

VICH Anthelmintic Working Group Member ¤ Ongoing participation

VICH Australia/New Zealand Participant ¤ 2 Nov 2020

VICH Biologicals Expert Working Group Expert ¤ Ongoing participation

VICH Combination Products Guidelines Expert Working Group Expert ¤ Ongoing participation

VICH Coordinators Meeting Participant ¤ 10 Feb 2021

VICH Extraneous Virus Testing Subgroup Initiation Meeting Participant ¤ 19 Apr 2021

51 Annual Report 2020-21

Meeting Contribution Date

VICH Medicated Premixes Taskforce Expert ¤ Ongoing participation

VICH Pharmacovigilance Expert Working Group Expert ¤ Ongoing participation

VICH Safety Expert Working Group Expert ¤ Ongoing participation

VICH Steering Committee Observer ¤ 16 to 19 Nov 2020

¤ 25 Feb 2021

¤ 21 Jun 2021

FAO = Food and Agriculture Organization of the United Nations; OECD = Organisation for Economic Co-operation and Development; VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; WHO = World Health Organization

Table 20: APVMA engagement with visiting international delegations

Meeting Date

Visit from a representative of the Government of the People’s Republic of Bangladesh 16 Feb 2021

Advertising and market research We did not undertake any advertising or market research in 2020-21.

Obtaining information from subsidiaries We have no subsidiaries.

Accountability

Corporate risk management The APVMA Risk Management Framework and Policy details how we engage with and manage risk to support our role as the regulator of agvet chemicals in Australia.

The Risk Management Framework and Policy has been developed to meet the requirements of section 16(a) of the PGPA Act and the Commonwealth Risk Management Policy issued by the Department of Finance. It follows the international standard on Risk Management — ISO 31000:2018 and articulates our:

¤ policy for the management of risk

¤ methodology used in the assessment of risk across the APVMA

¤ operation of risk registers and the integration of risk management through the APVMA

¤ strategies to develop a risk-aware organisational culture where proactive risk management is at the forefront of the decision making process.

Australian Pesticides and Veterinary Medicines Authority 52

CHAPTER 4 Corporate governance and management

The APVMA Risk Appetite and Tolerance Statement describes our attitude towards risk taking and details the level of risk we are willing to accept per individual risk. In conjunction with the Risk Management Framework and Policy, this statement supports the effective engagement with risk and ensures all staff understand what constitutes acceptable risk taking in both our day-to-day work and in achieving our strategic priorities.

In February 2021, BellchambersBarrett conducted an internal audit to assess the design adequacy and operating effectiveness of the APVMA’s Risk Management Framework. The audit identified we have a strong risk management approach, which is fit-for-purpose for an agency of our size and complexity, and confirmed we are managing risks associated with COVID-19 in a manner consistent with our documented risk management approach.

Fraud control We have a fraud control plan that complies with the Commonwealth Fraud Control Guidelines. The plan includes fraud prevention, detection, investigation, reporting and data collection procedures. The appropriateness of the fraud control plan and risk register are considered by our Audit Committee. We conduct regular fraud risk assessments as required under the fraud control plan.

Reporting The APVMA Gazette lists all notices and decisions required under the Agvet Code, including registrations, reviews and changes to registration status. The Gazette is published fortnightly and is available on our website at apvma.gov.au/news-and-publications/publications/gazette.

We publish regular reports that assess our performance in meeting regulatory timeframes and present a range of statistics, including:

¤ registration of chemical products

¤ approval of active ingredients

¤ issuance of permits

¤ licensing and audit of veterinary manufacturers

¤ preliminary assessment and pre-application assistance.

The reports include:

¤ the number of applications started and finalised

¤ the proportion of applications finalised within legislative timeframes

¤ work in progress at the end of the period.

Our performance reports can be accessed on our website at apvma.gov.au/node/26876.

Table 21 provides an overview of activities related to our regulatory decisions within the reporting period.

53 Annual Report 2020-21

Table 21: Activities related to APVMA regulatory decisions

Type of regulatory decisions Commenced Finalised/issued In progress

Pre-application assistance 244 169 39

Product registration - pesticides 1 336 1 466 387

Product registration - veterinary medicines 1 008 1 051 230

Permits 580 622 248

Actives 263 307 143

Items 8L, 8M, 8P 1 004 826 210

Technical assessment (Item 25) 12 11 9

Notifiable variations 1 011 1 011 0

Import consents 697 674 5

Certificates of export 479 492 21

Total 6 634 6 629 1 292

A description of these regulatory decisions (application types) is available on our website at apvma.gov.au/node/89926.

Chemical review The APVMA has powers under Part 2, Division 4 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) to conduct reviews of registered chemicals.

In September 2020, the reconsideration of 2,4-D was finalised and prior labels cancelled.

Our review of chlorpyrifos was progressed during 2020-21. Following a one-year suspension period, action was taken in July 2020 to cancel chlorpyrifos product registrations with combined agricultural and home garden or domestic uses on product labels, if applications had not been made to remove cancelled uses.

Public consultation was undertaken to seek information from interested stakeholders about use patterns for anticoagulant rodenticide products. This consultation closed in July 2020 and the summary of submissions was published in September 2020.

Technical work was completed for 3 reconsiderations (molinate, procymidone and malathion), with proposed regulatory decisions intended to be published in the first half of the 2021-22 financial year.

No reconsiderations were commenced during the 2020-21.

No actions were taken under section 99 of the Schedule to the Agvet Code during the reporting period.

Australian Pesticides and Veterinary Medicines Authority 54

CHAPTER 4 Corporate governance and management

Adverse Experience Reporting Program The Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the use of a registered agvet chemical product.

We record, assess and classify adverse experiences to detect uncommon events not evident during the initial registration process of a product. The program provides a means of facilitating regulatory action that may be necessary to ensure the continued safety, quality and effectiveness of registered products.

Anyone can report an adverse experience to the AERP - for example, farmers, pet owners, gardeners, veterinarians or the general public. One adverse incident may be reported multiple times - for example, the vet, pet owner and registrant may all report the same incident.

In 2020-21 we processed 7,366 adverse experience reports. The total number of reports received includes duplicate reports, reports classified as unrelated to the registered product, and non-serious reports.

Table 22: Summary of adverse experience reports received by the APVMA in 2020-21

Type of reports

Number of reports received Percentage of total reports

Duplicate, unrelated, and non-serious reports 6 357 86%

Serious incidences related to registered products 1 009 14%

Total reports 7 366 100%

Table 23: Summary of serious adverse experience reports received in 2020-21 by classification

Classification Number of reports Percentage of total

Animal health 543 54%

Crop health 3 <1%

Efficacy 360 36%

Environment 31 3%

Human 72 7%

Total serious reports 1 009 100%

AERP data was used to inform registration and permit applications, compliance matters and chemical review processes.

55 Annual Report 2020-21

Standards During the 2020-21 reporting period there were no standards made or varied by the APVMA under section 6E of the Schedule to the Agvet Code.

Ecologically sustainable development and environmental performance In 2020-21 the APVMA’s ECONet group, a voluntary network of staff who encourage and promote environmentally friendly office practices, diverted further waste from landfill by implementing a 10 cent ‘return and earn’ recycling program for cans and bottles in the Canberra office (already implemented in the Armidale office) and composting in the Armidale office through Armidale Regional Council’s City to Soil program.

We strive to be a ‘paperless office’ and use an electronic document and records management system to reduce the amount of paper and printer consumables used within our offices.

Our office buildings are also installed with low-power LED motion-activated lighting to improve our energy efficiency, and meeting rooms are equipped with videoconferencing capabilities to minimise travel.

Privacy We adhere to the Privacy Act 1988 and the Australian Government Agencies Privacy Code (the Code). Our Privacy Policy is published on our website at apvma.gov.au/node/59876.

One Privacy Impact Assessment was conducted in 2020-21 and an audit of our privacy processes against the agency’s obligations under the Code did not identify any compliance gaps.

Our operations were not subject to any report or determinations by the Privacy Commissioner in 2020-21.

Indemnities and insurance premiums The APVMA’s insurance with Comcover includes liability cover up to $150 million for general liability, professional indemnity, and directors’ and officers’ liability. The insurance premium paid to cover the 2020-21 financial year was $88,926.30 (including GST).

Australian Pesticides and Veterinary Medicines Authority 56

CHAPTER 4 Corporate governance and management

Judicial decisions and reviews by outside bodies

Parliamentary committees and other reviews In September 2020 we appeared before the House of Representatives Standing Committee on the Environment and Energy public hearing inquiry into the problem of feral and domestic cats in Australia.

We appeared before the Senate Estimates Rural and Regional Affairs and Transport Legislation Committee hearings on 22 October 2020 (budget) and 27 May 2021 (budget).

In November 2020 we appeared before the Senate Standing Committee on Community Affairs public hearing inquiry into the investigation of a possible cancer cluster in the Bellarine Peninsula, Victoria.

Auditor General’s reports The ANAO did not publish any Auditor General’s reports on our operations in 2020-21.

Administrative Appeals Tribunal We were named as the respondent in 3 applications before the Administrative Appeals Tribunal lodged during the 2020-21 reporting period.

Two of these applications sought review of our decisions to issue recall notices pursuant to sections 101 and 103 of the Schedule to the Agvet Code.

The third application sought review of our decision to refuse an application for extension of an emergency use permit pursuant to section 115 (3B) of the Agvet Code.

Each of these matters remained in progress at 30 June 2021.

Federal Court On 15 December 2020 an application was made to the Federal Court of Australia, which sought judicial review of our internal review decision on 20 November 2020 to affirm our original decision under section 41 of the Agvet Code to cancel the approvals of certain swimming and spa pool sanitiser products containing hydrogen peroxide and polyhexanide hydrochloride.

In February 2021 we signed orders consenting to the setting aside of both the internal review and original decisions to cancel the relevant products on natural justice grounds.

57 Annual Report 2020-21

Chapter 5

Financial performance

Financial performance

Summary of financial performance

Tables 24 to 27 provide an overview of our financial performance for 2020-21. Full details are in the audited financial statements on the following pages.

Income The APVMA’s total income for 2020-21 was $43.423 million (Table 24) and incorporates relocation and Enabling Technologies funding.

