Corporate Plan 2021–22

1. Foreword

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is established under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Administration Act). Our principal responsibilities are described in the Administration Act and the Agricultural and Veterinary Chemicals Code Act 1994.

We regulate the supply of safe and effective agricultural and veterinary (agvet) chemicals in Australia. Robust risk assessment methods are used to scientifically evaluate new and existing pesticides and veterinary medicines. Through efficient and effective regulation, we ensure the registration of agvet chemical products delivers appropriate protections for human health and safety, animals and the environment and supports international trade.

Our regulatory responsibility extends from registration and manufacturing through to the point of sale. By agreement, the states and territories are then responsible for regulating and monitoring how agvet chemicals are used.

Our culture and capability support resilience, stakeholder-focused thinking and professional growth. Our people exhibit high levels of integrity and accountability in their work, acting fairly and impartially to promote trust and confidence.

We will build on the collaborative and innovative work practices adopted during the COVID-19 pandemic to ensure the continued delivery of regulatory services.

We will work to minimise cost recovery charges, consistent with the Australian Government Cost Recovery Guidelines, through the efficient implementation of cost recovered activities.

1.1. Statement of preparation by the Chief Executive Officer

As the Accountable Authority of the APVMA, I present the APVMA Corporate Plan 2021–22, which covers the period 2021–22 to 2024–25, as required under paragraph 35(1)(b) of the Public Governance, Performance and Accountability Act 2013 and section 51 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.

Ms Lisa Croft
Chief Executive Officer

1 June 2021

2. About the APVMA

2.1. Our vision

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

2.2. Our purpose

We regulate agricultural and veterinary chemicals to manage the risks of pests and diseases for the Australian community and to protect Australia’s trade and the health and safety of people, animals and the environment.

2.3. Our role

The APVMA has a clearly defined role as the regulator of agricultural and veterinary (agvet) chemicals in Australia. We are the independent statutory authority responsible for assessing and registering pesticides and veterinary medicines proposed for supply in Australia.

As the national regulator, the APVMA regulates agvet chemicals in line with the responsibilities described in the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994. In this role, we:

• ensure Australians have access to safe and effective agvet chemicals to control pests and diseases in animals and plants
• monitor and enforce compliance with the Agvet Code and other legislation we administer
• maintain the Record and Register of approved agvet constituents, registered products and approved labels.

2.4. Our values

The APVMA upholds the Australian Public Service (APS) values as set out in the Public Service Act 1999. In addition to the APS values, we demonstrate the following behaviours:

• We apply science-based decisions pragmatically, consistently and proportionately to the risk.
• We actively engage with all stakeholders to build confidence in our regulatory system.
• We are committed to meeting our statutory obligations.
• We demonstrate leadership and trustworthiness and act with integrity.
• We encourage innovation and embrace technology.

2.5. Our corporate structure

The APVMA’s organisation structure (Figure 1) supports effective operation, communication and strategic understanding at all levels of our agency.

Figure 1: APVMA organisation structure

 

3. Our planning framework

The APVMA Corporate Plan 2021–22 outlines the planning framework against which our performance frameworks are aligned (Figure 2). Our planning framework aligns the activities we will undertake to ensure we are working in a coordinated and structured way to achieve our purpose. Establishing and maintaining a robust planning framework allows us to effectively monitor our achievements, identify risks and respond to changes in our operating environment.

Figure 2: Our planning framework

 

3.1. Our environment

3.1.1. COVID-19

The COVID-19 pandemic changed how the public sector operates. New approaches and innovations in service delivery models and working arrangements have created opportunities for the public sector to improve services in the longer term.

We recognise the importance of preparing for a post-COVID world and the need to engage with and support the agvet sector.

We will continue to support the flexible working arrangements introduced for our staff in response to the pandemic, facilitate effective collaboration and engagement with our stakeholders, and continue to evolve and streamline our processes including the delivery of our regulatory responsibilities.

We are well placed to react to the emerging situations and challenges that may face industry and the Australian community. Our agile workforce and strong stakeholder engagement will ensure we are well positioned to maintain business-as-usual activities and deliver a timely and efficient regulatory service.

3.1.2. Agvet chemical sector

The Australian agvet chemical sector has experienced a number of recent challenges, including drought, bushfires, pest outbreaks and the COVID-19 pandemic. While the sector has demonstrated resilience and adaptability during these periods, other challenges (including high research and development costs, market volatility and the introduction of new pests and diseases) persist and have the potential to impact Australia’s agricultural competiveness.

