M. Rahman - APVMA: Roles and efficacy considerations in the regulation of biopesticides in Australia

Mizanur Rahman, Senior Risk Evaluator, Risk Assessment Capability (Efficacy and Safety), Australian Pesticides and Veterinary Medicines Authority (APVMA), Australia speaks on "APVMA: Roles and efficacy considerations in the regulation of biopesticides in Australia".

The farming community has depended heavily on synthetic chemical pesticides to control agricultural pests and prevent yield losses over the past 60 years. Synthetic pesticides, when used appropriately, can give excellent control with minimal adverse effects. However, their use can be associated with some level of risk to human health, the environment, trade, and pest resistance. Consequently, the emergence of biopesticides is generating strong interest in their use in integrated pest management practices. Biopesticides typically exhibit toxicity to a narrow range of target species, are IPM friendly, and degrade to environmentally benign compounds. They are therefore valued with respect to social acceptability and environmental stewardship. However, the limitations challenging greater adoption of biopesticides include the high cost of refined commercial products and certain factors which influence efficacy. By the nature of biological processes which underpin their activity, effectiveness may be limited by the speed and persistence of pesticidal action as well as the significance of timing applications with respect to target pest life cycle and population dynamics.
In Australia, the Australian Pesticides and Veterinary Medicines Authority (APVMA) defines a biopesticide as an agricultural chemical product where the active constituent is derived from a living organism (plant, animal, micro-organism, etc.). APVMA registration and approval is required for all products prior to use. The legislation sets out requirements, prior to registering any new product, that it must be safe and effective, if used in accordance with the instructions for its use. The APVMA has specific guidelines for biopesticide assessment of efficacy and safety. The APVMA’s Efficacy and Safety team are exploring ways to improve the guidance in view of the principles of acceptable efficacy with a view to regulating the effectiveness and safety of biopesticides, commensurate with risk. Concepts under development include a tiered approach to biopesticide efficacy, a systemic perspective of biopesticide use within integrated crop protection systems, and the need for a quantitative understanding of the indirect benefits and costs associated with biopesticide use. Regulations, guidance, and policies for the efficacy of biopesticides vary from country to country although the work of certain global agencies provides for some flexibility in biopesticide regulation. The international efficacy guidance is considered in a discussion of how contemporary regulation can acknowledge the broader value of biopesticides in agricultural pest management systems. The APVMA is working towards such goals as the Australian delegate for the OECD Expert Group on Biopesticides (EGBP).