Table 24: APVMA income, 2020-21

Income source Income ($’000) %

Receipts from industry

Levies 20 089 46.26%

Application fees 8 449 19.46%

Annual fees (renewal fees) 7 311 16.84%

Other receipts from industry 2 980 6.86%

Parliamentary appropriation 4 400 10.13%

Other revenue 194 0.45%

Total income 43 423 100.00%

Australian Pesticides and Veterinary Medicines Authority 60

CHAPTER 5 Financial performance

Table 25: Agency Resourcing Statement, 2020-21

Resourcing description

Actual available appropriation for 2020-21 ($’000)

Payments made in 2020-21 ($’000)

Balance remaining in 2020-21 ($’000)

Ordinary annual service department expenses

Previous year unspent ordinary appropriations

19 471 19 471 -

Departmental appropriations 4 400 (14 452) 18 852

Revenue from independent sources 194 194 -

Total departmental appropriations 24 065 5 213 18 852

Special appropriations

Unspent special appropriations from previous years 12 229 12 229 -

Special appropriations collected 38 829 16 467 22 362

Total special appropriations 51 058 28 696 22 362

Total resourcing and payments 75 123 33 909 41 214

Expenditure Total operating expenses for 2020-21 were $36.385 million (Tables 26 and 27).

Table 26: APVMA expenditure, 2020-21 (including comparison with PBS)

Individual lines of expenditure

2020-21 actual expenditure ($’000) % of expenditure 2020-21 budget (per PBS) ($’000)

Employee benefits 23 894 65.67% 23 753

Supplier expenses 9 471 26.03% 13 432

Depreciation, amortisation and impairment of assets

2 829 7.78% 3 537

Other 191 0.52% 201

Total expenditure 36 385 100.00% 40 923

61 Annual Report 2020-21

Table 27: Expenses for Outcome 1

Outcome 1: Protection of the health and safety of people, animals, the environment, and agricultural and livestock industries through regulation of pesticides and veterinary medicines

2020-21 2019-20

Budget ($’000)

Actual ($’000) Variance ($’000)

Actual ($’000)

Program 1.1 (APVMA) Department expenses

Ordinary annual service (Appropriation Bill 1) 4 400 4 400 - 23 430

Revenue from independent sources 509 194 315 226

Special appropriation 36 014 31 791 4 223 17 498

Total expenses for Outcome 1 40 923 36 385 4 538 41 154

Equity The APVMA recorded a net operating surplus of $7.038 million for 2020-21, resulting in an equity balance at 30 June 2021 of $40.346 million.

Audit results The APVMA achieved an unqualified audit result and there were no adverse findings.

Financial reserve The APVMA’s revenue is primarily received as levy payments in December and June and registration payments in May. Subsequently, the APVMA receives the majority of its revenue at 3 times during the year. Unrestricted cash holdings can exceed $9 million at various stages through the financial year.

To manage this, the APVMA monitors daily cash balances to ensure cash is available to pay creditor expenses, particularly during times when the cash balances are reducing in the months when income is not anticipated.

The APVMA operates to keep the unrestricted cash level above $9 million as an operating reserve (an equity position of $9 million is equivalent to 3 months’ operating expenses).

Consultancies In 2020-21 the APVMA entered in to 4 new consultancy contracts totalling $0.454 million (including GST), of which $0.118 million was expended. The consultancies related to information services and the Enabling Technologies program.

In addition, 2 ongoing consultancy contracts from previous years were active, involving expenditure of $0.057 million (incl GST).

Australian Pesticides and Veterinary Medicines Authority 62

CHAPTER 5 Financial performance

Selection processes are described in terms drawn from the Commonwealth procurement guidelines. ‘Direct sourcing’ refers to a selection process in which neither a tender nor a panel was used. In these situations the APVMA obtained multiple quotes, the number of which was determined by the value of the procurement.

APVMA procedures outline the number of quotes required (see Table 28). Exemptions to these requirements may be approved in some circumstances.

This Annual Report contains information about actual expenditure on contracts for consultancies (see Table 17). Information on the value of contracts and consultancies is available on the AusTender website.

Table 28: Purchasing - number of quotes required

Purchase limit for goods/services Quotes required

to $2 000 1 quote

$2 001 to $10 000 2 written quotes

$10 001 to $100 000 3 written quotes

$100 001 to $400 000 High-value procurement procedures

$400 000 and over Tender

63 Annual Report 2020-21

GPO Box 707 CANBERRA ACT 2601 38 Sydney Avenue FORREST ACT 2603 Phone (02) 6203 7300 Fax (02) 6203 7777

INDEPENDENT AUDITOR’S REPORT

To the Minister for Agriculture and Northern Australia

Opinion

In my opinion, the financial statements of the Australian Pesticides and Veterinary Medicines Authority (‘the Entity’) for the year ended 30 June 2021:

(a) comply with Australian Accounting Standards - Reduced Disclosure Requirements and the Public Governance, Performance and Accountability (Financial Reporting) Rule 2015; and

(b) present fairly the financial position of the Entity as at 30 June 2021 and its financial performance and cash flows for the year then ended.

The financial statements of the Entity, which I have audited, comprise the following statements as at 30 June 2021 and for the year then ended:

• Statement by the Accountable Authority and Chief Finance Officer; • Statement of Comprehensive Income; • Statement of Financial Position; • Statement of Changes in Equity; • Cash Flow Statement; and • Notes to the financial statements, comprising an Overview, Summary of Significant Accounting Policies and

other explanatory information.

Basis for opinion

I conducted my audit in accordance with the Australian National Audit Office Auditing Standards, which incorporate the Australian Auditing Standards. My responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Statements section of my report. I am independent of the Entity in accordance with the relevant ethical requirements for financial statement audits conducted by the Auditor-General and his delegates. These include the relevant independence requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (the Code) to the extent that they are not in conflict with the Auditor-General Act 1997. I have also fulfilled my other responsibilities in accordance with the Code. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinion.

Accountable Authority’s responsibility for the financial statements

As the Accountable Authority of the Entity, the Chief Executive Officer is responsible under the Public Governance, Performance and Accountability Act 2013 (the Act) for the preparation and fair presentation of annual financial statements that comply with Australian Accounting Standards - Reduced Disclosure Requirements and the rules made under the Act. The Chief Executive Officer is also responsible for such internal control as the Chief Executive Officer determines is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.

In preparing the financial statements, the Chief Executive Officer is responsible for assessing the ability of the Entity to continue as a going concern, taking into account whether the Entity’s operations will cease as a result of an administrative restructure or for any other reason. The Chief Executive Officer is also responsible for disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the assessment indicates that it is not appropriate.

ANAO Letter

Australian Pesticides and Veterinary Medicines Authority 64

CHAPTER 5 Financial performance

Auditor’s responsibilities for the audit of the financial statements

My objective is to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes my opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian National Audit Office Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements.

As part of an audit in accordance with the Australian National Audit Office Auditing Standards, I exercise professional judgement and maintain professional scepticism throughout the audit. I also:

• identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for my opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control; • obtain an understanding of internal control relevant to the audit in order to design audit procedures that are

appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Entity’s internal control; • evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the Accountable Authority; • conclude on the appropriateness of the Accountable Authority’s use of the going concern basis of accounting

and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Entity’s ability to continue as a going concern. If I conclude that a material uncertainty exists, I am required to draw attention in my auditor’s report to the related disclosures in the financial statements or, if such disclosures are inadequate, to modify my opinion. My conclusions are based on the audit evidence obtained up to the date of my auditor’s report. However, future events or conditions may cause the Entity to cease to continue as a going concern; and • evaluate the overall presentation, structure and content of the financial statements, including the

disclosures, and whether the financial statements represent the underlying transactions and events in a manner that achieves fair presentation.

I communicate with the Accountable Authority regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that I identify during my audit.

Australian National Audit Office

Josephine Bushell Senior Director

Delegate of the Auditor-General

Canberra 6 September 2021

65 Annual Report 2020-21

Statement by the accountable authority and the Chief Financial Officer

Signed  ………………………………..       Signed  ………………………………..      

Lisa Croft Chief Executive Officer

6 September 2021

Keith A Lockyer  Chief Finance Officer

6 September 2021

STATEMENT BY THE ACCOUNTABLE AUTHORITY AND THE CHIEF FINANCE OFFICER

In our opinion, the attached financial statements for the year ended 30 June 2021 comply  with subsection 42(2) of the Public Governance, Performance and Accountability Act 2013  (PGPA Act), and are based on properly maintained financial records as per subsection 41(2)  of the PGPA Act.

In our opinion, at the date of this statement, there are reasonable grounds to believe that  the Australian Pesticides and Veterinary Medicines Authority (APVMA) will be able to pay its  debts as and when they fall due.

Australian Pesticides and Veterinary Medicines Authority 66

CHAPTER 5 Financial performance

Financial statements

Australian Pesticides and Veterinary Medicines Authority

STATEMENT OF COMPREHENSIVE INCOME for the year ended 30 June 2021

Original Budget

2021 2020 2021

Notes $'000 $'000 $'000

NET COST OF SERVICES Expenses   Employee benefits 1.1A  23 894   23 352     23 753 

  Suppliers 1.1B  9 471   14 075     13 432 

  Depreciation and amortisation 2.2A  2 829   3 520     3 537 

  Finance costs 1.1C   191    207    201 

Total expenses  36 385   41 154     40 923 

Own‐Source Income

Own‐source revenue   Other revenue 1.2A   194    217    509 

Total own‐source revenue   194    217    509 

Gains   Gains from sale of assets  â€    9   â€ 

Total gains  â€    9   â€ 

Total own‐source income   194    226    509 

Net cost of services  36 191   40 928     40 414 

Revenue from government 1.2B  43 229   57 239     40 113 

Surplus/(Deficit)     7 038   16 311  ( 301)

OTHER COMPREHENSIVE INCOME Items not subject to subsequent reclassification to profit and loss     Change in asset revaluation surplus  â€  (  557)  â€ 

Total other comprehensive income  â€  (  557)  â€ 

Total Comprehensive income/(loss)  7 038   15 754  ( 301)

The above statement is to be read in conjunction with the accompanying notes.

1

67 Annual Report 2020-21

Australian Pesticides and Veterinary Medicines Authority

STATEMENT OF COMPREHENSIVE INCOME for the year ended 30 June 2021

Budget Variance Commentary:

Commentary is provided for major variances between the actual amounts and the original budget. Variances are considered to be  ‘major’ (or significant) where: (a) for items in the Statement of Financial Position, the variance between budget and actual is greater than +/‐10% of the budget  and greater than $250,000 for the line item (b) for items in the Statement of Comprehensive Income, the variance between budget and actual is greater than +/‐2% of  expenses.

Variance explanations are also provided where major changes to business activities may not be numerically material, but by their  very nature will assist users in understanding underlying business changes that have occurred since the original budget was  released.

Statement of Comprehensive Income

Supplier expenses are $3.961 million (29.49%) under budget as reported in the Portfolio Budget Statements. The variation is  mainly due to the expenditure for the Enabling Technologies Program, to stabilise and transform our ICT environment. Delays in  the project has resulted in this variance.   

