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Biopesticides offer attractive and environmentally-benign components in IPM strategies for organic growers, and include biochemical and microbial active ingredients, and plant-incorporated protectants. They are distinguished from conventional chemical pesticides by their natural occurrence, target pest specificity, low volume use, lack of persistence in the environment and in general, low toxicity to humans. Before a pesticide is registered in the U.S., risk assessments are conducted to ensure that there are no unacceptable risks to human health and the environment when the pesticide is used in accordance with label instructions. The U.S. Environmental Protection Agency (US EPA) uses a tiered testing paradigm for evaluating hazards and exposures of pesticide uses. Information and data necessary to assess hazards are established in data requirements designed to address the primary disciplines of product characterization and manufacturing, human health, and environmental effects. Data requirements are grouped in a tiered testing framework and potential risks are determined first from estimates of hazard and exposure under “worst-case” scenarios (Tier I). Subsequent testing (Tiers II, III and IV) may be required to assess adverse effects under more realistic use or environmental conditions, especially when lower-tiered studies suggest potentially unacceptable risks. The US EPA has over 30 years of experience in preparing risk assessments to inform its registration decisions for biopesticides. The presentation will provide an overview of microbial pesticides and the tiered risk assessment approach for biopesticide regulation.<p><p>Keywords: