© Australian Pesticides and Veterinary Medicines Authority 2020
ISSN 2200-8322 (electronic)
ISBN 978-1-922188-92-2 (electronic)
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Assistant Director, Communications
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
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Telephone: +61 2 6770 2300
The Australian community derives many benefits from the use of agricultural chemical and veterinary medicine (agvet) products. The most obvious is increased productivity in agricultural industries. Others include the wellbeing of companion animals and the protection from pests and diseases across Australian households and community spaces.
In enjoying those benefits, the community has certain expectations of the Australian Pesticides and Veterinary Medicines Authority (APVMA) as the national agvet chemical regulator. Even if some do not know our name, or our role in the National Registration Scheme for agvet chemicals, there is an expectation that we will function as an active gatekeeper to ensure only those products that are safe and effective are approved.
Australians also rely on us, along with our partners in the cooperative registration scheme, to monitor the market to ensure compliance with regulatory standards.
We take these responsibilities very seriously, and all of our decisions are independent, risk-based, evidence-based, and where applicable peer-reviewed. Because of this thorough approach, we continue to be a world-class agvet chemical regulator.
Our strategic priorities in this Corporate Plan build certainty for the APVMA and our clients and stakeholders. To reinforce our status as an independent, world-class agvet chemical regulator, we will maintain a robust program of post-registration compliance and reviews. We will reach out to other trusted regulators and work with them on global reviews and international standards.
At the same time, we will deliver a better regulatory service by aiming to further improve our timeframe performance. We will continue to regulate proportionate to risk, and we will focus on further developing our internal capability to continue making high-quality, evidence-based decisions.
We will improve the delivery of our regulatory services by refining our quality assurance framework. A key component of this is listening to our clients and stakeholders, which will help improve our processes and make them more user-centric. To do this, we will increase our engagement activities and put in place mechanisms to better capture feedback. We are on track to update our funding model through the cost recovery implementation process, which will ensure our operations are fit for purpose and adequately resourced to deliver appropriate regulatory outcomes.
Through these strategies, we will strengthen our reputation for the quality decisions we make to protect our community, animals, and the environment.
Thanks to the dedication of our staff, we have faced changes and continued to improve our operations. The organisation is on a much better footing than it was four years ago when the relocation policy order was issued. We look forward to implementing this plan to deliver world class regulation for the Australian community.
Dr Chris Parker
Chief Executive Officer
A Corporate Plan for the Australian Pesticides and Veterinary Medicines Authority (APVMA) is 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.
This 2020–21 Corporate Plan sets out the strategic priorities for the APVMA for the period 2020–21 to 2023–24.
Progress toward meeting the goals of this plan will be reported each year in the APVMA Annual Report.
The Corporate Plan will be reviewed annually and adjusted as necessary.
The APVMA is the independent statutory authority responsible for assessing and registering agricultural chemicals and veterinary medicines proposed for supply and use in Australia.
Our functions are set out in Part 2, Section 7 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
We administer the National Registration Scheme for Agricultural and Veterinary Chemicals (National Registration Scheme), while the Department of Agriculture, Water and the Environment is responsible for international and domestic policy on agvet chemicals, and for Commonwealth agvet chemical legislation.
We operate under an Intergovernmental Agreement between the Commonwealth Government and all states and territories. Under this agreement, we manage the regulatory services for the supply of safe and effective agricultural chemicals and veterinary medicines in Australia.
Our regulatory responsibility extends from registration and manufacturing through to the point of sale. Compliance and monitoring powers in the Agricultural and Veterinary Chemicals Code Act 1994 provide a mechanism for the APVMA to undertake post-registration surveillance and testing to ensure the continued safety and effectiveness of registered products.
State and territory governments are responsible for regulating and monitoring how chemicals are used.
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.
To be a global leader in agricultural and veterinary chemicals regulation for the benefit of Australia.
As a public service agency we are impartial, committed to service, accountable, respectful and ethical.
We commit to 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, act with integrity and demonstrate trustworthiness.
- We encourage innovation and embrace technology.
The APVMA operates with community and industry expectations for timeliness and efficiency, while facing the challenges of evolving science, changing technology and business practices, globalisation of supply chains and changing market needs.
As a result, we must always strive to identify new and improved ways to do our work, be it our core science-based regulatory decisions, our engagement or our administrative activities.
Effective regulation of all agricultural chemical and veterinary medicine products presents the APVMA with a range of challenges. Our corporate strategies address our key activities from 2020–21 to 2023–24 and provide a focus for allocating our resources and monitoring our performance to support positive outcomes and future improvement.
Further details about our key activities for 2020–21 are outlined in the APVMA Operational Plan 2020–21.
Figure 1: Our current corporate strategies
Strategy 1: Continue to be a world-class leader in agvet chemical regulation
Australia’s expertise in regulatory science is recognised around the world. To remain a world-class agvet chemical regulator, we must adapt and evolve with the environment and the industries we regulate. The safety of the Australian community, our animals, and our environment is paramount, and must be balanced with the need to support industry through timely regulation of agvet chemical products.