Depreciation and amortisation reflects the change in accounting estimate, resulting in the decelerated amortisation of the  software assets that will be replaced by the outcomes of the Enabling Technologies funded project. 

Other revenue was less than originally budgeted due to a decrease in interest received and other revenues.

Revenue from government was $3.116 million (7.77%) over budget, due to higher than budgeted fees and levies collected.

2

Australian Pesticides and Veterinary Medicines Authority

Original Budget

2021 2020 2021

Notes $'000 $'000 $'000

ASSETS Financial assets   Cash and cash equivalents 2.1A  1 117   1 736     1 696 

  Trade and other receivables 2.1B  40 218   30 498     31 213 

Total financial assets  41 335   32 234     32 909 

Non‐financial assets

  Leasehold improvements1 2.2A  16 764   18 333     16 862 

  Property, plant and equipment 2.2A   692   1 089     1 931 

  Intangibles 2.2A  2 289   3 177     1 569 

  Other non‐financial assets 2.2B   624    419    419 

Total non‐financial assets  20 369   23 018     20 781 

Total assets  61 704   55 252     53 690 

LIABILITIES Payables   Suppliers 2.3A  1 351   1 653    460 

  Other payables 2.3B   522    527    910 

Total payables  1 873   2 180     1 370 

Interest bearing liabilities

  Leases 2.4A  14 289   15 466     14 466 

Total interest bearing liabilities  14 289   15 466     14 466 

Provisions   Employee provisions 4.1A  5 196   4 298     4 847 

Total provisions  5 196   4 298     4 847 

Total liabilities  21 358   21 944     20 683 

Net assets  40 346   33 308     33 007 

EQUITY   Contributed equity  6 675   6 675     6 675 

  Retained surplus  33 390   26 352     26 051 

  Reserves   281    281    281 

Total equity  40 346   33 308     33 007 

The above statement is to be read in conjunction with the accompanying notes.

STATEMENT OF FINANCIAL POSITION as at 30 June 2021

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Original Budget

2021 2020 2021

Notes $'000 $'000 $'000

ASSETS Financial assets   Cash and cash equivalents 2.1A  1 117   1 736     1 696 

  Trade and other receivables 2.1B  40 218   30 498     31 213 

Total financial assets  41 335   32 234     32 909 

Non‐financial assets

  Leasehold improvements1 2.2A  16 764   18 333     16 862 

  Property, plant and equipment 2.2A   692   1 089     1 931 

  Intangibles 2.2A  2 289   3 177     1 569 

  Other non‐financial assets 2.2B   624    419    419 

Total non‐financial assets  20 369   23 018     20 781 

Total assets  61 704   55 252     53 690 

LIABILITIES Payables   Suppliers 2.3A  1 351   1 653    460 

  Other payables 2.3B   522    527    910 

Total payables  1 873   2 180     1 370 

Interest bearing liabilities

  Leases 2.4A  14 289   15 466     14 466 

Total interest bearing liabilities  14 289   15 466     14 466 

Provisions   Employee provisions 4.1A  5 196   4 298     4 847 

Total provisions  5 196   4 298     4 847 

Total liabilities  21 358   21 944     20 683 

Net assets  40 346   33 308     33 007 

EQUITY   Contributed equity  6 675   6 675     6 675 

  Retained surplus  33 390   26 352     26 051 

  Reserves   281    281    281 

Total equity  40 346   33 308     33 007 

The above statement is to be read in conjunction with the accompanying notes.

STATEMENT OF FINANCIAL POSITION as at 30 June 2021

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STATEMENT OF FINANCIAL POSITION as at 30 June 2021

1. Right‐of‐use assets are included in Leasehold Improvements.

Budget Variance Commentary:

Statement of Financial Position

Cash and cash equivalents are below budget due to the timing of payments to creditors and drawdown of special appropriation  leading up to 30 June 2021. 

Trade and other receivables are above budget due to the timing in expenditure for the Enabling Technologies projects and the  higher than anticipated industry income. As a result less funds have been drawn down from the special appropriation receivable  than planned.

Property, plant and equipment are lower than originally budgeted with lower capital replacements.

The value of intangibles are more than budgeted due to the change in accounting estimate, resulting in the decelerated  amortisation of the software assets that will be replaced by the outcomes of the Enabling Technologies Program.

Suppliers and other payables are over budget due to the receipt of a large number of invoices at the end of the financial year.

Employee provisions are above budget due to applying the new shorthand method used for calculating long service leave  developed by the Department of Finance. Assumptions around the employee profile were more detailed in the new model which in  turn increased the provision.

Retained surplus is higher than anticipated due to expenditure for the Enabling Technologies projects carried over to the 2021‐22  financial year and the higher than anticipated industry income. 

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2021 2020

CONTRIBUTED EQUITY Notes $'000 $'000 $'000

Opening balance   Balance brought forward from previous period  6 675   6 675     6 675 

Opening balance  6 675   6 675     6 675 

Closing balance as at 30 June     6 675   6 675     6 675 

RETAINED SURPLUS Opening balance   Balance brought forward from previous period  26 352   8 888     26 352 

  Adjustment on initial application of AASB 16  â€    315   â€ 

Adjusted opening balance  26 352   9 203     26 352 

Comprehensive income Surplus/(Deficit) for the period  7 038   16 311  (  301)

Asset revaluation reserve â€ no longer required  â€    838   â€ 

Total comprehensive income  7 038   17 149  (  301)

Closing balance as at 30 June     33 390   26 352     26 051 

ASSET REVALUATION RESERVE Opening balance   Balance brought forward from previous period   281    838    281 

Opening balance   281    838    281 

Comprehensive income Other comprehensive income  â€  (  557)  â€ 

Total comprehensive income  â€  (  557)  â€ 

Closing balance as at 30 June  2.2A   281    281    281 

TOTAL EQUITY Opening balance   Balance brought forward from previous period  33 308   16 401     33 308 

  Adjustment on initial application of AASB 16  â€    315   â€ 

Adjusted opening balance  33 308   16 716     33 308 

Comprehensive income Surplus/(Deficit) for the period  7 038   16 311  (  301)

Other comprehensive income  â€    281   â€ 

Total comprehensive income  7 038   16 592  (  301)

Closing balance as at 30 June     40 346   33 308     33 007 

STATEMENT OF CHANGES IN EQUITY for the year ended 30 June 2021

The above statement is to be read in conjunction with the accompanying notes.

Original Budget  2021

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STATEMENT OF CHANGES IN EQUITY for the year ended 30 June 2021

Accounting Policy

Equity Injections

Amounts appropriated which are designated as ‘equity injections’ for a particular year (less any formal reductions) and  Departmental Capital Budgets (DCBs) are recognised directly in contributed equity in that year.

Other Distributions to Owners

The Governance, Performance and Accountability (Financial Reporting) Rule 2015 (FRR) requires that distributions to owners be  debited to contributed equity unless it is in the nature of a dividend. 

Budget Variance Commentary:

Statement of Change in Equity

The surplus for the period is higher than anticipated due to expenditure for the Enabling Technologies projects carried over to the  2021‐22 financial year and the higher than anticipated industry income.

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Original Budget

2021 2020 2021

Notes $'000 $'000 $'000

OPERATING ACTIVITIES Cash received Agricultural and Veterinary Chemicals (Administration)  Act 1992 contribution  28 696   32 708     35 137 

Corporate Commonwealth entity payment item  4 400   5 695     4 400 

Net GST received  1 310   1 963     1 578 

Interest received   1    21    50 

Other cash received   165    196    264 

Total cash received  34 572   40 583     41 429 

Cash used Employees  23 010   27 635     23 731 

Suppliers  10 083   18 569     15 237 

Interest on lease liabilities   191    202    201 

Total cash used  33 284   46 406     39 169 

Net cash flows from operating activities  1 288  (5 823)  2 260 

INVESTING ACTIVITIES Cash used Purchase of property, plant and equipment   191    604     1 300 

Total cash used   191    604     1 300 

Net cash flows from or (used by) investing activities ( 191) ( 604) (1 300)

FINANCING ACTIVITIES Cash used Principal payments of lease liabilities  1 716    755     1 000 

Total cash used  1 716    755     1 000 

` (1 716) ( 755) ( 1 000)

Net increase or (decrease) in cash held ( 619) (7 182) ( 40)

 1 736   8 918     1 736 

Cash and cash equivalents at the end of the reporting period 2.1A  1 117   1 736     1 696 

 The above statement is to be read in conjunction with the accompanying notes.

CASH FLOW STATEMENT for the year ended 30 June 2021

Cash and cash equivalents at the beginning of the reporting  period

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CASH FLOW STATEMENT for the year ended 30 June 2021

Budget Variance Commentary:

There was less cash received as there was less drawn down from the special appropriation as a result of a decrease in supplier  expenses compared with budget.

The variation in cash used for suppliers is mainly due to the Enabling Technologies Program. The delay in payments for the program  has resulted in this variance.

Investment activities have been restricted mainly to the completion of the new fit‐out for the new Canberra office.

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OVERVIEW

Objectives of the Australian Pesticides and Veterinary Medicines Authority

Basis of Preparation of the Financial Report

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an Australian Government controlled not‐for‐profit corporate  entity.  The APVMA is responsible for the assessment and registration of pesticides and veterinary medicines and for their regulation up to  the point of retail sale.  The APVMA administers the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS) in  partnership with the states and territories along with the active involvement of other Australian Government agencies.  Its role is to  independently evaluate the safety and performance of chemical products intended for sale, ensuring that the health and safety of people,  animals, the environment and trade are protected.

The APVMA was established under the Agricultural and Veterinary Chemicals (Administration) Act 1992.  Following the introduction of the  Public Governance, Performance and Accountability Act  2013 on 1 July 2014, the APVMA was reclassified as a corporate Commonwealth  entity.

The financial statements are general purpose financial statements and are required by section 42 of the Public Governance, Performance  and Accountability Act 2013. 

The financial statements and notes have been prepared in accordance with:

Events After the Reporting Period

There were no subsequent events between balance date and signing of the financial statements that had the potential to significantly affect  the ongoing structure and financial activities of the APVMA. 

a) Public Governance, Performance and Accountability (Financial Reporting) Rule 2015 (FRR) ; and

The APVMA financial statements have been prepared on an accrual basis and in accordance with the historical cost convention, except for  certain assets at fair value.  Except where stated, no allowance is made for the effect of changing prices on the results or the financial  position.  The financial report is presented in Australian dollars and values are rounded to the nearest thousand dollars unless otherwise  specified.

