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.