Getting this balance right is critical as agriculture accounts for about 14 per cent of Australian exports and around three per cent of Australia’s gross domestic product (GDP) (ABARES, 2019). Our post-registration compliance activities must also be robust, and we will focus on progressing chemical reconsiderations to a proposed regulatory decision to provide assurance that all registered agvet chemical products continue to be safe and effective.
Over the next four years the APVMA will continue to:
- 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.
Strategy 2: Deliver high-quality decision making that is timely, science-based and proportionate to risk
By making risk-based decisions, we invest our regulatory effort in areas more likely to support Australian productivity while protecting the Australian community, animals, the environment, and trade. The focus in the recent past has been on stabilising our regulatory timeframe performance.
While this work continues, maintaining and improving the frameworks that support our decision-making is just as important. Embedding a comprehensive Quality Management Framework is an important component of this work, and it ensures our scientific expertise aligns the effort of regulatory intervention with the risks being managed.
Over the next four years the APVMA will continue to:
- 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.
Strategy 3: Improve our regulatory operations
To ensure our success, we are focused on enabling our operations to deliver effective regulatory evaluation and registration of agricultural and veterinary chemical products. This is supported through the continued implementation of our enabling technology program, in particular, the Application Transformation Project, which will lead to service delivery improvements for the APVMA and our regulated industries.
Another important aspect of improving our operations is increasing our client and stakeholder engagement activities and to apply their feedback, where applicable.
Over the next four years the APVMA will continue to:
- engage with internal and external stakeholders and consider feedback to improve or 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 measures and targets for these activities in 2020–21 are outlined in the Operational Plan 2020–21.
The APVMA regulates agricultural chemicals (such as pesticides, herbicides, biocides, insecticides, seed treatments, insect repellents, and garden sprays) and veterinary medicines (such as parasiticides, antibiotics, immunobiologicals, ethicals, nutritionals, and some therapeutic stock feeds and pet foods).
In the 2018–19 financial year, industry reported $2.74 billion in agricultural chemical product sales and $1.1 billion in veterinary medicines product sales (APVMA Gazette, 10 March 2020).
Following the World Health Organization’s declaration of the novel coronavirus (COVID-19) pandemic, and subsequent advice from the Australian Government, the APVMA implemented business continuity measures to ensure the efficient, effective and ongoing delivery of regulatory services.
While the external factors are beyond our control, we have capable business continuity plans and enabling technologies in place to ensure our operations continue with minimal disruption.
The industries the APVMA regulate are major contributors to Australia’s agricultural productivity, with Australia’s agricultural industries worth around $60 billion per year (National Farmers Federation, 2019).
In Australia, crop protection products such as herbicides and insecticides increase Australian crop yields by about 40 per cent and increase the value of our food production by $13 billion each year (CropLife, 2019). Conversely, the negative economic impact of weeds is estimated to be more than $4.8 billion each year (Centre for Invasive Species Solutions, 2018).
Bio-controls such as bio-insecticides and bio-herbicides, based on naturally occurring biochemicals, minerals, and microbes, operating individually or in combination with existing chemical solutions, are increasingly being developed (OECD, 2020).
It is estimated that veterinary medicines directly contribute almost $2.7 billion to the Australian economy, support around 10,000 jobs, and generate more than $578 million in wages (Animal Medicines Australia, 2018). Furthermore, through contributions to the wider animal industry, these medicines are vital for supporting both the production and companion animal industries.
Our production animal industry is vital in ensuring the Australian community can access safe and nutritious meat and related products. It is also a significant contributor to the Australian economy through domestic and international trade. The off-farm meat value (domestic expenditure plus export value) of the Australian beef industry was approximately $19.6 billion in 2018–19.
Australia is also the world’s largest exporter of sheep meat and is the world’s second largest producer of lamb and mutton. Domestic expenditure was estimated at around $2.6 billion on lamb and $51 million on mutton in 2018–19 (Meat & Livestock Australia, 2019). The pork and poultry industries also contribute significantly.
There are almost 29 million pets in Australia today and owners are spending increasing amounts on premium products, including therapeutic products and medicines, for their animals (Animal Medicines Australia, 2019). More than 62 per cent of Australian households own a pet.
Of these, 38 per cent are dog owners and 29 per cent are cat owners. Taking into consideration all pet costs, including food, veterinary services and more, the average dog will cost a household $1475 per year and the average cat $1029 per year (Pet Industry Association, 2018).
Now that the relocation of our operations to Armidale in regional New South Wales has been completed, we are concentrating on refining our operations to maintain our status as a 'world-class agricultural chemical regulator’ (National Farmers Federation, 2019).
Since 2019, we have updated or developed and implemented various governance frameworks, including quality management, risk management, performance management, and knowledge management frameworks, to support the ongoing development of our current and future workforce and underpin the quality of our regulatory decisions.