New Australian Accounting Standards

All other new standards, revised standards, interpretations or amending standards that have been issued by the Australian Accounting  Standards Board prior to the sign‐off date and are applicable to the current reporting period did not have a material impact on the APVMA’s  financial statements.  

b) Australian Accounting Standards and Interpretations â€ Reduced Disclosure Requirements, issued by the Australian Accounting Standards  Board (AASB) that apply for the reporting period.

The APVMA is exempt from all forms of taxation except Fringe Benefits Tax (FBT) and the Goods and Services Tax (GST).

Taxation

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1.1: Expenses

2021 2020

$'000 $'000

1.1A: Employee benefits Wages and salaries  17 902   17 691 

Superannuation:

Defined contribution plans  2 498   2 241 

Defined benefit plans   437    606 

Leave and other entitlements  2 605   2 044 

Separation and redundancies  â€    326 

Other employee benefits   452    444 

Total employee benefits  23 894   23 352 

1.1B: Suppliers Goods and services supplied or rendered     Consultants   845    781 

    Contractors  4 600   8 606 

    Travel   88    349 

    IT services  2 115   2 456 

    Other  1 690   2 350 

Total goods and services supplied or rendered  9 338   14 542 

Goods supplied   90    359 

Services rendered  9 248   14 183 

Total goods and services supplied or rendered  9 338   14 542 

Accounting Policy Accounting policies for employee related expenses is contained in the people and relationships section.

Note There were four staff separations expensed in the 2019‐20 financial year and recorded under "Separations and redundancies".

Major expenses comprising "Other employee benefits" included costs associated with staff relocation and learning and  development costs.

Comparative information An adjustment has been made in the split of the superannuation expense in the prior year. This has no impact on the net result  reported in the comparative figures and has been done to correctly align the actual cost with the budget.

FINANCIAL PERFORMANCE â€ This section analyses the financial performance of the Australian Pesticides and Veterinary                                                       Medicines Authority for the year ended 30 June 2021

Note "Other" supplier expenses included costs associated with the digitisation of paper files and general office running expenses.

Comparative information In the current year, the APVMA has re‐classified recruitment costs from "Other employee benefits" reported under "Employee  benefits" to "Other" reported under Suppliers. This has resulted in a $0.339 million transfer from employee benefits to supplier  expenses in the Statement of Comprehensive Income in the prior year. This has no impact on the net result reported in the  comparative figures and has been done to correctly align the actual cost with the budget.

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1.1: Expenses

2021 2020

$'000 $'000

FINANCIAL PERFORMANCE â€ This section analyses the financial performance of the Australian Pesticides and Veterinary                                                       Medicines Authority for the year ended 30 June 2021

Other supplier expenses Operating lease rentals   49  (  575)

Workers compensation premiums   84    108 

Total other supplier expenses   133  (  467)

Total supplier expenses  9 471   14 075 

1.1C: Finance Costs Interest on lease liabilities   191    202 

Unwinding of discount  â€    5 

Total finance costs   191    207 

    Within 1 year  1 191   1 202 

    Between 1 to 5 years  4 778   3 848 

    Over 5 years  9 631   11 933 

Total operating lease commitments  15 600   16 983 

Accounting Policy Where an asset is acquired under a finance lease, the asset is capitalised at either the lease property's fair value or, if lower, the  present value of minimum lease payments at the inception of the contract.  A liability is recognised at the same time and for the  same amount. 

The discount rate used is the interest rate implicit in the lease.  Leased assets are amortised over the lease period.  Lease  payments are allocated between the principal component and the interest expense. 

Operating lease payments are expensed on a straight‐line basis which is representative of the pattern of benefits derived from  the leased assets. 

Commitment for minimum lease payments in relation to non‐cancellable operating  leases are payable as follows:

Leasing Commitments

The lease at 18 Wormald Street, Symonston, Canberra, was terminated early, in March 2020.  The reduced occupancy from 3 June  2019 resulted in a provision for onerous property lease payments of $1.355 million being created which due to the classification  as a short term lease under AASB 16 has been written back against rent expense.  

Accounting Policy All borrowing costs are expensed as incurred. 

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2021 2020

$'000 $'000

OWN‐SOURCE REVENUE

1.2A: Other revenue Resources received free of charge     Remuneration of auditors   54    54 

Other revenue   140    163 

Total other revenue   194    217 

Accounting Policy

Resources Received Free of Charge Resources received free of charge are recognised as revenue when fair value can be reliably determined and the donated services  would have been purchased.  Use of those resources is recognised as an expense.  Resources received free of charge are recorded  as either revenue or gains depending on their nature.

Other Revenue Revenue relating to services to the portfolio department is recognised as income under AASB 1058 when APVMA obtains controls  of the cash.

Revenue from the sale of goods is recognised when control has been transferred to the buyer. 

Interest revenue is recognised using the effective interest method.

"Other revenue" is predominantly made up of specific services to the portfolio department throughout the 2020‐21 financial year.

1.2: Own‐Source Revenue, Gains and Revenue from Government

FINANCIAL PERFORMANCE â€ This section analyses the financial performance of the Australian Pesticides and Veterinary                                                       Medicines Authority for the year ended 30 June 2021

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2021 2020

$'000 $'000

1.2: Own‐Source Revenue, Gains and Revenue from Government

FINANCIAL PERFORMANCE â€ This section analyses the financial performance of the Australian Pesticides and Veterinary                                                       Medicines Authority for the year ended 30 June 2021

REVENUE FROM GOVERNMENT

1.2B: Revenue from government

Corporate Commonwealth entity payment item 1

 4 400   23 430 

Department of Agriculture contribution Agricultural and Veterinary Chemicals (Administration) Act 1992 (refer below)  38 829   33 809 

Total revenue from government  43 229   57 239 

Note

Levies  20 089   18 553 

Annual renewal fee  7 311   6 009 

Product application fees  8 449   6 489 

Good manufacturing practice (GMP) licence fees   901   1 123 

Permits, actives and other fees  2 039   1 566 

Penalties    40    69 

Total industry contributions  38 829   33 809 

Note

Accounting Policy 

Revenue from government  Funding received or receivable from non‐corporate Commonwealth entities (appropriated to the non‐corporate Commonwealth  entity as a corporate Commonwealth entity payment) is recognised as revenue from government by the corporate  Commonwealth entity unless the funding is in the nature of an equity injection or a loan.

Fees and Levies  Fees and levies are recognised as income when they are received.

Department of Agriculture, Water and the Environment contribution is equal to the following fees and charges paid by industry:

1. $17.735 million of administered funds under Appropriation Bill No. 5 2019‐20 was not drawn down but brought to account as  revenue and a receivable from government in June 2020.

Infringement income does not form part of the Department of Agriculture, Water and the Environment (DAWE) contribution, but is  returned to the Consolidated Revenue Fund (CRF). Infringement income of $126,000 was not included above for the 2020‐21  financial year and is being returned through DAWE to the CRF.

Infringement revenue from prior years totalling $270,200 was recorded previously as Department of Agriculture, Water and the  Environment (DAWE) contributions. The APVMA has agreed with DAWE to reduce the Special Appropriation account in the 2021‐22  financial year by $270,200 to return the infringements to the CRF. 

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2.1: Financial Assets

2021 2020

$'000 $'000

2.1A: Cash and cash equivalents     Cash at bank  1 117   1 736 

Total cash and cash equivalents  1 117   1 736 

2.1B: Trade and other receivables

Contribution receivable Department of Agriculture, Water and the Environment  22 362   12 229 

Total contribution receivable  22 362   12 229 

Other receivable Receivable from the Australian Taxation Office   106    320 

Undrawn appropriation  17 735   17 735 

Other   15    214 

Total other receivables  17 856   18 269 

Total trade and other receivables (gross)  40 218   30 498 

Less impairment allowance account:

Goods and services  â€   â€ 

Total impairment allowance account  â€   â€ 

Total trade and other receivables (net)  40 218   30 498 

Credit terms for goods and services were within 30 days.

Accounting Policy

Cash is recognised at its nominal amount.

Accounting Policy

Trade and Other Receivables Trade and other receivables that have fixed or determinable payments, and are not quoted in an active market, are classified  as 'receivables'.  Receivables are measured at amortised cost using the effective interest method less impairment.

Impairment Trade and Other Receivables are assessed for impairment at the end of each reporting period.

FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

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2.2: Non‐Financial Assets

Leasehold Other         Computer

Improvements1 P P & E Software2 Total

$'000 $'000 $'000 $'000

 19 412     1 089     9 441     29 942 

( 1 079)  â€  ( 6 264) ( 7 343)

 18 333     1 089     3 177     22 599 

  173    18   â€    191 

Right‐of‐use assets  â€   â€   â€   â€ 

Revaluation recognised in other comprehensive income  â€   â€   â€   â€ 

( 1 526) (  415) (  888) ( 2 829)

Other movements (  216)  â€   â€  (  216)

 â€   â€   â€   â€ 

 â€   â€   â€   â€ 

Total as at 30 June 2021  16 764    692     2 289     19 745 

 19 369     1 107     9 441     29 917 

( 2 605) (  415) ( 7 152) ( 10 172)

 16 764    692     2 289     19 745 

 13 743   â€   â€   13 743  Carrying amount of right‐of‐use assets

Accumulated depreciation and impairment Gross book value

Disposals:

Additions:

Total as of 30 June 2021 represented by:

Accumulated depreciation and impairment

Disposal Accumulated depreciation of disposed assets

Total as at 1 July 2020

FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

Reconciliation of the opening and closing balances for 2021

As at 1 July 2020

Purchase

Depreciation and amortisation expense

Total as of 30 June 2021 represented by:

Gross book value

2.2A:  Reconciliation of the Opening and Closing Balances of Property, Plant and Equipment and Intangibles

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2.2: Non‐Financial Assets

FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

Notes 1. The carrying amount of right‐of‐use assets included in leasehold improvements is $13.743 million. The depreciation expense  on right‐of‐use assets during the 2020‐21 year was $1.255 million.

2. The carrying amount of computer software includes $0.124 million purchased software and $2.165 million internally generated  software.

The right of use asset was adjusted by $0.216 million as a result of a modification of the lease at Faulding St, Canberra.

Revaluations of Non‐Financial Assets

On 30 June 2020, an independent valuer conducted the revaluation of non‐financial assets. Revaluation increments were credited  to equity under the heading of revaluation reserve and decrements were recognised directly through the operating result. The  previous revaluation reserve was reversed as the assets relating to the reserve were disposed of during the 2019‐20 financial  year.

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FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

Asset Recognition Threshold

Purchases of property, plant and equipment are recognised initially at cost in the statement of financial position, except for  purchases costing less than $5 000, which are expensed in the year of acquisition (other than where they form part of a group of  similar items which are significant in total).

