Better Regulation of Agricultural and Veterinary Chemicals
The Australian Government is implementing reforms for the better regulation of agricultural and veterinary medicines (agvet chemicals) that will directly benefit the community, manufacturers, importers, wholesalers, retailers and users of agvet chemicals. These reforms aim to reduce regulatory complexity for farmers and other businesses and encourage the development of modern, cleaner and safer chemicals, with a range of benefits for farmers and other users, the environment and the community.
Reform legislation has been passed
The bulk of the reforms are made possible by the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013, which was passed by the parliament in June 2013 and commences on 1 July 2014. Amendments made by the Act reform the approval, registration and review of agvet chemicals to better protect human, animal and environmental health and safety, improve the efficiency and effectiveness of the current regulatory arrangements (for the regulator, the Australian Pesticides and Veterinary Medicines Authority (APVMA)) and provide greater certainty to the community that chemicals approved for use in Australia are safe.
The reforms are in five areas, to:
- Simplify and modernise agvet chemicals legislation to improve the efficiency and effectiveness of assessment processes for agvet chemical applications for approvals, registrations , permits and licenses and for reconsiderations (reviews) of chemical approvals and registrations
- Enhance the consistency, efficiency and transparency of agvet chemical approvals, registrations and reconsiderations by publishing principles and processes for APVMA regulatory action and by implementing these principles and processes to better align regulatory effort with chemical risk
- Ensure the ongoing safety of agvet chemicals and improve the effectiveness of current agvet chemical review arrangements by implementing a mandatory re-approval and re-registration scheme, designed to identify potentially problematic chemicals while minimising impacts on affected businesses; and by providing legislated guidance to the regulator about its application of discretion
- Improve the ability of the APVMA to enforce compliance with its regulatory decisions by providing the APVMA with a graduated range of compliance enforcement powers; and
- Improve consistency in data protection provisions and removes disincentives for industry to provide data in support of ongoing registration of agvet chemicals and in support of permit applications.
The Act provides for a five year review of the amendments made by the Act and for rolling 10 year reviews of all agvet chemicals legislation.
The Act and the explanatory memorandum are available on the ComLaw website.
In addition, the Council of Australian Governments is progressing reforms of the control of chemical use of agvet chemicals. This process complements the government’s better regulation reforms and aims to improve consistency of agvet chemical regulation across Australia.
Regulations have been amended
Amendments to the regulations associated with the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 have been finalised and the Agricultural and Veterinary Chemicals Legislation Amendment (2013 Measures No. 2) Regulation 2013 (Amendment Regulation) has been published. The reform related amendments will commence on 1 July 2014.
The Amendment Regulation and explanatory material is available on the ComLaw website.
The Amendment Regulation includes:
- timeframes for assessments that include the total time elapsed, including the time taken to provide more information, as well as timeframes and work plans for reconsiderations
- the method for determining end dates and last renewal dates for the mandatory re-approval and re-registration scheme
- measures for infringement notices and conditions of registration and approval to improve the ability of the APVMA to enforce compliance with its regulatory decisions in a graduated manner
- amendments to allow alternative levy collection arrangements to be implemented
- amendments to fees and levies consistent with the approved cost recovery impact statement; and
- amendments to address other minor issues that have been identified with the regulations, including removing redundant provisions and addressing some errors.
Implementation of the reforms
The Australian Pesticide and Veterinary Medicines Authority (APVMA) is an Australian Government statutory authority established in 1993 responsible for registration, quality assurance and compliance of agvet chemicals up to and including the point of retail sale.
The APVMA’s focus for 2013–14 will be working with the industry and the Department of Agriculture, Fisheries and Forestry to implement the reforms.
Details of the reform implementation by the APVMA.
In 2010–11, the government announced funding for the APVMA of $8.8 million over four years to support reforms to the regulation of agvet chemicals in Australia. This funding will also enable the APVMA to upgrade its information and communications technology infrastructure.
31 Jul 2013