This content is current only at the time of printing. This document was printed on 13 September 2020. A current copy is located at http://www.xlg888.com/our-science/14586
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The APVMA uses a regulatory framework to assess and manage the use of agricultural and veterinary (agvet) chemical products. The framework involves applying scientific methods within the context of agvet chemicals legislation.?
We want to remain a world leader in independent chemical regulation, and to do this we use evidence-based decision making to register safe products that advance Australia’s agricultural productivity and animal health. ?We regulate so that Australians can have confidence that agricultural chemicals and veterinary medicines (agvet products) are safe and will work.
The Office of the Chief Regulatory Scientist works from a One Health approach, which focuses on the interconnectedness of human, animal, and environmental health. We provide expert scientific advice to the APVMA on matters including:
1. emerging technologies that need to be understood and assessed for use in Australia
2. regulatory issues affecting specific industry sectors or complex topics requiring intense examination
3. best-practice regulatory methods to ensure the APVMA‘s ongoing approach to regulation is efficient and proportional
4. new ways to increase APVMA scientific capability.
We also engage with national and international networks and counterpart authorities on matters of common interest affecting regulatory science and the application of technology to agvet chemicals.
Dr Maggie Hardy was appointed as Chief Regulatory Scientist in October 2018.
Dr Maggie Hardy – Chief Regulatory Scientist
Dr Maggie Hardy, the Chief Regulatory Scientist at the APVMA, is responsible for ensuring the APVMA’s regulatory framework incorporates current scientific knowledge and contemporary risk assessment methodologies. Dr Hardy holds a PhD in Chemistry and Structural Biology from the University of Queensland, a Masters in Entomology from The University of Hawaii, and a graduate certificate in Higher Education.
Dr Hardy has held a number of senior roles – including most recently with the CDC (Centers for Disease Control and Prevention) in Atlanta, Georgia. Prior to this she was a research fellow at the University of Queensland. She has more than a decade of risk management experience, and has previously developed communication and training programs for scientists.
Having held a number of leadership and board roles for professional and non-profit institutions, Dr Hardy has broad expertise in biosafety and biosecurity, the development of quality management systems (QMS), and emergency preparedness and response. She has been elected as a Fellow of the Royal Entomological Society (United Kingdom) and a Fellow of the Institute for Managers and Leaders (Australia and New Zealand).
The Chief Regulatory Scientist publishes blog posts discussing current and topical matters relevant to Australia’s regulatory scientist science community. Read her?latest posts.
The Regulatory Framework
The APVMA regulates agvet chemical products using a structured process combining scientific methodology, legislation and risk assessment.
We harness existing scientific research and specific methodology that is collectively known as regulatory science to understand agvet chemical products. We apply this knowledge to legislation to form the regulatory framework, which enables any risks associated with the use of agvet products to be managed, ensuring the product is safe to use.
The relationship between research, regulatory science and regulation
Our risk assessment approach
The APVMA conducts risk assessments on agvet chemicals to identify aspects of the product that may affect people, animals, the environment and the agricultural industry.?Our assessment of risk—or the likelihood of harm occurring from the use of agvet products—considers both the toxicity posed by an agvet product (the hazard) and the extent of exposure (exposure) to the agvet product.?We use a six-step process to analyse risk.
How risk is dependent on hazard and exposure
The regulatory framework guides APVMA’s risk assessment of agvet products, which requires the use of valid scientific information.
We consider the entire set of available evidence including any credible contradictory evidence, to ensure that all risks associated with the use of an agvet product are identified and understood.
We then propose risk management measures to mitigate the potential risks of harm occurring when using the agvet product.
If management measures can be applied and the agvet product can be used safely, the product will be approved for use according to the label instructions.?
Read more about how we manage risk.?
APVMA principles of good regulatory science practice (GRSP)
This APVMA standard sets out the principles of good regulatory science practice (GRSP) that we follow. The standard is consistent with the principles described in other good practice standards, such as the standards for good manufacturing practice, good laboratory practice and good clinical practice.
GRSP also draws upon international standards set out in ISO:9001:2015 that provide methods and standards concerning the creation and maintenance of quality in our management systems.
The GRSP standard strengthens the regulatory science quality that underpins our regulatory decisions. A working definition of regulatory science quality is:
Protecting the health and safety of people, animals and the environment and supporting agricultural and livestock industries by making sound science-based regulatory decisions regarding pesticides and veterinary medicines within a framework of accepted international risk assessment and risk management practices.