The initial cost of an asset includes an estimate of the cost of dismantling and removing the item and restoring the site on which  it is located.  This is particularly relevant to ‘make good’ provisions in property leases taken up by the APVMA where there exists  an obligation to restore the property to its original condition.  These costs are included in the value of the APVMA’s leasehold  improvements with a corresponding provision for ‘make good’.

Lease Right of Use (ROU) Assets

Leased ROU assets are capitalised at the commencement date of the lease and comprise of the initial lease liability amount,  initial direct costs incurred when entering into the lease less any lease incentives received. These assets are accounted for by  Commonwealth lessees as separate asset classes to corresponding assets owned outright, but included in the same column as  where the corresponding underlying assets would be presented if they were owned.

On initial adoption of AASB 16 the APVMA has adjusted the ROU assets at the date of initial application by the amount of any  provision for onerous leases recognised immediately before the date of initial application. Following initial application, an  impairment review is undertaken for any right of use lease asset that shows indicators of impairment and an impairment loss is  recognised against any right of lease asset that is impaired. Lease ROU assets continue to be measured at cost after initial  recognition in Commonwealth agency, GGS and whole of government financial statements.

2.2: Non‐Financial Assets

Accounting Policy

Assets are recorded at cost on acquisition except as stated below.  The cost of acquisition includes the fair value of assets  transferred in an exchange and any liabilities undertaken.  Financial assets are initially measured at their fair value plus  transaction costs where appropriate.

Assets acquired at no cost, or for nominal consideration, are initially recognised as assets and income at their fair value at the  date of acquisition, unless acquired as a consequence of a restructuring of administrative arrangements.  In the latter case, assets  are initially recognised as contributions by owners at the amounts at which they were recognised in the transferor’s accounts  immediately prior to the restructuring. 

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FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

2.2: Non‐Financial Assets

2021

Leasehold improvements                                                                            Shorter of lease term or  useful life

Property, plant and equipment                                                                   3 to 15 years

Non‐Financial Asset Revaluations

All non‐financial assets are initially recognised at cost.  Property, plant and equipment are then carried at fair value once they  have been revalued in accordance with policy. Valuations are conducted with sufficient frequency to ensure that the carrying  amounts of assets do not differ materially from the assets’ fair values at reporting date.  The regularity of independent valuations  depends upon the volatility of movements in market values for the relevant assets.  Assets are presently revalued on a three year  cycle.

All assets (except for intangibles) were revalued as at 30 June 2020 by an independent valuer.  

Revaluation adjustments are made on a class basis.  Any revaluation increment is credited to equity under the heading of asset  revaluation reserve except to the extent that it reverses a previous revaluation decrement of the same asset class that was  previously recognised through the operating result.  Revaluation decrements for a class of assets are recognised directly through  the operating result except to the extent that they reverse a previous revaluation increment for that class.

Any accumulated depreciation as at the revaluation date is eliminated against the gross carrying amount of the asset and the  asset restated to the revalued amount.

Depreciation

Depreciable property plant and equipment assets are written‐off to their estimated residual values over their estimated useful  lives to the APVMA using, in all cases, the straight‐line method of depreciation. 

Depreciation rates (useful lives), residual values and methods are reviewed at each reporting date and necessary adjustments are  recognised in the current, or current and future reporting periods, as appropriate.

Depreciation rates applying to each class of depreciable asset are based on the following useful lives:

Impairment Where indications for impairment exist, the asset’s recoverable amount is estimated and an impairment adjustment made if the  asset’s recoverable amount is less than its carrying amount.

The recoverable amount of an asset is the higher of its fair value less costs to sell and its value in use.  Value in use is the present  value of the future cash flows expected to be derived from the asset.  Where the future economic benefit of an asset is not  primarily dependent on the asset’s ability to generate future cash flows, and the asset would be replaced if the APVMA were  deprived of the asset, its value in use is taken to be its depreciated replacement cost.

APVMA commenced work from its new Canberra office in March 2020.  Assets from the old Canberra office have been disposed  of due to obsolescence or disrepair. 

All assets were assessed for impairment at 30 June 2021.  

2020

Shorter of lease term or  useful life 3 to 15 years

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FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

2.2: Non‐Financial Assets

Derecognition An item of property, plant and equipment is derecognised upon disposal or when no further future economic benefits are  expected from its use or disposal.

Dependent on the outcome of management's assessment of Canberra office space, some items of property, plant and equipment  may be sold or disposed of within the next 12 months, but are not material in value.

Intangibles The APVMA’s intangibles comprise internally developed and externally acquired software for internal use.  These assets are  carried at cost less accumulated amortisation and accumulated impairment losses.

Software is amortised on a straight‐line basis over its anticipated useful life.  The useful lives of the APVMA’s software are 3 to 10  years (2019‐20: 3 to 10 years).

All software assets were assessed for indications of impairment as at 30 June 2021. 

The APVMA currently has a project underway to replace its internally developed software with a cloud‐based solution. The  existing software is expected to be in use until 30 June 2024 which has resulted in a change to the accounting estimate.

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2.2: Non‐Financial Assets 

2021 2020

$'000 $'000

2.2B:  Other non‐financial assets   Prepayments   624    419 

Total other non‐financial assets   624    419 

No indicators of impairment were found for other non‐financial assets.

2.3: Payables

2021 2020

$'000 $'000

2.3A: Suppliers   Trade creditors and accruals  1 351   1 653 

Total supplier payables  1 351   1 653 

Settlement is usually made within 30 days.

2.3B: Other payables   Salaries and wages   515    518 

  Superannuation   7    9 

Total other payables   522    527 

2.4: Interest Bearing Liabilities

2021 2020

$'000 $'000

2.4A: Leases   Lease liabilities  14 289   15 466 

Total leases  14 289   15 466 

FINANCIAL POSITION â€ This section analyses Australian Pesticides and Veterinary Medicines Authority's assets                                             used to conduct its operations and the operating liabilities incurred as a result.                                            Employee related information is disclosed in the People and Relationships section.

Accounting Policy

Suppliers Supplier payables are measured at their nominal amounts.

Total cash outflow for leases for the year ended 30 June 2021 was $1.202 million. There was a modification of the Faulding St,  Canberra lease which resulted in a decrease in lease liabilities as at 1 July 2021 of $0.216 million.

Accounting Policy

Refer Overview section for accounting policy on leases.

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3.1: Regulatory Charging Summary

3.1A: Regulatory Charging Summary

2021 2020

$'000 $'000

Balance carried from previous period  12 229   11 128 

External revenue:

   Levies, fees and charges  39 333   34 401 

Available for payments:  51 562   45 529 

Amounts applied (Drawn down) (29 200) (33 300)

Balance carried to next period and represented by:  22 362   12 229 

FUNDING â€ This section identifies the Australian Pesticides and Veterinary Medicine's funding structure

Documentation (Cost Recovery Implementation Statement) for the above activities is available at: apvma.gov.au/node/4161 

The APVMA has implemented a new Cost Recovery Implementation Statement effective 1 July 2020.

The APVMA does not generally receive material funding from the government, but is funded through fees, levies and other  charges imposed under various sections of legislation.  

The only change to this is when the government funds specific projects to improve and/or enhance the APVMA's ability to  perform its legislated functions such as the relocation to Armidale, NSW and the information technology environment refresh.

These fees, levies and charges are credited to a special appropriation created under s 58 (6) of the Agricultural and Veterinary  Chemicals (Administration) Act 1992, (Agvet Admin Act), which is held and managed by the Department of Agriculture, Water  and the Environment (DAWE) for and on behalf of the APVMA.  

The purpose of this special appropriation is:

         (a) to pay or discharge the costs, expenses or other obligations incurred by the APVMA in the                  performance of its functions          (b) to make payment of any remuneration and allowances payable to any person under this Act          (c) to make any other payments that the APVMA is authorised or required to make by or under                 this Act or any other law of the Commonwealth or any law of a state or territory that is                 expressed to confer functions or powers on the APVMA.

Under s 58 of the Agvet Admin Act, monies received by the APVMA from infringement notices is not to be credited to the special  appropriation account. Infringement revenue from prior years totalling $270,200 was recorded previously as DAWE contributions.  The APVMA has agreed with DAWE to reduce the Special Appropriation in the 2021‐22 financial year by 270,200 to return the  infringements to the Consolidated Revenue Fund.

The balance on this account is recorded as a receivable from the Department at Note 2.1B: Trade and other receivables â€  Contributions receivable.  

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4.1: Employee Provisions

2021 2020

$'000 $'000

4.1A:  Employee provisions Annual leave  2 074   1 690 

Long service leave  3 122   2 608 

Total employee provisions  5 196   4 298 

Employee provisions are expected to be settled in:

  No more than 12 months  1 821   1 624 

  More than 12 months  3 375   2 674 

Total employee provisions  5 196   4 298 

Accounting Policy

Liabilities for short‐term employee benefits and termination benefits expected within 12 months of the end of the reporting  period are measured at their nominal amounts, and reported in Note 2.3B Other payables.

Leave The liability for employee benefits includes provision for annual leave and long service leave. The leave liabilities are calculated on the basis of employees’ remuneration at the estimated salary rates that will be applied at  the time the leave is taken, including the entity’s employer superannuation contribution rates to the extent that the leave is likely  to be taken during service rather than paid out on termination.

The liability for long service leave has been determined by reference to the 'short‐hand method' as outlined in the Resource  Management Guide No. 125 â€ Commonwealth Entities Financial Statements Guide as at 30 June 2021.  The estimate of the  present value of the liability takes into account attrition rates and pay increases through promotion and inflation and is  discounted using the 10 year bond rate at 30 June 2021.

Superannuation The APVMA's staff are members of the Commonwealth Superannuation Scheme (CSS), the Public Sector Superannuation Scheme  (PSS), the PSS accumulation plan (PSSap) or other superannuation funds held outside the Australian Government.

The CSS and PSS are defined benefit schemes for the Australian Government.  The PSSap is a defined contribution scheme.

The liability for defined benefits is recognised in the financial statements of the Australian Government and is settled by the  Australian Government in due course.  This liability is reported in the Department of Finance’s administered schedules and notes.

The entity makes employer contributions to the employees' defined benefit superannuation scheme at rates determined by an  actuary to be sufficient to meet the current cost to the government.  The entity accounts for the contributions as if they were  contributions to defined contribution plans.

The liability for superannuation recognised as at 30 June 2021 represents outstanding contributions.

PEOPLE AND RELATIONSHIPS â€ This section describes a range of employment and post employment benefits                                                           provided to our people and our relationship with key people.