In a context where it can cost up to US$250 million to bring a new product to market, research and development budgets in recent years have focused on genetically modified and biological controls as well as the traditional chemical technologies. Biological controls such as bio-insecticides and bio-herbicides, operating individually or in combination with existing chemical solutions, are increasingly being developed.

The Australian market is very small in international terms and the APVMA plays but a small role in the supply chain of getting a new product to market. Nonetheless, it is the APVMA’s responsibility to respond to any application in a manner that is timely, science-based and proportionate to the risk being managed. For us, this will mean increasing the use of international data, assessments and standards where applicable.

Given the importance of the agvet sector to Australia’s agricultural productivity, our assessment process must be efficient, predictable and transparent. Equally, we must maintain sophisticated compliance and monitoring strategies to deal with the global movement of chemicals through the supply chain.

3.1.3. Community expectations

The Australian community derives many benefits from the use of agvet chemicals. The most obvious is increased agricultural productivity, while others include the wellbeing of companion animals, environmental safety and protection from pests and diseases.

In enjoying those benefits, the community has certain expectations of the APVMA as the regulator of agvet chemicals to ensure registered products are safe and effective to use and to monitor the market to ensure compliance with regulatory standards.

Today there are more than 29 million pets in Australia and owners are spending more than ever on premium products for their animals. The market for animal health products continues to grow as owner attitudes have shifted in favour of preventative health care and away from the more traditional treatments of disease, illness and injury.

Consumer expectations regarding safe food continue to evolve. Access to social and mass media is influencing consumer attitudes toward chemical residues. The growing organic food sector and social movements promoting farm-to-table are influencing agricultural practice and changing the types of chemicals and veterinary medicines being brought to market.

As a regulator, it is important we clearly communicate our area of responsibility to ensure the integrity of the regulatory system is maintained.

3.1.4. Regulatory reform

On 5 September 2019, Senator the Hon. Bridget McKenzie, then Minister for Agriculture, appointed an independent panel to comprehensively review the regulatory framework for agvet chemicals. The final report was delivered to the Minister for Agriculture, Drought and Emergency Management in May 2021.

On 18 September 2019, the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 was introduced into the Australian Parliament. The Bill amends the Agricultural and Veterinary Chemicals (Administration) Act 1992, the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994.

3.2. Our capability

3.2.1. Workforce

Managing and supporting our workforce is critical to the success of the APVMA. The implementation of our Workforce Plan will facilitate continued investment in our people to ensure they have the skills, knowledge and attributes required to meet current and emerging needs.

Our culture and capability support resilience, stakeholder-focused thinking and professional growth. Our people exhibit high levels of integrity and accountability in their work, acting fairly and impartially to provide trust and confidence.

We will build on the collaborative and innovative work practices adopted during the COVID-19 pandemic to ensure the continued delivery of regulatory services.

We will continue to review, target and enhance our systems, policies and processes to reflect our dynamic and diverse workforce and priorities. We will also continue to drive organisational transformation supported by our change management actions.

3.2.2. Technology

The APVMA’s Digital Strategy sets out a clear direction for managing our information communication technology (ICT) services to ensure they operate efficiently. The strategy also outlines our ICT reform agenda which will reinvigorate our platforms for application assessment and management to improve productivity and reporting capabilities.

3.2.3. Cost Recovery Implementation Statement

The APVMA is a corporate Commonwealth entity funded by a combination of government appropriations, cost-recovered levies and fee-for-service charges.

Our cost recovery framework is underpinned by the application of 3 principles across all stages of the cost recovery process:

• Efficiency and effectiveness
• Transparency and accountability
• Stakeholder engagement

The APVMA’s Cost Recovery Implementation Statement (CRIS) outlines how we propose to implement revised cost recovery arrangements, which enables us to fulfil our statutory function to ensure agvet chemicals sold within Australia are safe and effective to use and do not unduly prejudice trade.

Current and future cost recovery arrangements will work to minimise cost recovery charges, consistent with the Australian Government Cost Recovery Guidelines, through the efficient implementation of cost recovered activities.

3.3. Our risks

The effective management of risk is integral to achieving our purpose. Our approach to risk management is embedded in business-as-usual practices through the use of consistent language, approaches and documentation, and the adoption of appropriate risk analysis tools across our agency.

