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AgVetLink Issue 64, October 2007, Special Issue on Regulatory Reform

ACVM Reform Programme

Regulatory control of activities

The ACVM Act controls the importation, manufacture, sale and use of agricultural compounds and veterinary medicines. All of these activities can introduce hazards that could cause harm in the relevant risk areas. As discussed below, the activities will be addressed in two parts.

1. Preparation and presentation of product for sale/supply

A discussion document dealing with the manufacture of agricultural compounds and veterinary medicines will be released around February 2008. It will also address issues of advertising/promotion and transferring information about such products, proposing that everyone should be held responsible for the way they present information to the public about what agricultural compounds are and how they can/should be used.

It is expected that this will lead to the making of Regulations governing:

• the manufacture of all agricultural compounds and veterinary medicines

• advertising/promotion of and information transfer about such products.

2. Use of agricultural compounds and veterinary medicines, particularly in regard to uses not provided for in the conditions of registration or exemption from registration

In the same timeframe, a separate discussion document will consider aspects about use.

The document will cover the use of generic chemicals that are not offered for sale as agricultural compounds or veterinary medicines but could be used for such purposes.

It will also cover use of authorised agricultural compounds and veterinary medicines in a manner not specifically assessed. (This is often referred to as off-label use or minor use/minor species use.)

The discussion document will not focus to any extent on uses that have been assessed and authorised in registrations or exemptions from registration because these uses will not in general be altered as a result of the reform.

It is intended that this will lead to the making of Regulations controlling use.

Regulatory control of product groups

The reform will address in detail the need for and nature of regulatory control of certain product groups. Some groups, like oral nutritional compounds (including animal feeds) and fertilisers, are already regulated under the ACVM Act and the development work will focus on reviewing present controls. Other product groups such as public health insecticides, cleaners, disinfectants and sanitisers, which may be brought under the ACVM Act, will require consideration for the first time.