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2021 2020

$ $

Short‐term employee benefits 1 735 774  2 017 415 

Post‐employment benefits  246 069   285 752 

Other long‐term employee benefits:  46 218   44 299 

Terminations  â€   388 084 

Total key management personnel remuneration expenses 1 2 028 061  2 735 550 

Note

1. The above key management personnel remuneration excludes the remuneration and other benefits of the Portfolio Minister. The  Portfolio Minister's remuneration and other benefits are set by the Remuneration Tribunal and are not paid by the entity.

Key management personnel (KMP) are those persons who comprise the Executive Committee (EC) at anytime throughout the year  in either a permanent or acting capacity.  The KMP group has the authority and responsibility for planning, directing and controlling  the activities of the APVMA, recognising that ultimate responsibility resides with the CEO who is in turn responsible for the  APVMA's performance to the relevant Portfolio Minister.

Key management personnel remuneration for the reporting period

PEOPLE AND RELATIONSHIPS â€ This section describes a range of employment and post employment benefits                                                           provided to our people and our relationship with key people.

The total number of key management personnel included in the above table is 14 (2019‐20: 12 staff members). Of these 14 staff, seven individuals held positions for only part of the year (2019‐20: five individuals were in this category). 

The Chief Executive Officer's remuneration and other benefits are determined by the Remuneration Tribunal, and paid by the  APVMA. 

The balance of the KMP remuneration and other benefits are determined by the CEO, under s24 of the  Public Service Act 1999 . 

Comparative information Termination benefits have been revised in the comparative amounts for 2019‐20 as a result of recognising accrued termination  payments.  This adjustment is for KMP disclosure only, and does not impact on the net result reported in the Statement of  Comprehensive Income.

4.2: Key Management Personnel Remuneration

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4.3: Related Party Disclosures

The APVMA is an Australian Government controlled entity, and is part of the Department of Agriculture, Water and the  Environment portfolio.  Related parties to this entity are relevant Federal Government Ministers including the Portfolio Minister,  the Executive Committee, comprising the Chief Executive Officer, the Deputy Chief Executive Officer,  three Executive Directors,  the Chief Regulatory Scientist, General Counsel, and other Commonwealth Government entities.

Transactions with related parties: Given the breadth of government activities, related parties may transact with the government sector in the same capacity as  ordinary citizens.  Such transactions include the payment or refund of taxes, receipt of a Medicare rebate or higher education  loans. These transactions have not been separately disclosed in this note.

All transactions with other Commonwealth Government entities have been made under normal terms and conditions and,  therefore have not been disclosed separately.

There have been no transactions with related parties this year.  All APVMA staff, including the Executive Committee, are required  to sign an annual conflict of interest declaration.

PEOPLE AND RELATIONSHIPS â€ This section describes a range of employment and post employment benefits                                                           provided to our people and our relationship with key people.

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5.1: Contingent Assets and Liabilities

Quantifiable contingencies

Unquantifiable contingencies

Accounting Policy

Contingent liabilities and contingent assets are not recognised in the statement of financial position but are reported in the notes.   They may arise from uncertainty as to the existence of a liability or asset or represent an asset or liability in respect of which the  amount cannot be reliably measured. Contingent assets are disclosed when settlement is probable but not virtually certain and  contingent liabilities are disclosed when settlement is greater than remote.

MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

The APVMA had no unquantifiable contingencies.  (2019‐20: nil) 

The APVMA has no quantifiable contingent liabilities relating to litigation costs. (2019‐20: nil) 

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MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

2021 2020

$'000 $'000

5.2A: Categories of financial instruments Financial assets at amortised cost Cash and cash equivalents  1 117   1 736 

Other sundry debtors  â€    214 

Total Financial assets at amortised cost  1 117   1 950 

Total Financial assets  1 117   1 950 

Financial liabilities Financial liabilities measured at amortised cost Other liabilities Trade creditors and accruals  1 351   1 653 

Other payables   522    527 

Lease liabilities  14 289   15 466 

Total financial liabilities measured at amortised cost  16 162   17 646 

Total financial liabilities  16 162   17 646 

5.2B: Net gains or losses on financial assets Financial assets at amortised cost Interest revenue   1    21 

Net gain/(loss) from financial assets   1    21 

5.2C: Net gains and losses on financial liabilities Financial liabilities measured at amortised cost Interest expense   191    202 

Net gain/(loss) from financial assets   191    202 

5.2: Financial Instruments

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MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

2021 2020

$'000 $'000

5.2A: Categories of financial instruments Financial assets at amortised cost Cash and cash equivalents  1 117   1 736 

Other sundry debtors  â€    214 

Total Financial assets at amortised cost  1 117   1 950 

Total Financial assets  1 117   1 950 

Financial liabilities Financial liabilities measured at amortised cost Other liabilities Trade creditors and accruals  1 351   1 653 

Other payables   522    527 

Lease liabilities  14 289   15 466 

Total financial liabilities measured at amortised cost  16 162   17 646 

Total financial liabilities  16 162   17 646 

5.2B: Net gains or losses on financial assets Financial assets at amortised cost Interest revenue   1    21 

Net gain/(loss) from financial assets   1    21 

5.2C: Net gains and losses on financial liabilities Financial liabilities measured at amortised cost Interest expense   191    202 

Net gain/(loss) from financial assets   191    202 

5.2: Financial Instruments

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MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

5.2D: Fair value of financial instruments

Effective Interest Method Income is recognised on an effective interest rate basis for financial assets that are recognised at amortised cost.         

Impairment of Financial Assets Financial assets are assessed for impairment at the end of each reporting period based on Expected Credit Losses, using the general  approach which measures the loss allowance based on an amount equal to lifetime expected credit losses where risk has  significantly increased, or an amount equal to 12‐month expected credit losses if risk has not increased.  

The simplified approach for trade, contract and lease receivables is used.  This approach always measures the loss allowance as the  amount equal to the lifetime expected credit losses.  

A write‐off constitutes a derecognition event where the write off directly reduces the gross carrying amount of the financial asset.

Accounting Policy

Financial Assets With the implementation of AASB 9 Financial Instruments for the first time in 2019, the entity classifies its financial assets in the  following categories: a) financial assets at fair value through profit or loss; b) financial assets at fair value through other comprehensive income; and c) financial assets measured at amortised cost.

The classification depends on both the entity's business model for managing the financial assets and contractual cash flow  characteristics at the time of initial recognition.  Financial assets are recognised when the entity becomes a party to the contract  and, as a consequence, has a legal right to receive or a legal obligation to pay cash and derecognised when the contractual rights to  the cash flows from the financial asset expire or are transferred upon trade date.  

Comparatives have not been restated on initial application.  

Financial Assets at Amortised Cost Financial assets included in this category need to meet two criteria: 1. the financial asset is held in order to collect the contractual cash flows; and 2. the cash flows are solely payments of principal and interest(SPPI) on the principal outstanding amount.

Amortised cost is determined using the effective interest method.

5.2: Financial Instruments

The net fair values of cash and cash equivalents, trade receivables and other receivables approximate their carrying amounts.

The net fair values for trade creditors and other liabilities are approximated by their carrying amounts.

AASB 9 contains the requirement for interest revenue to be calculated using the effective interest rate method.  Interest revenue  recognised by the APVMA is interest received on its bank account.  The change in relevant standards and definitions do not have an  impact on interest revenue recognised by the APVMA.

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MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

5.2: Financial Instruments

Financial Liabilities Financial liabilities are classified as either financial liabilities 'at fair value through profit or loss’ or other financial liabilities.   Financial liabilities are recognised and derecognised upon ‘trade date’.

Financial Liabilities at Fair Value Through Profit or Loss Financial liabilities at fair value through profit or loss are initially measured at fair value.  Subsequent fair value adjustments are  recognised in profit or loss.  The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability.

Financial Liabilities at Amortised Cost Financial liabilities, including borrowings, are initially measured at fair value, net of transaction costs.  These liabilities are  subsequently measured at amortised cost using the effective interest method, with interest expense recognised on an effective  interest basis.

Supplier and other payables are recognised at amortised cost.  Liabilities are recognised to the extent that the goods or services  have been received (and irrespective of having been invoiced).

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2021 2020

Valuation method $'000 $'000

Leasehold improvements Depreciated replacement cost adjusted for  impairment  3 021   3 119 

Property, plant and equipment Depreciated replacement cost adjusted for  impairment   692   1 089 

 3 713   4 208 

MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

5.3: Fair Value Measurements

Non‐financial assets

Accounting Policy

Non‐financial assets Initial recognition Assets are recorded at cost on acquisition except as stated below.  The cost of acquisition includes the fair value of assets transferred in an  exchange and any liabilities undertaken.  Financial assets are initially measured at their fair value plus transaction costs where appropriate.       Assets acquired at no cost, or for nominal consideration, are initially recognised as assets and income at their fair value at the date of  acquisition, unless acquired as a consequence of a restructuring of administrative arrangements.  In the latter case, assets are initially  recognised as contributions by owners at the amounts at which they were recognised in the transferor’s accounts immediately prior to the  restructuring.        Revaluations Property, plant and equipment are then carried at fair value once they have been revalued in accordance with policy.  Valuations are  conducted with sufficient frequency to ensure that the carrying amounts of assets do not differ materially from the assets’ fair values at  reporting date.  The regularity of independent valuations depends upon the volatility of movements in market values for the relevant assets.  Assets are presently revalued on a three year cycle.  If there are any major impacts on any asset group, the effect is assessed and the asset's  valuation will be adjusted.  As the asset groups are quite stable, any impacts are minimal.

All assets (except for intangibles) were revalued as at 30 June 2020 by an independent valuer.    

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MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

5.2: Financial Instruments

Financial Liabilities Financial liabilities are classified as either financial liabilities 'at fair value through profit or loss’ or other financial liabilities.   Financial liabilities are recognised and derecognised upon ‘trade date’.

Financial Liabilities at Fair Value Through Profit or Loss Financial liabilities at fair value through profit or loss are initially measured at fair value.  Subsequent fair value adjustments are  recognised in profit or loss.  The net gain or loss recognised in profit or loss incorporates any interest paid on the financial liability.

Financial Liabilities at Amortised Cost Financial liabilities, including borrowings, are initially measured at fair value, net of transaction costs.  These liabilities are  subsequently measured at amortised cost using the effective interest method, with interest expense recognised on an effective  interest basis.

Supplier and other payables are recognised at amortised cost.  Liabilities are recognised to the extent that the goods or services  have been received (and irrespective of having been invoiced).

