Any person wishing to supply agricultural or veterinary chemicals or chemical products must apply for a licence through the National Registration Authority (NRA) (replacing the State and Territory managed registration). Registration details are defined in the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code). The NRA, unlike NICNAS (14) is confined to agricultural and veterinary chemicals.
In broad terms, NRA registration is required for products, other than for human uses, that kill pests and control disease. Included are chemicals for agricultural and veterinary use (including for the domestic household and home garden).
Agricultural chemical products are defined in Section 4(1) and veterinary chemical products in Section 5(1) of the Code. Exemptions to agricultural chemical products are defined in Schedule 3 of the Regulation including sanitisers sold by retailers......to consumers for domestic use. The Guidelines for Registration of Biological Products define registration for biological products.
The scheme effectively applies up to the point of retail sale. State and Territory authorities, as agents of the NRA, apply a program of compliance and surveillance on the use, labelling and manufacture.
Products with new (ie. unregistered) active ingredients can only be registered on provision of extensive information. In addition to label details, information required by the NRA includes the chemistry, efficacy, toxicology, ecotoxicology, details of likely levels of residues in food and implications for trade.
Approval for veterinary products is subject to demonstrating compliance with the manufacturing practices detailed in the Australian Code of Good Manufacturing Practice for Veterinary Preparations; a similar code for the manufacture of agricultural products is planned. Compliance with standards of manufacturing applies to overseas manufacturers seeking to supply to Australia.
Registration is for the product and all the major and minor uses indicated on the label and supporting literature. The active ingredients of products must be approved before the product containing the active ingredient may be manufactured or imported. Approved active constituents are published in the Agvet Gazette.
Each year, (September), importers, manufacturers and exporters must provide the NRA with quantities (kilograms) of chemicals transacted including as a component of a formulated product.
A permit scheme allows for the use of an unregistered product or uses not included on the label for the purpose of research or trial (whith consideration of the amount and locations) for minor and emergency use (eg. an outbreak of pests or disease).
Under the NRA's Adverse Experience Reporting Program, registrants of veterinary chemical products are required to maintain records of adverse effects including lack of effect and provide a summary to the NRA.
Suspension or cancellation of registration may occur if there are breaches of the conditions of registration or failure to provide information to the NRA of which the registrant was aware.
Products are reviewed by the NRA for their toxicology, residues, OH&S, environmental issues, efficacy and implications for trade either when registered as a new product or under the Existing Chemicals Review Program (ECRP).
ECRP allows for the suspension or the cancellation of the registration of products (even during the review stage). The review may be initiated by the NRA including when nominated by manufacturers, users and government agencies. The review will consider if the product has been recently reviewed and its status in other countries. Priority chemicals (including products containing those chemicals) will also be selected for review.
The review shows that continuing use;
|Would not be an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and|
|Would not be likely to have an effect that is harmful to human beings; and|
|Would not be likely to have an unintended effect that is harmful to plants or things or to the environment; and|
|Would unduly prejudice trade or commerce between Australia and places outside of Australia; and|
|The use of the product in accordance with the recommendations for use would be effective.|
Reviews of registered chemicals are announced in the Agvet Chemicals Gazette.
The review and registration process involves expert input from other government agencies (including Worksafe Australia and the Chemicals Safety unit of the Department of Human Services and Health) for OH&S data and the EPA for assessment of environmental data. Considerations include; chemistry, efficacy, safety and potential impact on the environment and trade; residues; provided recommendations being consistent with anticipated use; and the labelling.
Public comment on summaries of reviews will be allowed. Based on review and public comment, the chemicals may be re-registered, deregistered or with amendment of the conditions of registration. The Agvet Chemicals Gazette and NRA News will be used for communication.
To maintain existing registration, or for new use patterns, the NRA has published Residue Guidelines in the NRA Gazette.
First Aid Instructions and Safety Directions for Agricultural and Veterinary Chemicals 1st Edition November 1996. Guidance for approval and registration of products in design and approval of labels for agricultural and veterinary chemicals. AGPS.
In April 1997, the NRAannounced it would ban the use of mevinphos insecticide from July. Mevinphos is used by growers of "brassica" vegetables (including cabbage and cauliflowers). Alternatives are being trialed.
Mevinphos is the first of chemicals being reviewed.
© 1996; Chemlink Pty Ltd, PO Box 673, West Perth, Western Australia
Chemlink Pty Ltd ABN 71 007 034 022. Publications 1997. All contents Copyright © 1997. All rights reserved. Information in this document is subject to change without notice. Products and companies referred to are trademarks or registered trademarks of their respective companies or mark holders. URL: www.chemlink.com.au/