Our workforce is stable, with around 140 of our staff based in our Armidale office, and the remainder supporting our operations from a smaller Canberra office.
Within the APVMA we have continued to develop and enhance our strong regulatory science capability through the learning and development framework managed by the Science Quality section of the agency.
Our strategies reflect our ongoing focus to embed ‘business as usual’ regulatory excellence into our operations.
ICT and infrastructure
In 2018, the APVMA was allocated $10.1 million over three years to implement the APVMA’s Digital Strategy. We have been putting that funding to good use, stabilising, modernising, and transforming our enabling technologies.
Through the development of systems that will streamline the application process and integrate with all parts of our business, we expect in future years to see efficiency gains.
Now that the relocation to Armidale is complete and our Canberra based staff are working from smaller fit-for-purpose premises, the APVMA’s infrastructure needs are expected to remain stable for the next four years.
The Canberra office relocation in particular has created significant costs savings, and with long-term infrastructure stability achieved, we can focus on improvement.
In September 2019, then-Minister for Agriculture, the Hon Bridget McKenzie, commissioned an independent review of the agvet chemical regulatory framework. An independent panel has been appointed to review the current system.
The review will examine the agvet chemical regulatory framework’s aims, structure and operation, and make recommendations to ensure that it is contemporary, fit for purpose and reduces unnecessary red tape.
Corporate governance provides the mechanisms to ensure that we set and pursue our objectives efficiently, effectively and ethically. This is based on an executive committee structure and a set of assurance arrangements to provide:
- clear leadership, direction and oversight
- sound planning
- robust performance management
- strong financial management
- appropriate systems and controls
- integrated risk management
- effective workforce planning
- business improvement
- accountability, transparency and integrity.
The Executive Leadership Team (ELT) and APVMA committees provide leadership and oversight of the APVMA’s overall performance and governance. The committee framework enables us to monitor and improve our performance and ensures that we comply with relevant legislation. ELT oversees the following committees:
- Change Management Committee.
- Science Quality Committee.
- Senior Leadership Team.
- Staff Consultative Committee.
Risk and quality management
The APVMA risk management framework outlines our approach to risk management, using elements of ISO 31000:2018. The APVMA risk appetite and tolerance statements, along with the framework, support us to address risk tolerances in a consistent manner.
ELT meets regularly to consider likely risk scenarios, capture these in an enterprise risk register, and ensure all potential risks have strategies for minimising disruption to the organisation. Managers responsible for risk across all business areas identify and outline these strategies to manage risk through team-based operational risk registers. These risks are assessed and rated.
Risks above our tolerances (generally ‘high’ and ‘extreme’ risks) are escalated to ELT and treatments are developed and controls documented. Risk treatments are regularly monitored to ensure they will be implemented correctly.
We maintain a quality management system and continually improve its effectiveness in accordance with elements of ISO 9001:2015. This ensures legislative obligations and stakeholder expectations are met. Oversight is provided by ELT through the Audit Committee and management reviews.
Collaboration and engagement
The corporate strategies outlined in this Corporate Plan are supported by the APVMA Stakeholder Engagement Framework 2020–23. The engagement framework details our stakeholder groups, engagement methods, and engagement principles.
Under the Intergovernmental Agreement between the Commonwealth and the states and territories, we manage regulatory services for the supply of safe and effective agricultural and veterinary chemicals in Australia, while our regulatory partners in the states and territories are responsible for regulating and monitoring how chemicals are used. As needed, we will engage these regulatory partners through the Harmonised Agvet Chemicals Control of Use Task Group (HACCUT). We will engage with relevant international regulators through international regulator forums.
Technology allows us to efficiently communicate with our stakeholders. Where applicable, we will meet our legislative requirements to publish our decisions on our website and in the digital APVMA Gazette and seek public consultation when appropriate. We inform and educate our stakeholders through information on our website, emailed news alerts, social media, and attendance at conferences and events.
The APVMA works to ensure the protection of the health and safety of humans, animals, and the environment and outlines our commitment to responsible financial management of our operations, including maintenance of equity reserve targets.
We have placed emphasis on transparency in our performance. We report our progress against regulatory key performance indicators through an annual Regulator Performance Framework self-assessment. Timeframe performance statistics are published on the APVMA website, and these statistics, along with our progress against Corporate Plan and Operational Plan goals, are included in the APVMA Annual Report.
We measure the quality of our regulatory decision-making by considering our consistency with our legislative requirements, our quality management and risk management frameworks, alignment with international best practices, and post-registration safety and compliance. Decisions are made following a robust process that aligns with legislative timeframes and may involve review by our Science Quality Committee.
Success in this area is measured through:
- reporting of operational performance against legislative timeframes
- maintaining a low number of regulatory decisions that are overturned by external bodies such as the Administrative Appeals Tribunal
- feedback received through consultation.
Operational activities and measures are outlined in the Operational Plan 2020–21.
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