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2021 2020

Valuation method $'000 $'000

Leasehold improvements Depreciated replacement cost adjusted for  impairment  3 021   3 119 

Property, plant and equipment Depreciated replacement cost adjusted for  impairment   692   1 089 

 3 713   4 208 

MANAGING UNCERTAINTIES â€ This section analyses how the Australian Pesticides and Veterinary Medicines Authority                                                         manages financial risks within its operating environment

5.3: Fair Value Measurements

Non‐financial assets

Accounting Policy

Non‐financial assets Initial recognition Assets are recorded at cost on acquisition except as stated below.  The cost of acquisition includes the fair value of assets transferred in an  exchange and any liabilities undertaken.  Financial assets are initially measured at their fair value plus transaction costs where appropriate.       Assets acquired at no cost, or for nominal consideration, are initially recognised as assets and income at their fair value at the date of  acquisition, unless acquired as a consequence of a restructuring of administrative arrangements.  In the latter case, assets are initially  recognised as contributions by owners at the amounts at which they were recognised in the transferor’s accounts immediately prior to the  restructuring.        Revaluations Property, plant and equipment are then carried at fair value once they have been revalued in accordance with policy.  Valuations are  conducted with sufficient frequency to ensure that the carrying amounts of assets do not differ materially from the assets’ fair values at  reporting date.  The regularity of independent valuations depends upon the volatility of movements in market values for the relevant assets.  Assets are presently revalued on a three year cycle.  If there are any major impacts on any asset group, the effect is assessed and the asset's  valuation will be adjusted.  As the asset groups are quite stable, any impacts are minimal.

All assets (except for intangibles) were revalued as at 30 June 2020 by an independent valuer.    

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2021 2020

$'000 $'000

Assets expected to be recovered in:

No more than 12 months Cash and cash equivalents  1 117   1 736 

Trade and other receivables  40 218   30 498 

Other non‐financial assets   624    419 

Total no more than 12 months  41 959   32 653 

More than 12 months Leasehold Improvements  16 764   18 333 

Property, plant and equipment   692   1 089 

Intangibles  2 289   3 177 

Total more than 12 months  19 745   22 599 

Total assets  61 704   55 252 

Liabilities expected to be settled in:

No more than 12 months Suppliers  1 351   1 653 

Other payables   522    202 

Leases  1 004   1 001 

Employee provisions  1 821   1 624 

Total no more than 12 months  4 698   4 480 

More than 12 months Other payables  â€    325 

Leases  13 285   14 465 

Employee provisions  3 375   2 674 

Total more than 12 months  16 660   17 464 

Total liabilities  21 358   21 944 

OTHER INFORMATION

6.1 Current/non‐current distinction for assets and liabilities

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Acronyms and abbreviations Glossary Compliance index

Index

Acronyms and abbreviations

Term Description

ACTRA Australasian College of Toxicology and Risk Assessment

Administration Act Agricultural and Veterinary Chemicals (Administration) Act 1992

AERP Adverse Experience Reporting Program

Agvet Agricultural and veterinary

Agvet Code Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994

Agvet Code Regulations

Agricultural and Veterinary Chemicals Code Regulations 1995

AMA Animal Medicines Australia

ANAO Australian National Audit Officer

APEC Asia-Pacific Economic Cooperation group

APS Australian Public Service

APVMA Australian Pesticides and Veterinary Medicines Authority

CEO Chief Executive Officer

CRIS Cost Recovery Implementation Statement

DAWE Department of Agriculture, Water and the Environment

EC Executive Committee

EL Executive Level

ELT Executive Leadership Team

FAO Food and Agricultural Organization of the United Nations

GMP Good Manufacturing Practice

GPA Grain Producers Australia

Australian Pesticides and Veterinary Medicines Authority 100

Acronyms and abbreviations  Glossary  Compliance index  Index

Term Description

HESI Health and Environmental Sciences Institute

ICT Information and Communications Technology

KMP Key management personnel

MLS-ILC Manufacturers’ Licensing Scheme - Industry Liaison Consultative Forum

MoUs Memoranda of Understanding

NFF National Farmers’ Federation

OECD Organisation for Economic Co-operation and Development

OGTR Office of the Gene Technology Regulator

PBS Portfolio Budget Statement

PGPA Act Public Governance, Performance and Accountability Act 2013

PMRA Health Canada Pest Management Regulatory Agency

RCEG Residues Chemistry Expert Group

US EPA United States Environmental Protection Agency

US FDA United States Food and Drug Administration

VICH International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

VMDA Veterinary Manufacturers and Distributors Association

WHO World Health Organization

WNT Working Group of National Coordinators of

the Test Guidelines Programme

101 Annual Report 2020-21

Glossary

Term Description

active constituent The component of a pesticide or veterinary medicine product that is responsible for its physiological or pharmacological action.

adverse experience Any undesirable experience arising from the use of a chemical; adverse experiences may affect human or animal health, the environment or other factors.

applicant A person or company who applies to the APVMA to register a

pesticide or veterinary chemical for use in Australia.

approved label The market product label that carries text approved and published by the APVMA.

compliance Compliance with any applicable agvet law. See also

non-compliance.

cost recovery Fees and charges relating to the provision of government goods and services (including regulation) to the private and other nongovernment sectors of the economy.

good manufacturing practice Standards that ensure products are consistently manufactured to the quality standards appropriate for their intended use and in accord with their registration specifications.

licence Authority to manufacture pesticides or veterinary medicines

according to s 123 of the Agvet Code.

minor use A use that would not produce sufficient economic return to

an applicant to meet the cost of registering the product for that use.

non-compliance Non-compliance with any applicable agvet law. Non-compliance may include the sale and use of unregistered products, supply of restricted products to unauthorised users, unapproved labels, unfounded claims in advertising or other media, or active constituents that do not conform to APVMA standards.

Australian Pesticides and Veterinary Medicines Authority 102

Acronyms and abbreviations  Glossary  Compliance index  Index

Term Description

pesticides Substances or mixtures of substances intended for

preventing, destroying, repelling or mitigating any pest; also known as agricultural chemical products.

registrant A person or company who registers a pesticide or veterinary

medicine product for use in Australia.

registration Official recognition that a pesticide or veterinary medicine is

safe and will work when used according to the label. Before an agricultural or veterinary chemical product can be legally supplied, sold or used in Australia, it must be registered by the APVMA.

statutory timeframe The legislatively prescribed timeframe in which the APVMA must process applications for registration.

this year; 2020-21 1 July 2020 to 30 June 2021.

veterinary medicines Substances or mixtures of substances intended for treating diseases or conditions in animals.

103 Annual Report 2020-21

Compliance index

PGPA Rule Reference Description Page

17BE(a) Details of the legislation establishing the body 8

17BE(b)(i) A summary of the objects and functions of the entity as set out in legislation 9

17BE(b)(ii) The purposes of the entity as included in the entity’s corporate plan for the reporting period 1

17BE(c) The names of the persons holding the position of responsible Minister or responsible Ministers during the reporting period, and the titles of those responsible Ministers

8

17BE(d) Directions given to the entity by the Minister under an Act or instrument during the reporting period N/A

17BE(e) Any government policy order that applied in relation to the entity during the reporting period under section 22 of the Act 20

17BE(f) Particulars of non-compliance with:

(a) a direction given to the entity by the Minister under an Act or instrument during the reporting period; or

(b) a government policy order that applied in relation to the entity during the reporting period under section 22 of the Act

20

17BE(g) Annual performance statements in accordance with paragraph 39(1)(b) of the Act and section 16F of the rule 24-39

17BE(h),

17BE(i)

A statement of significant issues reported to the Minister under paragraph 19(1)(e) of the Act that relates to non-compliance with finance law and action taken to remedy non-compliance

14

17BE(j) Information on the accountable authority, or each member of the accountable authority, of the entity during the reporting period 43

17BE(k) Outline of the organisational structure of the entity (including any subsidiaries of the entity) 10-12, 52

17BE(ka) Statistics on the entity’s employees on an ongoing and non-ongoing basis, including the following:

(a) statistics on full-time employees; (b) statistics on part-time employees; (c) statistics on gender; (d) statistics on staff location

14-16

17BE(l) Outline of the location (whether or not in Australia) of major activities or facilities of the entity 14

Australian Pesticides and Veterinary Medicines Authority 104

Acronyms and abbreviations  Glossary  Compliance index  Index

PGPA Rule Reference Description Page

17BE(m) Information relating to the main corporate governance practices used by the entity during the reporting period 42-46, 52-53

17BE(n),

17BE(o)

For transactions with a related Commonwealth entity or related company where the value of the transaction, or if there is more than one transaction, the aggregate of those transactions, is more than $10,000 (inclusive of GST):

(a) the decision-making process undertaken by the accountable authority to approve the entity paying for a good or service from, or providing a grant to, the related Commonwealth entity or related company; and

(b) the value of the transaction, or if there is more than one transaction, the number of transactions and the aggregate of value of the transactions

46-47

17BE(p) Any significant activities and changes that affected the operation or structure of the entity during the reporting period 20

17BE(q) Particulars of judicial decisions or decisions of administrative tribunals that may have a significant effect on the operations of the entity

57

17BE(r) Particulars of any reports on the entity given by:

(a) the Auditor-General (other than a report under section 43 of the Act); or (b) a Parliamentary Committee; or (c) the Commonwealth Ombudsman; or (d) the Office of the Australian Information Commissioner

57

17BE(s) An explanation of information not obtained from a subsidiary of the entity and the effect of not having the information on the annual report

N/A

17BE(t) Details of any indemnity that applied during the reporting period to the accountable authority, any member of the accountable authority or officer of the entity against a liability (including premiums paid, or agreed to be paid, for insurance against the authority, member or officer’s liability for legal costs)

N/A

17BE(taa) The following information about the audit committee for the entity:

(a) a direct electronic address of the charter determining the functions of the audit committee; (b) the name of each member of the audit committee; (c) the qualifications, knowledge, skills or experience of each

member of the audit committee; (d) information about each member’s attendance at meetings of the audit committee; (e) the remuneration of each member of the audit committee

45-46

17BE(ta) Information about executive remuneration 18-19

105 Annual Report 2020-21

Index

A

accountability, 52-56

accountable authority of APVMA, 11, 26, 42-43, 64-66

acronyms and abbreviations, 100-101

Administrative Appeals Tribunal, 24, 32, 35, 57

Adverse Experience Reporting Program (AERP), 10, 12, 55

adverse experience reports, 55

advertising and market research, 52

Agricultural and Veterinary Chemicals (Administration) Act 1992, 8, 42, 73, 75, 79, 87