Operational risk management occurs in line with the roles and responsibilities defined in the APVMA’s Risk Management Framework. The framework is consistent with the Commonwealth Risk Management Policy and the international standards set out in ISO 31000 — Risk Management. The Chief Executive Officer, taking into account the advice of the Executive Committee and Audit Committee, establishes the APVMA’s appetite and tolerance for risk and oversees the Risk Management Framework.

The Risk Management Framework identifies specific responsibilities for key personnel across the APVMA and the Enterprise Risk Register assigns owners and tolerances for identified enterprise-level risk, consistent with the approach being embedded in our operational practices.

3.3.1. Our strategic risks

Our strategic risks are those that, if realised, would materially affect our ability to achieve our purpose. Table 1 outlines our risk and mitigation strategies.

Table 1: Risk mitigation strategies

Strategic risk	Mitigation strategies
Loss of confidence in the APVMA’s capability and rigour	We use a systematic, scientific, evidence-based approach to decision making and operations. We engage with domestic and international partners on a range of matters, including regulatory decision making and compliance. We have a robust Quality Management System and Knowledge Management Framework that supports our risk-based approach.
Reduction of the APVMA’s operational capability	We monitor our operational timeframe performance and deliver regular, timely reports to the Executive that provide early advice on risks and opportunities and relevant options in response. We have a Workforce Management Plan and Learning and Development strategy that support continuous improvement and development of staff capability. We have a Digital Strategy and reform agenda which will modernise and improve our ICT infrastructure and systems to support operational needs.
Loss of confidence in the effectiveness of the APVMA	We have a Stakeholder Engagement Framework to help us strengthen our regulatory services. We engage with domestic and international partners on a range of matters, including regulatory decision making and compliance.
Reduction of the APVMA’s financial sustainability	Our business planning and budgeting process enables Executive oversight of the delivery of organisational activities. We have a financial strategy and budget that maintains a long-term view of the APVMA’s finances. We have a CRIS that supports the collection and management of fees and levies.

3.3.2. Risk mitigation strategies

Controls have been established to reduce the likelihood of the risks outlined in Table 1 from occurring. Risk mitigations draw support from across the APVMA to ensure risks are managed effectively.

Our staff are expected to practice active risk management and monitor risks. Risk training, appropriate to the role, is provided to support our staff and foster confidence in the risk management process. This includes escalating any perceived risks outlined in the framework.

Strategic risks are reviewed by the Executive Committee on a monthly basis, or whenever there is a change that may impact risk. Discussion and actions relating to these risks are captured in the minutes and provided to risk owners for action.

The risk appetite and tolerance statement is reviewed annually to ensure it reflects our role as the regulator of agvet chemicals and responsibilities in protecting Australia’s people, animals, crops and environment.

3.3.3. Our risk culture

We aim to foster a positive risk culture. Risk culture refers to the set of shared attitudes, values and behaviours that characterise how the APVMA considers risk in its activities. A positive risk culture promotes an open and proactive approach to engaging with and managing risk, that considers both opportunities and threats equally and where risk is appropriately identified, assessed, communicated and managed across all levels.

Senior management and other identified individuals are responsible for driving our risk culture through initiatives and processes. All senior staff proactively provide feedback through normal reporting channels on external interactions with key stakeholders regarding areas of potential risk. Every employee also has a role to play in contributing positively to this culture.

3.4. Our engagement

We collaborate and liaise with a broad range of stakeholders to achieve our purpose and support Australia’s National Registration Scheme (NRS). These stakeholders and corresponding outcomes are outlined in Table 2.

Table 2: Our partners

Partner	Outcomes
Government and regulatory partners	Implementation of the formal arrangement between the Commonwealth, state and territory partners in the NRS Harmonisation and development of standards, policies and guidance to facilitate efficient agvet chemical regulation and reduce regulatory burden Effective and efficient collaboration on regulatory matters, particularly control of use and labelling
Agvet industry, primary producers, individual companies and representative bodies	Making Australia an attractive destination for agricultural investment Confidence in our role as the national regulator of agvet chemicals Effective working relationships and systems for consultation and open communication
Scientific community	Domestic and international collaboration and sharing of information and research Training and development
Australian public and consumers	Trust and confidence in our ability to safely and effectively regulate agvet chemicals Transparency, accountability of decisions and effective consultation