A wide range of scientific data is submitted by sponsors in support of an application to approve an active constituent or register a product with the Australian Pesticides and Veterinary Medicines Authority (APVMA). On occasion, scientific information may be generated after a product has been registered or active constituent approved, which suggests previously unassessed risks may exist involving:
- human health
- animal safety
- crop safety
- the environment
- trade
- product ineffectiveness.
The APVMA can initiate a chemical reconsideration or review to assess any risks involved in the use of products or active constituents. These reconsiderations are managed by the Chemical Review program which determines what action the APVMA should take to ensure that a product or active constituent continues to meet the statutory criteria for approval or registration, if possible.
History of the chemical review program
From 1945 to 1993, each Australian state and territory had its own legislation in place to control the registration of chemicals, including agricultural and veterinary chemicals. In October 1990, a Special Premiers’ Conference identified the need to improve the registration and labelling of agricultural and veterinary chemicals, with a view to achieving a national uniformity in the registration process. The absence of a mechanism for systematically reviewing chemicals authorised for use (some of these dating back to the 1950s) under existing state and territory-based registration schemes was also identified.
In August 1991, the Australian Agricultural Council agreed to establish a single, national registration authority under Commonwealth legislation, with the Australian Agricultural and Veterinary Chemicals Council implementing the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). As a government policy initiative emanating from a 1990 Senate Select Committee inquiry into agricultural and veterinary chemicals, the NRS was to include a program to systematically review the safety of pesticides introduced prior to the advent of the modern regulatory system. This program was called the Existing Chemicals Review Program, now the Chemical Review Program.
The National Registration Authority for Agricultural and Veterinary Chemicals (NRA) was formed by the Commonwealth on 15 June 1993 as part of a microeconomic reform process to eliminate duplication and inconsistencies in specialist assessment advice provided by Commonwealth agencies in the areas of environment, human health, and occupational health and safety. Enabling legislation was passed in 1993 (establishing the NRA) and 1994, but full implementation of the NRS did not occur until 15 March 1995. The APVMA assumed responsibility for over 5,000 chemical registrations granted by Australia’s states and territories under earlier arrangements.
From an original list of over 300 chemicals that were nominated as potential candidates for review by stakeholders, a priority list of 80 agricultural and veterinary chemicals was established within the Existing Chemicals Review Program. Chemicals were ranked considering efficacy and trade, public health, environment and occupational health and safety.
The list of nominated chemicals has been reviewed and added too on a regular basis since 1995. Chemicals that have been prioritised for review are listed in the Priority candidate review list.