Agricultural and Veterinary Chemicals Code see Agvet Code

Agricultural and Veterinary Chemicals Code Act 1994, 8, 54

Agricultural and Veterinary Chemicals Code Regulations 1995, 8

Agvet Code, 8-9, 35, 37, 57

notices and decisions under, 53

reviews conducted under, 54

standards made or varied under, 56

Agvet Code Regulations, 8-9

annual performance statement see performance report

applications

processed, 33, 54

timeliness of decisions on, 4, 24, 25, 32-34

APS Code of Conduct, 44

APVMA see Australian Pesticides and Veterinary Medicines Authority (APVMA)

Armidale office, 14, 15, 56, 87

Audit Committee, 43, 44, 45-46

Audit Committee Charter, 45

Auditor General’s reports, 57

audits and auditing

of financial performance, 64

of privacy processes, 56

of risk management framework, 53

remote and hybrid auditing models, 37, 38

AusTender, 63

Australian National Audit Office (ANAO), 45, 57, 64-65

Australian Pesticides and Veterinary Medicines Authority (APVMA)

corporate Commonwealth entity, 8, 42, 73, 75, 79

Corporate Plan, 24, 25, 42

enabling legislation, 8

executive management, 10-12

functions and powers, 8, 9

Operational Plan, 24, 25, 42

organisation structure, 10

purpose, 1

significant activities and changes, 20

C

Canberra Office, 14, 56, 74, 84, 85

capability building within APVMA, 27, 28, 32

case studies

data harmonisation [for assessment of agvet chemicals], 29

Introducing remote and hybrid auditing models, 38

changes, significant, 20

Charter, Audit Committee, 45

Chay, Rachel, 12, 17, 19

see also Executive Director, Registration Management

Chief Executive Officer, 5, 10, 11, 17, 19, 20, 44, 45, 64, 89, 90

accountable authority, 26, 42-43, 66

remuneration, 18

Chief Financial Officer, 66

Chief Operating Officer (acting), 10, 11, 17, 19, 20,

Chief Regulatory Scientist, 10, 12, 17, 19, 90

chlorpyrifos, (insecticide), 54

classification of staff, 14

Australian Pesticides and Veterinary Medicines Authority 106

Acronyms and abbreviations  Glossary  Compliance index  Index

Client and Stakeholder Survey, 4, 47

code of conduct, 44

collaboration see consultation and collaboration

committees, governance, 43-44

compliance index, 104-105

consultancies, 62-63

consultation and collaboration, 47-52

‘control of use’, 9

core business, 5

corporate Commonwealth entity, 8, 42, 73, 75, 79

corporate governance see governance

Corporate Plan 2020-21, 24, 25

corporate profile and purpose, 8

corporate risk management, see risk management

corporate strategies, 24

cost of regulation see fees and levies

Cost Recovery Implementation Statement (CRIS), 5, 36, 87

court decisions, 35, 57

Croft, Lisa, 5, 11, 17, 19, 20, 26, 42, 43, 66

see also Chief Executive Officer

D

data harmonisation, case study, 29

decision making, 32-35

activities related to, 34, 54

evidence-based, 25, 32

reconsideration of decisions, 35, 54

reporting of decisions, 53

review of decisions, 35, 57

timeliness of decisions, 4, 32-35, 54

Deputy Chief Executive Officer (acting), 10, 11, 17, 19, 90

directions from minister, 20

domestic and feral cats, 57

E

ecologically sustainable development, 56

emergency permits, 4, 34

employees see staff

enabling legislation, 8

energy efficiency in offices, 56

Enterprise Agreement, 18

equity balance, 13, 62

Executive Committee, 44, 89, 90

Executive Director, Registration Management, 10, 12, 17, 19

Executive Director, Risk Assessment Capability (acting), 10, 12, 17, 19

expenditure, 13, 61-62

F

fall armyworm incursions, 4, 34

Federal Court of Australia, 35, 57

feedback, 36-39, 47, 48

fees and levies

align with cost of regulation, 36

cost recovery basis, 13

feral and domestic cats, 57

finance law, compliance with, 14

financial performance, 13-14, 60-63

financial reserve, 62

financial statements, 67-96

forums

international forums, 49-52

stakeholder engagement, 4, 30, 32, 37, 39, 47, 48-52

fraud control, 53

fruit fly, 4

full-time staff, 14-16

functions and powers, 8, 9

functions within organisation structure, 10

funding, 13, 60, 87

107 Annual Report 2020-21

G

Gazette (APVMA), 53

General Counsel, 10, 12, 17, 19, 90

glossary, 102-103

GMP (Good Manufacturing Practice), 5, 13, 30, 37, 38, 79

governance, 42-47

governance committees, 43-44

government policy orders, 20

grasshopper outbreak, 4, 34

guidance material for staff, 44

H

Hardy, Maggie, 12, 17, 19

see also Chief Regulatory Scientist

Hoefer, Peter, 45

human resources see staff

hybrid auditing model, 37, 38

Hynes, Susan, 12, 17, 19

see also General Counsel

I

income, 60-62, 67-68, 71-72, 78-79

indemnities, 56

Independent Review of the Agvet Chemicals Framework, 5

independent statutory authority, 8

industry, engagement with, 4, 39, 48-52

infringement notices, 37, 79, 87

insurance premiums, 56

international engagement

with international visitors, 52

participation in international forums, 49-52

J

judicial decisions, 35, 57

K

key management personnel, 17

remuneration, 18, 19, 89

khapra beetle incursions, 4, 34

L

legislation, enabling, 8

letter of transmittal, III

levies see fees and levies

Littleproud, Hon David, 8, 20

locations of staff, 14-16

Lockyer, K, 17, 19, 66

Logan, Sheila, 12, 17, 19

see also Executive Director, Registration Management

Lutze, Jason, 11, 17, 19, 42

see also Deputy Chief Executive Officer (acting)

M

malathion, reconsideration of, 54

market research, 52

members of Audit Committee, 45-46

Memoranda of Understanding (MoUs) see MoUs (Memoranda of Understanding)

minister, 8, 9, 14, 20, 42, 64

Minister for Agriculture, Drought and Emergency Management, 8, 20

ministerial directions, 20

molinate, reconsideration of, 54

MoUs (Memoranda of Understanding), 30, 31

mouse plague, 4, 34

N

National Registration Scheme for Agricultural and Veterinary Chemicals, 5, 8, 47, 75

non-compliance with finance law, 14

non-ongoing staff, 14, 16

Australian Pesticides and Veterinary Medicines Authority 108

Acronyms and abbreviations  Glossary  Compliance index  Index

O

office locations, 14

ongoing staff, 14, 15

Operational Plan 2020-21, 24, 25, 42

Performance against, 27-39

orders, government policy, 20

organisation overview, 8-20

functions and powers, 9

restructure, 20

structure, 10-12

see also staff

outlook 4

P

Parker, Chris, 17, 19, 20, 42

parliamentary committees, 57

part-time staff, 14-16

people see staff

performance report, 4, 27-39

results against performance criterion, 25

statement of preparation by CEO, 26

Strategy 1 performance, 27-31

Strategy 2 performance, 32-35

Strategy 3 performance, 36-39

see also financial performance

permits

emergency permits, 4, 34

issued, 33, 54

regulatory decisions for, 34

personnel see staff

pesticides, applications and registration of, 4, 33, 54

pests and diseases, 4, 34

policy orders, government, 20

Privacy Act 1988, 56

procymidone, reconsideration of, 54

products, permits and active constituents

regulatory decisions for, 4, 32, 33, 54

Public Governance, Performance and Accountability Act 2013, 8, 26, 42, 64, 66, 75

Public Governance, Performance and Accountability (Charging for Regulatory Activities) Order 2017, 20

Public Governance, Performance and Accountability (Location of Corporate Commonwealth Entities) Order 2016, 20

Public Service Act 1999, 14, 18, 44, 89

publications, 53

purpose statement, 1

R

reconsideration of decisions, 35, 54

registrations

adverse experiences associated with, 55

National Registration Scheme, 8, 47, 75

reporting of, 53

see also applications; permits

regulatory decision making see decision making

regulatory performance see performance report

regulatory processes

assessment, 27, 29

collaboration with domestic and international counterparts on, 31

delivery and feedback systems, 36-39

regulatory role of APVMA, 8

related entity transactions, 46-47

remote auditing model, 37, 38

remuneration

Audit Committee members, 45-46

Chief Executive Officer, 18

key management personnel, 18, 19

Senior Executive Officers, 18

reporting obligations, 53

responsible minister, 8

reviews by outside bodies, 57

reviews of registered chemicals, 54

internal review decisions, 35, 57

reporting of, 53

Risk Appetite and Tolerance Statement, 53

risk management

corporate risk management, 52-53

risk management framework, 32, 52-53

Risk Management Framework and Policy, 52-53

rodenticide products, 54

109 Annual Report 2020-21

S

Schaeffer, Darren, 46

senior executive officers, 14

remuneration, 18

Sheppard, Narelle, 45

significant activities and changes, 20

staff

executive management, 10-12

guidance material for, 44

key management personnel, 17

locations, 14-16

profile, 14-19

see also remuneration

Staff Consultative Committee, 44

stakeholder engagement and collaboration

Client and Stakeholder Survey, 4, 47

education of stakeholders about legislation, 39

guidance material for stakeholders, 4

Stakeholder Engagement Framework, 4, 47

stakeholder forums, 4, 47, 48-49

standards made or varied under Agvet Code, 56

states and territories

APVMA engagement with state authorities, 30

intergovernmental agreement with Australian Government, 9, 39, 75

and National Registration Scheme for agvet chemicals, 8

statistics reported, 54

strategies to achieve purpose

Strategy 1: Continue to be a world-class leader in agvet chemical regulation, 27-31

Strategy 2: Deliver high-quality decision making that is timely, science-based and proportionate to risk, 32-35

Strategy 3: Improve regulatory delivery and feedback systems, 36-39

subsidiaries, 52

summary and outlook, 4-5

swimming and spa pool sanitiser products, 35, 57

T

timeliness of regulatory decisions, 4, 24, 25, 32-34, 54

‘Top 20’ project, 4

training activities, participation in, 27-28

2,4-D herbicide, reconsideration of, 35, 54

V

values, 44

variation from APVMA Portfolio Budget Statement, 25

veterinary medicines

applications and registration of, 4, 33, 54

guidance, 5

vision statement, 1

W

website, ii

Audit Committee Charter, 45

Client and Stakeholder Survey results, 47

Gazette, 53

international standards, 29

performance reports, 53

Privacy Policy, 56

regulatory decision descriptions, 54

Work Health and Safety Committee, 44

Wright, Brendan, 11, 17, 19, 20

see also Chief Operating Officer

Y

year ahead, 5

Australian Pesticides and Veterinary Medicines Authority 110