This content is current only at the time of printing. This document was printed on 22 September 2018. A current copy is located at https://apvma.gov.au/node/987
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The APVMA manages potential risks posed by agvet chemicals by, among other things, imposing conditions on approvals or registrations, and through requiring that certain information be contained on chemical product labels. Further, access to certain agvet chemical products is restricted if the Agvet Code Regulations declare them to be restricted chemical products.
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 human beings, 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.