Agricultural and Veterinary Chemicals Code Regulations (Amendment)

Overview

The Agricultural and Veterinary Chemicals Code Regulations (Amendment) 1996 No. 162, issued under the authority of the Minister for Primary Industries and Energy, amends the Agricultural and Veterinary Chemicals Code Regulations in support of the Agricultural and Veterinary Chemicals Code Act 1994. This legislative package was enacted to implement the National Registration Scheme for agricultural and veterinary chemicals, ensuring the regulation and quality control of these products. The amendments focus on refining the scheme for the supervision of veterinary product manufacturing by the National Registration Authority for Agricultural and Veterinary Chemicals (NRA), aiming to maintain and enhance product quality standards. The changes introduce more precise definitions and administrative details, such as handling arrangements with subcontractors, managing changes in business ownership or licenceholder status, and setting annual licence fees. These fees range from $1500 to $300, with a reduction for small manufacturers, and are designed to cover the NRA's operational costs. The amendments align Australia with international practices in regulating veterinary product manufacturing.

Scope and Application

The Agricultural and Veterinary Chemicals Code Regulations (Amendment) 1996 No. 162 applies to entities and individuals involved in the manufacture of veterinary products within Australia, and it extends to the regulation and supervision of these activities by the National Registration Authority for Agricultural and Veterinary Chemicals (NRA). The Act provides for the oversight of manufacturing practices to ensure the quality and safety of veterinary products, extending its reach to include the specification of annual licence fees, the establishment of a scheme for the supervision of manufacturing, and the imposition of certain administrative obligations on licence holders. Exemptions under the Act include animal skin cleaners, shampoos, and other specific products, as well as certain subcontractors and new business owners under particular conditions. The fees for manufacturing licences vary based on the scale of production, with a reduction available for smaller manufacturers. These regulations serve to align Australian practices with those of other developed nations, ensuring consistent and high standards in the production and oversight of veterinary products.

Key Provisions

The Agricultural and Veterinary Chemicals Code Regulations (Amendment) 1996 No. 162 primarily modifies the existing regulations under the Agricultural and Veterinary Chemicals Code Act 1994. Regulation 1 (s.1) establishes that the amendments are made by these specific regulations and that they will commence on gazettal. Regulation 2 (s.2) exempts certain products from the manufacturing provisions of the Act, including animal skin cleaners or shampoos, externally-applied coat conditioners, equine hoof protectants, sheep branding substances, and certain stockfood additives. Regulation 3 (s.3) outlines exemptions from the Act's provisions for specific individuals and circumstances, such as subcontractors involved in packaging, labelling, or product testing, as well as the legal representatives of deceased licence holders and purchasers of a licensed manufacturing business, provided they notify the NRA within six weeks and apply for a licence. Regulation 4 (s.4) imposes obligations on licence holders, such as effectively supervising subcontractors, maintaining records of complaints and product failures, and notifying the NRA of any name changes or changes in their company's status, such as entering liquidation or receivership. Regulation 5 (s.5) sets out the fees for issuing a manufacturing licence, which range from $1500 to $300 per annum, with a refund of half the fees for any year if the manufacturer's wholesale value of veterinary chemicals is less than $50 000. The Act and its amendments impose several obligations on the parties it governs. Licence holders must ensure effective supervision of any subcontractors involved in the manufacture of veterinary products (Regulation 4(a) (s.4)). They are also required to maintain detailed records of any complaints and product failures, which must be readily accessible for review by the NRA (Regulation 4(b) (s.4)). Licence holders must promptly notify the NRA of any changes in their business name (Regulation 4(c) (s.4)) and inform the NRA if their company enters liquidation, receivership, or has a receiver or manager appointed (Regulation 4(d) (s.4)). Additionally, Regulation 3(a) (s.3) mandates that subcontractors who perform specific tasks for a licensed manufacturer are exempt from the Act's provisions, provided they do not engage in the actual manufacture of the products. Breach of the obligations and requirements set out in the Agricultural and Veterinary Chemicals Code Regulations (Amendment) 1996 No. 162 can result in various consequences. Failure to effectively supervise subcontractors, maintain required records, or notify the NRA of changes as stipulated in Regulation 4 (s.4) can lead to enforcement actions by the NRA. Although specific penalties are not detailed in the text, such breaches could result in fines, licence suspension, or revocation. The Act also empowers the NRA to take legal action against entities or individuals who do not comply with the regulations, potentially leading to civil or criminal penalties. The precise nature and extent of these penalties would depend on the severity and frequency of the breach, as well as the specific provisions of the Agricultural and Veterinary Chemicals Code Act 1994 and other relevant legislation.