This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/4131
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1. Cooperative scheme
There is a cooperative statutory scheme in place for the evaluation, registration and control of agricultural and veterinary chemical products. The scheme was established pursuant to:
- Agricultural and Veterinary Chemicals (Administration) Act 1992 (external site) (the Administration Act)
- Agricultural and Veterinary Chemicals Code Act 1994 (external site) (the Code Act) scheduled to which is the Agricultural and Veterinary Chemicals Code (the Agvet Code)
- Agricultural and Veterinary Chemicals Act 1994 (external site) (Cwlth).
The Administration Act formally established the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) which subsequently became the APVMA. It sets out the APVMA’s role as an independent statutory authority undertaking the Commonwealth’s responsibilities under the scheme. The APVMA has the functions and powers conferred upon it by the Administration Act and by the Agvet Code of the participating territories.
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
Agricultural and Veterinary Chemicals (Administration) Act 1992 (external site)
This Act establishes the APVMA as an independent statutory authority of the Commonwealth responsible for the regulation and control of agvet 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.
Agricultural and Veterinary Chemicals Act 1994 (external site)
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 s. 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 package applies, 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.
Agricultural and Veterinary Chemicals Code Act 1994 (external site)
This Act contains the Agvet Code as a schedule to it. 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 to 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 code.
Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 (external site)
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.
Agricultural and Veterinary Chemicals (Administration) Regulations 1995 (external site)
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.
Agricultural and Veterinary Chemicals Regulations 1999 (external site)
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.
Agricultural and Veterinary Chemicals Code Regulations 1995 (external site)
These Regulations prescribe detailed provisions 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.
3. Legislative instruments
Agricultural and Veterinary Chemicals Code Ingredient Determination 2015
This determination authorises the constituent to be used, for the purpose or purposes set out in the heading of a Part of the Veterinary Chemicals Products (Excluded Stockfood Non-active Constituents) Order 1995 (SNAC Order) under which the constituent is specified, in all substances or mixtures of substances.
Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Joint Health Products for Dogs and Horses) Standard 2014
This instrument sets out requirements in relation to veterinary chemical products, including the labelling and handling of the products, the long term use of which may help improve joint health and function in dogs and horses.
Agricultural and Veterinary Chemicals Code (Listed Chemical Product – Home Swimming Pool and Spa Products) Standard 2014
This instrument sets out requirements in relation to agricultural chemical products used for destroying bacteria, viruses and protozoa in home swimming pools and spas.
Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014
This instrument sets out the written principles to be observed in the manufacture of veterinary chemical products, unless the products are exempt from licensing under the Agvet Regulations.
Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012
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 which 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 publish, in an appropriate manner, in each calendar year approved standards for residues of chemical products in protected commodities.
Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2015
This instrument revokes the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 and sets out the criteria for working out which unit-based fee applies in a particular case. It also provides examples of the application of the criteria in particular cases.
Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014
This instrument sets out the criteria that are applied when considering whether a chemical product meets the efficacy criteria (as required by s14(1)(c) of the Agvet Code). The instrument sets out a class of chemical products that meet the efficacy criteria without further investigation of efficacy being required.
Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014
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.
4. Background to APVMA (NRA) legislation
Prior to March 1995, the Commonwealth held responsibility for the evaluation and assessment of selected agvet chemical products and their clearance for registration. The states and territories were responsible for the registration and control of use of all agvet chemical products.
Initially the Commonwealth’s involvement in the clearance process were informal, but from 1 July 1989 the arrangements were put on a legislative basis due to the enactment of the Agricultural and Veterinary Chemicals Act 1988;(Cwlth), which established the Australian Agricultural and Veterinary Chemicals Council to undertake clearance activities.
In July 1991, the Commonwealth, states and territories agreed to establish the National Registration Scheme (NRS) for agricultural and veterinary chemicals. The development of the NRS sought to place under one national umbrella the assessment and registration of all agvet chemical products previously undertaken independently by the Commonwealth and each of the states and territories.
The APVMA is a partnership between the Commonwealth and the states and territories under which the NRA, then the APVMA, was established as a Commonwealth statutory authority, with responsibility for the evaluation, registration and review of agricultural and veterinary chemicals and their control up to the point of retail sale. The states and territories retain responsibility for control-of-use activities, such as licensing pest control operators and aerial spraying.
The first major step in establishing the NRS was the establishment by the Commonwealth of the NRA on 15 June 1993 under the Agricultural and Veterinary Chemicals (Administration) Act 1992. The APVMA is an independent statutory authority. It implements the legislative powers and functions provided to it under the legislation on behalf of all jurisdictions. It has responsibility, in particular, for the implementation of the Agvet Codes.
The Agricultural and Veterinary Chemicals Act 1988, which provided the legislative basis for the former arrangements, was initially amended at the same time as the NRA was established to transfer the powers and functions of the outgoing Australian Agricultural and Veterinary Chemicals Council to the NRA.
However, on 15 March 1995, following the commencement of a suite of Commonwealth, state and territory legislation, the NRS came into full operation. The package of legislation repealed the 1988 Act and established a new legislative regime for the NRA’s operations.