1. Cooperative scheme
The Agvet Code is part of a cooperative statutory scheme in place for the evaluation, registration and control of agricultural and veterinary chemical products.
The Agvet Code makes provision for the evaluation, registration and control of agricultural and veterinary chemical products and for related matters. Mirror legislation is found in the states and territories of Australia, consistent with the arrangements set out in the Agricultural and Veterinary Chemicals Act 1994.
2. Legislation administered by the APVMA
This Act establishes the Australian Pesticides and Veterinary Medicines Authority (APVMA) as an independent statutory authority of the Commonwealth responsible for the regulation and control of agricultural and veterinary chemicals in Australia up to the point of retail sale. This Act contains all the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals and enforcement and inspectors.
This Act contains the constitutional and other legal provisions that enable the Agvet Code to have effect. It provides that the Agvet Code is to apply as a law of the participating territories. The participating territories means the Australian Capital Territory and any other territory declared by Regulations in force under section 25 of the Act to be a participating territory.
This Act sets up a scheme under which the Agvet Code of the participating territories is to operate in appropriate circumstances as if that code, together with the Agvet Code of each state, constituted a single national Agvet Code applying throughout Australia. Taken together they are referred to as the Agvet Codes. The Agvet Code of each state binds the Crown in right of the Commonwealth, of the Australian Capital Territory and of Norfolk Island.
While the Agvet Codes apply in the states and the Northern Territory as the law of those jurisdictions, the applied laws are partly federalised. That is, for most practical purposes they have the general characteristics of Commonwealth rather than state laws. In particular, this federalisation allows the Commonwealth’s Acts Interpretation Act 1901 to apply for the purposes of interpreting the Agvet Codes so there is a uniform interpretative regime. The Commonwealth’s administrative law framework also applies to decisions made under the Agvet Codes, allowing exclusive rights of review of APVMA decisions taken under the Agvet Codes as though the decisions were made under Commonwealth laws. The Commonwealth Director of Public Prosecutions is empowered to prosecute for any offences against the legislation even though such offences are offences against the laws of the states or territories concerned.
This Act contains the Agvet Code as a schedule. The Agvet Code, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels), and to issue permits and license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products, and provisions ensuring compliance with, and for the enforcement of, the Agvet Code.
This Act contains measures that allow for the assessment and collection of levies in regard to agricultural and veterinary products registered for use in Australia.
3. Legislative instruments
These Regulations, among other things, prescribe the fees for export certificates and the form of search warrant to be used when there is a suspected offence in relation to the importation, manufacture or exportation of agricultural or veterinary chemicals.
These Regulations prescribe functions in relation to the Director of Public Prosecutions of the Commonwealth that enable the director to bring prosecutions and proceedings for offences against the Agvet Codes or the Agvet Regulations.
These Regulations prescribe and specify a number of matters relating to the operation of the Agvet Code.
These Regulations prescribe the state laws under which an agricultural or veterinary chemical product is registered under the Collection of Levy Act and specifies the rate of levy applicable.
This determination lists authorised ingredients for excluded nutritional or digestive products (END products) for the purposes of subclause 5(3) of Schedule 3AA of the Agvet Code Regulations. END products do not require approval under the Agvet Code.
This instrument establishes a standard for use by the APVMA in determining whether or not to approve certain joint health products for dogs and horses, which includes requirements relating to the labelling and handling of the products.
This instrument sets out the standard to be used by the APVMA in determining whether or not to approve chlorine chemical products used for destroying bacteria, viruses and protozoa in home swimming pools and spas.
This instrument sets out the principles to be observed in the manufacture of veterinary chemical products unless the products are exempt from licensing under the Agvet Regulations.
This instrument sets out Maximum Residue Limits (MRLs) for agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain. These MRLs are set at levels that are not likely to be exceeded if the agricultural or veterinary chemicals are used in accordance with their approved label instructions. At the time the MRLs are set the APVMA undertakes a dietary exposure evaluation to ensure the levels do not pose an undue hazard to human health. Section 7A of the Agricultural and Veterinary Chemicals (Administration) Act 1992 requires the APVMA to approve standards, by legislative instrument, for residues of chemical products in protected commodities.
This instrument sets out the criteria for working out which unit-based fee applies in relation to particular kinds of pre-application assistance. It also provides examples of the application of the criteria in particular cases.
This instrument sets out the criteria that are applied when considering whether a chemical product meets the efficacy criteria (as required by section 14(1)(c) of the Agvet Code), which include criteria based on the type of product and the other circumstances in which a product will be taken to be effective.
This instrument sets out the information that must be contained in, or accompany an application under the Agvet Code. Such applications include: the approval of or variation of active constituents; registration of or variation of chemical products; approval of or variation of labels; a permit; a manufacturing licence; changing the holder of an approval or registration; nominating an agent; changing a nominated agent; and renewals of registration.
This instrument determines types of variations of relevant particulars for approvals and registrations that can be made by notice to the APVMA, rather than requiring an application.
This instrument sets out the kinds of variations of relevant particulars of approvals or registrations which are prescribed variations for the purposes of section 26B of the Agvet Code.
This instrument requires that agricultural products and active constituents for use in agricultural products must not be supplied if the manufacture of the active constituent or product contravenes, or fails to comply with, any manufacturing law of the country, or part of the country, in which it is manufactured. It does not apply to veterinary medicines or active constituents used in veterinary medicines.
The holder of a registration or approval must, on written request by the APVMA and within 28 days after the request is given provide the APVMA with written evidence that the manufacture of the product or active constituent does not contravene, or fail to comply with, any manufacturing law of the country, or part of the country, in which it is manufactured.
This instrument sets out standards specifying minimum purities, and where applicable, maximum levels for significant impurities, in active constituents for use in agricultural chemical products. This instrument is established under section 6E(1) of the Agvet Code following the procedures set out in regulation 8AF of the Agvet Code Regulations. It provides minimum quality standards to support the approval of active constituents, and registration of products, while maintaining our satisfaction with respect to the safety criteria under section 5A of the Code. It also provides a sound legal basis for the enforcement of quality standards for active constituents.
This instrument supports amendments to the Agvet Code introduced by Part 3 of Schedule 1 to the Agricultural and Veterinary Chemicals Legislation Amendment (Australian Pesticides and Veterinary Medicines Authority Board and Other Improvements) Act 2021 (the APVMA Board and Other Improvements Act).
Under the Agvet Code, certain types of information may be subject to a protection period or a limitation period. During a protection or limitation period, there are restrictions on how the APVMA may use the information.
This instrument allows the APVMA, upon application, to provide extensions to certain protection periods and limitation periods. It sets the conditions and qualifying criteria – such as the eligible application types and the prescribed uses that may trigger an extension – that apply in order to obtain an extension, and how long this extension will be.
This Instrument specified the prescribed extent (as defined in section 5AA of the Agvet Code) by which measured concentrations of constituents (both active and non-active) of registered agricultural chemical products may differ from the corresponding values on the Register for a particular product. The Instrument is established under section 6E(1) of the Agvet Code following the procedures set out in regulation 8AF of the Agvet Code Regulations. This Instrument assists both APVMA and industry in maintaining compliance of registered products with their relevant particulars, allowing for a reasonable level of variability in both manufacturing processes and analyses while maintaining satisfaction with respect to the statutory safety, efficacy and trade criteria.