Science-based regulatory decisions are made using a contemporary understanding of science, the identification and analysis of issues, the use of logic, and the documentation of risk assessment and risk management advice and decisions.
Principles of good regulatory science practice
- The Chief Scientist is responsible for the oversight of the quality assurance aspects of GRSP
- All APVMA staff are responsible for quality assuring their work.
- Team leaders and Executive Directors have overarching responsibility for the quality of work in their areas.
Personnel and training
APVMA staff receive training to support and implement the principles of GRSP including:
- understanding the objectives of regulation and the requirements of legislation
- risk assessment and management methods
- ensuring data and studies suit the purpose
- involving other agencies and advice providers in specialist technical assessments when required
- ensuring staff responsible for managing and supervising regulatory science quality have the skills and experience to ensure regulatory decisions are underpinned by GRSP.
Decisions must be consistent with the Agricultural and Veterinary Chemicals Code Act 1994
Criteria for technical assessments require that:
- all data received will be assessed for fitness for purpose to ensure suitability for evaluation
- risk assessment procedures will be appropriate to the particular application being considered and proportionate to the level of risk involved
- risk management decisions will be based on the risk assessment undertaken
- scientific issues will be addressed at the appropriate times during evaluation.
Criteria for documenting technical assessments include:
- risk assessment and proposed risk management strategies
- sufficient detail, appropriate to the level of risk for the product group, risk area or issue
- the level of risk for a particular product group or risk area will be reflected in written advice
- identifying and addressing relevant legislation.
Advice from agencies, technical service providers and international sources
- Advice provided by agencies, technical service providers and international sources will be analysed and considered prior to its use in regulatory decision-making.
- Information from international sources must meet the same criteria as Australian information before it will be used for assessments.
- Technical assessments and regulatory decision making require input from several APVMA staff to ensure objectivity.
- All technical assessments and regulatory decisions will be overseen by a senior or suitably experienced member of the APVMA to maintain quality control.?
Feedback and communication
- The regulatory guidelines used by the APVMA are updated when required and will be available for comment by the public on the APVMA website.
- We will seek stakeholders’ views on a wide range of scientific regulatory issues, most often via the APVMA website.
APVMA regulatory scientists
Regulatory science is a distinct and specialised branch of science. It involves applying scientific methods within a defined legislative framework to analyse scientifically-generated data for assessing safe and unsafe aspects of products intended for release onto the market. Regulatory scientists undertake this specialised work.
APVMA regulatory scientists evaluate data generated from experiments provided by registration applicants to assess agricultural and veterinary chemical products for release onto the Australian market. This is usually a complex process due to the abundance of detail in the data, covering a wide range of factors that must be evaluated within the constraints of intricate legislation. It requires the highest quality of scientific evaluation to ensure the registered products, used by the general public, are both safe and effective.
Occasionally we find components of an assessment that are uncertain and cannot be defined completely. In these cases, we apply insightful common sense to the product and its intended use to help form the best possible understanding of the factors affecting the safe use of the product.
Most APVMA regulatory scientists have backgrounds in biology, chemistry and agriculture. They hold formal qualifications in veterinary science, microbiology, medical science, toxicology, pharmacology, environmental science, food science, epidemiology, molecular biology and horticulture.
Accelerated Regulatory Science Training Program
To help build and maintain regulatory science capability, the APVMA offers the Accelerated Regulatory Science Training Program. The program is the first of its kind in the Commonwealth and is designed to improve consistency across our regulatory operations. The course builds our regulatory science capability, with graduates receiving a Diploma of Government (Regulatory Science).
Regulatory science strategy?
Our vision is to continuously improve the APVMA’s scientific capability to support quality regulatory decision-making to ensure the APVMA continues to be recognised for its risk-based, proportionate regulatory science.
The APMVA’s Regulatory Science Strategy (RSS) outlines how the APVMA will further enhance its scientific capacity and resources to fulfill its role of regulating agricultural and veterinary chemicals in order to protect the health and safety of people, animals, crops, the environment and trade.
The strategy outlines six key areas of focus:
- Boosting regulatory science capacity and capability
- Building national and international links
- Enhancing stakeholder communication and engagement
- Extending the ability to identify, monitor and respond to emerging regulatory issues
- Improving regulatory science methodologies
- Monitoring and enhancing regulatory science performance.