Regulatory Impact Analysis Data Requirements for Registering Pesticides under the Federal Insecticide, Fungicide and Rodenticide Act

摘要

Cost and benefits were evaluated for analyses of five alternative approaches to meeting society's need for information of the health and environmental effects of pesticide chemicals. The analysis was conducted in connection with rule-making on EPA pre-market data requirements for registration of new pesticides and re-registration of existing pesticides. The approaches varied in terms of government intervention from industry to self-certification to strict comprehensive data requirements without waivers. This report was prepared to meet the requirements for analyses specified in Executive Order 12291, the Regulatory Flexibility Act and the Federal Insecticide, Fungicide and Rodenticide Act. Pesticide registration explicitly accepts a trade-off of risks and benefits. A regulatory approach of specifying types of data necessary to support registrations while allowing flexibility in designing protocols was judged to offer the greatest level of net benefits and still achieve the necessary level of protection of human health and environments.