EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Instrument No. 2
(Repeal of 1997 Manufacturing Principles) 2007
Subsection 23(1) of the Agricultural and Veterinary Chemicals Act 1994 provides that the Australian Pesticides and Veterinary Medicines Authority (APVMA) may determine for the purposes of Part 8 of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 written principles to be observed in the manufacture of chemical products that are consistent with the Agvet Code, the Agricultural and Veterinary Chemicals Code Regulations 1995 and the laws of any jurisdiction that relate to occupational health or safety.
Subsection 33(3) of the Acts Interpretation Act 1901 provides that where any Act confers a power to make any instrument the power shall, unless the contrary intention appears, be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal any such instrument.
Subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the Chief Executive Officer of the APVMA may exercise any of the powers and functions of the APVMA.
The Commonwealth and all States and Territories have agreed to a National Registration Scheme for Agricultural and Veterinary Chemicals. The National Scheme sets out the regulatory framework for the management of pesticides and veterinary medicines in Australia by a single agency. The APVMA is the current name for the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) established in 1993 as an independent statutory authority responsible for the Commonwealth’s regulatory functions under the Scheme.
The National Registration Scheme also provides for a national, uniform and cooperative legislative regime throughout Australia administered by the APVMA. The centrepiece of the legislation is the Agvet Code, which has been applied to all Australian states and territories – the ‘participating territories’. Under the Agvet Code, the APVMA is responsible for the registration, quality assurance and compliance of pesticides and veterinary medicines up to and including the point of retail sale in Australia.
Part 8 of the Agvet Code provides for the licensing of manufacturers of veterinary medicines by the APVMA, where the manufacturer complies with the APVMA’s manufacturing principles.
The APVMA has determined new Manufacturing Principles, which have been collated from an Australian Code of Good Manufacturing Practice for Veterinary Chemical Products published by the APVMA on 29 March 2007. These new Manufacturing Principles are to replace the existing Principles determined by the then NRA on 14 April 1997. The Agricultural and Veterinary Chemicals Instrument No. 2 (Repeal of 1997 Manufacturing Principles) 2007 repeals the 1997 Principles.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
NOTES TO ITEMS
Item 1 Name of Instrument
1. This item states that the full name of the Instrument is the Agricultural and Veterinary Chemicals Instrument No. 2 (Repeal of 1997 Manufacturing Principles) 2007.
Item 2 Commencement
2. This item provides that the Instrument will commence on 1 May 2007.
Item 3 Determination – Repeal of 1997 Manufacturing Principles
3. This item determines that the Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination No. 1 of 1997 made by the then NRA on 14 April 1997 is repealed. The 1997 determination, made pursuant to subsection 23(1) of the Agricultural and Veterinary Chemicals Act 1994, determined for the purposes of Part 8 of the Agricultural and Veterinary Chemicals Code (the Agvet Code) written principles to be observed in the manufacture of veterinary chemical products. New Manufacturing Principles are being determined by the APVMA to replace the Principles set out in the 1997 determination.
Overview
The Agricultural and Veterinary Chemicals Instrument No. 2 (Repeal of 1997 Manufacturing Principles) 2007 was enacted to address the need for updated manufacturing principles for veterinary chemical products within the existing regulatory framework. The Australian Pesticides and Veterinary Medicines Authority (APVMA) was given the authority to establish these principles under subsection 23(1) of the Agricultural and Veterinary Chemicals Act 1994. The objective of this instrument was to repeal the outdated 1997 Manufacturing Principles, which were no longer consistent with contemporary practices and standards. By issuing new principles, the APVMA aimed to ensure that the manufacture of veterinary chemical products aligns with current best practices, thereby enhancing the safety and efficacy of these products in Australia. This legislative instrument was developed in the context of the National Registration Scheme for Agricultural and Veterinary Chemicals, which seeks to harmonise the regulation of such products across all Australian states and territories through a single agency, the APVMA.
Scope and Application
The Agricultural and Veterinary Chemicals Instrument No. 2 (Repeal of 1997 Manufacturing Principles) 2007 pertains to the repeal of the existing manufacturing principles for veterinary chemical products, which were established under the Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination No. 1 of 1997. This repeal is in line with the ongoing commitment to updating and refining the regulatory framework governing the manufacture of agricultural and veterinary chemicals in Australia. The instrument applies to entities involved in the manufacture of veterinary chemical products, ensuring that they adhere to the updated manufacturing principles set by the Australian Pesticides and Veterinary Medicines Authority (APVMA). These principles are consistent with the Agricultural and Veterinary Chemicals Code, the Agricultural and Veterinary Chemicals Code Regulations 1995, and relevant occupational health and safety laws. The repeal and replacement of the 1997 manufacturing principles reflect the evolving nature of the industry and the need for updated standards that align with current practices and safety requirements. The geographic reach of this instrument is national, applying across all participating territories in Australia.
Key Provisions
The main sections of this legislation, Agricultural and Veterinary Chemicals Instrument No. 2 (Repeal of 1997 Manufacturing Principles) 2007, are primarily concerned with updating and replacing the existing manufacturing principles for veterinary chemical products. The primary operative section, item 3, repeals the Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination No. 1 of 1997, which had previously set out the principles for manufacturing veterinary chemicals (subsection 23(1) of the Agricultural and Veterinary Chemicals Act 1994). This repeal is necessary to implement new Manufacturing Principles determined by the Australian Pesticides and Veterinary Medicines Authority (APVMA), which are more aligned with contemporary practices and standards. The new principles are intended to replace the outdated 1997 principles and ensure that manufacturers adhere to current best practices in the production of veterinary chemicals.
The obligations imposed by this Act on parties such as manufacturers and the APVMA are significant. Manufacturers of veterinary chemicals must now comply with the new Manufacturing Principles determined by the APVMA, which are designed to ensure the safety, quality, and efficacy of veterinary chemical products. These principles likely include requirements for facility standards, quality control processes, documentation, and personnel qualifications. The APVMA, as the regulatory body, has the duty to determine these new principles, review compliance, and take appropriate action if necessary. This includes issuing licenses to manufacturers who meet the specified standards and conducting inspections to ensure ongoing compliance with the principles.
There are potential civil and criminal consequences for breaches of the new Manufacturing Principles. Although the specific penalties are not detailed in this particular legislative instrument, under the Agricultural and Veterinary Chemicals Act 1994 and related regulations, non-compliance can lead to significant penalties. These may include fines, suspension or revocation of manufacturing licenses, and criminal charges for serious or repeated breaches. The exact penalties would depend on the nature and severity of the breach, as well as any relevant state or territory laws. The overarching aim of these penalties is to enforce adherence to the principles, thereby protecting public health and safety.