Agricultural and veterinary (agvet) chemicals are regulated according to their risks – a combination of both the likelihood of being exposed to the chemicals and the potential effects of the exposure.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) approaches risk via a risk analysis framework, which involves dividing our risk assessment, risk management and risk communication functions. Using the framework, we align our regulatory efforts to the risk that agvet chemicals present. This helps to reduce the regulatory burden on industry – especially for products and chemicals of low regulatory concern – while increasing the efficiency of APVMA operations.
APVMA scientific risk assessments consider both likelihood and effect of exposure to agvet chemicals.
Risk analysis framework
Risk assessment
Risk assessments are conducted by specialist scientific teams during the process to register an agvet product, approve an active constituent, or as a part of the chemical review process.
Our risk assessments focus on the scientific analysis of information and data relating to an agvet chemical to determine how toxic a chemical or product is (to humans and to plants and animals in the environment) and the extent to which people, plants or animals are likely to be exposed to the chemical when it is used according to the proposed label.
The APVMA uses these assessments to determine whether the risks associated with the proposed use(s) are acceptable and whether any identified risks can be appropriately managed or mitigated.
The potential risks involved in using a chemical product are communicated to relevant people, such as end users. One of the most important tools for risk communication is the product label that is attached to the product container.
We also assess potential risks to trade, including impacts on Australia’s international trade interests, obligations and agreements.
APVMA risk assessment manuals are available on our website.
Risk management
Our risk management activities consider the outcomes of risk assessments, regulatory policies and other relevant information. We then develop, recommend and implement options to manage identified risks and continue to maintain health and safety.
To manage risks, agvet chemical products and active constituents can – among other things – be regulated by:
- enforcing compliance, including cancelling or suspending a registration, approval or permit
- imposing registration or permit conditions
- restricting access to a chemical
- requiring certain information to be communicated on a product label.
Risk communication
Our risk communications are influenced by both risk assessment and risk management activities. Appropriate communications are distributed to effectively improve management of potential risks resulting from agvet chemical use.
This communication process is two-way between the APVMA and our stakeholders. It involves:
- industry stakeholders communicating risk information to the APVMA by supplying research data and information
- chemical users and the general community (farmers, veterinarians, pest controllers and other chemical users) reporting non-compliance or providing input to us to help prioritise chemicals to review
- the APVMA communicating health and safety information with industry, users and the community, by publishing information for chemical users and details of registered products and chemical reviews on our website, as well as distributing the APVMA Gazette and other news updates.
Product and active constituent holders must adhere to APVMA labelling codes. The relevant particulars need to be on the product label to effectively communicate the risks associated with a chemical or product and how to minimise them.
Aligning regulatory effort with risk
The APVMA’s legislative framework provides for the consistency, efficiency and transparency of agvet chemical approvals, registrations and reconsiderations, and helps us to align our regulatory effort with risk. Section 1A of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 sets out the purpose and framework for regulatory decision-making for agvet chemicals.
This section highlights the importance of maintaining a balance between our regulatory effort, the regulatory burden imposed on those affected, and the risk associated with chemical use. In administering the code, we aim to ensure regulatory compliance in keeping with what is reasonably necessary to manage risks to the health and safety of people, animals and the environment.
The legislative framework provides us with certain discretions, such as the extent to which we need to take into account particular matters in determining whether the efficacy and trade criteria have been met. By allowing us these discretions, constrained within appropriate limits by the Agvet Code Regulations, the framework makes us better able to match our regulatory effort with risk.
The statutory criteria that we will need to address in making regulatory decisions will include criteria for safety, efficacy, trade and labelling. Currently, we align regulatory effort with risk through the use of modular applications and registration models, thereby allowing reduced regulatory effort on applications for the proposed use of active constituents, products and permits that involve less risk.
Different product types give rise to risks and, as a result, the levels and types of assessment required for us to be satisfied of the statutory criteria in registering a new product vary.
Generally, lower-risk products require reduced levels of assessment for us to be satisfied of the statutory criteria. For example, to satisfy the statutory criteria in registering a new product, we may (subject to limitations on use of information and confidential commercial information) be able to use a nominated reference product that is very similar to the proposed product. This not only reduces our regulatory effort in determining whether the statutory criteria have been met but also reduces the effort required by applicants to address the criteria again.