14 December 2021, Sydney: The Commonwealth Parliament passed the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Bill 2019 on 1 December 2021. The new legislation will streamline the regulation of agricultural and veterinary chemicals and introduce a Governance Board for the Australian Pesticides and Veterinary Chemicals Authority (APVMA).
Simpler regulatory processes
The reforms provide simpler regulatory processes for chemicals of low regulatory concern, aligning the level of regulatory effort with the level of risk, similar to the APVMA’s existing streamlined options for prescribed variations to approvals or registrations.
The APVMA will identify prescribed registrations of chemical products and prescribed approvals of active constituents and labels. Examples may include consumer products with a history of safe use, applications with well-characterised chemistry or existing active constituents described in relevant monographs and standards. Simpler registrations processes apply for these approvals and registrations where minimal or no assessment of technical information occurs.
Extension of limitation and protection periods
The legislation provides for extensions to limitation and protection periods as an incentive for chemical companies to register new uses of chemical products. This will ensure that minor uses are registered, which might otherwise have insufficient commercial returns for chemical companies to add them to the product label. Where such uses are registered, the reforms allow for the extension of the time period in which the APVMA is not able to use innovators’ information to support the registrations, variation or reconsideration of another chemical product or active constituent. The maximum period of extension is for five additional years.
A key element of the reform is the establishment of a Governance Board for the APVMA to support the performance and accountability of the APVMA. The APVMA was one of the few corporate Commonwealth entities that did not have a governance board. This change brings the APVMA into line with comparable bodies, such as Food Standards Australia New Zealand. The APMVA previously had an Advisory Board, but the Governance Board will have a significantly greater role than the former model.
The Governance Board has functions and powers to:
- ensure the proper, efficient and effective performance of the APVMA’s functions
- determine the objectives, strategies and policies to be followed by the APVMA.
The Board is appointed by the Minister for Agriculture and consists of a Chair, the APVMA’s CEO and three other members with appropriate qualifications, skills or experience. Appointed Board members are required to have appropriate expertise in one or more of the following fields: financial management; law; risk management; public sector governance; science (including agricultural science and veterinary science); and public health or occupational health and safety.
The Australian Government has committed to funding the costs of establishing the Board and the first two years of operation, noting the APVMA is generally funded by registrant levies.
The legislation also introduces other changes, including simplifying reporting requirements for annual returns, supporting computerised decision-making, and introducing additional penalties and information requirements to improve the integrity of the system of users and the community.